Pfizer asks FDA to greenlight new omicron booster shots, which could arrive this fall

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Pfizer asks FDA to greenlight new omicron booster shots, which could arrive this fall
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Pfizer has submitted data on its bivalent COVID-19 booster shot that specifically targets the latest omicron subvariants. If authorized, the company says the shots could be ready as soon as September.

The new booster shot would be an update to Pfizer's current version of the shot, which was designed for the original strain of the coronavirus. On Monday, the drugmakers Pfizer and BioNTech announced that they've asked the Food and Drug Administration to authorize an updated version of their COVID-19 vaccine — this one designed specifically to target the omicron subvariants that are dominant in the U.S.

If the vaccine is authorized by the FDA, distribution could start "immediately" to help the country prepare for potential fall and winter surges of the coronavirus, Pfizer CEO Albert Bourla said in a statement. Instead of waiting for results from human trials, the FDA asked the drug companies to initially submit only the results of tests on mice,Regulators will rely on those results — along with the human neutralizing antibody data from earlier BA.1 bivalent booster studies — to decide whether to authorize the boosters.

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