FDA Panel Votes Against COVID-19 Booster Recommendation

By The Hill
Posted on 09/17/21 | News Source: The Hill

A federal advisory panel said Friday the Food and Drug Administration (FDA) should not approve a third booster dose of Pfizer and BioNTech's COVID-19 vaccine for everyone 16 or older, but indicated it would be open to boosters for older people.

The panel voted overwhelmingly against the recommendation, 16 to 2.

Friday's vote from the FDA's vaccine advisory committee deals a major blow to the Biden administration's plan to administer booster doses beginning Monday.

The increasingly contentious issue of boosters has divided outside scientists as well as some inside the FDA.

The panel's vote is not binding, so FDA doesn't have to accept the results. But if the agency doesn't, it will raise significant questions of political interference and pit agency scientists against political officials who signed off on the booster plan.

In an unusual move last month, President Biden and top health officials, including Surgeon General Vivek Murthy, acting FDA Commissioner Janet Woodcock and Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, publicly announced a booster shot program would begin next week, well before the FDA and CDC examined the evidence.

While officials have been careful to say the booster program is contingent on the FDA and CDC giving the green light, they have been criticized by some public health experts for speaking as if the approval was a given.