Republicans press FDA chief on COVID-19 booster scuffle

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Senior House Republicans on Tuesday accused President Biden of “playing politics” with COVID-19 booster shots and told the Food and Drug Administration to divulge what it told the White House ahead of a planned Sept. 20 start to the rollout.

House Minority Whip Steve Scalise and Rep. James Comer, the top Republican on the House Oversight Committee, said the decision to move ahead with a third dose of the Pfizer-BioNTech and Moderna vaccines “stunned” federal regulators who hadn’t vetted the data and signed off on the idea.

“President Biden, instead of following the science, is attempting to distract from his numerous crises by playing politics and moving out ahead of the FDA and the Centers for Disease Control [and Prevention] when it comes to the science on coronavirus vaccine booster shots,” Mr. Scalise and Mr. Comer wrote in a letter to acting FDA Commissioner Janet Woodcock.

The administration says the COVID vaccines remain effective at staving off severe illness, but it’s worried about data suggesting that immunity wanes after eight months, resulting in more breakthrough infections. It pointed to parallel data in Israel, which got an early start on vaccination, and top officials in multiple health agencies backed the plan. 

The White House’s COVID-19 team said the U.S. shouldn’t wait until vaccinated persons wind up in the hospital in large numbers, though Mr. Biden — somewhat confusingly — said the general population would start to get boosters on Sept. 20 even as he warned the plan is subject to regulatory approval.

“Top scientists and researchers were stunned by this decision—particularly because the CDC and the FDA had not yet conducted their independent review of the data,” Mr. Scalise and Mr. Comer wrote.

The GOP lawmakers, who sit on the House Select Committee on the Coronavirus Crisis, want Dr. Woodcock to provide FDA documents and communications on the plan.

And they want materials related to the departure of two senior FDA officials, Marion Gruber and Phil Krause, who reportedly decided to retire because the White House got ahead of their vaccine department on boosters.

Those scientists published a paper Monday that said available evidence does not support giving booster shots to the general population. They said even though immunity wanes, the vaccines’ effectiveness “is substantially greater against severe disease than against any infection.”

“Even in populations with fairly high vaccination rates the unvaccinated are still the major drivers of transmission and are themselves at the highest risk of serious disease,” the scientists wrote.

They said available doses should go to poorly immunized parts of the world, a point the World Health Organization has made repeatedly.

Republican lawmakers probing the issue said they want the FDA to divulge whether any punishment — or “adverse employment action” — was taken or considered against employees during the debate around boosters.

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