Why the FDA should approve the MenB vaccine

At least 12 college students have been diagnosed with Meningitis type B (MenB) this year, and cases like this may spread to other campuses unless the Food and Drug Administration intervenes.  While people of any age can contract the infection that affects the brain and spinal cord, children and people over 60 are more likely to contract the infection.  So, too, are college students because of their close contacts in dormitories and dining halls.  These students may share dining utensils, food, towels, or glasses or be exposed to roommates and others whose coughs or sneezes can be infectious.

I’m not writing to cause a panic among students, their parents, and college leaders.  I’m just wondering why the Food and Drug Administration has been dragging their feet in approving a vaccine that would immunize vulnerable students.  A MenB vaccine produced by Novartis is in use for people of all ages in the European Union, Australia and Canada.  In the United States, though, Bexsero can only be used on a very limited basis when there are outbreaks on an ad hoc basis.  Why? Because the FDA still has the MenB vaccine stalled in clinical trials, instead of making the preventative drug available for those at risk.

Where does that leave the eight students at Princeton University who have contracted MenB, and the four who have been affected at the University of California at Santa Barbara (UCSB)?  It leaves them among the 20,000-80,000 cases worldwide, with a 10% percent mortality rate.  Those who survive 20% percent are estimated to experience permanent disabilities, including brain damage, limb loss, and deafness.  Indeed, of the twelve reported cases, a lacrosse player at UCSB had his feet amputated.

Princeton has now responded by vaccinating nearly 2,000 of its 6,000 students. Every college needs to have that option.  As a former college president, I can attest to the heartbreak leaders feel when even one student is affected or dies, especially if the loss was preventable.  After the fact, there is the agonizing analysis that explores what might have been done differently, and how to prevent future consequences. How do campus leaders feel when they realize that outbreaks might have been prevented if the CDC-endorsed vaccination had been more available? How do they feel when they learn that meningitis vaccines that are widely used on college campuses do not cover the very strand that is infecting students at Princeton and UCSB?

While questions about cost-effectiveness are important to consider, many students will be able to afford the vaccine. At most campuses, students are required to share medical records with the student health center.  Students could be inoculated before they come to school, or, if they are vulnerable and have not had the vaccination, they can be inoculated on campus.  Obamacare allows students to stay on their parents’ health insurance until they are 26. Obamacare also requires students not covered by their parent’s health plan (perhaps because their parents don’t have health care – but that’s another story) to have health care. Their insurance policies may also cover the cost of the vaccine.  Or campuses can absorb the costs, as Princeton has, or implement a cost-sharing policy.

Some colleges and summer programs already require a meningitis vaccine, but because the MenB vaccine is not available in the U.S., hundreds of thousands of students are still vulnerable to infection, and all campuses must consider the possibility of outbreaks like those at Princeton and UCSB. These meningitis outbreaks are cause for concern, especially because meningitis is manifested by flu-like symptoms, and some may ignore the disease because they don’t think it is serious.  After all, who seeks medical treatment because he or she has a cold or the flu?

Without warning, the disease can strike people who seem healthy.  The twelve cases reported at Princeton and UCSB may have been prevented if Bexsero were approved for use in the U.S.  Instead, the FDA has been “studying” this for more than two years since the last clinical trials, putting too many at risk because of a slow bureaucracy. Meanwhile, the Centers for Disease Control (CDC) supports use of the MenB immunization, and other countries have tested the vaccination, which should give the FDA confidence that the MenB vaccination is safe to use here.

This is a public health matter that must be addressed.  There is an adage that “an ounce of prevention is worth a pound of cure”.  By failing to approve the MenB vaccination, the FDA’s ounce of prevention affects vulnerable students with a life-threatening pound of cure.  The FDA has the power to save lives by expediting the approval process for MenB and they won’t use it.  Why?

Julianne Malveaux is an economist and president emerita, Bennett College for Women.

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