US FDA to use existing Omicron booster data to review shots targeting new subvariants, says official
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Title : US FDA to use existing Omicron booster data to review shots targeting new subvariants, says official
Category : World
NEW YORK, July 1 ― US health regulators will not require companies to submit new clinical trial data on Covid-19 vaccines that target the now dominant BA.4 and BA.5 Omicron subvariants to authorise those shots, but will instead rely on studies showing the efficacy of targeting the earlier BA.1 subvariant, a top official said yesterday.Dr. Peter Marks, a senior official overseeing vaccines at the US Food and Drug Administration, told Reuters the agency would also consider manufacturing data specific to a BA.4 and BA.5 vaccine, and that preclinical data from animal studies and safety data for those shots could also be available.The FDA yesterday recommended Covid-19 vaccine manufacturers Pfizer Inc/BioNTech SE and Moderna Inc change the design of their booster shots beginning this fall to include components tailored to combat BA.4 and BA.5. It plans to review them for emergency …
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