Ask the Experts: Meningococcal B

Results (36)

Meningococcal disease is a bacterial infection caused by Neisseria meningitidis. Meningococcal disease usually presents clinically as meningitis (about 50% of cases), bacteremia (30% of cases), or bacteremic pneumonia (15% of cases). 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. Meningococcal disease can be severe. The overall case-fatality ratio in the U.S. is 15%, and 10%–20% of survivors have long-term sequelae such as neurologic disability, limb or digit loss, and hearing loss.

N. meningitidis is classified into 12 serogroups based on characteristics of the polysaccharide capsule. Most invasive disease (such as meningitis and sepsis) is caused by serogroups A, B, C, W, X and Y. The relative importance of serogroups depends on geographic location and other factors such as age. Between 2011 and 2020 in the United States, serogroup B caused about 60% of cases among children younger than 5 years old, and serogroups C, W, or Y caused about two out of three cases in people age 11 years or older. Serogroup A is rare in the U.S. Historically, serogroup A was common in the meningitis belt of sub-Saharan Africa, but after the implementation of a meningococcal serogroup A conjugate vaccine campaign, serogroup A disease has been nearly eliminated in the meningitis belt.

Nasopharyngeal carriage rates are highest in adolescents and young adults who serve as reservoirs for transmission of N. meningitidis.

Last reviewed: July 15, 2023

The incidence of meningococcal disease has declined steadily in the U.S. since a peak of reported disease in the late 1990s. Even before routine use of a meningococcal conjugate vaccine against serogroups A, C, W, and Y (MenACWY) was recommended for adolescents in 2005, the overall annual incidence of meningococcal disease had decreased 64%, from 1.1 cases per 100,000 population in 1996 to 0.4 cases per 100,000 population in 2005. In 2020, the rate of meningococcal disease in the United States reached a historic low of 0.07 cases per 100,000 population.

In 2020, of U.S. cases with known serogroup, 55 cases were serogroup B (incidence rate of 0.02 cases per 100,000 population) and 119 cases were serogroups C, Y, or W. The incidence of disease is extremely low in all age groups, but is highest in infants under 1 year (0.43 cases per 100,000), children age 1 through 4 years (0.12 cases per 100,000), and adolescents age 16–23 (0.09 cases per 100,000 years).

Last reviewed: July 15, 2023

In addition to risk based on age, non-specific risk factors for serogroups A, C, W and Y include having a previous viral infection, living in a crowded household, having an underlying chronic illness, and being exposed to cigarette smoke (either directly or second-hand).

The following groups are at increased risk for all meningococcal serogroups:

  • People with persistent (genetic) complement component deficiencies (a type of immune system disorder)
  • People who use complement inhibitors such as eculizumab (Soliris, Alexion Pharmaceuticals) and ravulizumab (Ultomiris, Alexion Pharmaceuticals) for treatment of atypical hemolytic uremic syndrome or paroxysmal nocturnal hemoglobinuria
  • People with anatomic or functional asplenia
  • Microbiologists routinely exposed to meningococcal isolates in a laboratory
  • People at increased risk during an outbreak of meningococcal disease
  • Military recruits
  • College students

Certain groups are at increased risk of serogroups A, C, W and Y, but not serogroup B:

  • People living with HIV
  • Men who have sex with men (MSM)
  • Travelers to countries where meningococcal disease is endemic or hyperendemic, such as the meningitis belt of sub-Saharan Africa
Last reviewed: July 15, 2023

The vaccines for meningococcal serogroups A, C, W, and Y (MenACWY; Menactra or MenQuadfi by Sanofi; Menveo by GSK) contain meningococcal conjugate in which the surface polysaccharide is chemically bonded (“conjugated”) to a protein to produce a robust immune response to the polysaccharide. Although each of the 3 MenACWY vaccine products uses a different protein conjugate, the products are considered interchangeable; the same vaccine product is recommended, but not required, for all doses.

A discontinued meningococcal polysaccharide vaccine (MPSV4, Menomune, Sanofi) was available in the United States until all doses expired in September 2017. With rare exception, it was not interchangeable with MenACWY conjugate vaccines.

Since late 2014, vaccines have become available that offer protection from meningococcal serogroup B disease (MenB; Bexsero by GSK; Trumenba by Pfizer). These vaccines are composed of proteins found on the surface of the bacteria. These vaccine products are not interchangeable; the same vaccine product is required for all doses.

MenACWY vaccines provide no protection against serogroup B disease, and meningococcal serogroup B vaccines (MenB) provide no protection against serogroup A, C, W, or Y disease. For protection against all 5 serogroups of meningococcus, it is necessary to receive both MenACWY and MenB.

Trade Name Type of Vaccine Serogroups Year Licensed Approved Ages
Menactra Conjugate A, C, W, Y 2005 9 mos.–55 years*
Menveo (two vial)
Menveo (one vial)
Conjugate
Conjugate
A, C, W, Y
A, C, W, Y
2010
2022
2 mos.–55 years*
10–55 years
MenQuadfi Conjugate A, C, W, Y 2020 2 years and older
Trumenba Protein B 2014 10–25 years*
Bexsero Protein B 2015 10–25 years*

*May be given to adults at increased risk older than the FDA-approved upper age limit (see ACIP recommendations, Table 11, page 41, www.cdc.gov/mmwr/volumes/69/rr/pdfs/rr6909a1-H.pdf)

Last reviewed: July 15, 2023

The most current comprehensive recommendations from the Advisory Committee on Immunization Practices (ACIP) for meningococcal vaccines is available on the MMWR website at www.cdc.gov/mmwr/volumes/69/rr/pdfs/rr6909a1-H.pdf. This document replaces all previously published reports and policy notes.

Last reviewed: July 15, 2023

MenB is routinely recommended for these groups:

  • People age 10 years and older who have functional or anatomic asplenia (including sickle cell disease)
  • People age 10 years and older who have persistent complement component deficiency (an immune system disorder) or who take a complement inhibitor such as eculizumab (Soliris, Alexion Pharmaceuticals) or ravulizumab (Ultomiris, Alexion Pharmaceuticals)
  • People age 10 years and older who are exposed during an outbreak caused by serogroup B
  • Microbiologists who work with meningococcal isolates in a laboratory

For adolescents and young adults not otherwise at increased risk for meningococcal B disease, ACIP recommends that a MenB series may be administered to people 16 through 23 years of age (preferred age 16 through 18 years) on the basis of shared clinical decision-making. The shared clinical decision-making recommendation allows the clinician and patient to decide together based upon the risks and benefits of vaccination for the individual patient.

Last reviewed: July 15, 2023

The change from “Category B” to “shared clinical decision-making” was done to describe more clearly the intent of the recommendation that the patient should be informed of the option to be vaccinated against meningococcal serogroup B disease and that the decision to vaccinate against MenB should be made by the provider and patient together. ACA requires coverage of vaccines as indicated on the recommended immunization schedule, including vaccines with shared clinical decision-making recommendations. The Vaccines for Children (VFC) program also covers vaccines recommended for shared clinical decision-making.

Last reviewed: July 15, 2023

To assist with the shared clinical decision-making around the option to vaccinate against meningococcal serogroup B disease and the timing of vaccination, CDC has provided some specific considerations about the disease and the vaccine that the patient and provider may weigh:

  • Serious nature of invasive meningococcal serogroup B infection, with a high risk of death and permanent complications
  • Low level of serogroup B disease in the United States, with an average of 34 cases each year among people age 16 through 23 years between 2015 and 2018, declining to 9 cases in 2020.
  • Increased risk among college students, especially those who are freshmen, attending a 4-year university, living in on-campus housing, or participating in sorority and fraternity life
  • Protection of MenB vaccine against most strains of meningococcal serogroup B bacteria
  • Estimated relatively short duration of MenB vaccine protection, with antibody levels waning within 1–2 years of completing the primary series; however, if a booster is indicated (e.g., during an outbreak) antibody titers rise in one to two weeks after booster dose administration
  • Evidence to date suggests no impact of MenB vaccine on meningococcal B carriage (may protect an individual from invasive disease but is unlikely to impact transmission of the bacteria to others)
Last reviewed: July 15, 2023

MenB vaccines were approved based on the serologic response to the vaccine. No data are available on vaccine effectiveness against clinical disease or duration of protection against clinical disease. Short term protection refers to the known duration of the antibody response. Available data indicate that protective antibody levels wane in most recipients within 1–2 years of completion of the primary series.

Last reviewed: July 15, 2023

Several small outbreaks of meningococcal serogroup B disease have occurred on college campuses since 2013. However, the disease incidence in college students remains very low (0.03 cases per 100,000 college students age 18 to 24 years in 2020). ACIP does not routinely recommend MenB vaccine for college students. However, the recommendation for shared clinical decision-making applies to all college students age 16 through 23 years who may choose to receive MenB vaccine to reduce their risk of meningococcal serogroup B disease. In addition, some colleges and universities require MenB vaccination for incoming students.

If a college student completes the MenB vaccine series at least 6 months to 1 year before being identified as at risk during an outbreak, a single booster dose of the same brand can boost levels of protective antibodies within 1-2 weeks. The ability to be protected quickly during an outbreak by a single booster dose may be an important consideration for college students, families, and administrators when deciding about getting the MenB vaccine primary series.

Last reviewed: July 15, 2023

Trumenba (MenB-Fhbp, Pfizer) is either a 2-dose series with doses administered at least 6 months apart or a 3-dose series with the second and third doses administered 1–2 and 6 months after the first dose. Bexsero (MenB-4C, GSK) is a 2-dose series with doses given at least 1 month apart.

Last reviewed: July 15, 2023

Healthy adolescents who are not at increased risk for meningococcal B disease should receive 2 doses of Trumenba (MenB-FHbp) administered at 0 and 6 months. If the second dose is given at an interval of less than 6 months, a third dose should be given at least 4 months after the 2nd dose.

For people age 10 years and older at increased risk for meningococcal B disease, 3 doses of Trumenba should be administered at 0, 1–2, and 6 months. The 3-dose series should be used for all people with functional or anatomic asplenia, people with persistent complement component deficiency (an immune system disorder) or those who take a complement inhibitor (eculizumab [Soliris] or ravulizumab [Ultomiris]), microbiologists who work with meningococcal isolates in a laboratory, and people exposed during serogroup B outbreaks.

Last reviewed: July 15, 2023

No. The 3-dose series (at 0, 1–2 and 6 months) is intended to rapidly induce immunity to serogroup B meningococcal bacteria. If a microbiologist or other person at increased risk has received 2 doses of Trumenba separated by 6 months their vaccine series can be considered to be complete.

Last reviewed: July 15, 2023

The only way to meet the school entry deadline for a complete series by September would be to restart a primary series with Bexsero (MenB-4C), which requires two doses spaced at least 4 weeks apart. You must wait a minimum of 4 weeks after the Trumenba dose to initiate the Bexsero series.

Last reviewed: July 15, 2023

The patient can complete the series with either vaccine. If Bexsero (MenB-4C) is chosen, the second and final dose should be administered at least 1 month after yesterday’s dose. If Trumenba (MenB-FHbp) is chosen and the patient is healthy (i.e., does not have a high-risk condition for meningococcal B disease such as asplenia), the second and final dose of Trumenba should be administered at least 4 months after yesterday’s Bexsero dose (6 months after the first Trumenba dose). If the person is at increased risk for meningococcal B disease and Trumenba is being used, a second Trumenba dose should be administered 1 month after yesterday’s Bexsero dose and a third dose should be administered 4 months after the second Trumenba dose.

Last reviewed: July 15, 2023

Immunize.org has prepared a document that provides a summary of the ACIP recommendations for use of MenB. The document is available at www.immunize.org/catg.d/p2035.pdf.

Last reviewed: July 15, 2023

No. The ACIP meningococcal serogroup B vaccine recommendations state that the same vaccine must be used for all doses in the MenB series, including booster doses. If the brand of a previous dose is unavailable or cannot be determined, restart the primary series with the available brand.

Last reviewed: July 15, 2023

Yes. The 2020 ACIP recommendations for MenB include a booster dose schedule for MenB vaccination of people at high risk for meningococcal serogroup B disease. The first booster dose is recommended one year after completion of the primary series, with a subsequent booster dose administered every 2–3 years thereafter, as long as risk remains. Because MenB vaccine brands are not interchangeable, all doses, including booster doses, should be of the same MenB brand. If the brand of the primary series is not known or not available, CDC recommends restarting the primary series with the available product.

Last reviewed: July 15, 2023

Eculizumab (Soliris) and the related long-acting compound, ravulizumab (Ultomiris) bind to C5 and inhibit the terminal complement pathway. People with persistent complement component deficiency due to an immune system disorder or use of a complement inhibitor are at increased risk for meningococcal disease even if fully vaccinated. This patient should be given a series of MenACWY vaccine, MenACWY (2 doses separated by at least 8 weeks) and a 2- or 3-dose series (depending on brand) of MenB vaccine. The patient should receive regular booster doses of MenACWY and MenB as long as he remains at risk: a booster dose of MenACWY every 5 years and a booster dose of MenB one year after completion of the primary series, followed by a booster dose of MenB every 2–3 years thereafter.

Because patients treated with complement inhibitors can develop invasive meningococcal disease despite vaccination, clinicians using Soliris or Ultomiris also may consider antimicrobial prophylaxis for the duration of complement inhibitor therapy.

Last reviewed: July 15, 2023

Recommendations to separate MenACWY and PCV only apply to one of the three MenACWY vaccines, MenACWY-D (Menactra), and also only apply to individuals with functional or anatomic asplenia or HIV infection. So, you do may administer the recommended vaccines at the same time. A 10-year-old with persistent complement component deficiency also should receive a 2- or 3-dose series (depending on brand) of MenB vaccine.

As long as the child remains at high risk of meningococcal disease due to complement inhibitor use, booster doses of both MenACWY and MenB are recommended. A MenACWY booster dose should be given every 5 years and a MenB booster dose should be given one year after the completion of the primary series, followed by a booster dose every 2–3 years thereafter.
Because patients treated with complement inhibitors can develop invasive meningococcal disease despite vaccination, clinicians using Soliris or Ultomiris also may consider antimicrobial prophylaxis for the duration of complement inhibitor therapy.

Last reviewed: July 15, 2023

Yes. Studies from the United States, South Africa, and the United Kingdom have shown that people with HIV infection have a risk of invasive meningococcal disease that is 11–24 times higher than the general population. In the United States, this excess risk is specifically for serogroups C, W, and Y. ACIP recommends routine MenACWY vaccination of all HIV-infected people 2 months of age and older. Children younger than age 2 years should be vaccinated using a multidose schedule based upon age (see the Immunize.org document “Meningococcal ACWY Vaccine Recommendations by Age and Risk Factor,” available at www.immunize.org/catg.d/p2018.pdf for details).

People age 2 years and older with HIV infection who have not been previously vaccinated should receive a 2-dose primary series of MenACWY (doses separated by at least 8 weeks). People with HIV infection who have previously received one dose of MenACWY should receive a second dose at the earliest opportunity (at least 8 weeks after the previous dose) and then receive booster doses at the appropriate intervals. ACIP does not recommend routine meningococcal serogroup B vaccination of people with HIV infection: MenB may be given based upon shared clinical decision-making to people with HIV who are age 16 through 23 years old, preferably between ages 16 and 18 years.

Last reviewed: July 15, 2023

Either Trumenba (MenB-FHbp) or the Bexsero MenB vaccine brand (MenB-4C) may be used for people with HIV infection. If Trumenba is administered, the CDC meningococcal subject matter experts recommend that the 3-dose schedule should be used. People with HIV infection do not appear to be at higher risk for meningococcal serogroup B disease, but because of their HIV infection they might not respond to the vaccine as well, the 3-dose schedule is preferred. When Bexsero is used, the schedule is 2 doses, regardless of risk status. Booster doses of MenB are not recommended for people with HIV in the absence of another indication for MenB vaccination.

Last reviewed: July 15, 2023

Use of either brand of MenB in persons younger than age 10 years is off-label in the U.S. There is no ACIP recommendation for use of this vaccine for this age group.

Bexsero (MenB-4C) has been studied among infants and is approved for infants by the European Medicines Agency (the European version of the U.S. Food and Drug Administration). It is routinely recommended for infants in the United Kingdom (see www.nhs.uk/conditions/vaccinations/pages/meningitis-b-vaccine.aspx for details). A clinician may choose to use a vaccine off-label if, in their opinion, the benefit of the vaccine exceeds the risk from the vaccine.

Last reviewed: July 15, 2023

ACIP recommends that microbiologists who work with meningococcal isolates in a laboratory receive both MenB and MenACWY vaccines. MenB can be given at the same time as any other vaccine. You can administer either two doses of Bexsero (MenB-4C) 4 weeks apart, or three doses of Trumenba (MenB-FHbp) on a 0-, 1–2-, and 6-month schedule.

Because protective antibody levels begin to wane within 1–2 years after completing the primary series, ACIP recommends a booster dose of MenB one year after completing the primary series, followed by a booster dose every 2–3 years thereafter, as long as risk remains. MenB vaccine brands work differently and are not interchangeable. All doses, including booster doses, should be of the same brand. If the brand of the primary series is not known or is not available, restart the primary series with the available brand.

Last reviewed: July 15, 2023

MenB is not specifically recommended for immunosuppressed people. However, after discussing the pros and cons of vaccination (also known as shared clinical decision-making), people age 16 through 23 years who are not at increased risk may receive routine MenB vaccination with either a 2-dose series of Bexsero (MenB-4C) 4 weeks apart, or a 2-dose series of Trumenba (MenB-FHbp) 6 months apart.

Last reviewed: July 15, 2023

ACIP does not recommend routine MenB vaccination for travel to countries in sub-Saharan Africa or to other countries for which MenACWY vaccine is recommended. Meningococcal disease in these areas is generally not caused by serogroup B.

Last reviewed: July 15, 2023

ACIP recommends booster doses of MenB vaccines for people at increased risk of MenB disease. Booster doses should be administered to people in the following groups as long as increased risk remains:

  • People with functional or anatomic asplenia, including sickle cell disease
  • People with persistent complement component deficiency (an immune system disorder)
  • People who take a complement inhibitor (eculizumab [Soliris] or ravulizumab [Ultomiris])
  • Microbiologists who routinely work with meningococcal isolates
  • Previously vaccinated people who are at risk during a meningococcal B disease outbreak

Because protective antibody levels produced by the primary series begin to wane within 1–2 years, the first booster dose is recommended one year after completion of the primary series, with subsequent booster doses every 2–3 years as long as increased risk remains. Previously vaccinated people identified by public health as being at risk during a meningococcal B outbreak should receive a booster dose if it has been at least one year since completion of their primary series, though depending upon the specific circumstances, public health may recommend a booster dose as little as 6 months after completion of the primary series.

Last reviewed: July 15, 2023

ACIP voted to recommend MenB booster doses for people at ongoing increased risk of meningococcal serogroup B disease in June 2019 and the recommendation was published in 2020 (www.cdc.gov/mmwr/volumes/69/rr/pdfs/rr6909a1-H.pdf). As long as you use Bexsero (MenB-4C) as the booster dose, the patient does not need to restart the primary series. This patient should be given a booster dose of Bexsero now and receive subsequent booster doses every 2–3 years.

Brands of MenB vaccine work differently and are not interchangeable. The only time ACIP recommends restarting the primary series is if the brand used for the primary series is not known or is unavailable.

Last reviewed: July 15, 2023

During an outbreak of meningococcal B disease, swift protection of those at risk is prioritized and CDC subject matter experts do not recommend delaying vaccination in order to locate records. Student health services with documentation of MenB vaccination (including brand) of incoming students, either in a state immunization registry or in student health records, will be able to respond most efficiently to an outbreak.

Students whose primary series of MenB vaccine was completed at least 1 year before the outbreak (or as little as 6 months before the outbreak, if recommended by public health) should receive a single booster dose of the same brand of MenB vaccine. If the same brand is unavailable, they should restart the primary series with the available brand. If the brand of the primary series is unknown, administer a dose of the available product and counsel the recipient to request records of the primary series: if the primary series brand is different, then in order to ensure optimal protection, the recipient should be given a booster dose of the primary series product or complete a primary series with the available product after a minimum interval of 4 weeks.

Last reviewed: July 15, 2023

Yes. MenB vaccines work differently and receiving mismatched MenB doses might result in inadequate protection. For this reason, documentation of the brand of vaccine in immunization is especially important. If a patient at high risk requires a booster dose and the brand of the primary series doses cannot be determined or is unavailable, then CDC recommends restarting the primary series with the available brand.

The first booster dose is recommended one year following completion of the primary series with subsequent booster doses every 2–3 years thereafter, as long as risk remains.

Last reviewed: July 15, 2023

In clinical trials and in postlicensure safety surveillance, the most common local adverse events within 7 days of receiving MenB were injection site pain, swelling or redness and the most common systemic symptoms were headache, fatigue and body aches. In general, these types of self-limited reactions are reported more frequently than with MenACWY vaccination.

Last reviewed: July 15, 2023

As with all vaccines, a severe allergic reaction (for example, anaphylaxis) to a vaccine component or to a prior dose is a contraindication to further doses of that vaccine. The tip caps of the Bexsero pre-filled syringes contain natural rubber latex which may cause allergic reactions in latex sensitive individuals. A moderate or severe acute illness is a precaution; vaccination should be deferred until the person’s condition has improved. Because MenB is an inactivated vaccine it can be administered to persons who are immunosuppressed as a result of disease or medications; however, response to the vaccine might be less than optimal. Data on MenB vaccination during pregnancy is limited. Pregnancy a precaution to MenB vaccination, but MenB may be administered if, in the judgment of the clinician, the benefits outweigh any potential risks.

Last reviewed: July 15, 2023

Few data are available on the effect of MenB vaccines on pregnancy. The manufacturers do not consider pregnancy to be a contraindication to use of MenB. GSK has established a Vaccination in Pregnancy registry. People who receive Bexsero during pregnancy may access information about the GSK Bexsero Pregnancy Registry here: https://pregnancyregistry.gsk.com/bexsero.html. Pfizer also maintains a Vaccination in Pregnancy registry for Trumenba, although specific contact details for this registry are not available. In general, vaccination against MenB should be deferred during pregnancy; however, MenB may be administered if, in the judgment of the clinician, the benefits outweigh any potential risk.

Last reviewed: July 15, 2023

Store at MenB at refrigerator temperature, between 2° and 8°C (between 36° and 46°F). The vaccines must not be frozen. Vaccine that has been frozen or exposed to freezing temperature should not be used. Do not use after the expiration date.

Last reviewed: July 15, 2023

All meningococcal conjugate vaccines (MenACWY, MenB) should be administered by the intramuscular route.

Last reviewed: July 15, 2023

Yes. MenACWY and MenB vaccines can be given at the same visit or at any time before or after the other.

Last reviewed: July 15, 2023

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