U.S. to Recommend Booster Shots for Most Americans 8 Months After Second Dose

By  Megan Redshaw

The Biden administration plans to offer Americans a third COVID booster dose by mid-September assuming Pfizer receives full FDA approval by then, despite health officials last month saying there wasn’t enough data to recommend a third dose.

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.

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.

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Via https://childrenshealthdefense.org/defender/covid-booster-shots-8-months-after-second-dose/