ACIP votes new policy options for MenB vaccine

In June, the Advisory Committee on Immunization Practices (ACIP) declined to recommend that a newly approved serogroup B meningococcal (MenB) vaccine series be used universally in adolescents aged 16 to 18 years, basically leaving the decision up to parents and providers.

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The committee stated: “A serogroup B meningococcal (MenB) vaccine series may be administered to adolescents and young adults 16 through 23 years of age to provide short term protection against most strains of serogroup B meningococcal disease. The preferred age for MenB vaccination is 16 through 18 years of age (Category B).”

The statement was a “Category B” recommendation as opposed to a “Category A” recommendation, which would have made it for “all persons in an age or risk factor-based group.”

According to an explanation in the November 2011 journal Vaccine, “Category B recommendations will be made for individual clinical decision making; Category B recommendations do not apply to all members of an age- or risk-factor-based group, but in the context of a clinician-patient interaction, vaccination may be found to be appropriate for a person.”

The ACIP has made about 3 Category B recommendations on vaccines since 2010 when it adopted the category system based on a framework called “Grading of Recommendations, Assessment, Development and Evaluation (GRADE),“ according to Doug Campos-Outcalt, MD, MPA, who was an ACIP member until recently.

The decision comes in the wake of 2 MenB vaccines, Trumenba and Bexsero, being approved last October for people aged 10 to 25 years.

At the meeting, the Centers for Disease Control and Prevention (CDC) staff presented data showing that in the 11- to 24-year age group in recent years there has been an estimated annual average of 54 to 67 cases of serogroup B, with 5 to 10 deaths and 5 to 13 cases with sequelae. There has been an estimated average of up to 39 annual deaths for all ages.

Although outbreaks on college campuses have received attention, in those aged 18 to 23 years there has been an average of 14 cases and 2 deaths among college students, but an average of 22 cases and 3 deaths among noncollege students. 

The CDC presented estimates that for 18-year-olds, for example, it would take 102,000 persons vaccinated to prevent a case and 638,000 to prevent a death. For college students, it would take 368,000 persons vaccinated to prevent a case and 2.3 million to prevent a death.

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The study estimated that it would cost $9.4 million per quality adjusted life year saved to vaccinate all college students.

Doing a “back of the envelope” calculation multiplying the number of adolescents in an annual cohort by the vaccine’s cost, Campos-Outcalt estimates it would cost between $2 billion and $4 billion annually to administer this vaccine on a universal basis for that group. He notes the entire CDC budget, with its wide range of programs, is only about $7 billion.

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What are pediatricians to do with this Category B recommendation? Campos-Outcalt says physicians should educate themselves about the vaccine. Beyond that, he says, it depends on how the doctor feels about the circumstance, including liability in the unlikely case a patient gets MenB and the doctor hasn’t mentioned the vaccine. One possibility, he says, is giving parents a handout with information including all the vaccines recommended for everyone. The handout could list MenB as an option with facts, including its rate of occurrence, for people who are particularly concerned or who may have a family member who has had the disease.

In terms of the safety data, Campos-Outcalt notes that the studies on the MenB vaccines have looked at tens of thousands of adolescents, but it would be difficult to discern any adverse event among the hundreds of thousands to millions it takes to prevent 1 case or death.

Asked in an interview if society may be reaching the point where it can do things that are just too expensive to do, Campos-Outcalt agrees with the notion.

With vaccines, he says, there will likely be more developed for relatively rare diseases. Decisions will not be simple, he states, as they were with the historic ones on diseases that caused so much morbidity and mortality.

However, he notes that the difficulty comes with these rare diseases, when parents stand up and say they lost their child, or when a young adult says, “I lost my arms because of this disease.”

The vote for the Category B recommendation means that insurance will pay for the vaccine, says Campos-Outcalt, and the decision says the product is probably safe and effective, although it’s not believed to meet the standard for universal administration.

This new recommendation is in addition to the ACIP’s recommendation in February that specific groups aged older than 10 years who are at risk of the disease should get the vaccine, including persons at risk in an outbreak. The other categories include persons with persistent complement component deficiencies; persons with anatomic or functional asplenia; and microbiologists routinely exposed to isolates of Neisseria meningitides.

The slides from the June 2015 meeting discussing MenB epidemiology, immunogenicity, vaccine safety, costs, and other data are on the ACIP website (see “What’s New/June 2015 Presentations”).

Discussion of the vaccines and the February recommendations appear in the CDC’s June 12 Morbidity and Mortality Weekly Report (MMWR).

The new Category B recommendation for those aged 16 to 23 years will likely be discussed in a future MMWR.

Ms Foxhall is a freelance writer in the Washington, DC, area. She has nothing to disclose in regard to affiliations with or financial interests in any organizations that might have an interest in any part of this article.