- The US Food and Drug Administration (FDA) approves Pfizer-BioNTech COVID-19 vaccine for people aged 16 and above
- It is the first COVID-19 vaccine to be granted full approval as opposed to emergency use authorisation (EUA) and will be marketed as Comirnaty
- The vaccine is still available to those aged 12 to 15 under the EUA, and a third does for individuals with certain immunocompromising conditions
- US President Joe Biden urged Americans yet to be vaccinated to get their jabs
- The full authorisation is also expected to prompt further workplaces and organisations to set vaccine requirements
The US Food and Drug Administration (FDA) has granted the first full approval for a COVID-19 vaccine to the Pfizer-BioNTech vaccine for people aged 16 and above.
Previously the vaccine – which will now be marketed as Comirnaty – was available for those aged 12 and above under the FDA’s Emergency Use Authorisation (EUA).
The vaccine is still available to those aged 12 to 15 under the EUA, and a third dose for individuals with certain immunocompromising conditions.
The first full approval
Acting FDA Commissioner Janet Woodcock said the approval marked a milestone in the battle against the pandemic which has claimed more than 4.4 million lives globally.
“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, effectiveness and manufacturing quality the FDA requires of an approved product.
“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instil additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the US.”
This was a sentiment echoed by US President Joe Biden in a speech following the approval on Monday afternoon.
“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. The moment you’ve been waiting for is here, it’s time for you to go get your vaccination and get it today.”
The US has been battling a surge in cases linked to the Delta variant of the virus. In the past 28 days, more than three million people in the country tested positive and 12,254 people lost their lives, according to data published by John Hopkins.
A mandate for a vaccine requirement?
The 46th President also cast the FDA approval as a mandate for leaders on various levels to introduce vaccine requirements.
“Today I’m calling on more companies in the private sector to step up with vaccine requirements that will reach millions more people. If you’re a business leader, a nonprofit leader, a state or local leader who has been waiting for full FDA approval to require vaccinations, I call on you now to do that, require it.”
Following the approval, Pentagon Spokesperson John Kirby said the state department was preparing to require all US service personnel to be vaccinated and that a timeline would be released in the coming days.
“These efforts ensure the safety of our service members and promote the readiness of our force. Not to mention the health and safety of the communities around the country in which we live,” Mr Kirby said.
There are several instances of vaccine mandates already in place in the US. On a state level, New Jersey announced all state workers would need to be vaccinated by mid-October or face regular COVID-19 tests.
Some major corporations have also been ahead of the curve with vaccine requirements. Goggle told employees they would need to be inoculated to return to the office, and Netflix followed suit with the same requirement for cast and crew on its US productions as well as workers in its offices.