MMWR - Meningococcal Vaccination: Recommendations of the Advisory Committee on Immunization Practices, United States, 2020

Recommendations and Reports / Vol. 69 / No. 9 September 25, 2020

Meningococcal Vaccination: Recommendations of

the Advisory Committee on Immunization Practices,

United States, 2020

U.S. Department of Health and Human Services

Centers for Disease Control and Prevention

Morbidity and Mortality Weekly Report

Recommendations and Reports

The MMWR series of publications is published by the Center for Surveillance, Epidemiology, and Laboratory Services, Centers for Disease Control and Prevention (CDC),

U.S. Department of Health and Human Services, Atlanta, GA 30329-4027.

Suggested citation: [Author names; first three, then et al., if more than six.] [Title]. MMWR Recomm Rep 2020;69(No. RR-#):[inclusive page numbers].

Centers for Disease Control and Prevention

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Patrick L. Remington, MD, MPH

Carlos Roig, MS, MA

William Schaffner, MD

Morgan Bobb Swanson, BS

CONTENTS

Introduction ............................................................................................................1

Methods

....................................................................................................................2

Background

.............................................................................................................3

Meningococcal Vaccines

.....................................................................................6

Evaluation of Efficacy of Meningococcal Vaccines

.................................... 7

Serogroups A, C, W, and Y Meningococcal Vaccines

.................................7

Serogroup B Meningococcal Vaccines

........................................................ 15

Vaccine Administration

.................................................................................... 20

Recommendations for Use of Meningococcal Vaccines

...................... 20

Future Directions in Meningococcal Vaccination

................................... 23

References

............................................................................................................. 24

CDC Adoption of ACIP Recommendations for

MMWR Recommendations and Reports, MMWR Policy Notes, and

Immunization Schedules (Child/Adolescent, Adult)

Recommendations for routine use of vaccines for children,

adolescents, and adults are developed by the Advisory

Committee on Immunization Practices (ACIP). ACIP is

chartered as a federal advisory committee to provide expert

external advice and guidance to the Director of CDC on

use of vaccines and related agents for the control of vaccine-

preventable diseases in the civilian population of the United

States. Recommendations for routine use of vaccines for

children and adolescents are harmonized to the greatest

extent possible with recommendations made by the American

Academy of Pediatrics (AAP), the American Academy of Family

Physicians (AAFP), the American College of Obstetricians

and Gynecologists (ACOG), and the American College of

Nurse-Midwives (ACNM). Recommendations for routine use

of vaccines for adults are harmonized with recommendations

of the American College of Physicians (ACP), AAFP, ACOG,

and ACNM. ACIP recommendations approved by the CDC

Director become agency guidelines on the date published in the

Morbidity and Mortality Weekly Report (MMWR). Additional

information is available at https://www.cdc.gov/vaccines/acip.

Recommendations and Reports

MMWR / September 25, 2020 / Vol. 69 / No. 9 1

US Department of Health and Human Services/Centers for Disease Control and Prevention

Meningococcal Vaccination: Recommendations of the Advisory

Committee on Immunization Practices, United States, 2020

Sarah A. Mbaeyi, MD

; Catherine H. Bozio, PhD

; Jonathan Duffy, MD

; Lorry G. Rubin, MD

; Susan Hariri, PhD

;

David S. Stephens, MD

; Jessica R. MacNeil, MPH

Division of Bacterial Diseases, National Center for Immunization and Respiratory Diseases, CDC;

Immunization Safety Office,

National Center for Emerging and Zoonotic Infectious Diseases, CDC;

Steven and Alexandra Cohen Children’s Medical Center of New York, New Hyde Park,

New York, and Hofstra North Shore–LIJ School of Medicine, Hempstead, New York;

Emory University School of Medicine, Atlanta, Georgia;

Office of the Director, National Center for Immunization and Respiratory Diseases, CDC

Summary

This report compiles and summarizes all recommendations from CDC’s Advisory Committee on Immunization Practices

(ACIP) for use of meningococcal vaccines in the United States. As a comprehensive summary and update of previously published

recommendations, it replaces all previously published reports and policy notes. This report also contains new recommendations

for administration of booster doses of serogroup B meningococcal (MenB) vaccine for persons at increased risk for serogroup B

meningococcal disease. These guidelines will be updated as needed on the basis of availability of new data or licensure of new

meningococcal vaccines.

ACIP recommends routine vaccination with a quadrivalent meningococcal conjugate vaccine (MenACWY) for adolescents

aged 11 or 12 years, with a booster dose at age 16 years. ACIP also recommends routine vaccination with MenACWY for

persons aged ≥2 months at increased risk for meningococcal disease caused by serogroups A, C, W, or Y, including persons who

have persistent complement component deficiencies; persons receiving a complement inhibitor (e.g., eculizumab [Soliris] or

ravulizumab [Ultomiris]); persons who have anatomic or functional asplenia; persons with human immunodeficiency virus

infection; microbiologists routinely exposed to isolates of Neisseria meningitidis; persons identified to be at increased risk because of

a meningococcal disease outbreak caused by serogroups A, C, W, or Y; persons who travel to or live in areas in which meningococcal

disease is hyperendemic or epidemic; unvaccinated or incompletely vaccinated first-year college students living in residence halls;

and military recruits. ACIP recommends MenACWY booster doses for previously vaccinated persons who become or remain at

increased risk.

In addition, ACIP recommends routine use of MenB vaccine series among persons aged ≥10 years who are at increased risk for

serogroup B meningococcal disease, including persons who have persistent complement component deficiencies; persons receiving a

complement inhibitor; persons who have anatomic or functional asplenia; microbiologists who are routinely exposed to isolates of

N. meningitidis; and persons identified to be at increased risk because of a meningococcal disease outbreak caused by serogroup B.

ACIP recommends MenB booster doses for previously vaccinated persons who become or remain at increased risk. In addition,

ACIP recommends a MenB series for adolescents and young adults aged 16–23 years on the basis of shared clinical decision-making

to provide short-term protection against disease caused by most strains of serogroup B N. meningitidis.

Introduction

Meningococcal disease is a serious bacterial infection that

primarily presents as meningitis, bacteremia, or both. Three

quadrivalent (serogroups A, C, W, and Y) meningococcal

conjugate (MenACWY) vaccines and two serogroup B

meningococcal (MenB) vaccines are licensed and available in

the United States and are recommended by CDC’s Advisory

Committee on Immunization Practices (ACIP) for the

prevention of meningococcal disease caused by these serogroups

(Table 1) (Box 1) (1–13). Details about groups recommended

to receive meningococcal vaccination, number of vaccine doses,

dosing regimens, contraindications, precautions, and special

circumstances are described elsewhere in this report.

This report compiles and summarizes all previously published

ACIP recommendations for use of meningococcal vaccines

in the United States (Box 2) (1–15). It also clarifies certain

existing recommendations and contains new recommendations

for administration of booster doses of MenB vaccine among

persons aged ≥10 years at increased risk for serogroup B

meningococcal disease. This report is intended for use by

clinicians and public health providers for guidance regarding

the use of meningococcal vaccines.

Corresponding author: Sarah A. Mbaeyi, MD, Division of Bacterial

Diseases, National Center for Immunizations and Respiratory Diseases,

CDC. Telephone: 404-639-3158; E-mail: [email protected].

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Methods

ACIP provides recommendations for the prevention and

control of meningococcal disease in the United States. The ACIP

Meningococcal Vaccines Work Group met by teleconference

once per month during 2005–2020, except during brief periods

of hiatus. Work group membership included voting members

of ACIP, representatives of ACIP ex-officio and liaison

organizations, and scientific consultants with expertise in

public health, vaccinology, medical specialties, vaccine research,

and assessments of vaccine efficacy and safety. Work group

discussions included topics such as meningococcal disease

surveillance and epidemiology and meningococcal vaccine

safety, immunogenicity, effectiveness, coverage, program

feasibility, and cost-effectiveness. Presentations were requested

from invited experts, and published and unpublished data were

discussed. These data were summarized by the work group and

presented to ACIP to help establish recommendations. When

evidence was lacking, the recommendations incorporated

expert opinion from ACIP. Meeting minutes and information

on ACIP membership and conflicts of interest are available

on the ACIP website (https://www.cdc.gov/vaccines/acip).

This report updates and replaces previously published ACIP

recommendations for meningococcal vaccines (9–13,16).

Grading of Recommendations, Assessment, Development

and Evaluation (GRADE) was adopted by ACIP in 2010

(17). Recommendations using the GRADE approach include

the use of MenACWY oligosaccharide diphtheria CRM

197

conjugate vaccine (MenACWY-CRM) among children aged

2–23 months at increased risk for meningococcal disease,

use of a MenACWY vaccine among persons infected with

human immunodeficiency virus (HIV), all MenB vaccine

recommendations, and use of a MenACWY tetanus toxoid

vaccine (MenACWY-TT) among persons aged ≥2 years

(9–11,13). GRADE evidence tables for these recommendations

are available (https://www.cdc.gov/vaccines/acip/recs/grade/

table-refs.html). In 2018, ACIP adopted the Evidence to

Recommendations (EtR) framework to facilitate the assessment

and ensure transparency of additional factors considered

in developing vaccine recommendations, including target

population values, stakeholder acceptability, and feasibility

of implementation (18). Recommendations for MenB

booster doses among persons aged ≥10 years at increased

risk for meningococcal disease and use of MenACWY-TT

among persons aged ≥2 years were further evaluated using

the EtR framework (19). The EtR frameworks for these

recommendations are available (https://www.cdc.gov/vaccines/

acip/recs/grade/etr.html). ACIP did not use GRADE or EtR for

updates of evidence related to recommendations made before

implementation of these approaches.

ACIP votes were held when a new routine or risk-based

recommendation was under consideration, with new age

indications or dosing regimens for a vaccine, or when additional

groups were identified as being at risk for meningococcal

disease. An ACIP vote was not required for use of newly

licensed products (e.g., MenACWY-TT in persons aged

≥2 years) when no changes in recommendations for vaccine

use in terms of dosing and schedules were made.

For this report, a systematic literature search was completed

to review all available evidence on the immunogenicity,

effectiveness, and safety of U.S.-licensed MenACWY and

MenB vaccines among age groups for which the vaccines

were approved, including separate reviews to assess evidence

related to MenB booster doses and MenACWY-TT.

PubMed, Medline, Embase, CINAHL, Scopus, Cochrane

Library, and ClinicalTrials.gov were searched for clinical

trials or observational studies published during 2000–2018

without language or geographic restrictions. The following

search terms were used: “(quadrivalent meningococcal

conjugate or tetravalent meningococcal conjugate or

meningococcal ACWY or MCV4 or MCV-4 or MenACWY

or MenACWY-D or MenACWY-CRM or Menactra or

Menveo or serogroup B meningococcal or meningococcal

serogroup B or meningococcal B or meningococcal group B

or group B meningococcal or MenB or Bexsero or MenB-4C

or rMenB+OMV NZ or 4CMenB or Trumenba or rLP2086

or MenB-FHbp or FHbp or Factor H binding protein)” and

“vaccin*” and “(immunogenicity or efficacy or effectiveness

or impact or safety or adverse event*).” For the review specific

to MenB booster vaccination, the same MenB vaccine

search terms plus the term “booster” were used to capture all

studies related to booster doses. To identify evidence related

to MenACWY-TT, licensed after the original systematic

literature search was conducted, as well as newly available

evidence related to other meningococcal vaccines, search

results were supplemented by data (using updated search

terms to include “MenACWY-TT,” “MenACYW-TT,” and

“MenQuadfi”) published in 2019–2020 or identified by work

group subject matter experts, or unpublished data provided by

the vaccine manufacturers.

To further assess vaccine safety, data were evaluated from the

Vaccine Adverse Event Reporting System (VAERS) and the

Vaccine Safety Datalink (VSD), two postlicensure surveillance

systems for adverse events. VAERS is a national passive public

health surveillance system operated by CDC and the Food and

Drug Administration (FDA) and accepts reports from anyone,

including health care professionals, vaccine manufacturers,

patients, and caregivers (20). Health care providers and patients

are encouraged to report clinically important or unexpected

adverse events, even if unsure whether the event is vaccine

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US Department of Health and Human Services/Centers for Disease Control and Prevention

BOX 1. Meningococcal vaccination recommendations — Advisory Committee on Immunization Practices, United States, 2020

ACIP recommends MenACWY vaccination for the following groups:

• Routine vaccination for adolescents aged 11 or 12 years, with a booster dose at age 16 years.

• Routine vaccination of persons aged ≥2 months at increased risk for meningococcal disease (dosing schedule varies by age and

indication, and interval for booster dose varies by age at time of previous vaccination):

Persons with certain medical conditions including anatomic or functional asplenia, complement component

deficiencies (e.g., C3, C5-C9, properdin, factor H, or factor D), complement inhibitor (e.g., eculizumab [Soliris] or

ravulizumab [Ultomiris]) use, or human immunodeficiency virus infection.

Microbiologists with routine exposure to Neisseria meningitidis isolates.

Persons at increased risk during an outbreak (e.g., in community or organizational settings, and among men who have

sex with men [MSM]).

Persons who travel to or live in countries in which meningococcal disease is hyperendemic or epidemic.

Unvaccinated or undervaccinated first-year college students living in residence halls.

Military recruits.

• Booster doses for previously vaccinated persons who become or remain at increased risk.

ACIP recommends MenB vaccination for the following groups:

• Routine vaccination of persons aged ≥10 years at increased risk for meningococcal disease (dosing schedule varies by

vaccine brand; boosters should be administered at 1 year after primary series completion, then every 2–3 years

thereafter):

Persons with certain medical conditions, such as anatomic or functional asplenia, complement component deficiencies, or

complement inhibitor use.

Microbiologists with routine exposure to N. meningitidis isolates.

Persons at increased risk during an outbreak (e.g., in community or organizational settings, and among MSM).

• Vaccination of adolescents and young adults aged 16–23 years with a 2-dose MenB series on the basis of shared clinical

decision-making. The preferred age for MenB vaccination is 16–18 years. Booster doses are not recommended unless the

person becomes at increased risk for meningococcal disease.

• Booster doses for previously vaccinated persons who become or remain at increased risk.

Abbreviations: ACIP=Advisory Committee on Immunization Practices; MenACWY=quadrivalent (serogroups A, C, W, Y) meningococcal conjugate vaccine;

MenB=serogroup B meningococcal vaccine.

related, and to provide medical documentation for reports

of serious adverse events (e.g., death, life-threatening health

event, hospitalization, or lasting disability after vaccination)

(20). VAERS can identify rare adverse events and detect

possible safety problems quickly, generating vaccine safety

hypotheses to be evaluated by other sources; however, VAERS

data cannot be used to determine whether a vaccine caused

an adverse event. VSD is a collaboration between CDC and

eight health care organizations that conducts active public

health surveillance and epidemiologic research about vaccine

safety. VSD collects individual-level data, including medical

and vaccine records, on approximately 10 million persons

annually (approximately 3% of the U.S. population) (21).

This allows for population-based observational studies with

longitudinal follow-up that can be used to calculate rates and

relative risks of vaccine adverse events. Therefore, VSD data

can be used for surveillance to identify vaccine safety signals

or for hypothesis testing to evaluate signals originating from

other sources such as VAERS.

Background

Meningococcal disease includes the spectrum of invasive

infections caused by Neisseria meningitidis, a gram-negative

diplococcus. Meningococcal disease usually presents clinically

as meningitis, bacteremia, or both (22). Meningococcal disease

also can present as other invasive syndromes such as bacteremic

pneumonia, arthritis, and pericarditis. Noninvasive infections

such as pneumonia without bacteremia, conjunctivitis, or

urethritis also might occur. Meningococcal disease develops

rapidly, often among previously healthy persons, and results

in high morbidity and mortality. Even with appropriate

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US Department of Health and Human Services/Centers for Disease Control and Prevention

BOX 2. Timeline of meningococcal vaccine licensure and recommendations, United States, 2005—2020

2005 FDA licensed MenACWY-D for persons aged 11–55 years. ACIP recommended routine vaccination of

adolescents with a single MenACWY-D dose at age 11–12 years and persons aged 11–55 years at increased risk for

meningococcal disease.

2006 Because of limited vaccine supply, MenACWY-D vaccination was limited to cohorts of adolescents entering high

school and college and persons aged 11–55 years at increased risk for meningococcal disease.

2007 After vaccine supply became sucient, ACIP recommended vaccination for all adolescents aged 11–18 years. FDA

expanded licensure of MenACWY-D to children aged 2–10 years, and ACIP recommended routine vaccination of

children in this age group at increased risk for meningococcal disease.

2010 FDA licensed a second vaccine, MenACWY-CRM, for persons aged 11–55 years. ACIP added a MenACWY

booster dose at age 16 years and recommended a 2-dose primary series be used for certain persons aged 11–55 years

at increased risk for meningococcal disease because of asplenia, persistent complement component deciency, or

human immunodeciency virus (HIV) infection (with another indication for vaccination).

2011 FDA extended licensure of MenACWY-CRM to children aged 2–10 years and of MenACWY-D to those aged

9–23 months. ACIP recommended a 2-dose primary series of MenACWY-D for children aged 9–23 months at

increased risk for meningococcal disease.

2012 FDA licensed Hib-MenCY-TT and ACIP recommended a 4-dose primary series for children aged 2–8 months at

increased risk for meningococcal disease.

2013 FDA extended licensure of MenACWY-CRM to children aged 2–23 months and ACIP recommended a 4-dose

primary series for children in this age group at increased risk for meningococcal disease.

2014 FDA licensed MenB-FHbp as a 3-dose series for persons aged 10–25 years.

2015 FDA licensed MenB-4C as a 2-dose series for persons aged 10–25 years. ACIP recommended persons at increased

risk for serogroup B meningococcal disease receive a MenB series, and persons aged 16–23 years were recommended

to be vaccinated with a MenB series on the basis of shared clinical decision-making.

2016 FDA licensed MenB-FHbp as a 2-dose series for persons aged 10–25 years.

2016 ACIP recommended persons with HIV infection be routinely vaccinated with a 2-dose MenACWY primary series.

2017 ACIP updated its recommendations for use of MenB-FHbp following a change in licensure that allowed both a

2- and 3-dose series. Distribution of MPSV4 and Hib-MenCY-TT was discontinued in the United States.

2019 ACIP recommended that persons with certain medical conditions and microbiologists routinely exposed to Neisseria

meningitidis isolates receive a MenB booster dose 1 year after primary series completion, then every 2–3 years there-

after. During an outbreak, a single MenB booster dose was recommended if it had been ≥1 year since primary series

completion (interval of ≥6 months may be considered if recommended by public health ocials).

2020 FDA licensed MenACWY-TT for persons aged ≥2 years.

Abbreviations: ACIP=Advisory Committee on Immunization Practices; FDA=Food and Drug Administration; Hib-MenCY-TT=meningococcal groups C

and Y and Haemophilus influenzae type b tetanus toxoid vaccine (MenHibrix); MenACWY-CRM=meningococcal groups A, C, W, and Y oligosaccharide

diphtheria CRM

197

conjugate vaccine (Menveo); MenACWY-D=meningococcal groups A, C, W, and Y polysaccharide diphtheria toxoid conjugate vaccine

(Menactra); MenACWY-TT=meningococcal groups A, C, W, and Y polysaccharide tetanus toxoid conjugate vaccine (MenQuadfi); MenB=serogroup B

meningococcal vaccine; MenB-4C=meningococcal group B vaccine (Bexsero); MenB-FHbp=meningococcal group B vaccine (Trumenba); MPSV4=meningococcal

polysaccharide vaccine, groups A, C, Y, and W combined (Menomune – A/C/Y/W-135).

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antimicrobial therapy, the overall case-fatality ratio in the

United States is 15%, and 10%–20% of survivors have long-

term sequelae such as neurologic disability, limb or digit loss,

or hearing loss (22,23).

N. meningitidis is classified into 12 serogroups according

to the composition of its polysaccharide capsule; serogroups

A, B, C, W, X, and Y cause most of the disease globally (24).

N. meningitidis colonizes mucosal surfaces of the nasopharynx

and is transmitted through direct contact with large-droplet

respiratory tract secretions from patients or asymptomatic

carriers. Nasopharyngeal carriage rates are highest in

adolescents and young adults, who serve as reservoirs for

transmission of N. meningitidis (25). Invasive disease is an

infrequent consequence of nasopharyngeal colonization.

Epidemiology of Meningococcal Disease

in the United States

Since the late 1990s, the incidence of meningococcal

disease has steadily decreased in the United States, from

1.2 cases per 100,000 population in 1996 to an historic

low of 0.1 cases per 100,000 population in 2018. During

2015–2018, approximately 360 cases occurred annually in

the United States, representing an average annual incidence of

0.11 cases per 100,000 population (26). Incidence is highest

among infants aged <1 year, followed by children aged 1 year

and adolescents and young adults aged 16–20 years (23).

During 2015–2018, the primary serogroups that caused

disease were B and C, causing 42% and 26% of cases in

which serogroup was known, respectively; serogroups W

and Y and nongroupable strains each caused 9%–14% of

cases (26). Decreases in meningococcal disease incidence

began before the introduction of MenACWY and MenB

vaccines and have been observed across all age groups and

for the predominant disease-causing serogroups in the

United States (23). Outbreaks account for approximately

5% of meningococcal disease cases across age groups in

the United States (27). In recent years, several outbreaks of

serogroup B meningococcal disease among university students

and serogroup C meningococcal disease among men who have

sex with men (MSM) have been reported (28,29).

Groups at Increased Risk for

Meningococcal Disease

Risk factors for meningococcal disease include antecedent

viral infection, household crowding, and smoking (30–34). In

addition, certain groups are at increased risk for meningococcal

disease, including the following:

• Persons with persistent complement component

deficiencies: Persons who have persistent (e.g., genetic)

deficiencies in the complement pathway (e.g., C3, C5–C9,

properdin, factor D, or factor H) have up to a 10,000-fold

increased risk for meningococcal disease (35). Persons with

complement deficiencies might experience recurrent

disease and inherited disorders might affect additional

family members; therefore, testing for complement

deficiency should be considered for patients with

meningococcal disease (36–38).

• Persons who use complement inhibitors: Use of

complement inhibitors (e.g., the currently licensed

eculizumab [Soliris] and its long-acting derivative

ravulizumab [Ultomiris] monoclonal antibody therapies

that block C5) is associated with a substantially increased

risk for meningococcal disease (39,40). Eculizumab use is

associated with an approximately 2,000-fold increased

incidence of meningococcal disease (41). Complement

inhibitor recipients remain at risk for meningococcal

disease even after meningococcal vaccination; therefore,

CDC guidance indicates that providers could consider

treating patients with antimicrobial prophylaxis for the

duration of complement inhibitor treatment (42).

• Persons with anatomic or functional asplenia: Persons

with anatomic or functional asplenia (including sickle cell

disease) appear to be at increased risk for meningococcal

disease and, compared with healthy persons, have a higher

mortality rate (40%–70%) from the disease (43–45).

• Persons living with HIV infection: In studies from the

United States, United Kingdom, and South Africa, persons

living with HIV infection or acquired immunodeficiency

syndrome have an elevenfold to twenty-four-fold increased

risk for meningococcal disease (46–50). Among persons

living with HIV infection, low CD4 count or high viral

load are associated with greater risk (48). Most

meningococcal cases reported among persons living with

HIV infection in the United States are caused by

serogroups C, W, or Y (47).

• Microbiologists routinely exposed to N. meningitidis

isolates: The annual attack rate of laboratory-acquired

meningococcal infection among microbiologists who

routinely work with N. meningitidis isolates has historically

been estimated to be 13 per 100,000 persons, which is

manyfold higher than the rate for adults among the general

population (51). This increased risk is likely related to

mechanical manipulation of isolates that generates droplets

or aerosols; increased risk was not observed among

laboratory workers who handle clinical specimens but not

isolates (51).

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• Persons at increased risk during an outbreak of

meningococcal disease: Approximately 5% of U.S. cases

are outbreak related (27). Outbreaks can occur in

community or organizational settings (52). During

outbreaks, the median attack rate is up to 1,400-fold

higher than in the nonoutbreak setting (27).

• Travelers to countries where meningococcal disease is

hyperendemic or epidemic: Travelers to countries where

meningococcal disease is hyperendemic or epidemic, such

as the meningitis belt of sub-Saharan Africa, are at

increased risk for exposure, and thus, disease. Historically,

serogroup A was the predominant meningococcal

pathogen in the meningitis belt. However, after the

implementation of a meningococcal serogroup A conjugate

vaccine (MenAfriVac), serogroup A disease has been nearly

eliminated in the meningitis belt (53). Endemic

meningococcal disease and outbreaks are now most

commonly caused by serogroups C, W, and X (54).

• College students: Historically, college freshman living in

residence halls were identified as being at increased risk

for meningococcal disease (55). With improved control

of serogroups C, W, and Y disease after widespread use of

MenACWY vaccine among adolescents, the risk for

meningococcal disease among college students is greatest

for serogroup B, with a relative risk of 3.5 compared with

persons not attending college, although serogroup B

disease incidence among this population is low (0.17 cases

per 100,000 population) (56). Risk factors for serogroup B

meningococcal disease among undergraduate college

students include age 18–20 years, attendance at a 4-year

college, freshman class year, and on-campus residence

(56,57). Although not assessed outside of outbreak

settings, participation in a fraternity or sorority is an

additional risk factor during serogroup B meningococcal

disease outbreaks (57).

• Military recruits: Historically, new military recruits were

identified as being at increased risk for meningococcal

disease and outbreaks, most likely related to the crowded

living conditions among persons originating from

different geographic areas carrying diverse N. meningitidis

strains (58,59).

• Men who have sex with men: Several outbreaks of

serogroup C meningococcal disease have been reported

among MSM in the United States (28). MSM have also

been shown to be at increased risk for meningococcal

disease outside of outbreaks, although the incidence of

disease remains low. HIV infection might be an important

factor for this increased risk in the United States,

particularly in nonoutbreak settings (60).

Clinical and Public Health Management of

Meningococcal Disease

Early recognition of meningococcal disease is important

for prompt diagnosis and initiation of antimicrobial therapy.

Symptoms of meningitis include sudden onset of high fever,

headache, nuchal rigidity, altered mental status, photophobia,

nausea, and vomiting. Meningococcemia might present as fever;

malaise; cold hands and feet; leg or other body pain; vomiting;

diarrhea; and maculopapular, petechial, or purpuric rash (61).

The diagnosis of confirmed meningococcal disease is made

either through isolation of N. meningitidis or detection of N.

meningitidis–specific nucleic acid in a specimen obtained from

a normally sterile body site (e.g., blood or cerebrospinal fluid)

(62). Culture is the preferred confirmatory test because it allows

for further characterization of the strain; however, serogroup-

specific polymerase chain reaction testing using a validated assay

is a sensitive method for identifying N. meningitidis, particularly

in situations in which antimicrobial therapy was initiated before

specimen collection (63). Because N. meningitidis infections

typically are severe, antibiotics should be started immediately

for a patient with suspected meningococcal disease without

waiting for laboratory confirmation. Several antibiotics are

available for the treatment of meningococcal disease, including

ceftriaxone, cefotaxime, and, when the diagnosis is confirmed,

penicillin (64).

Antimicrobial chemoprophylaxis of close contacts of a

patient with meningococcal disease is important to prevent

secondary cases. Several antibiotics are recommended for

chemoprophylaxis, including ciprofloxacin, rifampin, and

ceftriaxone; azithromycin can be used in areas with sustained

ciprofloxacin resistance (currently rare in the United States).

Additional information on identification of close contacts and

administration of chemoprophylaxis is available in CDC’s

Manual for the Surveillance of Vaccine-Preventable Diseases (65).

The investigation of and response to meningococcal disease

outbreaks rely on comprehensive epidemiologic and laboratory

investigation of cases, identification of persons at increased risk

for meningococcal disease as a result of the outbreak and, in

certain situations, implementation of vaccination campaigns

and use of expanded antimicrobial chemoprophylaxis.

Additional information is available in CDC’s Guidance for

the Evaluation and Public Health Management of Suspected

Outbreaks of Meningococcal Disease (52).

Meningococcal Vaccines

Three quadrivalent meningococcal conjugate (MenACWY)

vaccines are currently licensed and available in the United

States: 1) meningococcal groups A, C, W, and Y polysaccharide

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diphtheria toxoid conjugate vaccine (MenACWY-D)

(Menactra); 2) meningococcal groups A, C, W, and Y

oligosaccharide diphtheria CRM

197

conjugate vaccine

(MenACWY-CRM) (Menveo); and 3) meningococcal groups

A, C, W, and Y polysaccharide tetanus toxoid conjugate

vaccine (MenACWY-TT) (MenQuadfi) (Table 1). Additional

information is available in the package inserts (66–68).

In addition, two serogroup B meningococcal (MenB)

vaccines are licensed and available in the United States:

1) MenB-FHbp (Trumenba) and 2) MenB-4C (Bexsero)

(Table 1). MenB-FHbp consists of two purified recombinant

lipidated FHbp antigens, one from each FHbp subfamily

(A and B). MenB-4C consists of three recombinant proteins

(neisserial adhesin A [NadA], factor H binding protein [FHbp]

fusion protein from subfamily B, and neisserial heparin binding

antigen [NhbA] fusion protein) and outer membrane vesicles

(OMVs) containing outer membrane protein porin A (PorA)

serosubtype P1.4. Additional information on MenB vaccines

is available in the package inserts (69,70).

Two additional licensed meningococcal vaccines are no

longer available in the United States: 1) a quadrivalent

(serogroups A, C, W, and Y) meningococcal polysaccharide

vaccine (MPSV4) (Menomune – A/C/Y/W-135) and 2) a

combined Haemophilus influenzae type b and meningococcal

serogroups C and Y conjugate vaccine (Hib-MenCY-TT)

(MenHibrix) (71,72).

Evaluation of Efficacy of

Meningococcal Vaccines

Because of the low incidence of meningococcal disease in

the United States, vaccine efficacy estimates supporting U.S.

licensure of the current meningococcal vaccines are based on

demonstration of specific immune responses (e.g., immune

correlate of protection through serum bactericidal activity

[SBA]) and not direct evidence of clinical effectiveness).

Protection against invasive meningococcal disease is mediated

by bactericidal antibodies to meningococcal capsular

polysaccharides or protein antigens in the presence of

complement. This complement-dependent bactericidal activity

is measured by use of an SBA assay with a human (hSBA) or

baby rabbit (rSBA) complement source (73). SBA activity

has been demonstrated to correlate with immunity against

meningococcal disease and thus is accepted as the correlate

of protection (74). Because meningococci have greater

susceptibility to lysis by rabbit complement, antibody titers

measured by an rSBA assay are elevated compared with those

from an hSBA assay; thus, antibody titers measured by these

two assays are not directly comparable (74). An hSBA titer ≥1:4

(although a threshold of ≥1:8 also has been used to account for

assay variability) or an rSBA titer ≥1:8 and/or a fourfold rise in

rSBA or hSBA titers have been used to infer vaccine-mediated

immunologic protection against meningococcal disease (73).

For the purposes of U.S. licensure, immunogenicity was

assessed as the proportion of persons who achieved an SBA titer

above a predefined threshold or fourfold rise in SBA titers for

serogroups A, C, W, and Y and serogroup B strains tested. For

MenACWY vaccines, efficacy was inferred using either rSBA or

hSBA. For MenB vaccines, efficacy was inferred using hSBA.

MenB vaccines are not expected to protect against all strains of

serogroup B N. meningitidis because their mechanism of action

is against subcapsular proteins and not the polysaccharide

capsule (75,76). Because laboratory evaluation of vaccine

efficacy against all serogroup B meningococcal strains would

be impossible because of their antigenic and genetic diversity,

efficacy of MenB vaccines was inferred using hSBA titers

against selected strains (77).

Because MenB vaccines do not protect against all strains of

serogroup B N. meningitidis, assays have been developed to

provide additional insight into breadth of strain coverage. For

MenB-FHbp, a flow cytometric meningococcal antigen surface

expression (MEASURE) assay was developed to quantify the

level of FHbp expressed in serogroup B strains through mean

fluorescence intensity. On the basis of this assay, 91% of U.S.

and European serogroup B strains expressed sufficient FHbp

to be susceptible to MenB-FHbp–mediated bactericidal killing

(75). The meningococcal antigen typing system (MATS) was

developed to predict MenB-4C strain coverage using genotyping

for PorA and enzyme-linked immunosorbent assays for FHbp,

NhbA, and NadA. Using MATS, 91% of U.S. serogroup B

meningococcal disease strains are predicted to be covered by

MenB-4C, with FHbp and NhbA the greatest contributors

to U.S. strain coverage (76). A complementary strain coverage

prediction method using genotyping (gMATS) also has been

developed (78), as has the Bexsero antigen sequence type (BAST)

scheme to facilitate genomic surveillance of MenB-4C antigen

variants in invasive meningococcal disease isolates (79).

Serogroups A, C, W, and Y

Meningococcal Vaccines

MenACWY-D (Menactra)

MenACWY-D was first licensed in the United States in

2005. Clinical trials have demonstrated immunogenicity

of MenACWY-D among persons aged 9 months–55 years,

although antibody waning is observed during the 3–5 years

after primary vaccination (67,80–104). Booster vaccination

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elicits a robust immune response, and data in adolescents

demonstrate persistence for at least 4 years after a booster dose

(105,106). Clinical trials have demonstrated an acceptable

safety profile, with injection site pain and erythema as the

most common local reactions; irritability and drowsiness are

the most common systemic adverse events among infants and

children, and myalgia, headache, and fatigue are the most

common systemic adverse events among adolescents and adults

(67,80,81,85,87–90,92–96,98–103). Most adverse events are

mild to moderate and resolve within 3 days. Early postlicensure

surveillance raised the concern of a potential risk for Guillain-

Barré syndrome (GBS), but subsequent evaluations have not

identified an increased risk for GBS after MenACWY-D

vaccination (107–110). No other vaccine safety concerns have

been identified in postlicensure surveillance (111–114).

MenACWY-D Immunogenicity

Infants and Children

In clinical trials among infants who received MenACWY-D

as a 2-dose series at ages 9 and 12 months, 89%–96% achieved

an hSBA titer ≥1:8 against serogroup A, ≥98% against

serogroup C, 81%–92% against serogroup W, and 95%–97%

against serogroup Y 1 month after completion of the series

(80,98). Administration of MenACWY-D simultaneously with

routine vaccines did not result in reduced immune responses to

meningococcal serogroups A, C, W, or Y or measles, mumps,

rubella, or varicella antigens; however, when MenACWY-D was

administered simultaneously with seven-valent pneumococcal

conjugate vaccine (PCV7) (Prevnar), noninferiority criteria

were not met for three of seven pneumococcal serotypes

(98). By 3 years after primary series completion, substantial

MenACWY-D waning occurred, with 13%–46% of recipients

having an hSBA titer ≥1:8 across serogroups, although this

proportion increased to ≥98% 1 month after a single booster

dose (80).

Among toddlers receiving a 2-dose primary series at ages

12 and 15 months, 85% achieved an hSBA titer ≥1:8 against

serogroup A and ≥96% against serogroups C, W, and Y at

1 month after the primary series (80). In another study in which

MenACWY-D was administered at ages 12 and 18 months,

≥96% achieved rSBA titers ≥1:8 for all serogroups (95). In this

study, administration of MenACWY-D simultaneously with

routine vaccines did not result in reduced immune responses to

meningococcal serogroups A, C, W, or Y or tetanus, diphtheria,

pertussis, poliovirus, or H. influenzae type b antigens.

Among children aged 2–10 years, the rate of seroresponse

(defined as a greater than fourfold rise in hSBA or a titer ≥1:8

among persons with baseline titers <4) was highest for

serogroup A (80%) and lower for serogroups C, W, and Y

(42%–57%) at 1 month after a single dose (88). Studies

using rSBA demonstrated a higher proportion of seroresponse

across serogroups (≥86%) using different thresholds (either

a greater than fourfold rise in titers among persons with

baseline titers <1:8 or a titer ≥1:8) (91,93,96,104). Among

children aged 4–6 years, administration of MenACWY-D

simultaneously with routine vaccines did not result in reduced

immune response to meningococcal serogroups A, C, or W

or diphtheria, tetanus, or poliovirus antigens; however, the

noninferiority criteria were not met for serogroup Y and one

pertussis antigen (anti-fimbriae) (67). Because no clinical

correlates of protection are available for pertussis antigens,

the clinical significance of this finding is unknown. When

MenACWY-D was administered 30 days after diphtheria

and tetanus toxoids and acellular pertussis (DTaP) vaccine

(DAPTACEL), significantly lower geometric mean titers

(GMTs) were observed for all meningococcal serogroups (67).

Among children aged 4–6 years vaccinated previously at age

2–3 years, the proportions maintaining an rSBA titer ≥1:128

were 75%, 52%, 61%, and 90% for serogroups A, C, W, and Y,

respectively (97).

Adolescents and Adults

Among adolescents and adults aged 10–55 years, 64%–71%

achieved an hSBA titer ≥1:8 against serogroup A, 72%–99%

against serogroup C, 64%–90% against serogroup W, and

39%–82% against serogroup Y at 1 month after vaccination

with a single dose (81,87,89,99). In studies assessing

immunogenicity using rSBA, ≥80% and ≥88% achieved

seroprotection across serogroups when the thresholds of

≥1:128 and ≥1:8 were used, respectively (85,90,92,102,104).

Administration of MenACWY-D simultaneously with routine

vaccines did not result in reduced immune responses to

meningococcal serogroups A, C, W, or Y or tetanus, diphtheria,

pertussis, human papillomavirus (HPV), MenB-FHbp, or

typhoid antigens (67,94,100–103).

Persistence studies conducted among adolescents and adults

demonstrated antibody waning after primary vaccination;

however, serogroup-specific degree of waning varied between

the studies. In one study, antibody waning was observed

for all serogroups, particularly serogroup A, by 22 months

postvaccination and titers remained stable thereafter at 3 and

5 years postvaccination; 21%–34% of recipients achieved an

hSBA titer ≥1:8 for serogroup A, 58%–62% for serogroup C,

71%–74% for serogroup W, and 53%–54% for serogroup Y

between 22 months and 5 years postvaccination (83,84,86).

In another study, antibody waning was observed by 4–6 years

postvaccination but was more marked for serogroups C and Y

(44% and 39% achieved an hSBA titer ≥1:8, respectively)

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compared with serogroups A and W (65% and 69%,

respectively) (105). In a separate study, serogroup A waning

was most pronounced, although for the other serogroups the

proportion of recipients with hSBA titers ≥1:8 was higher

than that observed in previously mentioned studies and was

stable at 1, 3, and 5 years postvaccination with 32%–44%

seroprotected against serogroup A, 73%–81% against

serogroup C, 76%–85% against serogroup W, and 87%–91%

against serogroup Y (82). Thus, although antibody waning after

primary vaccination of adolescents and adults was observed

across studies, time points assessed and patterns of waning by

serogroup were not consistent. In a study of adolescents who

received a booster dose of MenACWY-D, ≥99% achieved hSBA

titers ≥1:8 against all serogroups at 1 month postvaccination;

this proportion remained ≥90% 4 years later (105,106).

MenACWY-D Safety

Clinical Trials

Among infants vaccinated at ages 9 and 12 months and

toddlers vaccinated at ages 12 months and 15 or 18 months,

the most commonly reported local reactions after either of the

doses were injection site pain (35%–59%) and erythema (23%–

43%) (80,95,98). The most commonly reported systemic

adverse events were irritability (49%–72%) and drowsiness

(27%–44%); fever was reported in 11%–50% of recipients.

Adverse events among infants were similar when MenACWY-D

was administered alone or simultaneously with other vaccines

(98). After receipt of a booster dose 3 years after vaccination

as an infant, rates of local and systemic adverse events were

similar to those observed for the primary series (115). Similar

adverse events were observed among children aged 2–10 years

after a single dose, although typically at a slightly lower rate;

injection site pain (32%–48%), induration (11%–22%), and

erythema (10%–30%) were the most commonly reported local

reactions, and drowsiness (9%–26%), irritability (7%–35%),

and fever (2%–11%) were the most common systemic adverse

events (67,88,93,96).

Among adolescents and adults aged 11–55 years who

received a single dose, injection site pain (31%–69%) was

the most common local reaction, followed by induration

(9%–20%), erythema (3%–20%), and swelling (1%–14%)

(81,85,87,89,90,92,99,102). Myalgia (15%–26%), headache

(11%–45%), fatigue or malaise (10%–28%), and diarrhea

or other gastrointestinal symptoms (11%–17%) were the

most commonly reported systemic adverse events; fever was

observed in <8%. Similar types and rates of adverse events

were observed after a booster dose administered 4 years later

(105). In general, MenACWY-D administered simultaneously

with HPV vaccine, tetanus and reduced diphtheria toxoids

and acellular pertussis vaccine (Tdap), MenB-FHbp, or

typhoid vaccines was well tolerated, although rates of some

adverse events (e.g., headache and fatigue) were slightly

higher with simultaneous administration compared with

MenACWY-D administered alone (67,94,100–103). Across

age groups, whether MenACWY-D was administered alone or

simultaneously with other vaccines, adverse events were mild

to moderate and typically resolved within 3 days.

Postlicensure Safety Monitoring

After licensure of the vaccine in 2005, several cases of GBS

after MenACWY-D vaccination were reported to VAERS

(116). ACIP reviewed the available data and determined

that the benefits of meningococcal vaccination outweighed

the small potential increased risk for GBS (107). By 2010,

two retrospective evaluations had been conducted in which

no GBS cases were observed in the 6 weeks after 2.3 million

doses of MenACWY-D were administered (108,110). The

excess risk for GBS after vaccination, if it exists, is estimated to

be <0.66 cases per 1 million adolescents vaccinated (110). In

2010, ACIP voted to remove the precaution for persons with

a history of GBS from the ACIP recommendations, although

it continues to be listed as a precaution in the package insert

(16

,67). Evaluations of VSD data through 2014 and VAERS

data through 2016 have since been conducted, identifying no

new GBS-related concerns (CDC, unpublished data, 2020).

In addition to assessing risk for GBS, data from VAERS

and VSD have been evaluated to assess for other potential

postvaccination adverse events. In a comprehensive review of

VAERS reports received from 2005 through June 2016, during

which approximately 70 million MenACWY-D doses were

distributed, no new safety concerns were identified (CDC,

unpublished data, 2020). A total of 13,075 adverse events

related to MenACWY-D were reported, of which 846 (6.5%)

were serious. Reports predominantly related to adolescents aged

11–18 years simultaneously vaccinated with MenACWY-D

and other vaccines. The most commonly reported events were

injection site erythema, fever, and headache, consistent with

findings from clinical trials.

An analysis of VSD during 2005–2014, when 1.4 million

doses, including 245,000 booster doses, were administered,

was conducted to evaluate prespecified outcomes (CDC,

unpublished data, 2020). Although rates of syncope and

medically attended fever increased after MenACWY-D

vaccination, no new safety concerns were identified.

Furthermore, tree-temporal scan data mining through VSD

of primary doses administered to 1.2 million adolescents aged

11–18 years during the same period identified no new or

unexpected adverse events within 42 days after MenACWY-D

administration (114). Several smaller studies, including

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VSD- and manufacturer-sponsored studies conducted

during 2005–2014, similarly did not identify any additional

safety concerns for MenACWY-D among infants, children,

adolescents, or adults (111–113).

MenACWY-CRM (Menveo)

MenACWY-CRM was first licensed in the United States

in 2010. MenACWY-CRM has been demonstrated to be

immunogenic among persons aged 2 months–55 years

(88,89,99,117–130). Antibody waning occurs by 3–5 years after

primary vaccination, and booster vaccination elicits a robust

immune response (83,84,131–133). No consistent or clinically

relevant concerns about MenACWY-CRM administered

simultaneously with other vaccines have been identified

(134–136). Clinical trials have demonstrated an acceptable

safety profile, with injection site pain and erythema as the

most common local reactions (88,118–124,126,127,129,137).

Irritability and sleepiness were the most commonly reported

systemic adverse events among infants and toddlers. Among

children, irritability, myalgia, headache, and sleepiness were

the most commonly reported systemic adverse events, whereas

myalgia, headache, and fatigue were the most commonly

reported systemic adverse events among adolescents and

adults. Most adverse events were mild to moderate and

resolved within 3 days. One study observed an increased risk

for Bell’s palsy among adolescents after MenACWY-CRM

vaccination, although this was based on a small number of

cases and the importance of this finding is uncertain (138). No

additional safety concerns have been identified in postlicensure

surveillance, although administration errors appear more

common than with other vaccines, predominantly because

of the need to reconstitute the vaccine using lyophilized and

liquid components (139,140).

MenACWY-CRM Immunogenicity

Infants and Children

Among infants vaccinated at ages 2, 4, and 6 months with

MenACWY-CRM and routine vaccines, 76%–89% achieved

an hSBA titer ≥1:8 for serogroup A and ≥94% for serogroups C,

W, and Y 1 month after the third dose (119,124,128,130,141).

Antibody titers waned by age 12 months, particularly for

serogroup A. Following the fourth dose in the infant series at

age 12–17 months, the proportions of infants with an hSBA

titer ≥1:8 were 89%–96% for serogroup A and ≥95% for

serogroups C, W, and Y. Administration of MenACWY-CRM

simultaneously with routine vaccines did not result in reduced

immune responses to meningococcal serogroups A, C, W, or Y

or diphtheria, tetanus, hepatitis B, poliovirus, measles, mumps,

rubella, varicella, H. influenzae type b, or most pneumococcal

antigens (136). For the few pneumococcal serotypes for which

noninferiority criteria were not met, results were not consistent

across studies and age of administration (136). Noninferiority

was not consistently met for pertussis antigens across studies

when MenACWY-CRM was administered with routine

vaccines; however, the clinical relevance is unclear because

of the lack of clinical correlates of protection for pertussis

antigens. By age 2 years, or 1 year after completion of a 4-dose

MenACWY-CRM series, 88%–89% achieved an hSBA titer

≥1:8 for serogroups W and Y, 61% for serogroup C, and 39%

for serogroup A (141). By age 40 months, most children still

had an hSBA titer ≥1:8 for serogroups W and Y (76% and

67%, respectively), although this proportion was only 34%

for serogroup C and 10% for serogroup A. By age 60 months,

similar but slightly lower proportions were observed; following

a single booster dose, ≥96% of recipients achieved hSBA titers

≥1:8 across all serogroups.

After a 2-dose series among older infants and toddlers at

either ages 7–9 months and 12 months or 12 and 15 months,

the proportions who achieved an hSBA titer ≥1:8 1 month

after the second dose were 88%–97% for serogroup A and

≥96% for serogroups C, W, and Y (125

,130). Administration

of MenACWY-CRM simultaneously with routine vaccines

did not result in reduced immune responses to meningococcal

serogroups A, C, W, or Y or measles, mumps, rubella, or

varicella antigens (136). Among children who received

the 2-dose primary series at ages 12–13 and 15 months,

serogroup-specific antibody waning patterns similar to those

among infants also were observed; however, the proportion of

recipients with an hSBA titer ≥1:8 was higher at age 40 months

(85%, 79%, 55%, and 31% for serogroups W, Y, C, and A,

respectively) among this group (131). Similar results were

observed by age 60 months; after a single booster, all subjects

achieved hSBA titers ≥1:8 for all serogroups (131).

Among children who received a single dose at age 2–10 years,

the proportions who achieved hSBA titers ≥1:8 (≥1:4 in

one study) were 72%–89% for serogroup A, 68%–94% for

serogroup C, 90%–96% for serogroup W, and 65%–91%

for serogroup Y (88,118,120,121,123,126). No data are

available on MenACWY-CRM administered simultaneously

with routine vaccines among this age group. Twelve months

after the primary dose, the proportion with seroprotective

titers declined, particularly for serogroups A and C (118,123).

Five years after a primary dose administered at age 2–10 years,

14%–22% of recipients remained seroprotected against

serogroup A, 32%–56% against serogroup C, 74%–80%

against serogroup W, and 48%–53% against serogroup Y;

these proportions were lower among those vaccinated at age

2–5 years compared with age 6–10 years. One month after a

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single booster dose, all recipients achieved hSBA titers ≥1:8

for all serogroups (132).

Adolescents and Adults

One month after a single MenACWY-CRM dose among

adolescents and adults aged 11–75 years, 66%–92% of recipients

achieved an hSBA titer ≥1:8 for serogroup A, 79%–98% for

serogroup C, 84%–99% for serogroup W, and 79%–96%

for serogroup Y (89,99,117,120–122,126,127,129). In one

study that reported immunogenicity separately for adults aged

≥55 years, those aged 56–65 years had results similar to those

aged 19–55 years (129). Administration of MenACWY-CRM

simultaneously with other vaccines did not result in reduced

immune responses to meningococcal serogroups A, C, W,

or Y or tetanus, diphtheria, HPV, hepatitis A, hepatitis B,

typhoid, yellow fever, Japanese encephalitis, or rabies antigens

(117,135,142–146). After simultaneous administration of

MenACWY-CRM and MenB-4C, a robust immune response

to meningococcal serogroups A, C, W, and Y and to select

meningococcal serogroup B strains was observed, although

the majority of persons had high prevaccine hSBA titers across

serogroups (134). Noninferiority criteria were not met for two

pertussis antigens (i.e., pertussis toxoid and pertactin) when

MenACWY-CRM and Tdap were administered simultaneously,

although the clinical relevance of this is unclear (135).

By 12–22 months postvaccination, substantial antibody

waning was observed for serogroup A, though the majority of

recipients remained seroprotected for serogroups C, W, and

Y (86,122). After this initial decline, hSBA titers remained

relatively stable at 3 and 5 years postvaccination, with 28%–32%

of recipients having an hSBA titer ≥1:8 against serogroup A,

59%–76% against serogroup C, 72%–82% against serogroup W,

and 64%–76% against serogroup Y (83,133). One month after a

single MenACWY-CRM booster dose administered at 3–6 years

after the primary dose, ≥94% of subjects achieved an hSBA titer

≥1:8 across all serogroups. Booster vaccination elicited a robust

immune response whether MenACWY-CRM or MenACWY-D

was used for the primary dose (83,147). By 2 years after the

booster dose, the proportion of recipients with an hSBA titer

≥1:8 decreased to 79% for serogroup A but remained at ≥95%

for serogroups C, W, and Y (84).

MenACWY-CRM Safety

Clinical Trials

Among infants and toddlers vaccinated with a MenACWY-

CRM series (4-dose and 2-dose series, respectively) administered

with routine vaccines, injection site pain (19%–39%) and

erythema (12%–22%) were the most common local reactions

after the third or fourth infant doses and second toddler

dose (119,124,137,141). Irritability (36%–50%), sleepiness

(22%–31%), and decreased appetite (15%–20%) were the

most common systemic adverse events; fever was reported

in 5%–9% of recipients. Reactogenicity among infants and

toddlers vaccinated with a 4- or 2-dose series, respectively,

did not increase with subsequent MenACWY-CRM doses.

Among children aged 2–10 years vaccinated with a single dose,

injection site pain (<40%) and erythema (<32%) were the most

commonly reported local reactions (88,118,120,121,123,126).

Irritability was reported in 7%–26%, myalgia in <29%,

headache in <21%, and fatigue in <21%. Adverse events were

similar whether vaccination was administered at ages 2–5 or

6–10 years. Adverse events were similar after a booster dose

administered 5 years after primary vaccination (132).

Among adolescents and adults aged 11–75 years who

received a single MenACWY-CRM dose, injection site pain

occurred in 8%–54%, erythema in <39%, and induration in

<24%. Commonly reported systemic adverse events include

headache (8%–41%), myalgia (<43%), and fatigue (3%–23%)

(99,120–122,126,127,129,148). When MenACWY-CRM

was administered simultaneously with HPV and Tdap vaccines,

headache, malaise, myalgia, and arthralgia occurred more often

than when MenACWY-CRM was administered alone (117).

In addition, adverse events after a booster dose administered

4–6 years after primary vaccination were similar to those among

persons receiving a first dose. Across age groups, whether

MenACWY-CRM was administered alone or simultaneously

with other vaccines, adverse events were mild to moderate and

typically resolved within 3 days.

Postlicensure Safety Monitoring

In a manufacturer-sponsored cohort study of approximately

49,000 vaccinated adolescents aged 11–21 years with a

self-controlled case series analysis, a statistically significant

increased risk for Bell’s palsy during the 84 days after

vaccination was observed when MenACWY-CRM was

administered simultaneously with other vaccines but not when

MenACWY-CRM was administered alone (138). However,

this finding was based on only eight patients, most of whom

received simultaneous vaccine administration, and several were

noted to have had conditions or infections that might precede

Bell’s palsy. Thus, the importance of this finding remains

uncertain. No other safety signals were observed among the

other predefined events of interest in this evaluation (138). No

increased risk for Bell’s palsy or any other new safety concerns

were observed in smaller studies conducted in the same health

system among children aged 2 months–10 years (140,149).

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A comprehensive review of VAERS reports from 2010 through

2015, during which 8.2 million MenACWY-CRM doses were

distributed, was conducted with no new safety concerns identified

(139). A total of 2,614 reports about MenACWY-CRM were

received, primarily related to adolescents aged 11–18 years in

whom MenACWY-CRM was administered simultaneously

with other vaccines. Reported adverse events were consistent

with the findings from prelicensure studies. The reporting rate

of GBS or Bell’s palsy was proportionate to the rate reported for

other vaccines. However, administration errors were reported

more commonly for MenACWY-CRM, predominantly because

of administration of only one component (most commonly

the liquid component) rather than reconstituting the vaccine

by mixing the liquid and lyophilized components together

before administration.

MenACWY-TT (MenQuadfi)

MenACWY-TT was first licensed in the United States in

2020 for the prevention of meningococcal disease caused by

serogroups A, C, W, and Y in persons aged ≥2 years (68). As

a result, relatively limited data on MenACWY-TT safety and

immunogenicity are available compared with other licensed

meningococcal conjugate vaccines. MenACWY-TT has been

administered to nearly 5,000 persons aged ≥2 years to date

through clinical trials, with demonstrated immunogenicity

in this age group and elicitation of a boost response among

adolescents vaccinated with MenACWY-TT who previously

received MenACWY-D or MenACWY-CRM (68,150–155).

No clinically relevant concerns about MenACWY-TT

administered simultaneously with HPV or Tdap vaccines

among adolescents have been identified (151). Clinical trials

have demonstrated an acceptable safety profile, with injection

site pain as the most common local adverse event, and myalgia,

headache, and malaise as the most commonly reported systemic

adverse events across age groups (68,150–155). Most adverse

events were mild to moderate (68,150–155).

MenACWY-TT Immunogenicity

Infants and Children

Because MenACWY-TT is currently only licensed for

persons aged ≥2 years in the United States, immunogenicity

and safety data for children aged <2 years are not presented

in this report. Among children who received a single dose at

age 2–9 years, the proportions who achieved hSBA titers ≥1:8

1 month after vaccination were 86% for serogroup A, 98% for

serogroup C, 95% for serogroup W, and 99% for serogroup Y

(155). MenACWY-TT seroresponse rates were demonstrated

to be noninferior to those observed for MenACWY-CRM

(155). No data are available on MenACWY-TT administered

simultaneously with routine vaccines or on persistence of the

immune response to MenACWY-TT among this age group;

data will be reviewed as they become available to inform

vaccine recommendations.

Adolescents and Adults

One month after a single MenACWY-TT dose among

adolescents and adults aged 10–55 years, the proportions who

achieved hSBA titers ≥1:8 were 94%–96% for serogroup A,

94%–99% for serogroup C, 95%–99% for serogroup W, and

97%–99% for serogroup Y (151,154). Among adults aged

≥56 years, these proportions were 89%–94%, 75%–90%,

77%–80%, and 81%–92% for serogroups A, C, W,

and Y, respectively (152,153). Across these age groups,

MenACWY-TT seroresponse rates were noninferior to those

of the comparator meningococcal vaccines (68,151,153).

MenACWY-TT administered simultaneously with HPV and

Tdap vaccines in adolescents did not result in reduced immune

responses to meningococcal serogroups or tetanus, diphtheria,

or HPV antigens (151). Noninferiority criteria were not met for

three pertussis antigens when MenACWY-TT and Tdap were

administered simultaneously, although the clinical relevance

of this is unclear. No data are available on persistence of the

immune response to MenACWY-TT. When available, data

will be reviewed to inform booster dose recommendations

for persons primed with MenACWY-TT. Among adolescents

and adults aged ≥15 years primed with MenACWY-D or

MenACWY-CRM 4–10 years previously, >99% achieved an

hSBA titer ≥1:8 across all serogroups at 1 month after booster

vaccination with MenACWY-TT (150).

MenACWY-TT Safety

Clinical Trials

Among children aged 2–9 years vaccinated with a single

MenACWY-TT dose, injection site pain occurred in 39%,

erythema in 23%, and swelling in 14%; systemic adverse

events included malaise in 21%, myalgia in 20%, headache in

13%, and fever in 2% within 7 days of vaccine administration

(68). Among adolescents and adults aged 10–55 years, the

most common local adverse event was injection site pain

(35%–45%); erythema and swelling occurred in 5% and

4%–5%, respectively (68,151). Systemic adverse events

included myalgia (27%–36%), headache (27%–30%), and

malaise (19%–26%); fever occurred in 1% (68,151). Rates

of local and systemic adverse events were typically similar

in adults aged ≥56 years compared with other age groups:

injection site pain (26%–31%), erythema (5%–12%), swelling

(5%–8%), myalgia (22%–35%), headache (19%–24%),

malaise (15%–22%), and fever (2%). When MenACWY-TT

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was administered simultaneously with HPV and Tdap vaccines

in adolescents, rates of local and systemic adverse events

were typically similar to those when MenACWY-TT was

administered alone, although myalgia occurred more frequently

(151). In addition, adverse events after a MenACWY-TT

booster dose administered 4–10 years after primary vaccination

with either MenACWY-D or MenACWY-CRM were similar

to those among persons receiving a first MenACWY-TT

dose (150). Across age groups, whether MenACWY-TT was

administered alone or simultaneously with other vaccines,

adverse events were mild to moderate (68,150–155).

Postlicensure Safety Monitoring

Given the recent licensure of MenACWY-TT, no

postlicensure data were available at the time of publication of

this report. Data from VAERS and VSD will be monitored

as part of postlicensure safety monitoring. (See Reporting of

Vaccine Adverse Events for information on how to report

MenACWY-TT adverse events to VAERS.)

MenACWY Vaccine Immunogenicity and

Safety in Persons with Underlying

Medical Conditions

Complement-mediated bactericidal activity is important for

protection against meningococcal disease; opsonophagocytic

killing elicited by meningococcal antibodies is another defense

against infection and is the presumed primary mechanism for

vaccine-induced protection against meningococcal disease

among persons with complement deficiency (35,156). No data

about immunogenicity of U.S.-licensed MenACWY vaccines

(MenACWY-D, MenACWY-CRM, or MenACWY-TT) are

available for persons with complement deficiency. Antibody

titers after vaccination with MPSV4, a vaccine that is no

longer available in the United States, are similar among persons

with late complement deficiency compared with healthy

persons and the antibodies produced are capable of eliciting

opsonophagocytosis; however, antibody titers might wane

more rapidly among persons with complement deficiency and

higher antibody levels might be needed for opsonophagocytosis

to function (35,157–160). Data are lacking to establish the

efficacy of meningococcal conjugate vaccines among persons

with complement deficiency. Thus, persons with complement

deficiency are at increased risk for meningococcal disease even

if they develop antibodies postvaccination (66–68).

Limited data are available about efficacy of meningococcal

vaccines among persons taking complement inhibitors.

However, some studies suggest that opsonophagocytic killing

of meningococci in the presence of eculizumab in sera from

persons vaccinated with MenACWY either does not occur or

is insufficient to prevent meningococcal proliferation (161).

In addition, reports of meningococcal disease despite recent

vaccination among persons taking eculizumab indicate that

meningococcal vaccines do not provide complete protection

among persons taking complement inhibitors, even if

antibodies develop after vaccination (42,66–68,161).

Although no data are available for U.S.-licensed

MenACWY vaccines (MenACWY-D, MenACWY-CRM, or

MenACWY-TT), adults with anatomic asplenia had a reduced

immunologic response compared with healthy persons after

1 dose of a serogroup C meningococcal conjugate vaccine;

after a second dose, most persons achieved seroprotection

(162–164). Among children and adolescents vaccinated with a

conjugate MenACWY-TT vaccine licensed outside the United

States, similar immune responses were observed in children

with functional or anatomic asplenia compared with healthy

controls after each of 2 doses (165). However, antibodies appear

to wane rapidly after serogroup C meningococcal conjugate

vaccination among children with functional asplenia due to

sickle cell disease, particularly among those who received

primary vaccination at age <2 years (166).

Among adolescents with HIV infection, immunogenicity to

MenACWY-D is reduced compared with adolescents without

HIV infection. By 4 weeks postvaccination with a single dose,

52%–73% of HIV-infected adolescents had a greater than

fourfold increase in rSBA across the meningococcal serogroups.

Lower CD4 percentage, higher viral load, and a more advanced

clinical stage were inversely associated with seroprotection

against serogroup C (167). By 72 weeks subsequent to a

second dose, a significantly greater proportion of adolescents

with a CD4 percentage ≥15% had seroprotective rSBA titers,

although this proportion was lesser for serogroup C than other

serogroups, compared with those with a CD4 percentage of

<15%, among whom seroprotection rates for all serogroups

was reduced (168). Among children aged 2–10 years with HIV

infection and a CD4 percentage ≥25%, antibody titers against

serogroup C waned substantially by 72 weeks after vaccination

(169). Similar trends were observed subsequent to vaccination

of HIV-infected children and adolescents with serogroup C

meningococcal conjugate vaccine (170–173).

Although data are limited, vaccination of persons with

asplenia or HIV infection appears to be safe and well tolerated,

with similar types of adverse events as reported among healthy

controls or during clinical trials (165,167,169,171). Among

HIV-infected children and adolescents vaccinated with

MenACWY-D, rates of adverse events typically were lower

than those reported during clinical trials of healthy children

and adolescents, although these lower adverse event rates

were not consistently observed among those vaccinated with

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a serogroup C meningococcal conjugate vaccine (80,167,169–

171). Among children with asplenia who received a conjugate

MenACWY-TT vaccine licensed outside the United States, an

acceptable safety profile was observed among all age groups,

although higher rates of adverse events were reported compared

with healthy controls; however, the small study size limits the

interpretation of this finding (165,170,171).

MenACWY Vaccines in Pregnant Women

Adverse outcomes (e.g., spontaneous abortion or birth

defects) are risks for all pregnancies, occurring in approximately

15%–20% and 3%, respectively, of clinically recognized

pregnancies in the United States (174,175). Although evidence

is limited, rates of these outcomes after MenACWY vaccination

during pregnancy are consistent with the estimated background

rates, and no additional concerning maternal or neonatal safety

patterns have been identified (66,67,112,139,176,177).

No controlled trials have been conducted to specifically

assess the safety of meningococcal vaccination among pregnant

women and birth outcomes of vaccinated women. However,

among approximately 2,000 pregnant Malian women

vaccinated during the third trimester with MenACWY-D

as a control group in an influenza vaccine trial, rates of local

and systemic adverse events were lower than those observed

during MenACWY-D clinical trials of adolescents and adults

and serious obstetric and nonobstetric adverse events were

rare, with similar rates between MenACWY-D and influenza

vaccination groups (176). In the MenACWY-D vaccinated

group, 98% of pregnancies resulted in live births, and among

infants, 0.3% had low birthweight and 0.2% had a congenital

malformation; no differences in these outcomes were observed

among women who received influenza vaccine.

Among approximately 5,000 adolescent or adult females

enrolled in MenACWY clinical trials, pregnancy was reported

in 43 women during the 6 months postvaccination (37 who

received MenACWY-CRM and six who received MenACWY-D)

(66,67). Of these, seven (19%) MenACWY-CRM recipients

reported spontaneous abortion (estimated dates of conception

were 5 days before vaccination for one woman, 6–17 weeks

postvaccination for five women, and 6 months postvaccination

for one woman). Congenital anomaly (hydrocephalus) was

reported in the infant of one MenACWY-D recipient with an

estimated conception date 15 weeks after vaccination.

Although data are limited, no concerning safety signals

have been identified through postlicensure surveillance. In

reviews of VAERS, 127 pregnancy-associated reports were

identified during the periods evaluated: 113 for MenACWY-D

(2005–2011) and 14 for MenACWY-CRM (2010–2015); the

differences in number of reports by vaccine type probably reflect

differences in numbers of doses administered during these

periods (139,177). The majority of vaccine administrations

occurred during the first trimester. Among the 113 pregnant

women who received MenACWY-D, spontaneous abortion

was reported in 17% and congenital anomaly was reported in

<1% of VAERS reports (177). Following MenACWY-CRM

vaccination in pregnancy, only three VAERS reports had

information on birth outcome, with no adverse events reported

(139). Among patients in a large health care organization, one

spontaneous abortion was identified among 18 MenACWY-D

exposures during pregnancy with known outcome (112).

Manufacturers of MenACWY vaccines maintain registries

that monitor pregnancy outcomes of women exposed to

MenACWY during pregnancy. Among 87 pregnant women

exposed to MenACWY-D during 2005–2016 from 30 days

before or at any time during pregnancy who had known

pregnancy outcome and who were enrolled in the registry

before outcome being known, spontaneous abortion was

reported in 7% and major congenital anomalies in 2% (67).

Among 82 pregnant women exposed to MenACWY-CRM

during 2014–2017 from 28 days before or at any time

during pregnancy who had known outcome, spontaneous

abortion was reported in 12% and congenital anomaly in 4%

(GlaxoSmithKline, unpublished data, 2019). No information

is available from the MenACWY-TT pregnancy registry

because of the recent licensure of the vaccine.

Effectiveness of MenACWY Vaccines

Overall vaccine effectiveness of a single dose of MenACWY-D

against meningococcal disease caused by serogroups A, C, W, or Y

among adolescents in the United States is estimated at 69%

(95% confidence interval [CI]: 51%–80%) in the 8 years after

vaccination: 77% (95% CI: 57%–88%) against serogroup C

and 51% (95% CI: 1%–76%) against serogroup Y (178).

Effectiveness was 79% (95% CI: 49%–91%) in the first year

but decreased to 69% (95% CI: 44%–83%) 1 to <3 years

postvaccination and 61% (95% CI: 25%–79%) 3 to <8 years

postvaccination. No data are available on the effectiveness of

MenACWY-CRM or MenACWY-TT.

Vaccination and Meningococcal Disease

Incidence

Measuring the association between adolescent MenACWY

vaccination on rates of meningococcal disease has been

challenging because of the low and decreasing incidence

of meningococcal disease among all age groups. However,

from MenACWY introduction through 2017, adolescents

experienced the greatest percentage decreases (>90%) in

meningococcal disease incidence due to serogroups C, W, or

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Y combined compared with other age groups (179). In the

setting of 85% coverage with at least 1 dose of MenACWY-D

or MenACWY-CRM among U.S. adolescents aged 13–17 years

and 44% coverage with at least 2 doses among adolescents aged

17 years by 2017, a twofold to threefold increase in the rate of

decline in incidence was observed during the postvaccination

period compared with the prevaccination period among

adolescents, suggesting that vaccination with MenACWY-D

or MenACWY-CRM is associated with reductions in disease

rates in adolescents (179,180). No data are available for

MenACWY-TT.

Vaccination and Oropharyngeal Carriage

Although vaccination with a serogroup C meningococcal

conjugate vaccine in Europe and a serogroup A meningococcal

conjugate vaccine in sub-Saharan Africa has been associated with

reductions in oropharyngeal carriage of these N. meningitidis

serogroups and resulted in herd immunity in the population

(181–183), data are limited for MenACWY vaccines. In

the United States, carriage prevalence of meningococcal

serogroups C, W, or Y combined among college students in

the setting of high MenACWY vaccination coverage is now

extremely low (<1%); however, no direct evidence exists that

this low prevalence is a result of vaccination (184–186). In

a small observational study of Polish military recruits, those

vaccinated with a MenACWY vaccine 1–3 years earlier

had lower rates of meningococcal carriage compared with

unvaccinated recruits (187). In a randomized controlled trial

of United Kingdom university students, those who received

MenACWY-CRM had significantly lower carriage prevalence

than controls for serogroup Y (39% carriage reduction) and

serogroups C, W, and Y combined (36% carriage reduction)

at 2 months postvaccination, although no differences in

carriage acquisition rates were observed (188). In contrast, in

a study conducted in a different United Kingdom university

population vaccinated with MenACWY-CRM in response

to rapid expansion of a serogroup W clone in England,

serogroup W carriage of this clone increased despite relatively

high vaccination coverage (189). However, because carriage

acquisition among university students is known to rapidly

increase at the beginning of the academic year (190), the

majority of serogroup W transmissions might have occurred

simultaneously with vaccination activities (i.e., during

September).

Cost-Effectiveness of MenACWY Vaccines

Cost-effectiveness of MenACWY vaccines in the United

States was last assessed in 2010 using Monte Carlo simulation

(191). In this evaluation, cost per quality-adjusted life year

(QALY) of vaccinating at ages 11 and 16 years was similar to

vaccinating at either age 11 or 15 years ($212,000–$256,000),

although the estimated number of cases and deaths averted

among the vaccinated cohort was substantially higher with a

2-dose strategy (184 and 22, respectively) compared with a

single-dose strategy (94–115 and 11–14, respectively) (16).

Serogroup B Meningococcal Vaccines

MenB-FHbp (Trumenba)

MenB-FHbp is only licensed for persons aged 10–25 years in

the United States; therefore, immunogenicity and safety data

for children aged <10 years are not presented in this report.

Available data for this age group have recently been summarized

elsewhere (192).

Clinical trials have demonstrated that although vaccination

of adolescents and young adults with either a 2- or 3-dose

schedule of MenB-FHbp is immunogenic, antibody titers

wane substantially by 1 year postvaccination and then remain

stable for up to 4 years (94,193–199). Subsequent to booster

vaccination 4 years after primary series completion, a robust

response is observed and persistence at 26 months after the

booster dose is superior to the response at a comparable period

after primary series completion for both 2-dose and 3-dose

primary series recipients (19,200). No clinically relevant

concerns related to MenB-FHbp administered simultaneously

with other vaccines have been identified (94,196,201).

MenB-FHbp is safe and well tolerated, although more

reactogenic than MenACWY (94,194–199,201). In clinical

trials, the most common local reactions were injection site pain,

induration, and erythema, and the most common systemic

adverse events were headache, fatigue, and myalgia. Symptoms

typically resolved within 5 days (94,

194–199,201). Adverse

events reported through postlicensure safety surveillance

are consistent with the clinical trial data, and no new safety

concerns have been identified (202).

MenB-FHbp Immunogenicity

Clinical trials for MenB-FHbp immunogenicity against four

reference strains, each expressing an FHbp antigen different

from those included in the vaccine, among persons aged

10–25 years were conducted using several dosing schedules,

including the licensed formulations of a 3-dose schedule

(0, 1, and 6 months or 0, 2, and 6 months) and a 2-dose

schedule (0 and 6 months). By 1 month after completion of

either of the 3-dose schedules, the proportion of persons with

hSBA titers ≥1:8 or at or above the lower limit of quantification

(LLOQ) of the assay (LLOQ: ≥1:8 or ≥1:16 depending on

the strain) was 91%–98% for test strain A22, ≥99% for A56,

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81%–95% for B24, 86%–96% for B44, and 84%–94% for

the composite response (i.e., response against all test strains)

(94,193–199). The proportions of persons with seroprotective

hSBA titers were similar between 0-, 1-, and 6-months and

0-, 2-, and 6-months schedules. In the study that assessed

the 2-dose schedule (0 and 6 months), the proportion with

hSBA titers ≥LLOQ was 97% for A22, 99% for A56, 81%

for B24, 78% for B44, and 77% for the composite response

(182,198). Administration of MenB-FHbp simultaneously

with other vaccines did not result in reduced immune response

to MenB-FHbp antigens, meningococcal serogroups A, C, W,

or Y or diphtheria, tetanus, or pertussis antigens (94,201).

Noninferiority criteria were not met for HPV 18 antigen,

although the GMTs were high and for each of the four HPV

types in the quadrivalent HPV vaccine (including type 18),

≥99% of persons seroconverted (197).

By 6 months postcompletion of a 3-dose (0, 2, and 6 months)

schedule among adolescents aged 11–18 years, the proportions

with hSBA titers ≥LLOQ were 60% for A22, 89% for A56,

57% for B24, 37% for B44, and 26% for the composite

response (193). By 12 months postcompletion of any 3-dose

series, the proportion with hSBA titers ≥LLOQ was 41%–54%

for A22, 69%–76% for A56, 41%–55% for B24, 23%–29%

for B44, and 22% for the composite response (193,198). These

proportions remained relatively stable thereafter (at 18, 24,

36, and 48 months postprimary series) (range: 35%–59% for

A22, 47%–73% for A56, 41%–57% for B24, 17%–27% for

B44, and 16%–19% for the composite response) (193,198).

After a 2-dose schedule, the proportion of recipients with

hSBA titers ≥LLOQ was slightly lower than that observed for

the 3-dose series but similarly stable 12–48 months after series

completion (range: 36%–48% for A22, 54%–60% for A56,

31%–37% for B24, 16%–20% for B44, and, by 48 months,

16% for the composite response) (193,198).

One month after a booster dose administered 48 months after

primary series completion, 94%–98% of persons who received

a 2-dose primary series and ≥97% of those who received a

3-dose primary series achieved an hSBA titer ≥1:4 against the

four test strains (19). Twelve months after MenB-FHbp booster

administration, 62%–82% of those who received a 2-dose

primary series and 73%–93% of those who received a 3-dose

primary series achieved hSBA titers ≥1:4 across the test strains

(composite response of 63% for both groups). By 26 months

postbooster, further antibody titer waning was observed among

persons who received a 2-dose series but not among those who

received a 3-dose series: 59%–67% and 71%–90% achieved an

hSBA titer ≥1:4 for the four test strains, respectively, although

decreases were observed in the composite response for both

groups (42% and 46%, respectively).

In addition to these trials demonstrating immunogenicity

to the four test strains, several evaluations have assessed

immunogenicity against genetically diverse and clinically

relevant strains. In one of the clinical trials, 63%–99% of

persons vaccinated with a 2-dose primary series at 0 and

2 months and 75%–99% vaccinated with a 3-dose primary

series achieved an hSBA titer ≥LLOQ against 10 additional

strains (195). In a manufacturer-sponsored evaluation, hSBA

responses measured against 27 clinically relevant strains

(including strains from four U.S. university outbreaks)

demonstrated that ≥32% of persons vaccinated with 2 doses

and ≥56% vaccinated with 3 doses achieved an hSBA titer

≥1:8 against all test strains (203). The proportion of persons

who achieved seroprotective hSBA titers was greater for strains

expressing the most common FHbp variants in the United

States (B24 and A22) at ≥81% and 88%–95%, respectively,

after the third dose. In another manufacturer-sponsored

study, 1 month after the third MenB-FHbp dose ≥73% of

adolescents achieved an hSBA titer ≥1:4 against eight French

serogroup B outbreak strains (204). In an independent study

among vaccinated U.S. health care workers, ≥93% achieved

an hSBA titer ≥1:4 against 14 serogroup B strains (including

strains from six university outbreaks) by 1 month after the third

dose; by 9–11 months postvaccination, 27%–90% remained

seroprotected against nine strains tested (205).

MenB-FHbp Safety

Clinical Trials and Research Studies

Among adolescents and young adults, injection site pain

(72%–93%), induration (21%–37%), and erythema (10%–

24%) were commonly observed local reactions after any dose

in either a 2- or 3-dose series (94,194–197,199). Headache

(27%–67%), fatigue (30%–66%), myalgia (21%–40%), and

arthralgia (11%–33%) were the most commonly reported

systemic adverse events; fever was reported in 2%–23% of

recipients. Reactogenicity did not increase with increasing

number of doses. Rates and types of adverse events subsequent

to a booster dose administered 4 years after primary series

completion were similar to those observed after the primary

series (198). Most adverse events were mild to moderate,

and symptoms typically resolved within 5 days of onset

(94,194–199).

Because MenB-FHbp contains factor H binding protein, a

theoretical risk exists for development of factor H autoantibodies

(implicated in diseases such as atypical hemolytic uremic

syndrome and C3 glomerulonephropathy) postvaccination

(206,207); however, whether factor H autoantibodies develop

after MenB-FHbp vaccination and, if so, whether they are

clinically significant is not known. Among persons who

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received MenB-FHbp in clinical trials, the proportion with

a newly diagnosed autoimmune disease during the trial or

during the 6-month follow-up period was low (0.14%) and

similar to unvaccinated controls (208). Furthermore, the onset

of symptoms consistent with the diagnosis occurred before the

first vaccination in most of these persons.

Postlicensure Safety Monitoring

In a comprehensive review of VAERS reports from licensure

in 2014 through June 2018, no new safety concerns were

identified (CDC, unpublished data, 2020). A total of 1,719

reports involving MenB-FHbp were identified; among these

reports, the median patient age at vaccination was 17 years,

and 36% involved simultaneous administration with other

vaccines. The most common adverse events reported were fever,

headache, and injection site pain. Reported adverse events

(e.g., headache, fever, chills, and myalgia) are consistent with

those identified in clinical trials. No safety signals related to

autoimmune or renal diseases were detected.

After a MenB-FHbp mass vaccination campaign in

response to a serogroup B meningococcal disease outbreak

on a university campus in which approximately 10,000 doses

were administered, adverse events were solicited via survey

subsequent to each of the 3 doses (202). Among survey

respondents, rates of injection site pain, fatigue, myalgia, fevers,

and chills were similar to those reported during clinical trials,

and no new safety concerns were identified.

MenB-4C (Bexsero)

MenB-4C was first licensed in the United States in 2015.

MenB-4C is licensed for persons aged 10–25 years in the

United States; therefore, immunogenicity and safety data

for children aged <10 years are not presented in this report.

Available data for this age group have been summarized

elsewhere (209).

Among adolescents and young adults, a 2-dose MenB-4C

primary series is immunogenic (148,210–213). Although

antibody persistence is difficult to assess because of heterogeneous

results by vaccine antigens (FHbp, NhbA, NadA, and PorA) or

between studies, different points assessed in different studies,

and elevated baseline titers in certain studies, antibody titers

appear to wane by 2 years postvaccination (148,213–216).

A robust immune response is demonstrated after either a

MenB-4C or investigational serogroups A, B, C, W, and Y

(MenABCWY) vaccine booster dose administered 2, 4, or

7.5 years after a MenB-4C primary series (215,217). Although

data are limited, persistence after a booster dose likely lasts

for several years based on observed and modeled data (218).

MenB-4C vaccine is safe and well tolerated, although more

reactogenic than MenACWY (188,210–213). In clinical trials,

the most common local reactions were injection site pain,

erythema, and swelling and the most common systemic adverse

events were headache, fatigue, and myalgia. In postlicensure

safety surveillance, local and systemic adverse events reported

are consistent with the clinical trial data (219–221).

MenB-4C Immunogenicity

Clinical trials were conducted to assess immunogenicity to

four test strains among persons aged 10–25 years using a 2-dose

primary series schedule (0 and 1–2 months), with seroprotection

defined as an hSBA titer ≥1:4 or ≥1:5. One month after the

second dose, ≥98% of recipients achieved seroprotection

against FHbp, ≥97% against NadA, ≥75% against PorA, and

≥68% against NhbA (148,210–213). At 5–6 months after the

primary series, ≥82% remained seroprotected against FHbp,

≥93% against NadA, and ≥75% against PorA (NhbA was not

assessed) (148,213). Antibody persistence at further points

was variable between studies. In a study conducted among

United Kingdom college students, in which the proportion

of persons with baseline (prevaccination) titers ≥1:4 ranged

from 57% to 69% for FHbp, NadA, and PorA, 85%–97% of

vaccinated students remained seroprotected for these antigens

at 11 months postcompletion of the primary series (148). In

a study of Chilean adolescents, in whom baseline titers were

also elevated, 75%–93% were seroprotected against FHbp,

NadA, and PorA by 18–23 months after the primary series and

29%–84% had seroprotection at 7.5 years (215,216). However,

the proportion seroprotected at 7.5 years was not significantly

different from baseline for three of the four antigens in the

original study cohort, although higher than an age-matched

unvaccinated population for three of four antigens. Among

participants in two different clinical trials in which most

had low baseline titers, results at 2 years (United States and

Poland) and 4 years (Canada and Australia) postvaccination

were relatively consistent: 30%–34% seroprotection against

FHbp, 84%–94% against NadA, 9%–16% against PorA, and

50%–75% against NhbA (

214,215). In a small clinical trial

of adult laboratory workers, in which most participants had

high baseline hSBA titers to serogroups A, C, W, and Y and

select serogroup B strains, simultaneous administration of

MenACWY-CRM and a 3-dose MenB-4C series resulted in

robust immune responses through 4 months after the second

dose and 1 month after the third dose (134).

In extension studies conducted in Chile, Canada, and

Australia, a MenB-4C booster was administered either

4 or 7.5 years after completion of the primary series (215).

One month after booster administration, ≥93% of persons

achieved an hSBA titer ≥1:4 across the four vaccine antigens.

No data on persistence of the immune response after a booster

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dose are available for this cohort. However, modeling of the

clinical trial data demonstrates that persistence likely lasts

for several years (218). In an extension of the U.S.-Poland

study, 11 persons previously vaccinated with a MenB-4C

primary series were randomized to receive an investigational

pentavalent (serogroups A, B, C, W, and Y) vaccine, in which

the serogroup B component was identical to the components

of the licensed MenB-4C product, as a booster dose 2 years

postcompletion of the primary series (217). One month

postbooster, ≥91% of persons achieved an hSBA titer ≥1:5

against FHbp, NadA, and NhbA, and 82% achieved an hSBA

titer ≥1:5 against PorA. At 12 months postbooster, all recipients

achieved an hSBA titer ≥1:5 against NadA, 82% against FHbp

and NhbA, and 45% against PorA, although confidence

intervals were wide because of the small study size (217).

In addition to clinical trials, several observational

immunogenicity studies have been undertaken. After a 2013

mass MenB-4C vaccination campaign at a U.S. university in

response to a serogroup B meningococcal disease outbreak

caused by a strain predicted by the MATS assay to be covered

by both the FHbp and NhbA antigens in MenB-4C, 66% of

serosurvey participants achieved an hSBA titer ≥1:4 against

the outbreak strain at 2 months after receipt of the 2-dose

series; immunogenicity against two vaccine antigen reference

strains was high (222). Antibody titers against the outbreak

strain appeared to wane rapidly postvaccination; by 20 months

postvaccination, 24% of recipients remained seroprotected

(223). Antibody titer waning also was observed among students

vaccinated with MenB-4C during a different U.S. university

outbreak. The proportion of students with an hSBA titer ≥1:4

against the outbreak strain and three additional university

outbreak strains ranged from 53% to 93% 1.5–2 months after

completion of the series, and this proportion decreased to

31%–86% at 7 months (224). In another evaluation using sera

from vaccinated adults, hSBA activity against 18 genetically

diverse serogroup B strains (including three reference strains

and six university outbreak strains) demonstrated that at

1 month postvaccination, ≥85% of recipients achieved an

hSBA titer ≥1:4 against most strains; however, this proportion

decreased to 70% for 14 of the strains and 45%–62% for the

remaining four strains (two from outbreaks) by 4–6 months

postvaccination (225).

MenB-4C Safety

Clinical Trials and Research Studies

Among adolescents and adults, injection site pain

(82%–98%), erythema (35%–68%), swelling (26%–47%),

and induration (10%–48%) were commonly reported local

reactions after primary vaccination (188,210–213). Headache

(21%–65%), fatigue and malaise (18%–73%), myalgia

(17%–75%), arthralgia (8%–42%), and nausea (8%–35%)

were commonly reported systemic adverse events; fever

was reported in 1%–10% of recipients. In a clinical trial

conducted among laboratory workers in which MenB-4C

was administered simultaneously with MenACWY-CRM,

local injection site adverse reactions were more common in

the arms in which MenB-4C was administered compared

with MenACWY-CRM; nausea and headache were more

frequently reported when the two vaccines were administered

simultaneously compared with MenB-4C administration

alone (134). After a MenB-4C or investigational MenABCWY

booster dose, rates of local or systemic adverse events typically

were similar to those observed among persons who received

doses as part of primary vaccination (215,217).

As with MenB-FHbp, MenB-4C contains components

that include factor H binding protein. Animal models and

an evaluation in humans demonstrated that antibodies

generated after MenB-4C vaccination were cross-reactive

with human factor H (226–228). In the human study, a

small proportion of persons vaccinated with MenB-4C had

transient development of factor H autoantibodies, although

factor H function was unaffected (228). Although these

findings do not suggest that factor H autoantibodies from

MenB vaccination are likely to cause factor H–associated

autoimmune conditions, the clinical significance remains

uncertain, and additional postlicensure safety surveillance

will be important. In FDA’s review of MenB-4C clinical trial

data, among study participants with an autoimmune disorder

diagnosed during the study follow-up period, the onset of

symptoms consistent with the disorder occurred before the

first vaccination in most trial participants (70).

Postlicensure Safety Monitoring

MenB-4C safety surveillance was conducted as part of

several mass vaccination campaigns in the United States and

Canada (219–221). MenB-4C mass vaccination campaigns

were implemented in response to outbreaks at two U.S.

universities (approximately 31,000 doses administered), under

an expanded access investigational new drug protocol before

U.S. licensure of the vaccine, and one university in Canada

(approximately 5,000 doses administered) (220,221). The

most commonly reported adverse events were consistent

with findings from clinical trial data (e.g., fever, injection site

pain, and arm pain), although 0.88 syncopal events per 1,000

persons in the U.S. evaluation were reported. Similarly, safety

surveillance for mass vaccination to control increased incidence

of serogroup B meningococcal disease in a region of Quebec,

Canada, in which nearly 60,000 doses were administered

to persons aged ≤20 years, demonstrated local and systemic

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adverse events consistent with those described in clinical

trials, although adverse event–related absenteeism or medical

consultations were frequent (219). However, four cases of likely

idiopathic nephrotic syndrome were identified in vaccinated

children aged 2–5 years during the 1-year postvaccination

safety monitoring period (229). Because of the small number

of cases and wide confidence intervals of risk estimates, whether

this finding represents a safety signal is unclear.

In a comprehensive review of VAERS reports from licensure

in 2015 through June 2018, no new safety concerns were

identified (CDC, unpublished data, 2020). A total of 1,470

reports involving MenB-4C vaccination were received;

the median patient age was 17 years, and 39% involved

simultaneous administration with other vaccines. The most

commonly reported adverse events were injection site pain,

fever, and headache. Transient decreased mobility of the arm

where the vaccine was injected was disproportionately reported

for MenB-4C compared with other vaccines. Overall, the

reported adverse events were consistent with the findings from

clinical trials. No autoimmune or renal disease–related safety

signals were detected.

MenB Vaccine Immunogenicity and

Safety in Persons with Underlying

Medical Conditions

Immunogenicity of MenB-4C was assessed in children and

adolescents aged 2–17 years with certain underlying conditions

(230). One month postcompletion of a 2-dose primary series,

the proportion of persons with complement deficiency or

complement inhibitor use with hSBA titers ≥1:5 was 87% for

FHbp, 95% for NadA, 68% for PorA, and 73% for NhbA

when exogenous complement was used. Among those with

asplenia, ≥84% had seroprotection against these four antigens,

which was similar to the proportion observed in healthy

control participants. However, among complement-deficient

persons, when endogenous complement was used, only

41%–68% had seroprotection against the four antigens; among

those with terminal component deficiencies or complement

inhibitor use, only 17% demonstrated any bactericidal activity

postvaccination. In addition, a lack of opsonophagocytic

killing of meningococci in the presence of eculizumab in sera

from persons vaccinated with MenB-4C has been observed,

and cases of serogroup or genogroup B meningococcal disease

have been reported despite recent vaccination among persons

using eculizumab (161,231,232). Although data are limited for

MenB-FHbp, similar concerns exist for the lack of complete

protection in vaccinated persons (69). Thus, persons with

complement deficiency or complement inhibitor use might

remain at increased risk for meningococcal disease even if they

develop antibodies postvaccination (69,70,94,201).

The safety profile of MenB-4C among children and

adolescents aged 2–17 years with certain underlying

medical conditions was similar to that observed in healthy

controls (230). In a small Spanish evaluation in adults with

complement deficiency, eculizumab use, asplenia, and history

of meningococcal disease, plus a microbiologist with an

immunodeficiency, the reactogenicity profile of MenB-4C

was similar to that reported in clinical trials in adolescents and

adults except for a slightly higher rate of fever (13%).

Vaccination in general might activate complement. Thus,

patients with complement-mediated diseases, such as those

in whom complement inhibitors are used for treatment

(e.g., paroxysmal nocturnal hemoglobinuria and atypical

hemolytic uremic syndrome), might experience increased signs

and symptoms of their underlying disease after vaccination.

In a safety review of patients treated with eculizumab in

Canada, an increased risk for anemia or hemolysis was

observed when patients receiving eculizumab were vaccinated

with MenB-4C, particularly in those who received an

eculizumab dose within 2 weeks of vaccination (233).

The Canadian package insert for eculizumab was updated

with the manufacturer’s recommendation that patients be

vaccinated (with any recommended meningococcal vaccine,

not specifically MenB-4C) before or at the same time as

eculizumab initiation; those receiving eculizumab treatment

are recommended to be vaccinated only when their disease

is controlled and the eculizumab concentration in the blood

is considered to be high (234). No similar safety concerns

have been identified in the United States to date; however,

meningococcal vaccination is likewise recommended at least

2 weeks before complement inhibitor initiation (39,40).

MenB Vaccines in Pregnant Women

Data on safety of MenB vaccines in pregnant women are

limited. No controlled trials have been conducted to specifically

assess the safety of MenB vaccination among pregnant

women and birth outcomes of vaccinated women. Among

approximately 6,000 adolescent or adult females enrolled in

MenB-FHbp clinical trials, pregnancy was reported during

the trial or in the follow-up period in 34 women who had

received at least 1 dose (94,194–199,201). Among these,

four (12%) spontaneous abortions were reported. Among

approximately 2,000 adolescent or adult females enrolled

in MenB-4C clinical trials, no pregnancies were reported in

the published literature (188

,210–213,215). Evaluation of

VAERS through June 2018 identified three reports related to

MenB-FHbp vaccination during pregnancy, with no maternal

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or fetal adverse events reported, and four related to MenB-4C,

with one spontaneous abortion reported (CDC, unpublished

data, 2020). Both manufacturers maintain pregnancy registries

to collect information on birth outcomes after maternal

vaccination; however, no data are available (GlaxoSmithKline

and Pfizer, personal communications, 2019).

Effectiveness of MenB Vaccines

After a mass vaccination program among persons aged

2 months–20 years in a region of Canada experiencing increased

incidence of serogroup B meningococcal disease due predominantly

to a single clone, MenB-4C vaccine effectiveness among all target

age groups was estimated at 79% (95% CI: -231% to 99%) in

the 4 years postvaccination, although the wide confidence intervals

encompassing the null effect value limit the interpretation of the

finding (235). No additional data on MenB-4C effectiveness are

available for adolescents and adults. In the United Kingdom,

where infants are vaccinated with MenB-4C at ages 2, 4, and

12 months, vaccine effectiveness among children who completed

the series was estimated at 59.1% (95% CI: -31.1% to 87.2%)

for all serogroup B strains in the 3 years after vaccination (236).

No data are available on MenB-FHbp vaccine effectiveness in

any age group.

Vaccination and Meningococcal Disease

Incidence

No information is available on the association between

MenB vaccination and meningococcal disease incidence in the

United States. This association cannot be assessed because of

the low incidence of serogroup B meningococcal disease and

low vaccination coverage after the 2015 ACIP recommendation

that adolescents be vaccinated on the basis of shared clinical

decision-making (22% of adolescents aged 17 years received

≥1 MenB dose in 2019) (237).

Vaccination and Oropharyngeal Carriage

Current evidence suggests that MenB vaccines probably

do not have a substantial effect on the prevalence or

acquisition of N. meningitidis oropharyngeal carriage. In a

large randomized controlled trial in Australia, MenB-4C

vaccination of adolescents did not result in a reduction of

carriage with N. meningitidis serogroup B or other disease-

causing N. meningitidis serogroups (238). In a smaller

randomized controlled trial of United Kingdom university

students, no immediate reduction in meningococcal carriage

was observed in the 1 month after MenB-4C vaccination.

By 3 months postvaccination, significantly lower carriage of

any meningococcal strain and of capsular groups B, C, W,

and Y was observed; however, no specific effect of MenB-4C

on serogroup B carriage was observed (188). No data from

large randomized controlled trials for MenB-FHbp are

available. However, two observational carriage evaluations

after vaccination of U.S. university students primarily with

MenB-FHbp during serogroup B outbreaks demonstrated

stable serogroup B carriage rates before and after vaccination,

suggesting that MenB-FHbp does not have a large or rapid

effect on carriage (185,186).

Cost-Effectiveness of MenB Vaccines

Cost-effectiveness of MenB vaccines among U.S. adolescents

was first assessed in 2015 and most recently evaluated in 2018

(10,239). Vaccination strategies included a MenB primary

series at age 11 years with a booster at age 16 years, a series

at age 16 years, a series at age 18 years, and a series among

college students. Cost per QALY saved for these four strategies

ranged from $9.6 million to $12.7 million, with the number

needed to vaccinate to prevent a case ranging from 152,000

to 305,000 and the number needed to vaccinate to prevent a

death ranging from 1.6 million to 2.8 million (239).

Vaccine Administration

MenACWY-D, MenACWY-CRM, MenACWY-TT, MenB-

FHbp, and MenB-4C are all administered intramuscularly at a

dose of 0.5 mL. However, for MenACWY-CRM, the lyophilized

MenA component must be reconstituted with the liquid

MenCWY component immediately before administration. If

the liquid MenCWY component is inadvertently administered

alone without the lyophilized MenA component, revaccination

is not necessary for persons who are not planning to travel

internationally because serogroup A meningococcal disease is

rarely reported in the United States. However, revaccination

is necessary if the person plans to travel internationally,

particularly to a region where serogroup A meningococcal

disease is endemic, or where vaccination is required, such as to

the Hajj pilgrimage. In this case, a dose prepared according to

the manufacturer’s instructions should be administered as soon

as feasible. Additional information on meningococcal vaccine

administration is available in the package inserts (66–70).

Recommendations for Use of

Meningococcal Vaccines

Adolescents and Young Adults

ACIP recommends routine administration of a MenACWY

vaccine for all persons aged 11–18 years (Table 2). In addition,

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ACIP recommends a MenB vaccine series for persons aged

16–23 years on the basis of shared clinical decision-making

to provide short-term protection against most strains of

serogroup B meningococcal disease (Table 2). The preferred

age for MenB vaccination is 16–18 years.

MenACWY Vaccines

ACIP recommends a single dose of MenACWY at age 11 or

12 years followed by a booster dose administered at age 16 years

(Table 2). Children who received MenACWY at age 10 years

do not need an additional dose at age 11–12 years but should

receive the booster dose at age 16 years. Children who received

MenACWY before age 10 years and with no ongoing risk for

meningococcal disease for which boosters are recommended

should still receive MenACWY according to the recommended

adolescent schedule, with the first dose at age 11–12 years and

a booster dose at age 16 years. For example, a healthy child who

received MenACWY at age 9 years because of short-term travel

to a country where meningococcal disease is hyperendemic or

epidemic and who is not otherwise at increased risk should

receive the MenACWY at age 11–12 years according to the

recommended ACIP adolescent vaccination schedule. Children

who received MenACWY before age 10 years and for whom

boosters are recommended because of an ongoing increased

risk for meningococcal disease (e.g., those with complement

deficiency, HIV infection, or asplenia) should follow the

booster schedule for persons at increased risk.

Adolescents who receive their first dose at age 13–15 years

should receive a booster dose at age 16–18 years; the booster

dose can be administered at any time, as long as a minimum

interval of 8 weeks between doses is maintained. Adolescents

who receive a first dose after their 16th birthday do not

need a booster dose unless they become at increased risk

for meningococcal disease. Persons aged 19–21 years who

have not received a dose after their 16th birthday can receive

a single MenACWY dose as part of catch-up vaccination.

MenACWY vaccines are interchangeable; the same vaccine

product is recommended, but not required, for all doses.

MenACWY vaccines can be administered simultaneously

with other vaccines indicated for this age group, but at a

different anatomic site, if feasible. MenACWY-TT, which is

conjugated to tetanus toxoid, is only licensed for the prevention

of meningococcal disease; use of this vaccine does not replace

doses or affect the dosing intervals of routinely recommended

tetanus toxoid–containing vaccines in any age group.

MenB Vaccines

MenB vaccination is not routinely recommended for all

adolescents. Instead, ACIP recommends a MenB series for persons

aged 16–23 years (preferred age 16–18 years) on the basis of shared

clinical decision-making (240) (Table 2). Shared clinical decision-

making refers to an individually based vaccine recommendation

informed by a decision-making process between the health care

provider and the patient or parent/guardian. Considerations for

shared clinical decision-making for vaccine administration and

timing of administration might include

• the serious nature of meningococcal infections, with high

rates of death and permanent sequelae in those who

develop invasive disease;

• the low number of serogroup B meningococcal disease

cases (average of 34 serogroup B cases annually among

persons aged 16–23 years in the United States during

2015–2018);

• the increased risk among college students, especially those

who are freshmen, attend a 4-year university, live in

on-campus housing, or participate in sororities and

fraternities;

• the protection provided by MenB vaccines against most

strains of serogroup B N. meningitidis;

• the estimated relatively short duration of MenB protection

(antibody waning within 1–2 years postcompletion of the

primary series); and

• the evidence to date suggesting that MenB vaccination has

no effect on meningococcal carriage (i.e., MenB vaccines

might provide individual protection against serogroup B

disease but herd protection is unlikely).

For adolescents who are not otherwise at increased risk for

meningococcal disease (e.g., due to complement deficiency

or asplenia), a 2-dose series of MenB vaccine should be

administered as follows: 2 doses of MenB-FHbp administered

at 0 and 6 months or 2 doses of MenB-4C administered

at 0 and ≥1 month. If the second dose of MenB-FHbp is

administered earlier than 6 months after the first dose, a third

dose should be administered at least 4 months after the second

dose. Either of the MenB vaccines can be used when indicated;

ACIP does not state a product preference. However, MenB

vaccines are not interchangeable, and the same vaccine product

must be used for all doses. If one MenB dose was received but

the vaccine product is unknown, the series must be restarted

with either product to ensure completion of a 2-dose series

using the same product. If 2 doses were administered using

different MenB products, one product should be selected for

administration of an additional dose at an appropriate interval

to ensure valid completion of a MenB series; the dose from the

product not selected for series completion should be considered

invalid. For situations in which a MenB dose or doses must

be repeated, a minimum interval of 4 weeks should be used

between any 2 doses. MenB vaccines can be administered

simultaneously with other vaccines indicated for this age group,

but at a different anatomic site, if feasible.

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Persons at Increased Risk for

Meningococcal Disease

Persons at increased risk for meningococcal disease are

recommended to receive routine meningococcal vaccination.

Vaccine product, number of doses, and booster dose

recommendations are based on age and risk factors (Tables 3,

4, 5, 6, 7, 8, 9, and 10). Although evidence suggests that

vaccination might not adequately prevent meningococcal

infections among persons with certain complement deficiencies

or those using a complement inhibitor (66–70), these persons

should continue to be vaccinated according to recommendations

because of a possible benefit among persons at high risk for

infection (Table 4). Persons using complement inhibitor should

be vaccinated at least 2 weeks before complement inhibitor

initiation unless the risks for delaying treatment outweigh

the risks for developing meningococcal disease. Among

unvaccinated patients for whom complement inhibitor therapy

cannot be delayed, antimicrobial prophylaxis (e.g., penicillin)

should be administered alongside meningococcal vaccination

and continued for 2 weeks after vaccine administration (39,40).

In addition, providers might consider antimicrobial prophylaxis

for the duration of complement inhibitor therapy. Among

persons undergoing elective splenectomy, meningococcal

vaccines should be administered at least 2 weeks before surgery,

if possible; otherwise, they should be administered after the

procedure as soon as the patient’s condition is stable (241).

MenACWY Vaccines

Children at increased risk for meningococcal disease

caused by serogroups A, C, W, or Y (Box 1) who received

MenACWY at age <11 years and for whom booster vaccination

is recommended because of an ongoing increased risk should

follow the booster dose schedule (Tables 4, 5, 6, 7, 8, and 9),

not the routine adolescent schedule. For example, a child with

HIV infection who received MenACWY at age 9 years should

receive the next dose at age 14 years. Booster doses administered

to children aged <15 years, repeated booster doses, and booster

doses administered at an interval of <4 years are not licensed

in the United States and are considered off-label (Table 11).

Because of the high risk for invasive pneumococcal disease,

children with functional or anatomic asplenia or HIV infection

should not be vaccinated with MenACWY-D before age 2 years

to avoid interference with the immune response to 13-valent

pneumococcal conjugate vaccine (PCV13); MenACWY-CRM

should be used in this group. If MenACWY-D is used in

persons of any age with these conditions, it should not be

administered until at least 4 weeks after completion of all

PCV doses.

In addition, MenACWY-D should be administered either

before or at the same time as DTaP to avoid interference of

DTaP with the immune response to meningococcal vaccine

among children at increased risk for meningococcal disease.

If MenACWY-D cannot be given before or at the same time

as DTaP, it should be administered 6 months after DTaP,

unless the child is at increased risk for meningococcal disease

because of travel to an area where disease is hyperendemic or

epidemic or where an outbreak is occurring, in which case

MenACWY-D should be administered regardless of timing of

DTaP receipt. If MenACWY-D is inadvertently administered

in the 6 months after DTaP administration, the dose does not

need to be repeated.

If a healthy person aged ≥2 years previously vaccinated with a

single dose of MenACWY develops an underlying condition for

which meningococcal vaccination is recommended as a 2-dose

primary series, a second dose should be administered as soon as

possible, provided that an 8-week minimum interval between

doses is maintained. For example, a person who received a single

MenACWY dose before travel and then years later developed

asplenia should receive another dose as soon as possible to

complete the 2-dose series recommended for persons with

asplenia; restarting the 2-dose series is not required. Booster

doses should then be administered according to the schedule

(Tables 4, 5, and 6), with the first dose administered either 3

or 5 years after completion of the primary series, depending

on age. MenACWY vaccines are interchangeable; the same

vaccine product is recommended, but not required, for all

doses. Administration of MenACWY-D or MenACWY-CRM

in persons aged ≥56 years, a 2-dose MenACWY primary series

in persons aged ≥2 years at increased risk for meningococcal

disease, administration of >1 booster dose, and administration

of a booster dose in persons aged <15 years or at an interval

of <4 years since the last dose are not licensed in the United

States and are considered off-label ACIP recommendations

(Table 11).

First-year college students living in residence halls should

receive at least 1 dose of MenACWY within 5 years before

college entry. The preferred timing of the most recent dose is

on or after their 16th birthday. If only 1 dose of vaccine was

administered before the 16th birthday, a booster dose should

be administered before enrollment. Adolescents who received

a first dose after their 16th birthday do not need another dose

before college entry unless >5 years have elapsed since the dose.

MenB Vaccines

For persons at increased risk for meningococcal disease

(Box 1), including during serogroup B meningococcal disease

outbreaks, either a 3-dose MenB-FHbp series or 2-dose

MenB-4C primary series should be administered. For persons

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who previously completed a MenB primary series who become

or remain at increased risk for meningococcal disease, booster

vaccination should be administered according to the dosing

schedule (Tables 4, 5, 7, and 8). Primary series vaccination in

persons aged ≥26 years and booster vaccination in persons at

increased risk for meningococcal disease are not licensed in the

United States and are considered off-label (Table 11).

For the MenB-FHbp primary series, the 3-dose series

(at 0, 1–2, and 6 months) should be administered to provide

earlier protection and maximize short-term immunogenicity. If

the second dose is administered at an interval of ≥6 months, a

third dose does not need to be administered. If the third dose

is administered earlier than 4 months after the second dose, a

fourth dose should be repeated at least 4 months after the third

dose. For MenB-4C, doses should be administered at 0 and

≥1 months. The two MenB vaccines are not interchangeable;

the same vaccine product must be used for all doses, including

booster doses. Because efficacy has not been established for

persons receiving MenB vaccines interchangeably, every effort

should be made to determine vaccine product for all received

doses, including booster doses, because receiving mismatched

MenB vaccine products might result in inadequate protection

(see Vaccination of Adolescents and Adults). For situations in

which a dose or doses must be repeated, a minimum interval

of 4 weeks should be used between any 2 doses. MenB vaccines

can be administered simultaneously with other vaccines

indicated for this age group, but at a different anatomic site,

if feasible.

Establishment of Vaccine-Mediated

Immunity

ACIP does not recommend evaluation of antibody

titers against meningococcal serogroups for the purposes

of establishing immunity or the need for vaccination.

Commercially available immunoglobulin (e.g., IgG) testing

should not be used to infer individual seroprotection against

meningococcal disease.

Precautions and Contraindications

Because postvaccine syncope can occur with all injectable

vaccines, procedures should be in place to prevent falling

injuries and manage syncopal reactions. Vaccine providers,

particularly when vaccinating adolescents, should consider

observing patients (with patients seated or lying down) for

15 minutes after vaccination to decrease the risk for injury

should they faint. If syncope develops, patients should be

observed until symptoms resolve (241). Similarly, anaphylaxis

can occur after any vaccination. Furthermore, because the tip

caps of prefilled MenB-4C syringes contain natural rubber latex

and might cause allergic reactions, latex sensitivity is included

as a precaution for MenB-4C (70). Appropriate medical

treatment must be available should an acute allergic reaction,

including an anaphylactic reaction, occur. In addition, because

apnea after intramuscular vaccination has been observed in

some infants born prematurely, prematurity is a precaution

for MenACWY-CRM vaccination (66). Finally, although

postlicensure data have not established a risk for Guillain-

Barré syndrome after MenACWY-D vaccination, previous

history of Guillain-Barré syndrome is listed as a precaution

for MenACWY-D in the package insert (67).

For all meningococcal vaccines, severe allergic reaction

to a previous dose or any component of the vaccine is a

contraindication to vaccination (66–70). For MenACWY-D

and MenACWY-CRM, severe allergic reaction to any

diphtheria toxoid– or CRM

197

–containing vaccine is also a

contraindication (66,67). For MenACWY-TT, severe allergic

reaction to a tetanus toxoid–containing vaccine is also a

contraindication (68).

Pregnancy and Lactation

Pregnant and lactating women should receive MenACWY

vaccine if indicated. Because limited data are available for

MenB vaccination during pregnancy, vaccination with MenB

should be deferred unless the woman is at increased risk and,

after consultation with her health care provider, the benefits

of vaccination are considered to outweigh the potential risks.

Reporting of Vaccine Adverse Events

Adverse events that occur in a patient following meningococcal

vaccination can be reported to VAERS. Reporting is encouraged

for any clinically significant adverse event even if it is uncertain

whether the vaccine caused the event. Information on how to

submit a report to VAERS is available at https://vaers.hhs.gov

or by calling 1-800-822-7967.

Future Directions in Meningococcal

Vaccination

Although meningococcal disease incidence in the United

States is low and decreasing, continued surveillance and

evaluations are needed to assess the safety and effectiveness

of MenB vaccines, including repeated booster doses among

persons at increased risk for meningococcal disease. In addition

to MenB, continued monitoring of MenACWY use is necessary

to help evaluate the meningococcal vaccination program and

provide information about the need and strategy for additional

Recommendations and Reports

24 MMWR / September 25, 2020 / Vol. 69 / No. 9

US Department of Health and Human Services/Centers for Disease Control and Prevention

meningococcal vaccines, such as investigational serogroups A,

B, C, W, and Y (MenABCWY) vaccines, in the United States

(210,242). Furthermore, efforts are under way to reduce the

global incidence of meningococcal disease and other causes of

meningitis through a strategy that includes optimizing the use

of current vaccines as well as developing additional vaccines,

such as an expanded conjugate vaccine that includes serogroups A,

C, W, Y, and X for use in sub-Saharan Africa (243,244).

Acknowledgments

Amy Blain, Elizabeth Briere, Doug Campos-Outcalt, James Cope,

Amanda Cohn, Temitope Folaranmi, LeAnne Fox, Andrew Kroger,

Lucy McNamara, Ismael Ortega-Sanchez, Monica Patton, and

Xin Wang, CDC.

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Disclosure of Relationship and Unlabeled Use

All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of

potential conflicts of interest. No potential conflicts of interest were disclosed.

This report includes discussion of the unlabeled use of meningococcal vaccines in the following situations:

• Two-dose primary series of quadrivalent meningococcal conjugate vaccine (MenACWY) for persons aged ≥2 years at increased

risk for meningococcal disease because of certain underlying medical condition (i.e., persons who have persistent complement

component deficiencies, complement inhibitor use, anatomic or functional asplenia, or HIV infection).

• Repeated booster doses of MenACWY for certain persons who remain at increased risk for meningococcal disease for a

prolonged period. MenACWY-D and MenACWY-CRM are licensed for a single booster dose for persons aged 15–55 years

if at least 4 years have elapsed since the last dose; MenACWY-TT is licensed for a single booster dose for persons aged ≥15 years

if at least 4 years have elapsed since the last dose of MenACWY.

• The administration of MenACWY-D or MenACWY-CRM in certain persons aged ≥56 years at increased risk for

meningococcal disease.

• The administration of a MenB vaccine in certain persons aged ≥26 years at increased risk for meningococcal disease.

• The administration of MenB booster doses for certain persons aged ≥10 years who remain at increased risk for

meningococcal disease.

Advisory Committee on Immunization Practices

Membership as of June 1, 2020

Chair: Jose Romero, MD, University of Arkansas for Medical Sciences and Arkansas Children’s Hospital, Little Rock, Arkansas.

Executive Secretary: Amanda Cohn, MD, National Center for Immunization and Respiratory Diseases, CDC, Atlanta, Georgia.

Members: Robert Atmar, MD, Baylor College of Medicine, Houston, Texas; Kevin Ault, MD, University of Kansans Medical Center, Kansas City, Kansas;

Lynn Bahta, RN, Minnesota Department of Health, Saint Paul, Minnesota; Beth Bell, MD, University of Washington, Seattle, Washington; Henry Bernstein,

Zucker School of Medicine at Hofstra/Northwell Cohen Children’s Medical Center, New Hyde Park, New York; Sharon Frey, MD, Saint Louis University Medical

School, St. Louis, Missouri; Paul Hunter, MD, City of Milwaukee Health Department, Milwaukee, Wisconsin; Grace Lee, MD, Lucile Packard Children’s Hospital,

Stanford, California; Veronica McNally, JD, Franny Strong Foundation, West Bloomfield, Michigan; José Romero, MD, University of Arkansas for Medical Sciences

and Arkansas Children’s Hospital, Little Rock, Arkansas; Katherine Poehling, MD, Wake Forest School of Medicine, Winston-Salem, North Carolina; Pablo Sánchez,

MD, Research Institute at Nationwide Children’s Hospital, Columbus, Ohio; Peter Szilagyi, MD, University of California, Los Angeles, Los Angeles, California;

Helen Keipp Talbot, MD, Vanderbilt University, Nashville, Tennessee.

Ex Officio Members: Mary Beth Hance, Centers for Medicare and Medicaid Services, Baltimore, Maryland; Eric Deussing, MD, U.S. Department of Defense, CDC,

Atlanta, Georgia; Jane Kim, MD, U.S. Department of Veterans Affairs, Durham, North Carolina; Doran Fink, MD, Food and Drug Administration, Bethesda,

Maryland; Thomas Weiser MD, Indian Health Service, Portland, Oregon; John Beigel, MD, National Institutes of Health, Bethesda, Maryland; Tammy Beckham, DVM,

U.S. Department of Health and Human Services, District of Columbia.

Liaison Representatives: American Academy of Family Physicians, Pamela Rockwell, DO, Ann Arbor, Michigan; American Academy of Pediatrics, David Kimberlin, MD,

Birmingham, Alabama, Bonnie Maldonado MD, Stanford, California; American Academy of Physician Assistants, Marie-Michèle Léger, MPH, Alexandria, Virginia;

American College Health Association, Susan Even, MD, Columbia, Missouri; American College of Nurse Midwives, Carol Hayes, CNM, Atlanta, Georgia; American

College of Obstetricians and Gynecologists, Linda O’Neal Eckert, MD, Seattle, Washington; American College of Physicians, Jason Goldman, Boca Raton, Florida;

American Geriatrics Society, Kenneth Schmader, MD, Durham, North Carolina; American Immunization Registry Association, Rebecca Coyle, MSEd, Washington,

DC; American Medical Association, Sandra Adamson Fryhofer, MD, Atlanta, Georgia; American Nurses Association, Charles Rittle, DNP, Pittsburgh, Pennsylvania;

American Osteopathic Association, Stanley Grogg, DO, Tulsa, Oklahoma; American Pharmacists Association, Stephan Foster, PharmD, Memphis, Tennessee;

Association of Immunization Managers, Christine Finley, RN, Burlington, Vermont; Association for Prevention Teaching and Research, W. Paul McKinney, MD,

Louisville, Kentucky; Association of State and Territorial Health Officials, Nathaniel Smith, MD, Little Rock, Arkansas; Biotechnology Industry Organization,

Phyllis Arthur, MBA, Washington, DC; Canadian National Advisory Committee on Immunization, Caroline Quach, MD, Montréal, Canada; Council of State

and Territorial Epidemiologists, Christine Hahn, MD, Boise, Idaho; Infectious Diseases Society of America, Carol Baker, MD, Seattle, Washington; International

Society for Travel Medicine, Elizabeth Barnett, MD, Boston, Massachusetts; National Association of County and City Health Officials, Matthew Zahn, MD, Santa

Ana, California; National Association of Pediatric Nurse Practitioners, Patricia Stinchfield, RN, St. Paul, Minnesota; National Foundation for Infectious Diseases,

William Schaffner, MD, Nashville, Tennessee; National Immunization Council and Child Health Program, Mexico, Luis Duran, MD, Mexico; National Medical

Association, Patricia Whitley-Williams, MD, New Brunswick, New Jersey; Pediatric Infectious Diseases Society, Sean O’Leary, MD, Denver, Colorado; Pharmaceutical

Research and Manufacturers of America, David Johnson, MD, Swiftwater, Pennsylvania; Society for Adolescent Health and Medicine, Amy Middleman, MD, Houston,

Texas; Society for Healthcare Epidemiology of America, David Weber, MD, Chapel Hill, North Carolina.

Recommendations and Reports

34 MMWR / September 25, 2020 / Vol. 69 / No. 9

US Department of Health and Human Services/Centers for Disease Control and Prevention

ACIP Meningococcal Vaccines Work Group

Membership as of June 1, 2020

Chair: Veronica McNally, JD, East Lansing, Michigan.

Members: Nina Ahmad, MD, Albany, New York; Oliver Baclic, MD, Ottawa, Canada; Carol Baker, MD, Houston, Texas; Henry Bernstein, MD, New Hyde

Park, New York; Michael Brady, MD, Columbus, Ohio; Ruth Brenner, MD, Falls Church, Virginia; Susan Even, MD, Columbia, Missouri; Kathleen Harriman,

Richmond, California; Mary Healy, Houston, Texas; Rachel Herlihy, Denver, Colorado; Nneka Holder, MD, Jackson, Mississippi; Lucia Lee, MD, Rockville,

Maryland; Martin Luta, MD, Dover, Delaware; Ruth Lynfield, MD, St. Paul, Minnesota; Paul McKinney, MD, Louisville, Kentucky; Cody Meissner, MD, Boston,

Massachusetts; Kelly Moore, MD, Nashville, Tennessee; Paul Offit, MD, Philadelphia, Pennsylvania; Anuja Rastogi, MD, Rockville, Maryland; Lorry Rubin, MD,

New Hyde Park, New York; William Schaffner, MD, Nashville, Tennessee.

CDC contributors: Alison Albert, MPH; Amy Blain, MPH; Douglas Campos-Outcalt, MD; Amanda Cohn, MD; James Cope, PhD; Jonathan Duffy, MD;

LeAnne Fox, MD; Rachel Gorwitz, MD; Susan Hariri, PhD; Angela Jiles, MPH; Andrew Kroger, MD; Jessica MacNeil, MPH; Sarah Mbaeyi, MD; Sara Oliver, MD;

Ismael Ortega-Sanchez, PhD; Xin Wang, PhD; Charnetta Williams, MD.

Secretariat: Lucy McNamara, PhD, CDC, Atlanta, Georgia.

Recommendations and Reports

MMWR / September 25, 2020 / Vol. 69 / No. 9 35

US Department of Health and Human Services/Centers for Disease Control and Prevention

TABLE 1. Licensed and available* meningococcal vaccines — United States, 2020

Vaccine product Manufacturer Trade name Age group Year licensed

Conjugate (serogroups A, C, W, and Y)

MenACWY-D Sanofi Pasteur Menactra

†

9 mos–55 yrs 2005

MenACWY-CRM GlaxoSmithKline Menveo

2 mos–55 yrs 2010

MenACWY-TT Sanofi Pasteur MenQuadfi

≥2 yrs 2020

Protein based (directed at serogroup B)

MenB-FHbp Pfizer Trumenba** 10–25 yrs 2014

MenB-4C GlaxoSmithKline Bexsero

††

10–25 yrs 2015

Abbreviations: MenACWY-CRM=meningococcal groups A, C, W, and Y oligosaccharide diphtheria CRM

197

conjugate vaccine; MenACWY-D=meningococcal groups A,

C, W, and Y polysaccharide diphtheria toxoid conjugate vaccine; MenACWY-TT=meningococcal groups A, C, W, and Y polysaccharide tetanus toxoid conjugate vaccine;

MenB-4C=four-component meningococcal group B vaccine; MenB-FHbp=meningococcal group B factor H binding protein vaccine.

* Two licensed meningococcal vaccines are no longer available in the United States (Menomune – A/C/Y/W-135 [Source: Menomune – A/C/Y/W-135. Package insert.

Swiftwater, PA: Sanofi Pasteur; 2016. https://www.fda.gov/media/83562/download] and MenHibrix [Source: MenHibRix. Package insert. Rixensart, Belgium:

GlaxoSmithKline Biologicals; 2012. https://www.fda.gov/media/83688/download]).

†

Source: Menactra. Package insert. Swiftwater, PA: Sanofi Pasteur; 2018. https://www.fda.gov/media/75619/download.

Source: Menveo. Package insert. Sovicille, Italy: GlaxoSmithKline Vaccines; 2019. https://www.fda.gov/media/78514/download.

Source: MenQuadfi. Package insert Swiftwater, PA: Sanofi Pasteur; 2020. https://www.fda.gov/media/137306/download.

** Source: Trumenba. Package insert. Philadelphia, PA: Pfizer; 2018. https://www.fda.gov/media/89936/download.

††

Source: Bexsero. Package insert. Sovicille, Italy: GlaxoSmithKline Vaccines; 2018. https://www.fda.gov/media/90996/download.

TABLE 2. Recommended meningococcal vaccines and administration schedules for children and adults — Advisory Committee on Immunization

Practices, United States, 2020

Age group

Serogroups A, C, W, and Y meningococcal conjugate vaccines

MenACWY-D (Menactra, Sanofi Pasteur) or

MenACWY-CRM (Menveo, GlaxoSmithKline) or

MenACWY-TT (MenQuadfi, Sanofi Pasteur)

Serogroup B meningococcal vaccines

MenB-FHbp (Trumenba, Pfizer) or

MenB-4C (Bexsero, GlaxoSmithKline)

2 mos–10 yrs Not routinely recommended

See Table 3 for persons at increased risk

No recommendations for use of MenB vaccines in this population*

11–23 yrs Primary vaccination

†

: 1 dose at age 11–12 yrs

Booster: 1 dose at age 16 yrs if first dose administered before

16th birthday

Catch-up vaccination: Although routine vaccination is only

recommended for adolescents aged 11–18 yrs, MenACWY may be

administered to persons aged 19–21 yrs who have not received a dose

after their 16th birthday

Note: MenACWY vaccines are interchangeable

Primary vaccination: MenB series at age 16–23 yrs on basis of shared

clinical decision-making (preferred age 16–18 yrs)

• MenB-FHbp

: 2 doses at 0 and 6 mos

• MenB-4C: 2 doses ≥1 mo apart

Booster: Not routinely recommended unless the person becomes at

increased risk for meningococcal disease

Note: MenB-FHbp and MenB-4C are not interchangeable

≥24 yrs Not routinely recommended

See Table 3 for persons at increased risk

Not routinely recommended

See Table 3 for persons at increased risk

Abbreviations: MenACWY-CRM=meningococcal groups A, C, W, and Y oligosaccharide diphtheria CRM

197

conjugate vaccine; MenACWY-D=meningococcal groups A,

C, W, and Y polysaccharide diphtheria toxoid conjugate vaccine; MenACWY-TT=meningococcal groups A, C, W, and Y polysaccharide tetanus toxoid conjugate vaccine;

MenB-4C=four-component meningococcal group B vaccine; MenB-FHbp=meningococcal group B factor H binding protein vaccine.

* MenB vaccines are licensed in the United States only for persons aged 10–25 years.

†

College freshmen living in residence halls should receive at least 1 dose of MenACWY within 5 years before college entry. The preferred timing of the most recent

dose is on or after their 16th birthday. If only 1 dose of vaccine was administered before the 16th birthday, a booster dose should be administered before enrollment.

Adolescents who received a first dose after their 16th birthday do not need another dose before college entry unless it has been more than 5 years since the dose.

Certain schools, colleges, and universities have policies requiring vaccination against meningococcal disease as a condition of enrollment.

When given to healthy adolescents who are not otherwise at increased risk for meningococcal disease, 2 doses of MenB-FHbp should be administered at 0 and

6 months. For persons at increased risk for meningococcal disease and for use during serogroup B meningococcal disease outbreaks, 3 doses of MenB-FHbp should

be administered at 0, 1–2, and 6 months to provide earlier protection and maximize short-term immunogenicity.

Recommendations and Reports

36 MMWR / September 25, 2020 / Vol. 69 / No. 9

US Department of Health and Human Services/Centers for Disease Control and Prevention

TABLE 3. Recommended meningococcal vaccines for persons at increased risk for meningococcal disease — Advisory Committee on

Immunization Practices, United States, 2020

Risk group MenACWY vaccine MenB vaccine Table

Persons with complement component deficiency (e.g., C5–C9, properdin,

factor H, or factor D), including patients using a complement inhibitor

Aged ≥2 mos Aged ≥10 yrs 4

Persons with functional or anatomic asplenia (including sickle cell disease) Aged ≥2 mos Aged ≥10 yrs 5

Persons with HIV infection Aged ≥2 mos No recommendation 6

Microbiologists routinely exposed to Neisseria meningitidis Age appropriate* Age appropriate

†

Persons exposed during an outbreak of meningococcal disease due to a

vaccine-preventable serogroup

Aged ≥2 mos Aged ≥10 yrs 8

Persons who travel to or live in countries where meningococcal disease is

hyperendemic or epidemic

Aged ≥2 mos No recommendation 9

College freshmen living in residence halls Age appropriate* No recommendation 10

Military recruits Age appropriate* No recommendation 10

Abbreviations: HIV=human immunodeficiency virus; MenACWY=meningococcal groups A, C, W, and Y; MenB=meningococcal group B.

* Persons aged ≥2 months in these risk groups are recommended to receive MenACWY vaccination.

†

Persons aged ≥10 years in this risk group are recommended to receive MenB vaccination.

TABLE 4. Recommended vaccination schedule and intervals for persons with persistent complement deficiencies* (including patients using a

complement inhibitor)

†

— Advisory Committee on Immunization Practices, United States, 2020

Age group

Serogroups A, C, W, and Y meningococcal conjugate vaccines

MenACWY-D (Menactra, Sanofi Pasteur)

MenACWY-CRM (Menveo, GlaxoSmithKline)

MenACWY-TT (MenQuadfi, Sanofi Pasteur)**

Serogroup B meningococcal vaccines

MenB-FHbp (Trumenba, Pfizer) or

MenB-4C (Bexsero, GlaxoSmithKline)

2–23 mos Primary vaccination: MenACWY-D (aged ≥9 mos): 2 doses ≥12 wks apart

or MenACWY-CRM if first dose at age

• 2 mos: 4 doses at 2, 4, 6, and 12 mos

• 3–6 mos: See catch-up schedule

§§

• 7–23 mos: 2 doses (second dose ≥12 wks after the first dose and

after the 1st birthday)

No recommendations for use of MenB vaccines in this population

††

2–9 yrs Primary vaccination

¶¶

: MenACWY-D***

or MenACWY-CRM

or MenACWY-TT: 2 doses ≥8 wks apart

Boosters (if person remains at increased risk)

†††

• Aged <7 yrs: Single dose at 3 yrs after primary vaccination and

every 5 yrs thereafter

• Aged ≥7 yrs: Single dose at 5 yrs after primary vaccination and

every 5 yrs thereafter

No recommendations for use of MenB vaccines in this population

††

≥10 yrs Primary vaccination

††

: MenACWY-D

or MenACWY-CRM

or MenACWY-TT: 2 doses ≥8 wks apart

Boosters (if person remains at increased risk)

†††

: Single dose at

5 yrs after primary vaccination and every 5 yrs thereafter

Primary vaccination

††

: MenB-FHbp: 3 doses at 0, 1–2, and 6 mos

or MenB-4C: 2 doses ≥1 mo apart

Boosters (if person remains at increased risk)

§§§

: Single dose at 1 yr after

completion of primary vaccination and every 2–3 yrs thereafter

Note: MenB-FHbp and MenB-4C are not interchangeable

Abbreviations: DTaP = diphtheria and tetanus toxoids and acellular pertussis vaccine; MenACWY-CRM = meningococcal groups A, C, W, and Y oligosaccharide

diphtheria CRM

197

conjugate vaccine; MenACWY-D= meningococcal groups A, C, W, and Y polysaccharide diphtheria toxoid conjugate vaccine;

MenACWY-TT=meningococcal groups A, C, W, and Y polysaccharide tetanus toxoid conjugate vaccine; MenB-4C=four-component meningococcal group B vaccine;

MenB-FHbp=meningococcal group B factor H binding protein vaccine.

* Persistent complement deficiencies include C3, C5–C9, properdin, factor H, or factor D.

†

Includes eculizumab (Soliris) and ravulizumab (Ultomiris). Meningococcal vaccines should be administered at least 2 weeks before the first dose of complement

inhibitor, unless the risk for delaying complement therapy outweighs the risk for developing meningococcal disease.

Licensed in the United States only for persons aged 9 months–55 years. Vaccination of persons aged ≥56 years is considered off-label.

Licensed in the United States only for persons aged 2 months–55 years. Vaccination of persons aged ≥56 years is considered off-label.

** Licensed in the United States only for persons aged ≥2 years.

††

Licensed in the United States only for persons aged 10–25 years. Vaccination of persons aged ≥26 years is considered off-label.

§§

If MenACWY-CRM is initiated at ages 3–6 months, catch-up vaccination includes doses at intervals of 8 weeks until the infant is aged ≥7 months, at which time an

additional dose is administered at age ≥7 months, followed by a dose at least 12 weeks later and after the 1st birthday.

¶¶

Primary vaccination licensed as a single dose in persons aged 2–55 years for MenACWY-D and MenACWY-CRM or ≥2 years for MenACWY-TT. Two-dose primary

series is considered off-label.

*** MenACWY-D should be given either before or at the same time as DTaP to avoid interference with the immune response to meningococcal vaccine in children.

†††

Licensed in the United States only for a single booster dose for persons aged 15–55 years for MenACWY-D and MenACWY-CRM or aged ≥15 years for MenACWY-TT.

Booster doses administered outside of these ages or administration of >1 booster dose are considered off-label.

§§§

Licensed in the United States only for a primary series. Administration of booster doses is considered off-label.

Recommendations and Reports

MMWR / September 25, 2020 / Vol. 69 / No. 9 37

US Department of Health and Human Services/Centers for Disease Control and Prevention

TABLE 5. Recommended vaccination schedule and intervals for persons with anatomic and functional asplenia (including sickle cell disease) —

Advisory Committee on Immunization Practices, United States, 2020

Age group

Serogroups A, C, W, and Y meningococcal conjugate vaccines

MenACWY-D (Menactra, Sanofi Pasteur)* or

MenACWY-CRM (Menveo, GlaxoSmithKline)

†

MenACWY-TT (MenQuadfi, Sanofi Pasteur)

Serogroup B meningococcal vaccines

MenB-FHbp (Trumenba, Pfizer) or

MenB-4C (Bexsero, GlaxoSmithKline)

2–23 mos Primary vaccination: MenACWY-CRM: If first dose at age

• 2 mos: 4 doses at 2, 4, 6, and 12 mos

• 3–6 mos: See catch-up schedule

• 7–23 mos: 2 doses (second dose ≥12 wks after the first dose and

after the 1st birthday)

No recommendations for use of MenB vaccines in this population**

2–9 yrs Primary vaccination

††

: MenACWY-D

§§,¶¶

: 2 doses ≥8 wks apart

and ≥4 wks after completion of PCV13 series

or MenACWY-CRM

or MenACWY-TT: 2 doses ≥8 wks apart

Boosters (if person remains at increased risk)***:

• Aged <7 yrs: Single dose at 3 yrs after vaccination and

every 5 yrs thereafter

• Aged ≥7 yrs: Single dose at 5 yrs and every 5 yrs thereafter

No recommendations for use of MenB vaccines in this population**

≥10 yrs Primary vaccination

††

: MenACWY-D

¶¶

: 2 doses ≥8 wks apart

and ≥4 wks after completion of PCV13 series

or MenACWY-CRM

or MenACWY-TT: 2 doses ≥8 wks apart

Boosters (if person remains at increased risk)***: Single dose

at 5 yrs after primary vaccination and every 5 yrs thereafter

Primary vaccination**: MenB-FHbp: 3 doses at 0, 1–2, and 6 mos

or MenB-4C: 2 doses ≥1 mo apart

Boosters (if person remains at increased risk)

†††

: Single dose at 1 yr

after completion of primary vaccination and every 2–3 yrs thereafter

Note: MenB-FHbp and MenB-4C are not interchangeable

Abbreviations: DTaP = diphtheria and tetanus toxoids and acellular pertussis vaccine; MenACWY-CRM = meningococcal groups A, C, W, and Y oligosaccharide

diphtheria CRM

197

conjugate vaccine; MenACWY-D= meningococcal groups A, C, W, and Y polysaccharide diphtheria toxoid conjugate vaccine;

MenACWY-TT=meningococcal groups A, C, W, and Y polysaccharide tetanus toxoid conjugate vaccine; MenB-4C=four-component meningococcal group B vaccine;

MenB-FHbp=meningococcal group B factor H binding protein vaccine; PCV=pneumococcal conjugate vaccine.

* Licensed in the United States only for persons aged 9 months–55 years. Vaccination of persons aged ≥56 years is considered off-label.

†

Licensed in the United States only for persons aged 2 months–55 years. Vaccination of persons aged ≥56 years is considered off-label.

Licensed in the United States only for persons aged ≥2 years.

If MenACWY-CRM is initiated at ages 3–6 months, catch-up vaccination includes doses at intervals of 8 weeks until the infant is aged ≥7 months, at which time an

additional dose is administered at age ≥7 months, followed by a dose at least 12 weeks later and after the 1st birthday.

** Licensed in the United States only for persons aged 10–25 years. Vaccination of persons aged ≥26 years is considered off-label.

††

Primary vaccination licensed as a single dose in persons aged 2–55 years for MenACWY-D and MenACWY-CRM or ≥2 years for MenACWY-TT. Two-dose primary

series is considered off-label.

§§

MenACWY-D should be given either before or at the same time as DTaP to avoid interference with the immune response to meningococcal vaccine in children.

¶¶

Because of the high risk for invasive pneumococcal disease, children with functional or anatomic asplenia or human immunodeficiency virus infection should not

be vaccinated with MenACWY-D (Menactra) before age 2 years to avoid interference with the immune response to PCV. If MenACWY-D is used in a person (of any

age) with these conditions, it should not be administered until at least 4 weeks after completion of all PCV doses.

*** Licensed in the United States only for a single booster dose for persons aged 15–55 years for MenACWY-D and MenACWY-CRM or aged ≥15 years for MenACWY-TT.

Booster doses administered outside of these ages or administration of >1 booster dose are considered off-label.

†††

Licensed in the United States only for a primary series. Administration of booster doses is considered off-label.

Recommendations and Reports

38 MMWR / September 25, 2020 / Vol. 69 / No. 9

US Department of Health and Human Services/Centers for Disease Control and Prevention

TABLE 6. Recommended vaccination schedule and intervals for persons with human immunodeficiency virus infection — Advisory Committee

on Immunization Practices, United States, 2020

Age group

Serogroups A, C, W, and Y meningococcal conjugate vaccines

MenACWY-D (Menactra, Sanofi Pasteur)* or

MenACWY-CRM (Menveo, GlaxoSmithKline)

†

MenACWY-TT (MenQuadfi, Sanofi Pasteur)

Serogroup B meningococcal vaccines

MenB-FHbp (Trumenba, Pfizer) or

MenB-4C (Bexsero, GlaxoSmithKline)

2–23 mos Primary vaccination: MenACWY-CRM: If first dose at age

• 2 mos: 4 doses at 2, 4, 6, and 12 mos

• 3–6 mos: See catch-up schedule

• 7–23 mos: 2 doses (second dose ≥12 wks after the first dose

and after the 1st birthday)

No recommendations for use of MenB vaccines in these populations unless

otherwise indicated (in persons aged ≥10 yrs)

≥2 yrs Primary vaccination**: MenACWY-D

††,§§

: 2 doses ≥8 wks apart

and ≥4 wks after completion of PCV13 series

or MenACWY-CRM

or MenACWY-TT: 2 doses ≥8 wks apart

Boosters (if person remains at increased risk)

¶¶

• Aged <7 yrs: Single dose at 3 yrs after primary vaccination

and every 5 yrs thereafter

• Aged ≥7 yrs: Single dose at 5 yrs after primary vaccination

and every 5 yrs thereafter

See Table 2 for recommendations in persons aged 16–23 yrs

Abbreviations: DTaP = diphtheria and tetanus toxoids and acellular pertussis vaccine; MenACWY-CRM = meningococcal groups A, C, W, and Y oligosaccharide

diphtheria CRM

197

conjugate vaccine; MenACWY-D= meningococcal groups A, C, W, and Y polysaccharide diphtheria toxoid conjugate vaccine;

MenACWY-TT=meningococcal groups A, C, W, and Y polysaccharide tetanus toxoid conjugate vaccine; MenB-4C=four-component meningococcal group B vaccine;

MenB-FHbp =meningococcal group B factor H binding protein vaccine; PCV=pneumococcal conjugate vaccine; Td = tetanus and diphtheria toxoids vaccine;

Tdap = tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine.

* Licensed in the United States only for persons aged 9 months–55 years. Vaccination of persons aged ≥56 years is considered off-label.

†

Licensed in the United States only for persons aged 2 months–55 years. Vaccination of persons aged ≥56 years is considered off-label.

Licensed in the United States only for persons aged ≥2 years.

If MenACWY-CRM is initiated at ages 3–6 months, catch-up vaccination includes doses at intervals of 8 weeks until the infant is aged ≥7 months, at which time an

additional dose is administered at age ≥7 months, followed by a dose at least 12 weeks later and after the 1st birthday.

** Primary vaccination licensed as a single dose in persons aged 2–55 years for MenACWY-D and MenACWY-CRM or ≥2 years for MenACWY-TT. Two-dose primary

series is considered off-label.

††

MenACWY-D should be given either before or at the same time as DTaP to avoid interference with the immune response to meningococcal vaccine in children.

MenACWY-D may be given at any time in relation to Tdap or Td.

§§

Because of the high risk for invasive pneumococcal disease, children with functional or anatomic asplenia or human immunodeficiency virus infection should not

be vaccinated with MenACWY-D (Menactra) before age 2 years to avoid interference with the immune response to PCV. If MenACWY-D is used in a person (of any

age) with functional or anatomic asplenia or HIV infection, it should not be administered until at least 4 weeks after completion of all PCV doses.

¶¶

Licensed in the United States only for a single booster dose for persons aged 15–55 years for MenACWY-D and MenACWY-CRM or aged ≥15 years for MenACWY-TT.

Booster doses administered outside of these ages or administration of >1 booster dose are considered off-label.

TABLE 7. Recommended vaccination schedule and intervals for microbiologists routinely exposed to isolates of Neisseria meningitidis — Advisory Committee

on Immunization Practices, United States, 2020

Age group

Serogroups A, C, W, and Y meningococcal conjugate vaccines

MenACWY-D (Menactra, Sanofi Pasteur)* or

MenACWY-CRM (Menveo, GlaxoSmithKline)

†

MenACWY-TT (MenQuadfi, Sanofi Pasteur)

Serogroup B meningococcal vaccines

MenB-FHbp (Trumenba, Pfizer) or

MenB-4C (Bexsero, GlaxoSmithKline)

≥10 yrs Primary vaccination: MenACWY-D

or MenACWY-CRM

or MenACWY-TT: 1 dose

Boosters (if person remains at increased risk)**: Single dose

at 5 yrs after primary vaccination and every 5 yrs thereafter

Primary vaccination

: MenB-FHbp: 3 doses at 0, 1–2, and 6 mos

or MenB-4C: 2 doses ≥1 mo apart

Boosters (if person remains at increased risk)

††

: Single dose at 1 yr after

completion of primary vaccination and every 2–3 yrs thereafter

Note: MenB-FHbp and MenB-4C are not interchangeable

Abbreviations: MenACWY-CRM=meningococcal groups A, C, W, and Y oligosaccharide diphtheria CRM

197

conjugate vaccine; MenACWY-D=meningococcal groups A,

C, W, and Y polysaccharide diphtheria toxoid conjugate vaccine; MenACWY-TT=meningococcal groups A, C, W, and Y polysaccharide tetanus toxoid conjugate vaccine;

MenB-4C=four-component meningococcal group B vaccine; MenB-FHbp=meningococcal group B factor H binding protein vaccine.

* Licensed in the United States only for persons aged 9 months–55 years. Vaccination of persons aged ≥56 years is considered off-label.

†

Licensed in the United States only for persons aged 2 months–55 years. Vaccination of persons aged ≥56 years is considered off-label.

Licensed in the United States only for persons aged ≥2 years.

Licensed in the United States only for persons aged 10–25 years. Vaccination of persons aged ≥26 years is considered off-label.

** Licensed in the United States only for a single booster dose for persons aged 15–55 years for MenACWY-D and MenACWY-CRM or aged ≥15 years for MenACWY-TT.

Booster doses administered outside of these ages or administration of >1 booster dose are considered off-label.

††

Licensed in the United States only for a primary series. Administration of booster doses is considered off-label.

Recommendations and Reports

MMWR / September 25, 2020 / Vol. 69 / No. 9 39

US Department of Health and Human Services/Centers for Disease Control and Prevention

TABLE 8. Recommended vaccination schedule and intervals for persons who are at risk during an outbreak* attributable to a vaccine serogroup —

Advisory Committee on Immunization Practices, United States, 2020

Age group

Serogroups A, C, W, and Y meningococcal conjugate vaccines

MenACWY-D (Menactra, Sanofi Pasteur)

†

MenACWY-CRM (Menveo, GlaxoSmithKline)

MenACWY-TT (MenQuadfi, Sanofi Pasteur)

Serogroup B meningococcal vaccines

MenB-FHbp (Trumenba, Pfizer) or

MenB-4C (Bexsero, GlaxoSmithKline)

2–23 mos Primary vaccination: MenACWY-D (aged ≥9 mos):

2 doses ≥12 wks apart

or MenACWY-CRM: If first dose at age

• 2 mos: 4 doses at 2, 4, 6, and 12 mos

• 3–6 mos: See catch-up schedule

††

• 7–23 mos: 2 doses (second dose ≥12 wks after the first dose

and after the 1st birthday)

No recommendations for use of MenB vaccines in this population**

2–9 yrs Primary vaccination: MenACWY-D

§§

or MenACWY-CRM or MenACWY-TT: 1 dose

Boosters (if previously vaccinated and identified as

being at increased risk)

¶¶

• Aged <7 yrs: Single dose if ≥3 yrs since vaccination

• Aged ≥7 yrs: single dose if ≥5 yrs since vaccination

No recommendations for use of MenB vaccines in this population**

≥10 yrs Primary vaccination: MenACWY-D

or MenACWY-CRM

or MenACWY-TT: 1 dose

Boosters (if person previously vaccinated and identified as

being at increased risk during an outbreak)

¶¶

• Aged <7 yrs: Single dose if ≥3 yrs since vaccination

• Aged ≥7 yrs: Single dose if ≥5 yrs since vaccination

Primary vaccination: MenB-FHbp: 3 doses at 0, 1–2, and 6 mos

or MenB-4C: 2 doses ≥1 mo apart

Boosters (if person previously vaccinated and identified as

being at increased risk during an outbreak)***: Single dose if ≥1 yr

after MenB primary series completion (≥6 mos interval might also be

considered by public health professionals)

Note: MenB-FHbp and MenB-4C are not interchangeable

Abbreviations: DTaP = diphtheria and tetanus toxoids and acellular pertussis vaccine; MenACWY-CRM = meningococcal groups A, C, W, and Y oligosaccharide

diphtheria CRM

197

conjugate vaccine; MenACWY-D= meningococcal groups A, C, W, and Y polysaccharide diphtheria toxoid conjugate vaccine;

MenACWY-TT=meningococcal groups A, C, W, and Y polysaccharide tetanus toxoid conjugate vaccine; MenB-4C=four-component meningococcal group B vaccine;

MenB-FHbp=meningococcal group B factor H binding protein vaccine.

* Detailed recommendations on outbreak management are available at https://www.cdc.gov/meningococcal/downloads/meningococcal-outbreak-guidance.pdf.

†

Licensed in the United States only for persons aged 9 months–55 years. Vaccination of persons aged ≥56 years is considered off-label.

Licensed in the United States only for persons aged 2 months–55 years. Vaccination of persons aged ≥56 years is considered off-label.

Licensed in the United States only for persons aged ≥2 years.

** Licensed in the United States only for persons aged 10–25 years. Vaccination of persons aged ≥26 years is considered off-label.

††

If MenACWY-CRM is initiated at ages 3–6 months, catch-up vaccination includes doses at intervals of 8 weeks until the infant is aged ≥7 months, at which time an

additional dose is administered at age ≥7 months, followed by a dose at least 12 weeks later and after the 1st birthday.

§§

MenACWY-D should be given either before or at the same time as DTaP to avoid interference with the immune response to meningococcal vaccine in children.

¶¶

Licensed in the United States only for a single booster dose for persons aged 15–55 years for MenACWY-D and MenACWY-CRM or aged ≥15 years for MenACWY-TT.

Booster doses administered outside of these ages or administration of >1 booster dose are considered off-label.

*** Licensed in the United States only for a primary series. Administration of booster doses is considered off-label.

Recommendations and Reports

40 MMWR / September 25, 2020 / Vol. 69 / No. 9

US Department of Health and Human Services/Centers for Disease Control and Prevention

TABLE 9. Recommended vaccination schedule and intervals for persons who travel to or are residents of countries where meningococcal

disease is hyperendemic or epidemic* — Advisory Committee on Immunization Practices, United States, 2020

Age group

Serogroups A, C, W, and Y meningococcal conjugate vaccines

MenACWY-D (Menactra, Sanofi Pasteur)

†

MenACWY-CRM (Menveo, GlaxoSmithKline)

MenACWY-TT (MenQuadfi, Sanofi Pasteur)

Serogroup B meningococcal vaccines

MenB-FHbp (Trumenba, Pfizer) or

MenB-4C (Bexsero, GlaxoSmithKline)

2–23 mos Primary vaccination: MenACWY-D (aged ≥9 mos)**:

2 doses ≥12 wks apart (may be administered as early as

≥8 wks apart in travelers)

or MenACWY-CRM: If first dose at age

• 2 mos: 4 doses at 2, 4, 6, and 12 mos

• 3–6 mos: See catch-up schedule

§§

• 7–23 mos: 2 doses (second dose ≥12 wks after the first dose and

after the 1st birthday)

No recommendations for use of MenB vaccines in this population unless

otherwise indicated

††

≥2 yrs Primary vaccination: MenACWY-D**

or MenACWY-CRM

or MenACWY-TT: 1 dose

Boosters (if person remains at increased risk)

¶¶,

***

• Aged <7 yrs: Single dose at 3 yrs after primary vaccination

and every 5 yrs thereafter

• Aged ≥7 yrs: Single dose at 5 yrs after primary vaccination

and every 5 yrs thereafter

See Table 2 for recommendations in persons aged 16–23 yrs

Abbreviations: DTaP = diphtheria and tetanus toxoids and acellular pertussis vaccine; MenACWY-CRM = meningococcal groups A, C, W, and Y oligosaccharide

diphtheria CRM

197

conjugate vaccine; MenACWY-D= meningococcal groups A, C, W, and Y polysaccharide diphtheria toxoid conjugate vaccine;

MenACWY-TT=meningococcal groups A, C, W, and Y polysaccharide tetanus toxoid conjugate vaccine; MenB-4C=four-component meningococcal group B vaccine;

MenB-FHbp=meningococcal group B factor H binding protein vaccine; Td = tetanus and diphtheria toxoids vaccine; Tdap = tetanus toxoid, reduced diphtheria toxoid,

and acellular pertussis vaccine.

* For international travelers, vaccination is recommended for those visiting the parts of sub-Saharan Africa known as the meningitis belt during the dry season

(December–June). Vaccination may also be considered for travelers to countries that contain areas included in the meningitis belt but who travel to areas outside

of the meningitis belt zone. Advisories for travelers to other countries are issued by CDC when epidemics of meningococcal disease caused by vaccine-preventable

serogroups are detected. Traveler’s health information is available from CDC toll free by calling 1-877-394-8747 (1-877-FYI-TRIP) or at https://wwwnc.cdc.gov/

travel. Additional information about geographic areas for which vaccination is recommended can be obtained from international health clinics for travelers and

state health departments.

†

Licensed in the United States only for persons aged 9 months–55 years. Vaccination of persons aged ≥56 years is considered off-label.

Licensed in the United States only for persons aged 2 months–55 years. Vaccination of persons aged ≥56 years is considered off-label.

Licensed in the United States only for persons aged ≥2 years.

** MenACWY-D should be given either before or at the same time as DTaP to avoid interference with the immune response to meningococcal vaccine in children.

MenACWY-D may be given at any time in relation to Tdap or Td.

††

Some countries recommend routine use of MenB vaccines for infants; persons living in these countries might follow the vaccination recommendations of

these countries.

§§

If MenACWY-CRM is initiated at ages 3–6 months, catch-up vaccination includes doses at intervals of 8 weeks until the infant is aged ≥7 months, at which time an

additional dose is administered at age ≥7 months, followed by a dose at least 12 weeks later and after the 1st birthday.

¶¶

Licensed in the United States only for a single booster dose for persons aged 15–55 years for MenACWY-D and MenACWY-CRM or aged ≥15 years for MenACWY-TT.

Booster doses administered outside of these ages or administration of >1 booster dose are considered off-label.

*** International travelers should receive a booster dose of MenACWY if the last dose was administered 3–5 or more years previously (depending on the age at most

recent dose received). Vaccination is required by the Kingdom of Saudi Arabia (KSA) for all travelers to Mecca during the Hajj and Umrah pilgrimages. Travelers

should confirm current vaccination requirements with the KSA embassy.

Recommendations and Reports

MMWR / September 25, 2020 / Vol. 69 / No. 9 41

US Department of Health and Human Services/Centers for Disease Control and Prevention

TABLE 10. Recommended vaccination schedule and intervals for college freshmen living in residence halls* and military recruits — Advisory Committee on

Immunization Practices, United States, 2020

Age group

Serogroups A, C, W, and Y meningococcal conjugate vaccines

MenACWY-D (Menactra, Sanofi Pasteur)

†

MenACWY-CRM (Menveo, GlaxoSmithKline)

MenACWY-TT (MenQuadfi, Sanofi Pasteur)

Serogroup B meningococcal vaccines

MenB-FHbp (Trumenba, Pfizer) or

MenB-4C (Bexsero, GlaxoSmithKline)

≥10 yrs Primary vaccination: MenACWY-D

or MenACWY-CRM

or MenACWY-TT: 1 dose

Boosters**:

• College freshmen living in residence halls: Not routinely recommended

unless person becomes at increased risk due to another indication

• Military recruits: Every 5 yrs on basis of assignment

††

No recommendations for use of MenB vaccines in this population

unless otherwise indicated

See Table 2 for recommendations in persons aged 16–23 yrs

Abbreviations: MenACWY-CRM=meningococcal groups A, C, W, and Y oligosaccharide diphtheria CRM

197

conjugate vaccine; MenACWY-D=meningococcal groups A,

C, W, and Y polysaccharide diphtheria toxoid conjugate vaccine; MenACWY-TT=meningococcal groups A, C, W, and Y polysaccharide tetanus toxoid conjugate vaccine;

MenB-4C=four-component meningococcal group B vaccine; MenB-FHbp=meningococcal group B factor H binding protein vaccine.

* College freshmen living in residence halls should receive at least 1 dose of MenACWY within 5 years before college entry. The preferred timing of the most recent

dose is on or after their 16th birthday. If only 1 dose of vaccine was administered before the 16th birthday, a booster dose should be administered before enrollment.

Adolescents who received a first dose after their 16th birthday do not need another dose before college entry unless it has been more than 5 years since the dose.

Some schools, colleges, and universities have policies requiring vaccination against meningococcal disease as a condition of enrollment.

†

Licensed in the United States only for persons aged 9 months–55 years. Vaccination of persons aged ≥56 years is considered off-label.

Licensed in the United States only for persons aged 2 months–55 years. Vaccination of persons aged ≥56 years is considered off-label.

Licensed in the United States only for persons aged ≥2 years.

Licensed in the United States only for a single booster dose for persons aged 15–55 years for MenACWY-D and MenACWY-CRM or aged ≥15 years for MenACWY-TT.

Booster doses administered outside of these ages or administration of >1 booster dose are considered off-label.

††

Vaccination recommendations for military personnel are made by the U.S. Department of Defense on the basis of high-risk travel requirements.

TABLE 11. Off-label meningococcal vaccination recommendations for persons at increased risk for meningococcal disease, by age group and

indication — Advisory Committee on Immunization Practices, United States, 2020

Age group Indication

≥2 yrs Administration of a 2-dose MenACWY primary series in persons at increased risk for serogroups A, C, W, or Y meningococcal disease

Repeated booster doses of MenACWY for certain persons who remain at increased risk for serogroups A, C, W, or Y meningococcal disease

(MenACWY-D and MenACWY-CRM are licensed for a single booster dose for persons aged 15–55 yrs if at least 4 yrs have elapsed since the last

dose. MenACWY-TT is licensed for a single booster dose for persons aged ≥15 yrs if at least 4 yrs have elapsed since the last dose of MenACWY)

≥10 yrs MenB booster doses in certain persons who remain at increased risk for serogroup B meningococcal disease

≥26 yrs MenB primary series administration in persons at increased risk for serogroup B meningococcal disease

≥56 yrs Administration of MenACWY-D or MenACWY-CRM in persons at increased risk for serogroups A, C, W, or Y meningococcal disease

Abbreviations: MenACWY = quadrivalent meningococcal conjugate vaccine; MenACWY-CRM=meningococcal groups A, C, W, and Y oligosaccharide diphtheria

CRM

197

conjugate vaccine; MenACWY-D=meningococcal groups A, C, W, and Y polysaccharide diphtheria toxoid conjugate vaccine; MenACWY-TT=meningococcal

groups A, C, W, and Y polysaccharide tetanus toxoid conjugate vaccine; MenB = serogroup B meningococcal vaccine.

ISSN: 1057-5987 (Print)

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