Albuquerque Journal

Biden’s booster plan seen facing resistance from CDC panel, FDA

White House getting ahead of the science data, agencies warn


Medical experts who advise U.S. regulators on vaccines are chafing at what they perceive as political interferen­ce in the review process by the Biden administra­tion.

Last month, the White House announced plans to begin distributi­ng COVID-19 booster shots to Americans Sept. 20. However, the effort still needs the Food and Drug Administra­tion and the Centers for Disease Control and Prevention to sign off. Members of a key panel that advises the CDC on vaccines have pushed back considerat­ion of the plan to mid-September and said this week they were concerned that politics was getting ahead of the process.

It’s “very frightenin­g to me that health-care providers are trying to do the best job that they can, and are taking guidance from HHS and the White House,” said Helen Talbot, a Vanderbilt University professor of medicine and member of the CDC’s Advisory Committee on Immunizati­on Practices, in a meeting Monday.

Pfizer Inc. and BioNTech SE, makers of one of the two vaccines included in the booster plan, filed for authorizat­ion for the extra shot last month. Moderna Inc. applied for clearance late Wednesday.

Some short-term data from Israel supports the use of booster shots. Yet the public push by the White House to get a rollout underway has raised concerns the administra­tion is rushing ahead without enough data and regulatory oversight, said Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelph­ia. Meanwhile, European health authoritie­s said there’s no urgent need for wide use of boosters, although some countries are offering them.

“I would be very surprised if the CDC recommende­d a third dose of the vaccine to the general population,” said Offit, a former member of the CDC’s advisory panel of outside experts that evaluates vaccine data for the agency.

The committee originally planned to evaluate boosters at an Aug. 24 meeting that was postponed to Monday and delayed again to the middle of this month. Rather than an expected vote on the shots Monday, CDC’s Sara Oliver briefly set out guidelines for considerin­g boosters, making clear that current vaccine regimens are safe and prevent hospitaliz­ations and deaths.

Biden first described the booster plan in a statement signed by the top health profession­als, including Walensky, medical adviser Anthony Fauci and FDA Acting Commission­er Janet Woodcock.

“They reviewed mountains and mountains of available data on vaccine effectiven­ess and made a clinical judgment that boosters would be needed,” White House Press Secretary Jen Psaki said Wednesday, asked about concern that the administra­tion got ahead of the science. “Our responsibi­lity and our objective is to save more lives, protect more people, and as soon as this data — the science — made clear that boosters would help do that, we wanted to put that informatio­n out to the public.”

The plan is for people to get boosters eight months after their second shots of either Pfizer or Moderna vaccine, which would put older people and health workers first in line.

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