COMMENTARY

Give the MenB Vaccine

Paul A. Offit, MD

Disclosures

August 26, 2015

Editorial Collaboration

Medscape &

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Hi. My name is Paul Offit, and I am talking to you today from the Vaccine Education Center here at The Children's Hospital of Philadelphia.

As of January of this year, two new serogroup B meningococcal (MenB) vaccines were licensed for use in adolescents and young adults between 10 and 25 years of age. Then in February, the Advisory Committee on Immunization Practices (ACIP) made a recommendation that these vaccines be given to groups at highest risk—people with complement deficiencies or functional or anatomical asplenia, those who are in the midst of an outbreak of serogroup B infection (for example, on a college campus), as well as microbiologists, either in a clinical or research setting.

Reassessing MenB Vaccine Recommendations

In June of this year, the ACIP met again to determine whether they wanted to give these two newly approved serogroup MenB vaccines, Trumenba® and Bexsero®, a broader recommendation.

Trumenba contains two factor H binding proteins and is a three-dose vaccine.

Bexsero contains four proteins: a factor H protein, a heparin binding antigen, a Neisseria meningitidis adhesion molecule, and a Neisseria meningitidis outer membrane vesicle (which contains a porin protein). Bexsero is a two-dose vaccine.

The question is, should a MenB vaccine be recommended routinely to those at highest risk within the 10-25 age group? If you look at those who are most likely to get infected and die from this infection, it's those older than 16 years of age. The ACIP considered a routine recommendation (also known as a category A recommendation) for patients aged 16-18 years but decided against it. They decided to give it a category B or "permissive" recommendation. This means that it isn't routinely recommended but is covered by the Vaccines for Children Program, and—at least in theory—should be covered by insurance companies.

Why a Category B Recommendation?

Why didn't the MenB vaccines get a routine recommendation? The biggest reason was epidemiology. The annual number of cases of serogroup B meningococcal disease in 10- to 25-year-olds is about 50. About 10% of those who get this infection will die from it. About 25% of those who get this infection will suffer permanent harm from it (typically loss of limbs, loss of kidney function, and other complications.)

So, one reason that the MenB vaccine wasn't routinely recommended was that—and I put this in quotes—there were "only 50 cases."

The second reason was a question concerning duration of protection. From the level of antibodies that are protective (ie, serum bactericidal antibodies), protection may not last longer than 4 years.

The other issue concerned platforms. It's hard to give two or three doses of the vaccine to 16- to 18-year-olds because it's hard to get them into the doctor's office to receive the vaccine.

That's why the vaccine got permissive recommendation.

I Say, Give It

I have been getting a lot of calls from physicians asking, "Should we give this vaccine or not? Is this vaccine being recommended or not?" They feel that they are caught in this middle ground with a half-recommendation.

This is the way I feel about this; I'm not representing the interests of the Centers for Disease Control and Prevention or the American Academy of Pediatrics. This is just my personal opinion and this is the answer that I give to people who ask me the question: "Yes. I think you should give it." The question shouldn't be, "When do you know everything?" The question is, "When do you know enough?"

What we know about this vaccine is that it is likely to produce serum bactericidal antibodies that are protective. Those protective antibodies will last 4 years. That may not be many years, but it should last years. The vaccine is made from proteins. There is no reason to think that it would be anything other than safe. We know that although this disease is relatively rare, when it occurs it can be devastating. It's a low-burden, high-impact disease.

I would say, "Give the vaccine." If my children were in this age group I would give it to them. This is the way I feel. I hope this helps. Thank you.

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