Pfizer-BioNTech vaccine gets full approval by top US drugs agency
US made Pfizer-BioNTech Covid-19 vaccine has finally received full approval from the US Food and Drug Administration.
Pfizer’s double shot vaccine, which was initially approved for emergency use, now becomes the first vaccine to gain a full US FDA approval, and can now be administered on people ages 16 and older.
The shot will now be marketed in the US under the brand name Comirnaty.
“The public can be very confident that this vaccine meets the high standards of safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” acting FDA Commissioner Janet Woodcock said in a statement on Monday.
With the approval coming amid vaccines hesitancy among a significant number of Americans, health experts are hopeful that it will encourage more skeptics to get the jab, especially as the US battles a surge in cases driven by the highly transmissible delta variant.
Pfizer CEO Albert Bourla said on Monday that the FDA’s full approval of the company’s Covid-19 vaccine should help ease hesitancy.
“For those people that were a little bit reluctant because they wanted to see a full approval, now they have the full confirmation of one of the most respected agencies in the world, the FDA, that the vaccine is effective and safe,” Bourla said.
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US President Joe Biden has urged Americans to get vaccinated, reiterating the safety and efficacy of the shot.
“Let me say this loudly and clearly — if you’re one of the millions of Americans who said that they will not get the shot until it has full and final approval of the FDA — it has now happened,” Biden said, adding that “The moment you’ve been waiting for is here. It’s time for you to get your vaccination.”
Meanwhile, the global health nonprofit Doctors Without Borders (MSF) called on the pharmaceutical giant to share its vaccine technology to help accelerate global supply.
According to MSF, hundreds of millions of Pfizer doses have been administered globally.
Only one per cent of Pfizer’s vaccine supply has been delivered to countries on the African continent, while over 200 million doses have been administered in mainland US.
“The only reason these vaccines aren’t being produced more widely is because Pfizer-BioNTech and Moderna are refusing to share mRNA vaccine technology and information with manufacturers, including those in Egypt, Morocco, South Africa, and Tunisia that could have the capacity to produce up to 100 million doses annually within a 10-month timeframe,” Lara Dovifat, campaign manager for MSF’s Access Campaign, noted in a statement.
Other than Pfizer’s vaccine, Moderna has also applied for full approval, also known as a Biologics Licensing Application.
Makers of single shot Johnson & Johnson have not yet applied for full approval and the vaccine remains in use under emergency authorization.
