The FDA and CDC heads are rebuking the White House's proposal for COVID-19 booster shot.
According to The New York Times, the officials need more time for data review on additional doses.
This is yet another setback for the Biden administration's plan that reportedly led to resignations at FDA.
Another setback is in store for the booster-shot plan of the Biden administration.
The New York Times reported that top health officials told the White House that they need more data and time before authorizing additional doses.
According to the report, the heads of the Food and Drug Administration and Centers for Disease Control and Prevention suggested to the White House that they might be able recommend boosters for some recipients of the Pfizer BioNTech vaccine within the next few weeks.
The FDA and CDC chiefs issued an unusual joint statement on August 18 stating that they would start offering boosters starting September 20 to people who have been eight months since their last doses of the Moderna or Pfizer vaccines. Officials stated that boosters would likely be available to people who received the Johnson & Johnson single-dose vaccine.
This announcement and timeline was much more impressive than the FDA or CDC review process. Politico and Endpoint News reported that the FDA's Office of Vaccines Research and Review's top two leaders recently resigned from the agency. This was partly due to the White House's announcement of a booster-plan.
According to The Times, Janet Woodcock (interim head of FDA) and Rochelle Walensky (CDC Director), met with Jeffrey Zients (White House pandemic coordinator), on Thursday, in order to discuss scaling back the booster plan.
This raises questions about whether the regulatory process will be in line with the Biden administration’s timeline for boosters.
Some agency advisors still aren't convinced of the importance of boosters
Dr. Paul A. Offit. Matt Rourke/AP Photos
Three days prior to the White House's scheduled start date for booster rollout, the FDA will convene its independent advisory group to review booster data.
Although boosters may not be needed, virologists aren't unanimous in their belief. Recent data suggests that the shots are still very effective at preventing death and hospitalization, even though protection has waned in less severe cases.
Lynn Bahta (a registered nurse who is part of the CDC's advisory committee on vaccines) stated Monday that if we are going to move in the right direction, then I want to see the data.
Paul Offit is a vaccine expert and sits on an FDA independent review group. He has repeatedly stated that boosters are not needed. To justify using boosters, the virologist stated that he would like to see data that shows the risk of death and hospitalization for people who have been vaccinated.
Insider received no response from the White House, FDA, or CDC.
According to a White House spokesperson, the administration is still waiting for approval from the FDA for booster shots.