Adjuvanted H1N1 Vaccine Excites FDA Panel, But Jury Is Still Out
This article was originally published in The Pink Sheet Daily
Pending further data on adjuvants from firms and NIH, FDA's Vaccines and Related Biological Products Advisory Committee is comfortable with FDA's plans to license unadjuvanted H1N1 flu vaccines under the strain change process.
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The October panel will not review a specific application, but is expected to offer FDA advice on whether emergency use authorization is an appropriate pathway for COVID vaccines, and what data would be needed for full licensure. Sponsors may present data on their candidate vaccines.
Beyond vaccine experts, specialists in medical areas where there might be safety concerns, as well as epidemiologists, could be helpful to aid the FDA in understanding the data in a coronavirus vaccine application.
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.