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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.
The vaccination, commonly known as the Pfizer shot, will be rebranded and marketed under the name Comirnaty. It had previously been granted an emergency use authorisation.
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.”
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A woman wearing a protective mask walks on a street, following new cases of Covid-19, in Shanghai, China. Reuters -
FILE PHOTO: Patients suffering from the coronavirus disease (COVID-19) get treatment at the casualty ward in Lok Nayak Jai Prakash (LNJP) hospital, amidst the spread of the disease in New Delhi, India April 15, 2021. REUTERS / Danish Siddiqui / File Photo To match Special Report AFGHANISTAN-CONFLICT / REUTERS-SIDDIQUI -
A worker places the coffin of Sri Lanka's former foreign minister Mangala Samaraweera, who died today due to Covid-19, in the furnace to be cremated at Colombo's main cemetery. AFP -
Palestinians receive a shipment of doses with the Moderna coronavirus disease (COVID-19) vaccine donated by the U. S, in Salem village, in the Israeli-occupied West Bank, August 24, 2021. REUTERS / Mohamad Torokman -
FILE PHOTO: A mass cremation of victims who died due to the coronavirus disease (COVID-19), is seen at a crematorium ground in New Delhi, India, April 22, 2021. Picture taken with a drone. REUTERS / Danish Siddiqui / File Photo To match Special Report AFGHANISTAN-CONFLICT / REUTERS-SIDDIQUI -
(FILES) In this file photo taken on April 17, 2020 A pharmacist at a Boots Pharmacy, in PPE including a full face mask as a precautionary measure against COVID-19, passes a completed prescription to Bikeworks cycling instructor Jelil Adebiyi (L), for him to to deliver to vulnerable people as part of the Bikeworks Cycle Delivery Service (COVID-19) in east London on April 17, 2020. - British pharmacies Boots are launching a new service in 14 UK cities, including London and Edinburgh, to deliver medicines and cosmetics by courier with the Deliveroo platform. (Photo by ISABEL INFANTES / AFP)
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.”
President Joe Biden delivers remarks on the full FDA approval of the Pfizer vaccine at the White House campus. AP
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 acting FDA commissioner
“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.”
Emergency use authorisation
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.
