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The Biden administration has decided most Americans should get a COVID vaccine booster dose eight months after they received their second shot, despite consensus among U.S. health experts last month there wasn’t enough data to recommend boosters for the general population.

Officials are planning to announce the decision as early as this week and a third dose could be offered as early as mid-September, according to administration officials familiar with the discussions.

Doses would only begin to be administered widely once the U.S. Food and Drug Administration (FDA) formally approves the vaccines — an action expected to happen for the Pfizer vaccine within weeks.

The administration’s goal is to let Americans who received the Pfizer or Moderna vaccines know they will need additional protection against the Delta variant responsible for the surge of U.S. COVID cases.

(INSERT by Sandra:  we have a new and frightening word (“Variant”) for what used to be a mutation or adaptation.)

The first boosters are likely to go to nursing home residents, healthcare workers and emergency workers, followed by older people who were near the front of the line when vaccinations began late last year and then the general population.

Federal health officials are waiting for more data before offering guidance for Johnson & Johnson vaccine recipients. However, officials expect a booster will also be needed.

Pfizer and BioNTech said Monday a third dose is safe and elicits an antibody response at levels that “significantly exceed” those seen in individuals who receive two doses of the jab.

Federal health officials have been actively looking at whether booster doses for the vaccinated would be needed as early as this fall, reviewing case numbers in the U.S. and Israel, where preliminary studies suggest the vaccine’s protection against serious illness is waning among those vaccinated in January.

The announcement comes just days after the Centers for Disease Control and Prevention (CDC) voted to recommend COVID booster shots for certain immunocompromised patients.

On Aug. 12, the FDA amended Emergency Use Authorization of Pfizer and Moderna’s COVID vaccines to authorize a booster shot for this population.

Pfizer CEO confident third dose will increase immunity, no phase 3 data

According to Kaiser Health News, Pfizer lacks late-stage clinical trial results to confirm a booster will work against COVID variants, including Delta — which now accounts for 93% of new infections across the U.S.

Pfizer in July announced its global phase 3 trial — which assesses the safety, efficacy and immunogenicity of a third dose — but the trial’s completion date isn’t until 2022. Phase 3 results generally are required before regulatory approval.

“We are confident in this vaccine and the third dose, but you have to remember the vaccine efficacy study is still going on, so we need all the evidence to back up that,” Jerica Pitts, Pfizer’s director of global media relations, said last week.

Moderna’s clinical trial “designed to assess the safety, reactogenicity and immunogenicity of a delayed vaccine boost” has an estimated primary completion date of May 28, 2023, and study completion date of 2025.

Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital in Philadelphia and an adviser to the National Institutes of Health and FDA, said the pharmaceutical industry’s rush to recommend boosters for the public is “a little frustrating.”

(INSERT, Sandra:  If Offit has learned that schilling for industry comes with risks and costs, good for him.  He has the appearance of maybe changing horses?  In Word AND Deed?  remains to be seen,)

2018-10-30 Dr. Paul Offit’s Promo for ‘BAD ADVICE’ Falls Flat; Robert F Kennedy challenges Offit to a Debate with Experts.

Even if a booster is found to be safe, Offit said, the U.S. effort should focus on “vaccinating people who are unvaccinated.” In any case, decisions about boosters do not rest with vaccine makers, he said.