U.S. regulators are likely to greenlight a coronavirus booster vaccine for vaccinated adults beginning at the six-month gap following the previous shot instead of eight months, according to a report.
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.
The WSJ report comes on the heels of the FDA fully approving Pfizer’s coronavirus vaccine, making it the first jab to receive the agency’s full approval outside of emergency use authorization.
“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,” said Acting FDA Commissioner Janet Woodcock, M.D.
“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,” he added
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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