(WXYZ) — Pfizer’s COVID-19 vaccine has been granted full approval by the FDA, making it the first Emergency Use Authorization vaccine to receive full approval for people aged 16 and up.
Absolutely, this is a milestone that I and many in the medical community have been waiting for. Full FDA approval will definitely lead to more COVID-19 vaccinations because:
· Number one, the folks who have been waiting for full approval can now feel confident that Pfizer’s vaccine has been scrutinized and meets the FDA’s high standards for safety, effectiveness, and manufacturing quality
· And number two, places like hospitals, businesses and universities can now require Pfizer’s vaccine - which by the way, is now being marketed as Comirnaty (koe-mir’-na-tee)
Now, to get this approval, Pfizer provided expanded safety and efficacy data from roughly 44,000 clinical trial participants. And based on the results, the vaccine was found to be 91% effective in preventing severe disease. That’s slightly lower than the initial 95% efficacy rate but still very protective. As for safety, more than half of the participants were followed for four months, with 12,000 being followed for at least six months. There were no new side effects found - the main ones being pain at the injection site, fatigue, headache, fever, and muscle pain.
The FDA did note there was an increased risk of the heart conditions myocarditis and pericarditis, especially for males between the ages of 12 and 17. But they said that most who developed these rare types of heart inflammation recovered quickly. However, the FDA is requiring Pfizer to further assess the risks with continued studies.
As for Pfizer’s vaccine only getting full approval for 16 and up, remember, Pfizer’s vaccine was first granted Emergency Use Authorization back in December. The FDA only granted Emergency Use for ages 12 and up in May of this year. So Pfizer just needs more time to collect the necessary data the FDA requires in order to apply for full approval for kids aged 12 and 15.
I’m sure we'll be hearing more about this in the coming months. Overall, Pfizer getting full FDA approval is fantastic news. And even though 92 million Americans have already rolled up their sleeves and got the Pfizer shots, the FDA’s full stamp of approval will go a long way in helping the US get more folks vaccinated. And help to save more lives.
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