Vaccine
Talk

N.B. The only Men B found in Egypt is Bexsero (MenB-4C).
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 from 2 months

Please tell us about meningococcal disease.

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.

What groups are at increased risk for meningococcal disease?

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), ravulizumab (Ultomiris, Alexion Pharmaceuticals), or sutimlimab (Enjaymo, Sanofi) 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

What meningococcal vaccines are available in the United States?

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. Bexsero and Trumenba are not interchangeable; the same vaccine product is required for all doses.

Who is recommended to be vaccinated against meningococcal B disease?

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 (examples include eculizumab [Soliris], ravulizumab [Ultomiris], and sutimlimab [Sanofi])
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.

The ACIP recommendations for meningococcal serogroup B (MenB) vaccine say the vaccine will provide "short term protection." What does "short term protection" mean?

MenB vaccines were approved based on the serologic response to the vaccine. Because meningococcal B disease is so rare, 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. Antibody levels rise sharply within 1-2 weeks of a booster dose.

What is the schedule for MenB?

Both MenB vaccine products, Trumenba (MenB-Fhbp, Pfizer) and Bexsero (MenB-4C, GSK) are routinely given as a 2-dose series with doses administered at least 6 months apart. A 3-dose schedule is recommended for people who need rapid protection against MenB due to an increased risk of MenB disease. For the 3-dose schedule, dose 2 is given 1-2 months after dose 1 and dose 3 at least 6 months after dose 1.

Penbraya (MenABCWY, Pfizer) contains MenB-Fhbp (Trumenba) and is given as two doses, 6 months apart, when vaccination against all 5 serogroups is needed. For adolescents and adults not at increased risk (who need only one dose of MenACWY vaccine), if Penbraya is used, Trumenba should be administered to complete the 2-dose MenB series. For people age 10 years or older at increased risk of meningococcal disease, Penbraya may be used for additional MenACWY and MenB doses (including booster doses) when both vaccines would be given on the same clinic day and at least 6 months have elapsed since most recent Penbraya dose.

In August 2024, FDA revised the licensed schedule for Bexsero to be the same as the schedule and dosing intervals of the other MenB vaccine product, Trumenba. The change was made due to evidence of a small, but significant, improvement in the immune response to Bexsero when 2 doses were given 6 months apart, instead of 1 month apart, as previously licensed. As with Trumenba, a third dose of Bexsero is due, at least 4 months after the second dose and 6 months after the first, if dose 2 is given less than 6 months after dose 1. No additional doses are recommended for people who previously completed the 2-dose Bexsero series using a 1-month interval as licensed and recommended at the time.

Why did FDA change the dosing schedule for Bexsero (GSK) in August 2024, and do I need to recall my patients who received Bexsero under the old schedule?

In August 2024, FDA revised the licensed schedule for Bexsero to be the same as the schedule and dosing intervals of the other MenB vaccine product, Trumenba (Pfizer). The change was made due to evidence of a small, but significant, improvement in the immune response to Bexsero when 2 doses were given 6 months apart, instead of 1 month apart, as previously licensed. No additional doses are recommended for people who completed the 2-dose Bexsero series using a 1-month interval, as licensed and recommended at the time.

A 3-dose schedule of Bexsero (dose 2 given 1-2 months after dose 1, and dose 3 given at least 6 months after dose 1 and 4 months after dose 2) is recommended for people who require accelerated protection from meningococcal B disease (those at increased risk).

Under the current Bexsero and Trumenba schedules, any MenB vaccine recipient whose second dose is administered less than 6 months after dose 1 should receive a third dose at least 6 months after dose 1 and 4 months after dose 2.

My patient with functional asplenia due to sickle cell disease inadvertently received MenB dose 3 too early, only 4 months after dose 1 and 3 months after dose 2. What do I do?

Dose 3 of a 3-dose MenB series should be administered at least 6 months after dose 1 and 4 months after dose 2. In this case, an additional (fourth) dose may be administered at least 4 months after the invalid, early dose 3 and 6 months after dose 1. Review the dosing error and the correct schedule with staff and take other appropriate measures to prevent this error from occurring in the future.

Which patients should receive a 2-dose schedule of MenB vaccine?

Healthy adolescents who are not at increased risk for meningococcal B disease should receive 2 doses of Trumenba (MenB-FHbp, Pfizer) or Bexsero (MenB-4C, GSK) 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 or Bexsero 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 (examples include eculizumab [Soliris], ravulizumab [Ultomiris], and sutimlimab [Sanofi]), microbiologists who work with meningococcal isolates in a laboratory, and people exposed during serogroup B outbreaks.
Penbraya (MenABCWY, Pfizer) contains MenB-Fhbp (Trumenba) and is FDA-licensed for ages 10 through 25 years as a two-dose series, given 6 months apart, for vaccination against all 5 serogroups. For adolescents or adults not at increased risk for meningococcal disease, if Penbraya is used for dose 1 of MenB, Trumenba should be administered for the second dose of MenB. For people age 10 years or older (including those older than age 25 years) at increased risk of meningococcal disease, ACIP recommends that Penbraya may be used for additional MenACWY and MenB doses (including booster doses) when both vaccines would be given on the same clinic day and at least 6 months have elapsed since most recent Penbraya dose.

If a patient received Trumenba meningococcal B vaccine (MenB-FHbp) 2 months ago and Bexsero meningococcal B vaccine (MenB-4C) yesterday, should they complete the series with Trumenba or with Bexsero since the two brands are not interchangeable?

The patient can complete the series with either vaccine. If the patient lacks a high-risk condition for meningococcal B disease and is not at high risk of exposure due to an ongoing outbreak, then simply administer the final dose in the 2-dose series 6 months after the initial dose of the selected product. There needs to be a 6-month interval between two doses of the same brand to complete a MenB series for a person who is not at increased risk.

If the person is at increased risk for meningococcal B disease and needs a 3-dose MenB series, then decide which product (Bexsero or Trumenba) you will use to complete dose 2 and dose 3 of the series. The second dose of the selected brand may be given no sooner than 4 weeks after the previous dose of the same brand AND at least 4 weeks after the last dose of the other brand. Dose 3 should be given no sooner than 6 months after dose 1 of the same brand and 4 months after dose 2 of the same brand.

Do any of the bacterial vaccines that are recommended for people with functional or anatomic asplenia need to be given before splenectomy? Do the doses count if they are given during the 2 weeks prior to surgery?

Pneumococcal conjugate vaccine (PCV), Haemophilus influenzae type b (Hib) vaccine, MenACWY, and meningococcal B vaccine should be given at least 14 days before a scheduled splenectomy, if possible. This is done so the patient is protected from these diseases before the spleen is removed; however, doses given during the 14 days before surgery also can be counted as valid. If the doses cannot be given prior to the splenectomy, they should be given as soon as the patient's condition has stabilized after surgery. If PCV20 or PCV21 is given, pneumococcal polysaccharide vaccine (PPSV23) is not needed; if PCV15 is given, administer a dose of PPSV23 at least 8 weeks after the dose of PCV15 if the patient is age 2 years or older.

My 36-year-old patient was diagnosed with idiopathic thrombocytopenic purpura and had a splenectomy three weeks ago. Prior to the splenectomy, he had one dose each of Hib, MenB, PCV20, and MenACWY (Menveo). What vaccines are recommended now?

Since the patient is asplenic, the second dose of the primary series of MenACWY should be given at least 8 weeks after the first dose. He will need a dose of MenACWY every 5 years for the rest of his life. The 3-dose series of MenB (whether Trumenba [Pfizer] or Bexsero [GSK]) should be completed. The first booster dose of MenB will be due one year after completion of the primary series and subsequent booster doses are recommended every 2–3 years for the rest of his life. The same MenB vaccine should be used for all doses in the series, including booster doses. People who receive Trumenba brand MenB vaccine have an option to receive MenABCWY (Penbraya, Pfizer) when both MenACWY and MenB vaccines are due at the same visit, as long as doses of Penbraya are spread out by at least 6 months. The patient has already received one dose of PCV20, in accordance with pneumococcal vaccination recommendations for immunocompromised adults younger than age 50, so no further doses are needed. Based on the patient's age, only one dose of Hib vaccine is recommended, so no further doses are needed. The patient should receive influenza vaccine annually.

Our practice has an 11-year-old patient who is having a splenectomy. The doctor requested meningococcal serogroup B vaccine (MenB) before the surgery and wants to know if the patient will need booster doses or a repeat MenB series at some point in the future (as in the meningococcal ACWY vaccine recommendations).

Yes. 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 products are not interchangeable, all doses, including booster doses, should be of the same MenB product (either MenB-4C, which is in Bexsero [GSK], or MenB-FHbp which is in Trumenba and Penbraya [Pfizer]). If the brand of the primary series is not known or not available, CDC recommends restarting the primary series with the available product.
Penbraya (MenABCWY, Pfizer) contains MenB-Fhbp (the MenB product in Trumenba) and is given as two doses, 6 months apart, when vaccination against all 5 serogroups is needed. For this 11-year-old child at increased risk of meningococcal disease, Penbraya may be used for MenACWY and MenB (Trumenba) doses (including booster doses) when both vaccines are needed on the same clinic day and at least 6 months have elapsed since the most recent Penbraya dose.

I have a patient with paroxysmal nocturnal hemoglobinuria who is being treated with Soliris (eculizumab). Should he receive meningococcal vaccine?

Eculizumab (Soliris) and related long-acting compounds, such as ravulizumab (Ultomiris) and sutimlimab (Enjaymo), 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 2-dose primary series of MenACWY vaccine (2 doses separated by at least 8 weeks) and a 3-dose series of MenB vaccine (0, 1-2 months, and 6 months). 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 MenB products are not interchangeable, all MenB doses should contain the same type of MenB vaccine (either MenB-4C, which is in Bexsero [GSK], or MenB-FHbp, which is in Trumenba and Penbraya [Pfizer]). If the brand of the primary series is not known or is unavailable, CDC recommends restarting the primary series with the available product.
Penbraya (MenABCWY, Pfizer) contains MenB-Fhbp (Trumenba, Pfizer) and is given as two doses, 6 months apart, when vaccination against all 5 serogroups is needed. For people age 10 years or older at increased risk of meningococcal disease, like this patient, Penbraya may be used for MenACWY and MenB (Trumenba) doses (including booster doses) if both vaccines would be given on the same clinic day and at least 6 months have elapsed since most recent Penbraya dose.
Because patients treated with complement inhibitors can develop invasive meningococcal disease despite vaccination, clinicians using these products also may consider antimicrobial prophylaxis for the duration of complement inhibitor therapy.

We have a 10-year-old getting renal dialysis. The nephrologist will be starting her on ravulizumab (Ultomiris), which interferes with C5 complement. If we administer MenACWY and pneumococcal conjugate vaccine (PCV) now, will the MenACWY interfere with the PCV?

Recommendations to separate MenACWY and PCV only applied to MenACWY-D (Menactra, Sanofi), which is no longer available in the United States. You may administer PCV vaccines and MenQuadfi, Menveo, or Penbraya (if this MenABCWY is indicated) at the same time. A 10-year-old with persistent complement component deficiency also should be vaccinated against MenB with an appropriate 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 Ultomiris or other complement inhibitors also may consider antimicrobial prophylaxis for the duration of complement inhibitor therapy.

If you choose to give MenB vaccine to a 16-year-old with HIV infection based on shared clinical decision-making, should you use the 2-dose (standard) schedule or the 3-dose (high-risk) schedule?

Either Trumenba (MenB-FHbp) or the Bexsero MenB vaccine brand (MenB-4C) may be used for people with HIV infection. People with HIV infection do not appear to be at higher risk for meningococcal serogroup B disease, and ACIP does not specify use of the 3-dose schedule for people with HIV. Booster doses of MenB are not recommended for people with HIV in the absence of another indication for MenB vaccination.

Penbraya (MenABCWY, Pfizer) is an option for people age 10 years and older only when both MenACWY and MenB (Trumenba) vaccines are due at the same visit and at least 6 months have elapsed since the most recent dose of Penbraya. An adolescent with HIV should receive a 2-dose primary MenACWY series (with the doses given 8 weeks apart), followed by MenACWY booster doses every 5 years. If this teen needs the MenACWY primary series vaccination and also chooses to receive Trumenba, Penbraya may only be used for one of the doses because dose 2 in the MenACWY primary series is due 8 weeks after dose 1 and the minimum interval between Penbraya doses is 6 months.

Are microbiologists recommended to receive MenB vaccine? And if so, how frequently?

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. For accelerated protection, you can administer a 3-dose series of Bexsero (MenB-4C) or Trumenba (MenB-FHbp) on a 0-, 1–2-, and 6-month schedule. If dose 2 is delayed and administered 6 months or longer after dose 1, the primary series is complete.
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 type (either MenB-FHbp or MenB-4C). If the primary series type is not known or is not available, restart the primary series with the available brand.
Microbiologists may receive a dose of MenABCWY (Penbraya, Pfizer) as an alternative to separate administration of MenACWY and MenB (MenB-FHbp, Trumenba) when both vaccines would be given on the same clinic day and at least 6 months have elapsed since most recent Penbraya dose.

We have a 19-year-old patient with a history of vasculitis, nephritis, and asthma. She is on azathioprine (Imuran) and is immunosuppressed. In addition to vaccinating her with pneumococcal conjugate vaccine in accordance with current guidelines, her rheumatologist also recommends she receive vaccine for meningococcal B disease (MenB). Is MenB vaccine recommended for immunosuppressed people?

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 for meningococcal B disease, such as this patient, may receive MenB vaccination. ACIP does not specify use of the 3-dose schedule for immunocompromised people who are not at increased risk for meningococcal B disease. Penbraya (MenABCWY, Pfizer) is also an option if both Trumenba and MenACWY vaccines are due at the same visit and it has been at least 6 months since the most recent dose of Penbraya.

Which groups should receive a booster dose of meningococcal B vaccine (MenB)?

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 (examples include eculizumab [Soliris], ravulizumab [Ultomiris], and sutimlimab [Enjaymo])
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.

I have a 28-year-old patient who received a 2-dose primary meningococcal B (MenB) vaccine series of Bexsero, with doses given 1 month apart, in 2015 when her spleen was removed. At that time, the ACIP did not have a recommendation for MenB booster doses and did not recommend a 3-dose Bexsero series. Do I need to give her a new primary series?

In August 2024, FDA changed the dosing interval for a 2-dose series of Bexsero (MenB-4C, GSK) from 1 month to 6 months, and recommends that people who receive a second dose of Bexsero less than 6 months after dose 1 receive a third dose at least 6 months after dose 1 and at least 4 months after dose 2. However, no additional primary series doses are recommended for people who previously completed the 2-dose series with the shorter interval, in accordance with the licensed and recommended Bexsero schedule at the time.

In June 2019, ACIP voted to recommend MenB booster doses for people at ongoing increased risk of meningococcal serogroup B disease 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, this patient should be given a booster dose of Bexsero now and receive subsequent booster doses every 2–3 years.

The two types 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.

What adverse events are expected after receiving MenB?

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.

What are the contraindications and precautions for MenB vaccination?

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. 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.

Should a pregnant person receive MenB vaccine?

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. 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.

Can MenACWY and MenB vaccines be given at the same visit?

Yes. MenACWY and MenB vaccines can be given at the same visit or at any time before or after the other. The pentavalent MenABCWY vaccine Penbraya (Pfizer) may be administered as an option for people age 10 or older who need both MenB-FHbp (Trumenba, Pfizer) and MenACWY vaccination at the same visit. For people age 10 years or older at increased risk of meningococcal disease, Penbraya may be used for additional MenACWY and MenB doses (including booster doses) if both would be given on the same clinic day and at least 6 months have elapsed since most recent Penbraya dose.

By what route should meningococcal vaccines be administered?

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