GSK gets favorable FDA recommendation
GlaxoSmithKline announced that the US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee has given a favorable recommendation for the company’s live, oral rotavirus candidate vaccine to prevent rotavirus gastroenteritis in infants.
GSK’s candidate two-dose oral rotavirus vaccine can be completed as early as 10 weeks and could be integrated into the current vaccine schedule during immunization visits.
The committee voted unanimously (12-0) in favor of GSK’s data being adequate to support the efficacy of the candidate vaccine.
The committee voted 11-1 in favor of GSK’s data being adequate to support the safety of the candidate vaccine.
The committee’s favorable recommendation, although not binding, will be considered by the FDA in its ongoing review of the Biologics License Application (BLA) for the candidate vaccine.
The two-dose oral rotavirus candidate vaccine contains a live, weakened form of human rotavirus derived from the most common human rotavirus strain.
The vaccine was registered and BFAD-approved in the
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