As of late August, nearly 170 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 the vaccine.
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.
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:
“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.
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 September 20, 2021, Pfizer submitted its application to the FDA for emergency use authorization for children between the ages of 5-11. If it is approved, authorization would likely be granted by the end of October.
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 to the FDA for approval. Currently, the application for Moderna remains under review. An estimated timeline has not been released.
Johnson & Johnson
The single-dose Johnson & Johnson vaccine was given emergency use authorization on February 27, 2021.
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.
Since it has FDA approval, Pfizer is now able to market its vaccine 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”.
“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.
Based on when Moderna submitted its BLA, the FDA could grant full approval of its COVID-19 vaccine at some point in the early fall.
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