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FDA fully approves Pfizer Coronavirus vaccine

Washington Post: “Federal regulators Monday granted full approval to the Pfizer-BioNTech coronavirus vaccine – a milestone that could help increase inoculation rates and spark a wave of vaccine mandates by employers and universities amid a surge of new cases and hospitalizations fueled by the ferocious delta variant, according to two individuals with direct knowledge of the decision. The Food and Drug Administration action marks the first licensing of a vaccine for the coronavirus, which has swept the United States in repeated and punishing waves since early 2020, exhausting nursing staffs, filling intensive care units and raising fears among the vaccinated and the unvaccinated. Critics for weeks had demanded that the FDA move faster on approving the vaccine, arguing that the millions of inoculations administered since late last year under an emergency authorization demonstrated the shots’ safety and effectiveness. But even as the FDA redoubled its efforts, increasing staff and computer resources dedicated to the review, the agency insisted on six months’ follow-up data for people enrolled in the pivotal clinical trial.”

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