FDA will not require clinical trial data to authorize redesigned COVID boosters -official

The U.S. Food and Drug Administration will not require companies to submit clinical trial data on COVID-19 vaccines modified to protect against the BA.4 and BA.5 versions of Omicron in order to authorize those shots, a top FDA official said on Thursday.

Dr. Peter Marks, head of the agency’s Center for Biologics Evaluation and Research, told Reuters the agency will rely on data from clinical trials vaccine makers have run on shots designed to combat the BA.1 lineage, as well as manufacturing data, for emergency use authorization submissions before the fall.

Preclinical data from animal studies and safety data could also be available, he said.

The FDA on Thursday recommended COVID-19 vaccine manufacturers change the design of their booster shots beginning this fall to include components tailored to combat the currently dominant Omicron BA.4 and BA.5 sublineages.

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Author: HP McLovincraft

Seeker of rabbit holes. Pessimist. Libertine. Contrarian. Your huckleberry. Possibly true tales of sanity-blasting horror also known as abject reality. Prepare yourself. Veteran of a thousand psychic wars. I have seen the fnords. Deplatformed on Tumblr and Twitter.

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