A pair of top Food and Drug Administration (FDA) officials overseeing the review of COVID-19 vaccine applications will depart the agency this coming fall, according to a Tuesday report.
Bloomberg News reports:
Marion Gruber, head of the regulator’s Office of Vaccines Research and Review, plans to retire on Oct. 31 and Philip Krause, deputy director for the FDA’s Center for Biologics Evaluation and Research, will be leaving the following month, according to an email to staff that was viewed by Bloomberg.
U.S. health officials have been working to evaluate Covid vaccines and treatments at top speed, with shots from Moderna Inc., Johnson & Johnson and the partnership of Pfizer Inc. and BioNTech SE cleared in record time. Now the agency is charged with considering the administration’s booster program, which is set to roll out additional shots for most U.S. vaccinated adults Sept. 20.
“We are confident in the expertise and ability of our staff to continue our critical public health work, including evaluating COVID-19 vaccines,” Stephanie Caccomo, a spokeswoman for the FDA, told the news outlet.
The report comes after President Joe Biden revealed that federal health officials are now considering guidelines for coronavirus booster shots just five months after individuals receive their complete immunizations.
“We’re considering the advice you’ve given that we should start earlier,” Biden stated during an Oval Office meeting with Israeli Prime Minister Naftali Bennett Friday. “Should it be as little as five months and that’s being discussed.”
Biden’s remarks follow a reportthat stated regulators were likely to approve a booster shot for vaccinated adults beginning at the six-month gap following the previous shot instead of eight months.
Per the Wall Street Journal:
Data from vaccine manufacturers and other countries under review by the Food and Drug Administration is based on boosters being given at six months, the person said. The person said approval for boosters for all three Covid-19 shots being administered in the U.S.—those manufactured by Pfizer Inc. and partner BioNTech SE, Moderna Inc. and Johnson & Johnson —is expected in mid-September.
Earlier this month, the FDA fully approving Pfizer’s coronavirus vaccine, making it the first shot to receive the agency’s full approval outside of emergency use authorization.
Acting FDA Commissioner Janet Woodcock said at the time:
The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product.
While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.
More than 200 million Pfizer doses have been administered in the U.S. under emergency provisions — and hundreds of millions more worldwide — since December. In going a step further and granting full approval, the Food and Drug Administration cited months of real-world evidence that serious side effects are extremely rare.
The Associated Press contributed to this report.
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