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Departing FDA officials say it’s too soon for COVID-19 boosters as White House plans rollout next week

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Does the general U.S. population need COVID-19 boosters? A group of renowned global health experts, including two key departing vaccine authorities at the FDA, don’t think so.

Even with the wave of delta variant-driven coronavirus cases in the U.S., the authorized vaccines appear to be staving off severe infections, according to a paper published in The Lancet. The group of authors includes top officials with the World Health Organization.

The paper stands in stark contrast to the Biden administration’s own booster shot plan, which some have criticized for jumping ahead of federal regulators. The White House has been planning to roll out the extra doses to the general population as early as next week following the FDA’s meeting on Friday to discuss Pfizer’s application for an extra shot. 

RELATED: Key vaccine leaders departing FDA as COVID-19 booster questions linger

Two of the authors are particularly noteworthy. Marion Gruber, Ph.D., director of the FDA’s Office of Vaccines Research and Review Director, and Deputy Director Phillip Krause, M.D., recently said they’d retire from the agency later this fall, just shortly after the president rolled out the administration’s booster plan.

The experts have not directly cited the White House’s maneuver as reasoning for their departures. But in the paper Monday, the officials strongly rebuked the notion that a wider swath of Americans need a COVID-19 booster for any of the currently deployed vaccines. They noted that the data to support boosters are “preliminary and difficult to interpret.” 

Instead, those vaccines could save more lives if delivered to other nations that have struggled to dole out even a single dose to their population. That would hold true even if the boosters were found to decrease the medium-term risk of serious disease, the experts wrote. 

In fact, boosting the general population too soon or too frequently could come with ramifications, the group argued. That’s because some of the shots have been tied to rare side effects, such as the cases of heart inflammation, known as myocarditis, detected after the mRNA jabs. 

“If unnecessary boosting causes significant adverse reactions, there could be implications for vaccine acceptance that go beyond COVID-19 vaccines,” the scientists wrote, arguing that widespread boosting should only go ahead if “there is clear evidence that it is appropriate.”

RELATED: Biden administration’s push for COVID boosters raises concerns about the science and morality of the plan

There may be  circumstances where a booster may be necessary, the authors wrote. For one, people with compromised immune systems may not adequately respond to the two-dose regimen from Pfizer-BioNTech and Moderna, or the single shot jab from Johnson & Johnson. 

However, it’s “not known whether such immunocompromised individuals would receive more benefit from an additional dose of the same vaccine or of a different vaccine,” they wrote. While boosters may ultimately be needed for the greater population once variants evolve, current evidence doesn’t suggest support giving additional doses.

The U.S. Department of Health and Human Services wasn’t immediately available for comment. 

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