On August 23, the US Food and Drug Administration (FDA) granted full approval of the Pfizer-BioNTech COVID-19 vaccine. This is the first full approval for any COVID-19 vaccine for people ages 16 and older.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” says Acting FDA Commissioner Janet Woodcock, MD. “While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization (EUA), as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product.”
The approval means Pfizer has shown enough effectiveness and safety data to meet the strict Biologics License Application requirements. These requirements include at least six months of safety data from a majority of the volunteers in a large, final stage clinical trial. The FDA visited the clinical trials sites, inspected the vaccine manufacturers and read through thousands of pages of patient data to do its own analyses. It also completed a risk-benefit analysis on data that came to light after the clinical trials were over, when hundreds of millions of people got the shot.
“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the US,” says Woodcock.
Pfizer was the first pharmaceutical company to request full approval in the U.S. and other COVID-19 vaccine manufacturers are expected to follow suit. At this time, Moderna and Johnson & Johnson COVID-19 vaccines have been granted EUA based on massive clinical trials involving tens of thousands of volunteers. Moderna said it plans to finish its application this month. Johnson & Johnson, which is currently gathering data from trials of two-dose regimens, also plans to file for full approval this year.
We are also closely following the CDC’s guidance for potential “booster” shots for immuno-compromised individuals who are more vulnerable to COVID. Mosaic will be providing further information and updates soon regarding how to access the “booster.” However, if you have any questions about your individual situation, please contact your primary care physician.
Finally, I want to close this week’s article with a simple fact about the vaccine. Although the vaccine is not perfect and does not stop 100 percent of those vaccinated from getting COVID, it does significantly decrease the recipient’s chance of severe illness or death. With the benefit of eight-plus months of data, we now know that unvaccinated individuals are approximately 29 times more likely to be hospitalized with COVID.