Mary Altaffer / AP
The leaders of two federal health authorities are calling on the White House to reconsider its plan to roll out COVID-19 vaccine boosters from September 20.
The leaders of the Food and Drug Administration and Centers for Disease Control and Prevention tell White House COVID-19 advisors that there is not enough data at this time to make a blanket recommendation about boosters and that it might be advisable to Boosters with older patients to start adults first, pending FDA approval. This comes from a source who is aware of the situation but is not empowered to speak publicly.
The development was first reported by The New York Times.
In mid-August, President Biden said the government would begin offering boosters on September 20 pending FDA and CDC approvals. It would apply to people who had received their second vaccination with the Pfizer or Moderna vaccine at least eight months ago.
Dr. Anthony Fauci, the White House medical advisor, said a booster would be needed based on data from the US and Israel showing immunity declines after six to eight months.
At a White House briefing Thursday to endorse a recommendation for boosters, Fauci presented additional data from Israel on the use of boosters in adults aged 60 and over.
The study looked at more than a million people who had received a third shot of the Pfizer vaccine as of late July. Those results showed a strong immune response, Fauci said, adding that he believes three-dose therapy of the Pfizer and Moderna vaccines would become “routine.”
Based on this and other data, Acting FDA Commissioner Janet Woodcock and CDC Director Rochelle Walensky reportedly urged White House COVID-19 advisor Jeffrey Zients to restrict introduction while more data is being collected on other age groups – and the timing is based on a careful scientific analysis of the existing data, with a focus on older adults.
In a statement released by the FDA earlier this week, the agency’s vaccines chief Peter Marks stressed that the agency would follow its normal procedures, including convening an advisory board meeting on Sept. 17 to review the data submitted by Pfizer in support a booster dose of his vaccine.
“The government recently announced a plan to prepare for additional COVID-19 vaccine doses, or ‘boosters’, this fall,” Marks said in the statement.
“The process of approving or approving the use of a booster dose of a COVID-19 vaccine involves each vaccine manufacturer submitting safety and efficacy data to the agency to support that use,” he added. “The FDA is evaluating data submitted by Pfizer-BioNTech in a supplemental biologics filing for its COVID-19 vaccine and will discuss it with the agency’s advisory committee to aid our decision-making.”
So far, the focus of a booster dose has been the two vaccines from Pfizer and Moderna based on mRNA technology. Pfizer was the first FDA approved vaccine for emergency use and the first to receive full approval for use in people 16 years of age and older.
Moderna was approved a week after Pfizers last winter. In addition, Pfizer’s application for a booster dose was filed with the FDA earlier than Moderna’s, so it is expected that any health agency action will likely be pending for Pfizer first and then for Moderna.
The Johnson & Johnson vaccine was approved by the FDA as the Moderna vaccine a few months later. Fauci and others have stated that they expect people who received this single-dose vaccine to also need an extra dose as a booster.
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