The Centers for Disease Control’s (CDC) Advisory Committee on Immunization Practices (ACIP) will vote today (Wednesday) on recommending routine vaccination against the Neisseria meningitidis serogroup (strain) B of bacterial meningitis, or “meningococcal disease.” Currently, the US government recommends that children around 11-12 years of age get vaccinated against four of the five strains—A, C, W and Y. A booster shot is recommended at age 16.
Up until October of last year, there was no vaccine against the the B strain. On October 29, 2014, the US Food and Drug Administration (FDA) granted accelerated approval of the Trumenba meningococcal group B vaccine for individuals 10-25 years of age. Trumenba is marketed by Pfizer, Inc. of New York, NY. The vaccine is produced by Pfizer subsidiary Wyeth Pharmaceuticals, Inc. of Philadelphia, PA.
The FDA notes that accelerated approval allows it to…
approve products for serious or life-threatening diseases based on evidence of a product’s effectiveness that is reasonably likely to predict clinical benefit, reducing the time it takes for needed medical products to become available to the public.
Meningococal disease is rare in the United States. According to the FDA, “about 500 total cases of meningococcal disease were reported in the United States in 2012; of those cases, 160 were caused by serogroup B.” Recent articles in magazines such Atlanta and Forbes peg the number at 600-1,000 cases annually. The CDC puts the number at 556 in 2013 and 386 in 2014.
But the disease is a serious one. It can be life-threatening. In an article titled “CDC to vote on new meningitis vaccine” and published in Atlanta magazine on June 23, 2015, Elizabeth Florio writes:
From March 2013 to March 2015, four college campuses experienced outbreaks. In the past school year, at least three college students died from the disease.
On January 23, 2015, the FDA approved a second vaccine—Bexsero—against B strain meningococcal disease. Again, on an accelerated track. Bexsero is produced by Novartis AG of Switzerland.
In January 2015, GlaxoSmithKline plc of the United Kingdom acquired Novartis’ vaccine business segment, creating a joint venture between GSK and Novartis on vaccines. As part of the deal, GSK agreed to sell its Nimenrix and Mencevax meningitis vaccines (both sold outside of the US). This was done to address antitrust regulatory concerns by the European Commission.
So what’s all the fuss? Okay, there is no epidemic of meningococcal disease in the US. Not by a long shot. Thousands of people aren’t coming down with it. Only a handful of people are dying from it. And the disease is effectively treatable with antibiotics if diagnosed quickly. But why not recommend vaccination against the disease if there are vaccines available?
The answer was perhaps best articulated by Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center (NVIC), in an interview she did with Dr. Joseph Mercola in 2011 (start at 4:29)…
I think the vaccine should be available for anyone who wants to use it. But the issue I have with a universal use recommendation by CDC for meningococcal vaccine for these children under 1 is that every time the CDC recommends a vaccine for universal use for children in the last quarter century, almost all of those vaccines have turned into mandates… State mandates. Meaning that we don’t have a choice. And that’s really, I think, the overarching issue that is becoming really a point of a lot of anxiety for parents… is that, it’s not that the vaccines are being recommended, it’s that the vaccines are being mandated, they’re being forced. And when anyone tries to make an educated, voluntary decision, they are thrown out of the doctor’s office. They’re harassed, they’re threatened.
ACIP will probably recommend routine vaccination against the B strain of meningococcal disease. At its meeting in February, the committee endorsed vaccinating against the disease in certain “high-risk” groups. The decision today will probably expand this policy to cover all adolescents.
The problem will come when State legislatures start doing the whole mandating thing. And you just know they will. They can’t seem to help themselves these days.
For a list of the 15 current members of ACIP, click ACIP Members July 1, 2014 – June 30, 2015