Aug 27, 2021 10:00 AM

Author: Kylene Metzger

Medical professionals are again urging broad vaccination among Americans who have been waiting for full licensure of COVID-19 vaccines. On August 23, 2021, the Food and Drug Administration (FDA) approved the first COVID-19 vaccine in the United States. The Pfizer-BioNTech COVID-19 vaccine, now marketed as Comirnaty, is approved for individuals 16 years of age and older to help prevent COVID-19 disease.

The process of receiving emergency use authorization (EUA) and full FDA authorization, or full licensure, is a rigorous process. Andrew Pavia, MD, chief of the Division of Pediatric Infectious Diseases at University of Utah Health, explains how the process works and why the vaccine can be trusted.

Emergency Use Authorization

On December 11, 2020, the Pfizer-BioNTech COVID-19 vaccine received EUA based on safety and efficacy data from a clinical trial that involved more than 40,000 participants. The results from the clinical trial found the vaccine was 91% effective in preventing COVID-19 infection.

“People understandably put a lot of attention on the fact that COVID-19 vaccines were under EUA, but that was not for safety or efficacy reasons,” Pavia says. “It’s for regulatory reasons.”

EUAs can be used during public health emergencies. The FDA determines whether a “medical product” is effective in preventing, diagnosing, or treating a disease and outweighs the known and potential risks of the product. Based on available data from Pfizer-BioNTech, the FDA determined they “provided clear evidence that its vaccine may be effective in preventing COVID-19.”

Full Licensure

The regulatory process of receiving full licensure by the FDA is thorough and takes time. According to Pavia, when there is no public health emergency, it could take between eight months to a year from submission to full licensure. It took nine months for the Pfizer-BioNTech COVID-19 vaccine, which Pavia says is impressive but not out of the ordinary. “It just meant a lot of FDA officials worked nights and weekends to do the paperwork faster,” he says. “There were no shortcuts taken and no steps skipped.” 

For Pfizer-BioNTech to receive full licensure of its COVID-19 vaccine, the FDA reviewed 340,000 pages of information. This included very specific, mandated requirements such as additional safety data, manufacturing capacity, inspection of plants and equipment, paperwork filing, etc.

“With full licensure, questions about the safety and efficacy of the vaccine should be answered now,” Pavia says. “It’s gone through every step that any vaccine would go through, with over 350 million doses given to more than 200 million Americans. It’s now one of the most studied vaccines.”

The FDA and Centers for Disease Control and Prevention have robust systems in place that continue to monitor the safety of COVID-19 vaccines.

Moderna and Johnson & Johnson Vaccines

Moderna and the Johnson & Johnson COVID-19 vaccines are available under EUA after an extensive review of safety and efficacy data from large clinical trials, with more than 30,000 participants each. Both the Moderna and J&J COVID-19 vaccines are available for individuals 18 years of age and older.

COVID-19 Vaccines for Children

The Pfizer-BioNTech COVID-19 vaccine is currently under EUA for individuals 12 to 15 years of age. While the process of getting full licensure is well underway, it will take time. Moderna isn’t far behind. Pavia expects a decision from the FDA on EUA for the Moderna vaccine for this age group soon.

Pfizer-BioNTech and Moderna both have COVID-19 vaccine trials underway for children 6 to 11 years old. Safety data on these trials are expected in the fall, but it’s uncertain at this time when the vaccine will become available for this age group.

Kylene Metzger

Public Affairs

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