FDA authorizes updated bivalent COVID-19 vaccine boosters

The U.S. Food and Drug Administration on Wednesday authorized updated COVID-19 booster shots from Pfizer (PFE.N)/BioNTech (22UAy.DE) and Moderna that target the dominant BA.4 and BA.5 Omicron subvariants, as the government prepares for a broad fall vaccination campaign that could begin within days.

The new vaccines also include the original version of the virus targeted by all the previous COVID shots.

The Washington Post (8/31, McGinley) reports, “New Omicron-targeting coronavirus booster shots are poised for rollout after being authorized Wednesday by the Food and Drug Administration – a move designed to improve protection against severe illness and death during a potential rise in COVID-19 cases this fall and winter.” These bivalent “boosters, reformulated to take aim at the BA.4 and BA.5 Omicron subvariants dominant in the United States, are scheduled to be reviewed by advisers to the” CDC and if approved, “some boosters may be available starting this weekend, with more showing up in pharmacies, [physicians’] offices and clinics after Labor Day.”

The AP (8/31, Neergaard) reports, “The updated boosters are only for people who have already had their primary vaccinations, using the original vaccines.” The shots “made by Pfizer and its partner BioNTech are for anyone 12 and older while Moderna’s updated shots are for adults – if it has been at least two months since their last primary vaccination or their latest booster.”

Reuters (8/31, Erman, Steenhuysen) reports the U.S. “has secured more than 170 million doses of the two shots” for the rollout.

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Aug 31 (Reuters) – The U.S. Food and Drug Administration on Wednesday authorized updated COVID-19 booster shots from Pfizer (PFE.N)/BioNTech (22UAy.DE) and Moderna that target the dominant BA.4 and BA.5 Omicron subvariants, as the government prepares for a broad fall vaccination campaign that could begin within days.

The new vaccines also include the original version of the virus targeted by all the previous COVID shots.

The FDA authorized the shots for everyone ages 12 and older who has had a primary vaccination series and is at least two months out from a previous booster shot, shorter than prior recommended intervals.

Dr. Peter Marks, a senior FDA official overseeing vaccines, said he hopes the shots will restore the very good protection against symptomatic disease that the original vaccines offered when launched in late 2020 and early 2021.

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