FDA Panel Recommends COVID-19 Booster Shots For Older Americans But Warns Against Widespread Use

Amid rising breakthrough COVID-19 cases, a federal advisory panel unanimously voted Friday to recommend the Food and Drug Administration (FDA) authorize a third booster dose of Pfizer and BioNTech’s coronavirus vaccine for Americans over the age of 65 as well as for other groups of people who are at high risk for COVID-19.

But, at the same time, the panel overwhelmingly voted against recommending the widespread use of boosters for Americans aged 16 and older. The move is seen as a rebuke to the Biden administration’s plan to administer booster shots to all Americans, over 16, which was set to begin on Sept. 20, the Hill reported.

The panel’s recommendation is much restricted compared to what companies and top officials of the Biden administration originally pursued.

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Panel member Michael Kurilla and clinical director at the National Institutes of Health said that there is no incremental benefit of the vaccine shown to the younger group yet. “We just can’t simply be in a position where we would just be vaccinating people every time we think there’s a problem.”

The FDA doesn’t have to accept the panel’s vote since it is not required. But if they don’t, it would most likely raise questions of political interference and might create a conflict between scientists and political officials who signed the booster plan.

The agency’s top vaccine regulator Peter Marks said that the recommendation could be modified.

If the FDA approves the recommendation, an advisory panel of the Centers for Disease Control and Prevention (CDC) will meet next week to determine other details about who is qualified for the booster shots and when will they be given.

The FDA panel members did not vote to specify who is considered high risk for the virus but will most likely include health care workers and people who have pre-existing conditions like diabetes, heart disease, and obesity.

Also Read: This COVID-19 Vaccine Is ‘Most Effective’ In Preventing Hospitalizations, According to CDC

After the panel’s decision, the White House stated that it is ready to move forward. “Today was an important step forward in providing better protection to Americans from COVID-19. We stand ready to provide booster shots to eligible Americans once the process concludes at the end of next week,” assistant press secretary Kevin Munoz said.

People who already have severely weakened immune systems are qualified to receive a third shot but the only booster allowed will be the vaccine from Pfizer-BioNTech.

Those who received the Moderna and Johnson & Johnson vaccine will not be qualified for the third shot until the FDA approves the said companies. Moderna already submitted their booster data in early September while Johnson & Johnson has not yet provided evidence.

The announcement to administer booster shots was made last month by President Biden and top health officials even before the FDA and CDC examined the evidence provided.

Officials were careful to say that the booster program is provisional on the FDA and CDC’s approval but they still were criticized by some public health officials for speaking as if they have already been given approval.