WASHINGTON, Sept 21 ― US regulators could authorise a booster shot of the Pfizer Inc/BioNTech SE Covid-19 vaccine for older and some high-risk Americans early this week in time for the government to roll them out by Friday.
The panel decided against recommending broader approval, citing a lack of evidence to support broad use, and they wanted to see more safety data, especially about any risk of heart inflammation in younger people after vaccination. The FDA could later widen access to the booster shots. Top FDA members have been split on the necessity of the boosters, with interim head Janet Woodcock backing them and some of the agency's top scientists arguing they are not needed yet.
Despite the narrow scope of the proposed authorisation, the panel's recommendation would cover most Americans who got their shots in the earliest stages of the US vaccination campaign and whose immunity may be waning.
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