A Food and Drug Administration official said COVID-19 vaccine makers won't need to carry out fresh clinical trials to receive approval for booster shots they're updating for newer Omicron variants. Dr. Peter Marks, who runs the FDA's Center for Biologics Evaluation and Research, told Reuters the agency will use data from trials for vaccines that target BA.1 — the Omicron variant that caused a huge surge in infections last winter — as well as manufacturing data to assess the vaccines. Safety data and preclinical data from animal studies may also be used.
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FDA says updated COVID-19 Omicron boosters won’t require new clinical trials
4th July 2022, 10:47
FDA says updated COVID-19 Omicron boosters won’t require new clinical trials 
