Princeton's license to distribute unapproved meningitis vaccine to expire

The University's special license to use Bexsero, a vaccine against meningitis B that is not yet licensed for use in the United States, will expire soon, after the last vaccination clinic takes place on Nov. 19.

Of the Class of 2018,1,281 members, or 97 percent, received the first dose of the vaccine this fall, according to University spokesperson Martin Mbugua. Eighty-three percent, or 1,098, have received both doses. Last year, 81 percent of the student body received the second dose in February, which was, at the time, the first opportunity to do so.

While it remains unclear whether the University still intends to administer the vaccine to future classes,Alison Albert, a health communications specialist at the Centers for Disease Control and Prevention, said she expects an official announcement regarding Bexsero’slicensure by March 2015. This tentative timeline would allow the University to administer the vaccine to the Class of 2019 if it decided to do so.

Bexsero, which has been licensed and administered in 34 countries, is awaiting Food and Drug Administration approval, according to Elizabeth Powers, Director of Media Relations at Novartis, the pharmaceutical company that developed the vaccine.

FDA consumer safety officer Rachael Conklin declined to disclose an approval date for Bexsero.

Director of Medical Services at University Health Services Dr. Peter Johnsen said that if the University wanted to use the vaccine again prior to its official licensure, it would have to consult the CDCas well as take New Jersey state regulations into account.

“Princeton won’t do anything in the future unless [Bexsero] is licensed or we have the CDC tell us we should do that,” he said.The University is awaiting further information from the CDC to finalize future vaccination timelines, he added.

Novartis submitted a Biologic License Application to the FDA in Junefor licensure of Bexseroin the United States. The vaccine received Breakthrough Therapy Designation and Priority Review from the FDA in April.

Powers said Bexsero, under a short-term licensed designation from the FDA, has been used to vaccinate more than 18,000 people at the University and the University of California, Santa Barbara.

A total of eight University students were infected with the Meningitis B strain not covered by the standard vaccine since March 2013, with the most recent case last November.

A Drexel University student died of the same strain after having contact with University students.

A San Diego State University freshman died of meningitis B last weekend, and a Georgetown University sophomore died of meningitis B in September.

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Nicole Basta, Associate Research Scholar in the Department of Ecology and Evolutionary Biology, said the CDC would declare the official end of the meningitis outbreak at the University.

“What it means for an outbreak to be over is very context-dependent,” she said. “There are really no hard and fast rules to say an outbreak of pathogen that has an asymptomatic carrier state is over.”

Basta is leading a cohort study to study the effects of the vaccine on newly enrolled freshman and graduate students after their first and second doses and one year after their vaccinations this fall. The study is in its preliminary stages.

“The vaccine has never been used before to control an outbreak,” Basta said. “We have this opportunity now to see how well it is protecting against the outbreak strain in addition to the vaccine’s strain.”