U.S. FDA Green Lights Omicron-Targeted COVID Boosters Ahead of Revaccination Campaign

Reuters | By Michael Erman and Julie Steenhuysen

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.

"We don't know for a fact yet whether we will get to that same level, but that is the goal here," Marks said.

The government has begun working on the fall rollout, which could start soon after the U.S. Centers for Disease Control and Prevention's (CDC) outside expert panel meets on Thursday and agency Director Rochelle Walensky makes a final recommendation.

The United States has secured more than 170 million doses of the two shots in an attempt to stave off the worst effects of a potential surge in infections as schools reconvene and people spend more time indoors due to colder weather.

This could be the last COVID vaccine provided for free to all Americans as the government plans to shift them to the commercial insurance market next year. read more

Moderna's retooled vaccine was authorized for those aged 18 and above, while the Pfizer/BioNTech shot will be available for those aged 12 and above, the FDA said.

Pfizer said it has some doses ready to ship immediately and can deliver up to 15 million doses by Sept 9. Moderna said it expects its new shot to be available "in the coming days."

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