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Two prospective vaccines aimed at protecting against a potentially deadly strain of meningitis not covered by existing shots have received breakthrough therapy status from the Food and Drug Administration. It could speed up federal consideration of the drugs.
Bexsero, a vaccine that targets meningitis B, received the designation Monday, officials with drugmaker Novartis announced. Already approved in Australia, Europe and Canada, Bexsero was given on an emergency use basis to students at Princeton University and the University of California, Santa Barbara, to combat ongoing outbreaks.
The FDA also gave breakthrough designation last month to Pfizer’s vaccine candidate bivalent rLP2086, which is being tested to protect children and young adults ages 10 to 25 against meningitis B.
The breakthrough designation is one of four levels of accelerated consideration for new drugs offered by the FDA. It’s aimed at expediting the development and review of new medicines that treat serious or life-threatening conditions, the FDA says.
Existing vaccines in the U.S. already cover four strains of bacterial meningitis, but not strain B. Of the 500 cases of meningococcoal disease in the U.S. in 2012, about 160 were caused by meningitis B. Although bacterial meningitis infections are rare, they kill about 10 percent of those who fall ill and leave 20 percent of the rest with devastating side effects.
So far this year, 14 people in the U.S. have contracted meningitis B and four have died, according to the Centers for Disease Control and Prevention.
Novartis and Pfizer still need to submit biologics license applications for the vaccines, but the breakthrough therapy designation is designed to speed up the process. Pfizer officials said the firm planned to submit an application in mid-2014. Novartis is shooting for the second quarter of this year, pending advice from FDA, officials said.
That’s welcome news for Alicia Stillman of West Bloomfield, Mich., whose 19-year-old daughter died last year from a fast-moving meningitis B infection. The college student had been vaccinated against the other strains.
“I think it is a wonderful step, but it has taken a long time,” Stillman said.