The FDA and Meningitis B

by Erik Telford
Jenny McCarthy isn’t the only dangerous anti-vaxxer.

Jenny McCarthy’s unfortunate and misinformed anti-vaccine campaign is helping reintroduce long-eradicated diseases like the measles among American children, but college students are being deprived of equally critical vaccinations for equally absurd reasons. While McCarthy’s campaign is based on pseudoscience (and, understandably, a mother’s heartache), the Food and Drug Administration’s refusal to approve the vaccine for meningitis type B (MenB) is steeped in bureaucratic incompetence, and has already contributed to the death of a young woman.

Stephanie Ross, a sophomore at Drexel University, died earlier this month in her sorority house after contracting a strain of MenB that had previously ravaged the campus of Princeton University, about 45 miles away. MenB is a highly contagious, infectious bacterial disease that can kill or permanently maim victims within days, but it is also a preventable disease. A drug called Bexsero, administered as a vaccine, has been proven safe and effective at preventing MenB in over 8,000 human trials and is widely used in Europe, Canada, and Australia.

The FDA, however, has refused to approve Bexsero despite having access to the same wealth of research about the drug that its European and other First World counterparts did. In fact, the FDA has approved vaccines for every strain of meningitis except MenB, which was responsible for 32 percent of meningitis cases in 2012. The agency’s inefficiency has left the government, universities, hospitals, and families entirely unable to respond to MenB outbreaks on college campuses and in other high-density living environments.

When a strain of MenB was isolated at Princeton over a year ago, the government’s response was shockingly inept, and the disease was allowed to wreak havoc on the campus — infecting at least eight students — before the FDA finally allowed Princeton to import a limited supply of Bexsero in December, nine months after the initial outbreak. While Princeton was waiting for its vaccine, a second strain of MenB broke out at UC Santa Barbara, infecting at least four students and forcing an 18-year-old to undergo a double amputation. Once again, the FDA did not respond in a timely manner, and UCSB had to wait several months for its first shipment of vaccine.

Ms. Ross’s tragic death is particularly frustrating because the MenB pathogen was almost certainly passed from Princeton to Drexel sometime during the past year. Because the FDA did not approve Bexsero for widespread use as it should have after the Princeton outbreak, and instead sent only a limited supply of the vaccine to the affected school, it left neighboring campuses exposed and highly vulnerable. Now, the MenB pathogen is on the campus of Drexel, which is powerless to protect its students from the infection or prevent them from passing it along to students at one of the dozen other colleges in the area.

By continuing to keep the MenB vaccine tied up with bureaucratic red tape and refusing to take preventive action, the FDA is inviting tragedy. In that way, it is no better than Jenny McCarthy and her army of anti-vaxxers — it has even less excuse. Whether leaving pre-schoolers vulnerable to the measles or college students at risk of a deadly infection, the forces in government and society that are halting medical progress are proving that ignorance and incompetence are the most lethal combination of all.

— Erik Telford is senior vice president of the Franklin Center for Government and Public Integrity.