Senior House Republicans accused President Biden of “playing politics” with COVID-19 booster shots on Tuesday 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-19 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.
Mr. Biden’s COVID-19 team has defended its decision to offer boosters to anyone who received the second dose of an mRNA vaccine eight months ago or more.
White House COVID-19 Coordinator Jeff Zients said the plan is supported by Dr. Woodcock, CDC Director Rochelle Walensky, Surgeon General Vivek Murthy and top officials at the National Institutes of Health, including Director Francis Collins and Dr. Anthony Fauci.
“Having reviewed all of the available data, it is in their clinical judgment that it is time to prepare Americans for a booster shot,” he told reporters in late August. “We announced our approach in order to stay ahead of the virus, give states and pharmacies time to plan, and to be transparent with the American people as to the latest data and expert clinical judgments from the team to give them time to do their own planning.”
“We have also been very clear throughout that this is pending FDA conducting an independent evaluation and CDC’s panel of outside experts issuing a booster dose recommendation,” he said.
Florida Gov. Ron DeSantis, a Republican, said Tuesday he does not know whether boosters are truly needed or not but he is worried the rollout will lead to shifting goalposts as the government mandates the shots through employers.
“If you’re forcing this on somebody on penalty of losing their job, say they got the two Moderna doses or the two Pfizer — then six months later, the government says you have to do a booster, let’s say. What if they think that they’re fine, would they lose their job then? Would they always have to keep doing it? I think it creates a lot of thorny issues,” he said.
Dr. Walensky told reporters on Friday that “currently, fully vaccinated is two doses of Pfizer or Moderna or a single dose of J&J,” but the CDC’s Advisory Committee on Immunization Practices might revisit the question in the future.
“I anticipate, over time, that may be updated, but we will leave that to our advisors to give us some recommendations,” Dr. Walensky said.
Mr. DeSantis said Florida will make boosters available to people if they are authorized but he remains worried about future implications.
“I think it raises questions as you go further down the line about what would even count as being vaccinated,” the governor said.