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.
This week, the FDA asked vaccine manufacturers to modify booster shots to target the Omicron BA.4 and
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