FDA May Need More Time to Review COVID-19 Booster Shot Plan

FDA May Need More Time to Review COVID-19 Booster Shot Plan hand holds vial as it fills syringe (ROBYN BECK/AFP via Getty Images)

By Theodore Bunker | Friday, 03 September 2021 01:49 PM

Top officials at the Food and Drug Administration and the Centers for Disease Control and Prevention have warned the White House that they may need more time to review data before the Biden Administration can begin introducing COVID-19 booster shots.

The New York Times reports that FDA acting commissioner Dr. Janet Woodcock and CDC Director Dr. Rochelle Walensky told White House pandemic coordinator Jeffrey Zients on Thursday that their agencies might be able to determine in the next few weeks if they will recommend COVID-19 booster shots for people who received the vaccine made by Pfizer-BioNTech. The Biden administration had planned to begin offering coronavirus booster shots later this month, according to the Times.

The newspaper’s sources said that it’s unclear how Zients responded to the warning, but he has consistently said that the Biden administration will follow the advice given by its scientists, whatever it may be.

A spokesperson for the White House, when asked about the meeting, told the Times that "we always said we would follow the science, and this is all part of a process that is now underway," and said that the administration is waiting for a "full review and approval" for the shots from the FDA and for a recommendation made by the CDC.

"When that approval and recommendation are made," spokesman Chris Meagher added, "we will be ready to implement the plan our nation’s top doctors developed so that we are staying ahead of this virus."

The Biden administration previously released a joint statement from medical experts and officials at the Department of Health and Humans Services, including both Walensky and Woodcock, concerning a plan for Covid-19 booster shots.

The statement notes that while the COVID-19 vaccines currently authorized "continue to be remarkably effective in reducing risk of severe disease, hospitalization, and death, even against the widely circulating delta variant … The available data make very clear that protection against SARS-CoV-2 infection begins to decrease over time following the initial doses of vaccination, and in association with the dominance of the delta variant, we are starting to see evidence of reduced protection against mild and moderate disease."

Due to this, they "conclude that a booster shot will be needed to maximize vaccine-induced protection and prolong its durability," and "have developed a plan to begin offering these booster shots this fall" following "an independent evaluation" on the safety and effectiveness of a booster shot for the Pfizer and Moderna vaccines, and "booster dose recommendations based on a thorough review of the evidence" by the CDC’s Advisory Committee on Immunization Practices.

"We are prepared to offer booster shots for all Americans beginning the week of September 20 and starting 8 months after an individual’s second dose," the statement said at the time.