What It Means: Pfizer-BioNTech COVID-19 Vaccine Receives FDA Approval

If you’ve been holding out on receiving one of the COVID-19 vaccines until they receive Food and Drug Administration (FDA) approval, now is the time to get your shot. The FDA has officially approved the Pfizer-BioNTech COVID-19 vaccine,will now be marketed as Comirnaty (koe-mir’-na-tee),  for persons age 16 years and older. The Moderna and Johnson & Johnson/Janssen COVID-19 vaccines remain available to the public under Emergency Use Authorization (EUA).

The Pfizer-BioNTech vaccine being the first to be approved for use against COVID-19 does not mean that the Moderna and Johnson & Johnson vaccines aren’t safe, it means that the Pfizer-BioNTech vaccine has been approved first; this makes sense, considering Pfizer and BioNTech were the first companies to submit their COVID-19 vaccine for FDA approval. 

Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. Pfizer and BioNTech submitted their request for FDA approval in May 2021, Moderna submitted their request for approval in August 2021, and as of August 2021 Johnson & Johnson has yet to formally submit a request for FDA approval.

What is the difference between an EUA and FDA approval?

Emergency Use Authorization (EUA)
EUAs, also issued by the FDA, allow the administration to authorize the use of non-FDA approved medical products in the context of public health emergencies. This authorization is only approved under rigorous and extensive testing, and the EUA status should not be taken lightly. These rigorous and extensive standards are only met when tens of thousands of study participants take place in clinical trials in multiple phases of experimentation and analyzation. 

FDA Approval
An FDA approval means that a medical product has been reviewed by the Center for Drug Evaluation and Research (CDER) and that the product has been determined to have medical benefits that decisively outweigh potential risks. The product review takes place within a series of 3 phases intended to analyze the information known and context of the medical condition being addressed by the product, assess benefits and risks of the product from clinical data, and develop strategies for managing those risks.

It cannot be stressed enough that all of the available COVID-19 vaccines (Pfizer-BioNTech, Moderna, and Johnson & Johnson) are all extensively tested, studied, and deemed safe for public use. While it would be negligent to deny the potential for side effects from the COVID-19 vaccines, it must be explicitly stated that any COVID-19 vaccine side effect is not nearly as dangerous as contracting COVID-19 without vaccine protection. 

Protect yourself, your loved ones, and your community by receiving the first available COVID-19 vaccine today: https://www.vaccines.gov.