The US Food and Drug Administration has granted full approval to Pfizer-BioNTech’s Covid-19 vaccine for people ages 16 and older, marking the first of three available US vaccines to be granted the status following their initial approval for emergency use.
The move is likely to set off a wave of vaccine requirements at businesses and institutions whose policies relied on the FDA’s full approval, and could push hesitant Americans who have waited for the FDA to weigh in before they got their jab.
The US Department of Defence will require vaccines for more than 1 million active service members, pending full approval. The state of Oregon has also issued a requirement for state workers.
Universities across the US have implemented vaccine policies pending the full FDA approval, and United Airlines will require employees to be vaccinated within five weeks of the FDA’s move.
US Surgeon General Vivek Murthy told CNN on Sunday that “for businesses and universities that have been thinking about putting vaccine requirements in place in order to create safer spaces for people to work and learn, I think that this move from the FDA ... will actually help them to move forward with those kinds of plans.”
“The FDA’s approval of this vaccine is a milestone as we continue to battle the Covid-19 pandemic,” said Acting FDA Commissioner Janet Woodcock said in a statement. “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 more than 170 million Americans have received at least two shots of Covid-19 vaccines or a shot of the single-dose Johnson & Johnson drug, the FDA recognises that “for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated,” she said.
A recent poll from the Kaiser Family Foundation reported that three in 10 unvaccinated Americans said they are more likely to get vaccinated if one of the vaccines currently authorised for emergency use were to receive full approval from the FDA, though two-third of adult respondents (including a majority of unvaccinated adults) believe that the vaccines currently available in the US already have full approval from the FDA or are unsure of their status.
The FDA’s full approval designation – arriving as the US combats rising infections and hospitalisations among unvaccinated people that have strained health systems as the more-contagious Delta variant dominates transmission – follows the agency’s review of reports finding that the Pfizer vaccine is 91 per cent effective in preventing disease.
Pfizer’s vaccine will continue to be available for people in the US ages 12 and under before the FDA determines whether to grant full approval.
Peter Marks, director of thee FDA’s Center for Biologics Evaluation and Research, said one of the gravest challenges against the crisis remains the “overwhelming amount” of misinformation and false claims circulating online about vaccines.
“Getting a Covid-19 can save your life,” he told reporters on 23 August.
Joe Biden’s administration also is moving towards “booster” shots for people eight months after their second dose, effective on 20 September, pending health officials’ approval.
US health offiicials are also reviewing a full approval application from Moderna for its two-dose vaccine, which could be within several weeks, and Johnson & Johnson is also expected to apply.
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