FDA Planning to Authorize Pfizer Vaccine Friday Evening: NYT

The first Covid-19 vaccine expected to be deployed in the U.S. won the backing of a panel of government advisers, a step that will likely help clear the way for emergency authorization by the Food and Drug Administration.

The committee of independent vaccine experts voted 17 to 4, with one abstention, that the benefits of the vaccine from Pfizer Inc. and BioNTech SE outweigh the risks for use in people ages 16 and older. The FDA doesn’t have to follow the recommendation, though often it does agree with its advisers.

An authorization could come from the FDA within days. That would open the gates for shots to be distributed across the U.S., in a massive undertaking that will put health-care workers and long-term care facility residents at the front of the line, and mark a first step toward ending a pandemic that has killed some 290,000 people in the U.S.

Part of the panel’s discussion focused on whether there was enough data to support the vaccine’s use in 16 and 17 year olds, leaving some pediatricians on the advisory committee uncomfortable with voting in its favor. However, other members said data from older trial participants could be extrapolated to younger people.

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