COVID-19

FDA Approval for COVID-19 Vaccines: The Latest

Three COVID-19 vaccines were given emergency use authorization by the FDA for millions of Americans. So where does the process stand for approval?

Aug. 27, 2021 3   min read

As of December, nearly 200 million Americans have been fully vaccinated against COVID-19. Those vaccinations have happened thanks to the Food and Drug Administration (FDA) giving emergency use authorization for the Pfizer-BioNTech, Moderna, and Janssen (Johnson & Johnson) vaccines.

Now that we have been administering vaccines for more than eight months, one of the next steps is for the FDA to issue final full approval for each of the vaccines.

Edward Walsh, MD, an infectious disease specialist, and Michael Pichichero, MD, director of the Rochester General Hospital Research Institute, share their insight into the timeline.

What does FDA approval look like?

Approval by the FDA is a process that requires a lot of time, data, and oversight. The FDA’s Center for Biologics Evaluation and Research is in charge of making sure vaccine developers follow all of the guidelines and regulations while creating and manufacturing a vaccine.

"We've learned through the adult approval process that emergency use authorization does not skip any of the safety steps and evaluation of effectiveness," Dr. Pichichero said. "The scrutiny of the files is very thorough. However there is still a process that occurs before you can get full licensure from the FDA."

After a company is given emergency use authorization for a vaccine, it then submits a Biologics License Application (BLA) to the FDA. This is a request to distribute and market a vaccine in the U.S. The application will have many thousands of pages of preclinical and clinical data, along with detailed descriptions of the manufacturing processes and the facility or facilities that will be used in manufacturing. In addition, the FDA visits and inspects the manufacturing process.

All of the information is to prove how safe and effective the vaccine is for the patients who will be receiving it. A standard FDA review team consists of:

  • physicians
  • chemists
  • statisticians
  • pharmacologists/toxicologists
  • microbiologists
  • experts in post-marketing safety
  • clinical study site inspectors
  • manufacturing and facility inspectors
  • labeling and communications experts

“With the COVID-19 vaccine, each team will be looking over at least six months of clinical trial data and inspecting the manufacturing sites where the vaccine will be produced and packaged in lots to be distributed,” Dr. Walsh said. “The idea is to make sure the entire process continues to stay safe.”

Once full approval is granted, the FDA will continue to monitor and testing the vaccines to make sure they are up to safety and effectiveness standards. Any issues are reported by different surveillance systems.

Where they stand

Pfizer

The Pfizer-BioNTech vaccine was given emergency use authorization on December 11, 2020 for people ages 16 and older. On May 10, 2021 emergency use authorization for 12-15 year olds was granted.

On May 7, 2021, Pfizer submitted its application for full FDA approval for ages 16 and older.

On August 23, 2021, the FDA gave approval for the Pfizer COVID-19 vaccine for people ages 16 and older. The vaccine remains under emergency use authorization for children ages 12-15.

On October 29, 2021, the CDC gave approval the Pfizer COVID-19 vaccine's emergency use authorization to include children between the ages of 5-11.

Moderna

The Moderna vaccine was given emergency use authorization on December 18, 2020 for people ages 18 and older.

On June 1, 2021, Moderna submitted its application for full approval to the FDA for for people ages 18 and older. Full approval was given for that age group on January 31, 2022.

On October 31, 2021, Moderna announced the FDA is taking extra time to review the vaccine's safety for children ages 12-17.

Johnson & Johnson

The single-dose Johnson & Johnson vaccine was given emergency use authorization on February 27, 2021 for people ages 18 and older.

Janssen, the manufacturer of the Johnson & Johnson vaccine, has not yet submitted an application to the FDA, nor has it said when that could happen.

What comes next?

Since both Pfizer and Moderna have FDA approval, both companies are now able to market their vaccines directly to consumers. More advertisements will likely be showing up for the COVID-19 vaccine. The Pfizer vaccine will be marketed with the name “Comirnaty”; Moderna plans to market its vaccine as “Spikevax

“Clinical trial data for younger age groups is still being collected, so Pfizer will likely be submitting applications for its vaccine to be approved for children once the data comes in,” Dr. Walsh said.

NEXT STEPS COVID-19 Vaccine Questions

Uncertainties are a common thing to experience during a large-scale health event like a global pandemic. Our experts at Rochester Regional Health are seeking out as many answers as they can on a daily basis.

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Edward E. Walsh, MD
Infectious Disease
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