What It Means Now That the Pfizer Vaccine Is Fully FDA Approved for Adults

What It Means Now That the Pfizer Vaccine Is Fully FDA Approved for Adults


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Pfizer’s COVID-19 vaccine is now fully approved for ages 16 and up, the FDA announced today. The Moderna and Johnson & Johnson vaccines are still covered under an emergency use authorization, as is the Pfizer vaccine’s use in children aged 12 to 15.

What happens now?

The vaccines are still the same, and the recommendations for who should get one have not changed.

One concern among some people who hadn’t gotten a COVID vaccine was that all the vaccines were only emergency authorized and not fully approved, making them seem “experimental” and potentially dangerous, even though there is a ton of safety data. One hope is that full approval could be reassuring to anyone who was holding out and waiting for more safety data.

Approval also means that more employers and organizations may be more willing to enact a vaccine mandate. Legally, they can require a vaccine even though it’s under EUA rather than full approval, but some employers may feel more comfortable requiring it now that it’s approved.

Normally full authorization allows providers to use the drug or vaccine however they think is appropriate; if that’s different from what the vaccine was approved for, it is called “off label” use. But the COVID vaccines are being provided through an agreement with the government, which prohibits them from being used for off-label boosters or in other age groups (such as children) in most cases.

Full approval also means that Pfizer gets to pick out a brand name for their vaccine. Instead of calling it “the Pfizer vaccine,” the vaccine can now be known as Comirnaty. (Accent on the second syllable, as if the “ehrmagerd” girl were trying to say “community.”)

What’s the difference between EUA and approval?

A vaccine’s full approval requires more safety data than its emergency authorization (six months of follow-up instead of two months) and also requires inspections and more scrutiny of the process used to manufacture the vaccine.

Most drugs and vaccines on the market are FDA approved; that’s the normal way things work. Because the country is under a national emergency for COVID-19 though, the FDA has allowed COVID vaccines to be “emergency use authorized” (EUA), which amounts to a temporary approval. If the emergency were to be lifted, the vaccines under EUA would no longer be able to stay on the market.

An EUA is different from approval in a few other ways, including that it’s easy to take an EUA product off the market by quickly rescinding the EUA. We wrote about the difference last year, back when regulators were considering which pathways would be appropriate for getting a COVID vaccine to the public.

What happens to the Moderna and Johnson & Johnson vaccines?

Moderna applied for full approval back in June, about a month after Pfizer submitted their application, so it’s likely that Moderna could get full approval soon. Johnson & Johnson plans to apply for full approval for their vaccine soon.

EUAs are generally only granted when no approved alternatives are available, leading to speculation that the EUAs for the other vaccines could be revoked. Regulators haven’t announced anything about revoking the existing EUAs, though.

 





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