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

NEW YORK (Reuters) - 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.

 

https://www.reuters.com/legal/government/fda-will-not-require-clinical-trial-data-authorize-redesigned-covid-boosters-2022-06-30/#:~:text=NEW YORK (Reuters) - The,FDA official said on Thursday. So to expedite this new booster omit possible adverse effects data 

"I actually think that this fall we have to go all out on our booster campaign," Marks said.

 

Ka-Chinggggg!

"Southern France, here I come...!"

FDA Commissioner