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The US Food and Drug Administration (FDA) has granted full approval to the Covid-19 vaccine manufactured by Pfizer-BioNTech, the agency announced on Monday.
Its full approval comes at a crucial time in the trajectory of the pandemic, as the US is ensnared in a wave of illness sparked by the highly transmissible Delta mutation. The administration of President Joe Biden has made increasing vaccinations a priority in its efforts to tamp down the latest Delta outbreak.
“All around the world, people want these vaccines, and here in America they're free, convenient and waiting,” Mr Biden said in remarks from the White House upon news of the FDA approval.
“So please, go today, for yourself, for your loved ones, for your neighbours, for your country.”
The two-dose regimen was initially made available in the US through an emergency authorisation late last year.
It has since become the most widely used of three available vaccines against the disease caused by the coronavirus, data from the Centres for Disease Control and Prevention (CDC) show, with more than 92 million people having received two shots.
The vaccine continues to be available to people age 12 to 15 under an emergency-use authorisation, the FDA said.
The approval is likely to boost confidence in the shot among people who say they are wary of its rapid-fire development and could open the door to more vaccination requirements among employers and businesses.
“Let me say this loudly and clearly: if you are one of the millions of Americans who have said that they will not get the shot until it has full and final approval of the FDA, it has now happened,” Mr Biden said in remarks on Monday afternoon. “Go get vaccinated.”
At least 44 per cent of unvaccinated people in the US surveyed by the Kaiser Family Foundation in June were more likely to be immunised if a vaccine received full authorisation by the FDA.
Mr Biden also called on private companies to mandate employees to be vaccinated against Covid-19 “or face strict requirements".
Several businesses across in many industries, including colleges and universities, have already enacted vaccination mandates as they would otherwise have to face constant Covid-19 testing or even termination — but some were awaiting full FDA approval for legal reasons.
The US is recording seven-day averages of 135,000 daily infections and 738 daily deaths, the CDC reported. The country also leads the world in official deaths from Covid-19, with 628,000 fatalities.
“The experts from the Yale School of Public Health [say the] pace of our vaccination efforts has saved over 100,000 lives and prevented over 450,000 hospitalisations,” Mr Biden said.
“This is critical progress. We need to move faster.”
The approval is also likely to solidify the shot’s status as a blockbuster for its makers.
Pfizer said last month it expects the vaccine to bring in $33.5 billion in revenue this year, a total that would place it among the biggest-selling drugs of all time. In the second quarter, the vaccine booked $7.8bn in sales.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the Covid-19 pandemic,” Janet Woodcock, the acting FDA commissioner, said in a press release.
“While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorisation, as the first FDA-approved Covid-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety.”
Comirnaty is officially approved for use in people aged 16 and up, though under the emergency use authorisation, children aged 12 to 15 can also receive the shot.
After the approval was announced, the Pentagon stated that it is prepared to issue updated guidance requiring all personnel to be vaccinated.
Defence Secretary Lloyd Austin earlier in August called on 1.3 million active-duty personnel in the US military to be vaccinated by mid-September or “immediately upon” the full FDA approval of any vaccine, whichever comes first.