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news.GlaxoSmithKline or GSK has said that the FDA Vaccines and Related Biological Products Advisory Committee has recommended approval for the company's oral rotavirus candidate vaccine, Rotarix, to prevent rotavirus gastroenteritis in infants.
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The committee has voted unanimously (12-0) in favor of company’s data being adequate to support the efficacy of the candidate vaccine. The committee voted 11-1 in favor of company’s data being adequate to support the safety of the candidate vaccine.
If approved by the FDA, the vaccine would allow for completion of the rotavirus vaccination series by four months of age and could be integrated into the current vaccine schedule at the two and four month immunization visits. The committee’s favorable recommendation, although not binding, will be considered by the FDA in its review of the biologics license application (BLA) for the candidate vaccine, which is currently underway.