California students wait on FDA’s approval for meningitis vaccine

By Adam Ulbricht | Watchdog.org

Students, parents and school officials at the University of California, Santa Barbara are waiting on the arrival of a new vaccine that will help stop the spread of a recent meningitis B outbreak on campus.

The Centers for Disease Control and Prevention announced a plan last week that would allow the vaccine, Bexsero, to be given to over 20,000 students to prevent a further outbreak that has affected four so far.

One of those students, an 18-year-old freshman lacrosse player, recently underwent double amputation of his feet after contracting the bacterial infection in November.

Although there is no set timeline for the drug’s arrival, that date can’t come soon enough for school officials, who describe the situation as “an ongoing process.” The CDC, however, is waiting to hear from the Food and Drug Administration, which hasn’t approved the vaccine for use in the United States.

Worried parents of students at UCSB have asked the school to quicken the process. Dr. Christina Lete, an obstetrician-gynecologist in Newton, Mass., who’s son attends UCSB, even went as far as sending him to London to acquire the vaccine during the school’s winter break.

Bexsero is the only known vaccine that successfully fights meningitis B for all ages. It has been approved for use in the European Union, Canada and Australia.

The drug has proven to prevent infection in nearly 8,000 clinical trials of infants, children and adults since 2011.

When asked why the drug has not received approval, FDA spokesman Paul Richards told Watchdog, “Federal disclosure regulations prohibit the FDA from releasing information related to an unapproved product.”

But according to a CDC report, even the FDA thinks the drug is safe. “FDA has concluded that the benefits of using the vaccine to prevent meningococcal disease outweigh the risks of possible adverse events in certain outbreak situations.”

The FDA has fast-tracked other vaccines in recent history. In late November, approval was granted to a drug that prevents the H5N1 virus before any confirmed cases were reported in the United States.

In a statement to Watchdog, Novartis, the parent company of Bexsero, did not comment on the lack of FDA licensing, but did say they are coordinating with the CDC, the university and the California Department of Health to respond to the public health threat on campus.

The outbreak in California is the second such incident since March, when students at Princeton University were diagnosed with the infection.

So far eight confirmed cases have been reported at Princeton, which led health officials in New Jersey to seek help from the CDC.

The FDA did approve emergency usage of Bexsero under an Investigational New Drug application to vaccinate more than 5,200 students last month at Princeton at the request of the CDC. Now the CDC is seeking a similar application for students at UCSB.

Due to similar flu-like symptoms, bacterial meningitis can be difficult to diagnose. According to the CDC, nearly one-third of all meningococcal cases reported in 2012 were caused by meningitis B. The infection kills about 1 in every 10 victims and leaves 1 in 5 survivors with a permanent disability.

The infection is easily spread through close contact, making college campuses susceptible to outbreaks. University officials at UCSB are urging students to practice better hygiene by washing their hands more often, and not sharing drink cups.

Adam can be reached by email at aulbricht@watchdog.org.

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