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.