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FDA gives full approval to Pfizer COVID-19 vaccine

A healthcare provider gives a young man a vaccine

The U.S. Food and Drug Administration (FDA) has approved the Pfizer COVID-19 vaccine for people ages 16 and older. This is the first COVID-19 vaccine to receive full FDA approval, as opposed to emergency use authorization (EUA). The vaccine will now be marketed under the name Comirnaty.

Kids ages 12 through 15 can still get the Pfizer vaccine under the EUA. And seniors, adults with underlying medical conditions, and adults who live or work in high-risk settings can get a booster dose under the EUA too.

What does this mean for the vaccine?

The FDA approval means the Pfizer vaccine has passed high standards for safety. And it has been thoroughly tested to make sure it works. FDA has found that the shot helps people avoid COVID-19, especially severe illness that might lead to a hospital stay or death.

As part of the approval process, FDA reviewed follow-up data from the original clinical trials. These showed that the Pfizer vaccine is 91% effective against COVID-19.

Before the FDA approval, the Pfizer vaccine had an EUA. EUAs allow new products like vaccines to be used before FDA completes a full review. EUAs are used during public health emergencies when other options are not available and there's clear evidence the benefits outweigh the risks. But it doesn't mean that vaccine makers were allowed to cut corners. All the vaccines authorized during the COVID-19 pandemic are safe and effective, and they were tested in clinical trials.

What does this mean for me?

Some people have been uneasy about getting a vaccine before it had full FDA approval. If that was the case for you, now you can get it with more confidence. The Pfizer vaccine has a great track record in keeping people safe from COVID-19.

Side effects are generally mild and may include pain, redness and swelling in the spot where you got your shot. Or you might experience tiredness, headache, muscle pain, chills, fever or nausea. These are normal and typically go away in a day or two.

While FDA approval means that doctors could legally give the vaccine to children ages 11 and under, the American Academy of Pediatrics has urged doctors not to offer this kind of "off label" use. The vaccine is still being tested for safety, success and appropriate dosing in this age group. Results are expected soon.

Want to learn more about COVID-19 vaccines? Visit our Coronavirus health topic center.

Reviewed 10/17/2021

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