Pfizer: New Study Makes Case for Booster Shots for All Adults

FDA says it will review application 'as expeditiously as possible'
By Newser Editors and Wire Services
Posted Nov 9, 2021 5:23 PM CST
Pfizer Asks FDA to OK Booster Shots for All Adults
Oakland Mayor Libby Schaaf gives a thumbs up after receiving a Pfizer COVID-19 vaccine booster shot at Asian Health Services in Oakland, Calif., Wednesday, Oct. 27, 2021.   (AP Photo/Jeff Chiu)

Pfizer asked US regulators Tuesday to allow boosters of its COVID-19 vaccine for anyone 18 or older, a step that comes amid concern about increased spread of the coronavirus with holiday travel and gatherings. Older Americans and other groups particularly vulnerable to the virus have had access to a third dose of the Pfizer and BioNTech vaccine since September. But the Food and Drug Administration has said it would move quickly to expand boosters to younger ages if warranted. Pfizer is submitting early results of a booster study in 10,000 people to make its case that it’s time to further expand the booster campaign, the AP reports.

While all three vaccines used in the US continue to offer strong protection against severe COVID-19 illness and death, the shots’ effectiveness against milder infection can wane over time. Pfizer’s new study concluded a booster could restore protection against symptomatic infection to about 95%, even as the extra-contagious delta variant was surging. Side effects were similar to those seen with the company’s first two shots. The Biden administration had originally envisioned boosters for all adults, but faced a setback in September when the FDA's scientific advisers rejected extra Pfizer doses for everyone. The panel wasn’t convinced that young healthy people needed another dose, particularly when most of the world’s population remains unvaccinated, and instead recommended boosters just for certain groups.

The current rules: People who initially received Pfizer or Moderna vaccinations are eligible for a booster six months later if they're 65 or older, or are at high risk of COVID-19 because of health problems or their job or living conditions. Because the single-dose Johnson & Johnson vaccine hasn't proven as effective as its two-dose competitors, any J&J recipient can get a booster at least two months later. FDA spokeswoman Alison Hunt said the agency would review Pfizer’s application "as expeditiously as possible," but would not set a timeline for a decision. She also said the FDA hasn’t yet decided whether to convene its panel of outside experts to vet the data. (More COVID booster shots stories.)

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