GSK’s Pandemic Vaccine Will Test Swine-To-Bird Approval Transmission
This article was originally published in The Pink Sheet Daily
FDA agreed to infer GSK’s H5N1 vaccine’s effectiveness from the effectiveness of the adjuvanted H1N1 vaccine; agency’s Vaccines and Related Biological Products Advisory Committee will weigh in – and consider Dynavax’s hep B vaccine Heplisav – on Nov. 14.
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FDA will ask its Vaccines and Related Biological Products Advisory Committee to talk about how to verify and describe the clinical benefit of the vaccine under the accelerated approval regulations.
Company says its hepatitis B vaccine, which had been placed on clinical hold at one point during its Phase III trials, will be discussed at a FDA advisory committee in November.
The firm is hoping to gain licensure for chronic kidney disease patients first, and eventually to expand the indication to the broader hepatitis B vaccination population.