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FDA Approves Pfizer Vaccine, What Does It Mean?

FDA Approves Pfizer Vaccine, What Does It Mean?

On August 23, 2021, the battle against the pandemic reached another milestone: The US FDA issued its approval for the Pfizer-BioNtech vaccine. But what does it mean, and how can it affect our fight against COVID-19? The answers and more here.

FDA Approves Pfizer Vaccine, What Does It Mean?

Since its development, the Pfizer-BioNtech vaccine has only operated under Emergency Use Authorization. EUA means authorities allow the use of unapproved medical products (such as a vaccine) during emergencies (like a pandemic). This is to treat and prevent severe or life-threatening conditions.

Although the vaccines operate under EUA, it doesn’t mean they didn’t undergo rigorous testing. This is why the World Health Organization approved their emergency use and has declared them safe and effective.

Now that the FDA approves the Pfizer vaccine, it can be marketed or commercially sold – just like any other approved vaccine or medicine – in the United States.

Comirnaty is its New Name, And it Changes Things

The FDA approves the Pfizer vaccine, now called Comirnaty. But what exactly changes besides the fact that people can buy the shot?

Experts say several things will change.

For one, FDA’s approval may help ease vaccine hesitancy since now the vaccine is no longer “experimental” for individuals aged 16 and up. It is now at par with the annual flu vaccines, which many people take in hospitals and clinics.

Additionally, many companies across the globe wait for full approval before they require their employees to get vaccinated.

Does it Mean Authorities Are No Longer Checking Pfizer Vaccine/Comirnaty?

The FDA approves the Pfizer vaccine – does it mean they’re no longer checking them?

Reports say despite full approval, the FDA will continue to monitor Comirnaty. They also required the company to conduct post-marketing studies to check the risk of heart inflammation after people got vaccinated.

Pfizer also committed to conducting post-marketing studies, including a pregnancy registry study. This aims to assess pregnancy and infant outcomes for pregnant women who received the shot.

Moreover, some aspects of the Pfizer vaccine are still under the Emergency Use Authorization, like its administration to 12 to 15 years old and its booster shots.

How About Other Vaccines?

The US FDA will probably focus on Moderna and Janssen next, but no one knows exactly when these two vaccines will receive full approval.

In the Philippines, available vaccines are Pfizer, Moderna, Janssen, Sputnik, AstraZeneca, and Sinovac. Currently, there are no talks over our own FDA’s approval for any of these vaccines to be sold commercially.

The FDA Approves The Pfizer Vaccine – Should You Choose Pfizer Over Other Vaccines?

Please remember that while the US FDA gave their full approval to Comirnaty, the other vaccines are also safe and effective in preventing severe COVID infections and hospitalization.

With the current surge in cases, especially with the more contagious Delta variant, it would be dangerous to wait for Pfizer or whichever you feel is the “best” vaccine. As soon as it’s your turn to receive the life-saving shot, accept it.

Key Takeaways

The US FDA approves the Pfizer vaccine to be sold commercially to people aged 16 and up. This means the vaccine, now called Comirnaty, is at par with other fully-approved vaccines, such as the annual flu shot. For many people, it means the vaccine is no longer experimental.

Still, the Food and Drug Administration will continue to monitor the shot for risk of heart inflammation. The company will also conduct post-marketing analysis to check for pregnancy and infant outcomes for expectant mothers who got the jab.

Note that a Pfizer booster shot and giving it to kids aged 12 to 15 still operate under the Emergency Use Authorization.

Learn more about Coronavirus here.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Emergency Use Authorization for Vaccines Explained

https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained

Accessed August 31, 2021

FDA Approves First COVID-19 Vaccine

https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine

Accessed August 31, 2021

Covid-19: FDA approves Pfizer-BioNTech vaccine in record time

https://www.bmj.com/content/374/bmj.n2096

Accessed August 31, 2021

FDA approves Pfizer COVID-19 vaccine: How approval differs from emergency use authorization

https://www.vcuhealth.org/news/covid-19/fda-approves-pfizer-covid-19-vaccine-how-approval-differs-from-emergency-use-authorization

Accessed August 31, 2021

PFIZER-BIONTECH COVID-19 VACCINE COMIRNATY® RECEIVES FULL U.S. FDA APPROVAL FOR INDIVIDUALS 16 YEARS AND OLDER

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-biontech-covid-19-vaccine-comirnatyr-receives-full

Accessed August 31, 2021

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Written by Lorraine Bunag, R.N. Updated 3 weeks ago
Fact Checked by Kristel Dacumos-Lagorza
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