New Meningococcal B Vaccines: Who Gets Them and When?

Sandra Adamson Fryhofer, MD


August 20, 2015

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Hello. I'm Dr Sandra Fryhofer. Welcome to Medicine Matters. The topic: the new Advisory Committee on Immunization Practices (ACIP) meningococcal B (MenB) vaccination recommendation. Here's why it matters.

The good news is that meningococcal disease outbreaks are rare. The bad news is that when they do occur, they are deadly and devastating. There are five main serogroups of meningococcal disease: A, B, C, W-135, and Y.[1]

In the United States, serogroups B, C, and Y cause most disease. The bacteria are transmitted from person to person through the exchange of respiratory or nasopharyngeal secretions—for example, through kissing or coughing, sharing eating utensils, or through prolonged contact, especially if living in the same household.[2]

Until recently, the available meningococcal vaccines for adolescents and young adults (Menomune, Menactra, and Menveo) only covered types A, C, W, and Y.[3] None covered serogroup B, the type causing recent outbreaks on college campuses (Princeton and the University of California, Santa Barbara).[2]

Fortunately, two new MenB vaccines are now US Food and Drug Administration (FDA)-approved:

  • MenB-FHbp (Trumenba®): A three-dose series, was FDA-approved on October 29, 2014.[4]

  • MenB-4C (Bexsero®): A two-dose series was FDA-approved on January 23, 2015. Bexsero is already licensed in 37 other countries.[5]

Both of these new vaccines are FDA-approved only for persons aged 10 through 25 years. However, as published in the June 12, 2015, issue of Morbidity and Mortality Weekly Report,[6] ACIP expanded this age indication to anyone aged 10 or older. ACIP recommends routine MenB vaccination for anyone in this age range who is at increased risk for serogroup B meningococcal disease. This includes patients with complement deficiencies, anatomic or functional asplenia, microbiologists at risk through work exposure, as well as those identified as being at increased risk during outbreaks.

Serogroup B meningococcal infections are to blame for about half of all cases of meningococcal disease in persons aged 17 through 22 years. Although the incidence of meningococcal disease, including infections caused by serogroup B, has been declining, 55-65 young people aged 16 through 24 years develop serogroup B meningococcal disease each year.[7]

The disease strikes quickly and is unforgiving and often deadly. Public testimony at the AICP meeting about loved ones lost to this disease was heart-wrenching. Serogroup B meningococcal infections are not limited to college campuses; 30%-60% of cases occur in young people who are not in college.[8]

The GRADE evidence-based analysis for routine use of MenB vaccines in adolescents and "college aged" students was presented to ACIP at its June 2015 meeting. After lengthy discussion and heart-breaking public testimony, the committee voted 14 to 1 in favor of a category B recommendation, which allows for individual clinical decision-making. The MenB vaccination series may be administered to those aged 16 through 23 years to provide short-term protection against most strains of meningococcus serogroup B. It's best to give it early. The preferred vaccination age range is age 16 through 18 years. Although either of the vaccines may be used (there is no preference), the two MenB vaccines are not interchangeable. You have to finish the series with the same product you started with. The same vaccine product should be used for all doses in the series. The committee acknowledged that more study was needed to determine duration of protection and answer other questions.

Some media outlets have blasted this ACIP recommendation and have described it as cautious, weak, and somewhat disappointing. However, the recommendation is evidence-based. We do need more information about these vaccines and how well they work.

This category B recommendation means that insurance companies now have to pay for MenB vaccination for those aged 16 through 23 years. Remember that ACIP category A and B recommendations now have coverage clout in new health plans under the Affordable Care Act. Insurance companies have to pay for MenB vaccination for those aged 16 through 23 years—without cost sharing—within 1 year after the ACIP recommendation is made.[8]

For Medicine Matters, I'm Dr Sandra Fryhofer.


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