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Thứ Hai, 10 tháng 11, 2014

FDA OKs First Vaccine for Group B Meningitis


The FDA has approved, for the first time, a vaccine against serogroup B meningococcal disease.
The agency gave the nod Wednesday to Trumenba, a vaccine based on a recombinant protein fromNeisseria meningitidis serogroup B and aimed at people ages 10 through 25.
A second vaccine, already on the market in 34 countries as Bexsero, is still in the approval process.
Some 30,000 doses of Bexsero were given last year, under an investigational new drug application, to students at Princeton University and the University of California Santa Barbara, in response to meningitis B outbreaks on those campuses.
"Recent outbreaks of serogroup B meningococcal disease on a few college campuses have heightened concerns for this potentially deadly disease," commented Karen Midthun, MD, director of the FDA's Center for Biologics Evaluation and Research, in a statement.

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