FDA advisory panel rejects widespread Pfizer booster shots

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FDA advisory panel rejects widespread Pfizer booster shots
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BREAKING: An influential federal advisory panel rejected a plan to offer Pfizer booster shots against COVID-19 to most Americans. The 16-2 vote was a blow to the Biden administration’s effort to increase virus protections amid the contagious delta variant.

The vote by the committee of outside experts assembled by the Food and Drug Administration was 16-12, with members expressing frustration that Pfizer had provided little data on the safety of extra doses. Many also raised doubts about the value of mass boosters, rather than ones targeted to specific groups.

Dr. Amanda Cohn of the Centers for Disease Control and Prevention said: “At this moment it is clear that the unvaccinated are driving transmission in the United States.” The FDA advisory panel was the first major hurdle that the Biden administration plan faced. The FDA itself has yet to make its own determination but typically follows the recommendations of its expert panel.

Sharon Alroy-Preis of Israel’s Ministry of Health said the booster dose improves protection tenfold against infection in people 60 and older. Pfizer pointed to Israeli data from nearly 3 million boosters to suggest side effect rates would be similar to that seen after second doses. But that was before FDA staff scientists had completed their own assessments of the data. Some experts questioned whether Biden was breaking his own pledge to “follow the science” on COVID-19 by getting out ahead of government scientists.

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