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What does full approval of Pfizer’s COVID-19 vaccine imply?

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What does full approval of Pfizer’s COVID-19 vaccine imply?

It means Pfizer’s shot for folks 16 and older has now undergone the identical rigorous testing and regulatory assessment as dozens of different long-established vaccines.

COVID-19 vaccines within the U.S. have been initially rolled out beneath the Meals and Drug Administration’s emergency use authorization, which permits the company to hurry the supply of medical merchandise throughout public well being emergencies.

Below the method, the FDA waived a few of its regular information necessities and procedures to make the COVID-19 vaccines out there months sooner than would have been attainable beneath regular circumstances.

Pfizer’s vaccine — together with these from Moderna and Johnson & Johnson — nonetheless underwent testing in tens of 1000’s of individuals to determine security and effectiveness in opposition to COVID-19. However the FDA initially required the businesses to submit about solely two months of security monitoring information on examine individuals, the interval when unwanted side effects are most probably to happen.

For full approval, the FDA required six months of follow-up information. FDA inspectors additionally visited the crops the place the vaccines are made and reviewed every step of the manufacturing course of for additional assurance that the pictures are made beneath secure, sterile circumstances.

As a result of vaccines are sometimes given to in any other case wholesome people, they’re usually topic to extra regulatory scrutiny than different medical merchandise, together with pharmaceuticals. Full approval means the Pfizer vaccine now carries the FDA’s strongest endorsement of security and effectiveness.

Public well being consultants hope the change will persuade extra unvaccinated folks to get the shot and spur extra employers to require vaccinations.

Moderna has additionally utilized for full approval, and Johnson & Johnson has mentioned it hopes to use later within the yr.

Pfizer’s shot nonetheless is on the market for 12- to 15-year-olds beneath emergency use authorization. The complete approval additionally doesn’t apply to boosters. The company will resolve individually whether or not an additional shot is important for wholesome folks.

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The AP is answering your questions in regards to the coronavirus on this sequence. Submit them at: [email protected] Learn extra right here:

Do I would like a booster if I obtained the Johnson & Johnson vaccine?

Do the COVID-19 vaccines have an effect on my probabilities of being pregnant?

Can I get ‘lengthy COVID’ if I’m contaminated after vaccination?

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