New Meningitis B Vaccines Sent for FDA Review

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Two vaccines that could protect against a potentially deadly strain of meningitis not covered by current shots have been sent for review by federal regulators.

Drugmakers Novartis and Pfizer announced Tuesday that they’ve each submitted applications to the Food and Drug Administration for vaccines aimed at preventing meningitis B infections like those that sparked outbreaks last year at two U.S. universities. Current vaccines cover four strains of bacterial meningitis, but not strain B.

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The move drew immediate praise from advocates like Alicia Stillman of West Bloomfield, Michigan, whose 19-year-old daughter died last year from a fast-moving meningitis B infection. Since then, Stillman has begun organizing trips to Canada, where the vaccine is available, to help protect others.

“I am excited, but still cautious as I know nothing happens fast in that world,” Stillman said Tuesday.

Meningitis infections affect about 500 people in the U.S. each year, including about 40 percent caused by the B strain. Though they’re rare, the infections kill about 10 percent of those who fall ill and leave 20 percent with devastating side effects.

The prospective vaccines, Novartis’ Bexsero, and Pfizer’s bivalent rLP2086, were granted breakthrough therapy status by the FDA earlier this year in a move that could speed up consideration of the drugs. If approval is granted, it could take months before the vaccines are available for consumers.

Novartis' Bexsero was granted emergency use status at Princeton University and the University of California, Santa Barbara, and is already approved in Europe, Canada and Australia.

Development of a vaccine has been 20 years in the making because meningitis B is much harder to target than other strains, said Dr. Andrin Oswald, head of Novartis’ vaccine division. Bexsero protects only against meningitis B, but Novartis has a combination vaccine in development.

“It’s clearly the vaccine that makes the most sense,” Oswald told NBC News. “For most parents, they want to protect their children and teenagers with one shot.”