Outgoing FDA vaccine officials co-author article explaining why vaccine boosters not currently needed

Two Food and Drug Administration officials who will be stepping down later this month co-authored a new medical article that questioned the need for COVID-19 vaccination booster shots.

What is the background?

Despite the proven efficacy of COVID vaccines, the Biden administration this summer began pushing for vaccine booster shots, claiming they are necessary to fortify COVID immunity.

But the campaign has been controversial. Two weeks ago, Dr. Marion Gruber, director of the FDA's Office of Vaccines Research and Review, and her deputy, Dr. Philip Krause, announced they would leave the agency in the coming months. According to Reuters, the FDA did not say why the pair was leaving the agency, despite Gruber, for example, having spent more than three decades with the FDA.

Politico later reported that Gruber and Krause had actually resigned in protest over the White House's micromanagement of vaccine plans:

A current health official said the pair, Marion Gruber and Philip Krause, left over differences with FDA's top vaccine official Peter Marks. Now the agency is facing a potential mutiny among its staff and outside vaccine advisers, several of whom feel cut out of key decisions and who view the plan to offer boosters to all adults as premature and unnecessary.

POLITICO spoke to 11 current and former health officials and people familiar with the matter who described growing exasperation with the administration's disjointed process for implementing its booster plan. Those sources said there is little coordination between federal health agencies, even as two top FDA officials try to guide the rollout.

What happened now?

In a newly published article in Lancet, a peer-reviewed medical journal, Gruber and Krause, along with 17 others, argued for the efficacy of the COVID-19 vaccines and cautioned against pushing booster shots.

"The vaccines that are currently available are safe, effective, and save lives," the medical experts wrote. "The limited supply of these vaccines will save the most lives if made available to people who are at appreciable risk of serious disease and have not yet received any vaccine. Even if some gain can ultimately be obtained from boosting, it will not outweigh the benefits of providing initial protection to the unvaccinated."

In fact, they explained that "currently available evidence does not show the need for widespread use of booster vaccination in populations that have received an effective primary vaccination regimen." That's because, as they earlier explained, "efficacy against severe disease remains high" in vaccinated populations, including infections caused by the delta variant.

The experts also warned about the political nature of booster advocacy.

"Careful and public scrutiny of the evolving data will be needed to assure that decisions about boosting are informed by reliable science more than by politics," they wrote.

Who should get a booster?

They recommended that boosting "could be appropriate for some individuals in whom the primary vaccination ... might not have induced adequate protection," such as immunocompromised individuals and people who received a vaccine with low efficacy.

Still, they added a major qualifier to booster appropriateness for such individuals.

"People who did not respond robustly to the primary vaccination might also not respond well to a booster," the medical experts wrote.

When will booster shots begin?

Politico reported this week the Biden administration is pushing forward with its plan to begin widespread COVID vaccine booster distribution by Sept. 20. Tensions over the plan, however, remain high, the report noted.

Details of the booster rollout remain similarly unclear, USA Today reported.

Editor's note: This story was updated to include details about the Biden administration's booster plan.