FDA grants full approval of Pfizer COVID-19 vaccine


Key takeaways:

  • The Pfizer COVID-19 vaccine now has full FDA approval for those ages 16 and up in the U.S.
  • Formal approval reaffirms the vaccine is safe and effective. 
  • Getting the COVID-19 vaccine is a proactive, simple step you can take to protect yourself and others.

The Food and Drug Administration recently granted the Pfizer COVID-19 vaccine full approval for those ages 16 and up in the U.S. This is an important milestone in our collective fight against COVID-19, as it further validates the vaccine’s safety and efficacy, especially for those who are hesitant.

The Pfizer COVID-19 vaccine now joins a long list of other critically important vaccines approved and proven to help prevent common and preventable illnesses such as flu, chickenpox and measles.

Our healthcare experts explain what FDA approval means and why it’s important in helping to address vaccine hesitancy.

What does FDA approval mean?

A vaccine or other drug can receive FDA approval after it proves it’s safe and effective and it meets other clinical and scientific benchmarks, including thorough reviews and expert analyses. After months of being closely monitored and studied, and successfully used in more than 200 million people in the U.S., the FDA gave the Pfizer COVID-19 vaccine its formal stamp of approval, reaffirming the vaccine is safe and effective in preventing COVID-19 and minimizing the risk of severe illness, hospitalization and death.

More approvals are on the horizon, too. Pfizer is also seeking full FDA approval for its COVID-19 vaccine in children ages 12—15 and Moderna is awaiting FDA approval of its COVID-19 vaccine for people ages 18 and up.

But, I’m still hesitant…

While millions of people have already safely received the COVID-19 vaccine, some people are still hesitant and waiting for FDA approval before getting vaccinated. It’s normal to have feelings of fear and hesitance when faced with something as serious as a global pandemic. You’re not alone.

Fortunately, after decades studying the science behind the COVID-19 vaccines and more than a year analyzing COVID-19, healthcare professionals and scientists know that the virus and disease caused by COVID-19 are far more dangerous than the known and generally mild side effects of a safe and effective vaccine. You can be assured that we know that the COVID-19 vaccines, including the now FDA-approved Pfizer vaccine, are safe and they work.  

If you’re still hesitant to get the COVID-19 vaccine, talk to your healthcare provider who can answer your questions and help you to make a decision that’s right for you. In the meantime, here are some other resources, common myths and the facts and information about the vaccines.

Vaccines save lives. Get vaccinated.

Getting the COVID-19 vaccine is a proactive, simple step you can take to protect yourself and others. With the highly transmissible Delta variant and hospitals increasingly overwhelmed with unvaccinated COVID-19 patients, now is the time to roll up your sleeve and get your vaccine if you haven’t yet. Our healthcare professionals are available and welcome conversations with you about the vaccines. With each shot, we’re supporting each other and our communities. 


Related resources

What to know about the Delta variant

Get the facts about the COVID-19 vaccine

Is COVID-19 vaccination safe during pregnancy?

Deciding whether to get the COVID-19 vaccine? 5 facts you should know

On the fence about getting your kids vaccinated for COVID? Here are a few reasons to consider it

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