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F.D.A. Authorizes Pfizer Booster Shot for Higher-Risk People

  • September 22, 2021

The F.D.A. not only narrowed Pfizer’s request, but authorized the third shot on an emergency basis instead of fully approving it.

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As a practical matter, since the F.D.A. fully approved the Pfizer-BioNTech vaccine as a two-dose regimen last month, physicians have had broad latitude to prescribe a third dose to people they deemed in need of one. Many Americans have already sought extra shots on their own, typically by finding a cooperative pharmacist or pretending to be unvaccinated.

“There’s anxiety about this public expectation that everyone should go get a booster,” said Dr. Marcus Plescia, the chief medical officer for the Association of State and Territorial Health Officials, which represents state health agencies. “If we pull back on that, then states are going to get left holding the bag.”

Dr. Jesse L. Goodman, a former chief scientist at the F.D.A., said that because of some uncertainty around the benefits of boosters, regulators were right to grant only an emergency clearance for the shots while continuing to study their safety and performance.

“A stepwise approach is very judicious,” he said.

Some state health officials greeted the F.D.A.’s move enthusiastically. Dr. Clay Marsh, West Virginia’s Covid-19 czar, said that his state’s success vaccinating older residents early meant that they were overdue for extra protection.

He also said that strained hospitals in the state could not afford to lose more staff, and that booster doses could protect frontline workers from milder infections that would require them to stay at home.

Article source: https://www.nytimes.com/2021/09/22/us/politics/pfizer-boosters-fda-authorize.html

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