Thursday, May 15, 2014

Colleges Using Unapproved Meningitis Vaccines

Princeton University and the University of California Santa Barbara recently experienced outbreaks of meningitis B. Meningitis B is a serologic group of bacterial meningitis. Meningitis in general is highly contagious in close quarters, such as college classrooms and dorms. There are FDA approved vaccines for other serologic groups, but no vaccine for type B.

There are 8 reported cases at Princeton and 4 at UCSB. The first case at Princeton was found in March 2013 and the first case at UCSB was found in November 2013. With no vaccines, Princeton was worried about the infection spreading. They were allowed to use an unapproved vaccine by the FDA under an "Investigational New Drug" tag to use the vaccine Bexsero, which is the only vaccine to protect against type B. The vaccine is approved in Europe, Australia, and Canada. About 5,000 students were vaccinated. Later that year, type B meningitis infections were found at UCSB. The same vaccine was allowed to prevent further outbreaks. A booster shot was offered at Princeton in February.

The CDC reports the FDA claims the vaccines are safe for use in specific situations, such as outbreaks in susceptible populations. There are no major side effects except a severe allergic reaction, which is extremely rare. The FDA uses the IND tag to approve use of a drug they feel is safe and the benefits are greater than the risks, and they applied it to Bexsero because they have not yet approved it for use for the general public in the US. The vaccine is a two-part intramuscular shot that requires a second booster 6 months after the initial vaccination to maximize protection.

Huffington Post

The Princeton Sun

CDC Type B Vaccine and Outbreaks

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