Pfizer's COVID Vaccine Gets Full FDA Approval

Pfizer’s COVID vaccine is officially the first to get full FDA approval

The Food and Drug Administration (FDA) just gave full approval to Pfizer’s two-dose COVID-19 vaccine, paving the way for vaccine mandates at schools, businesses, and hospitals across the country. The Pfizer shot is the first COVID vaccine to receive FDA approval.

The FDA put out a press release announcing the milestone, sharing that the vaccine will now be marketed as Comirnaty. The FDA has approved the shot for individuals over age 16 but continues to be available via emergency use authorization for kids ages 12-15 and the administration of a third dose for immune compromised individuals.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, 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,” said Acting FDA Commissioner Janet Woodcock, M.D. “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 U.S.”

Dr. Vivek Cherian, MD is an Internal Medicine Physician affiliated with the University of Maryland Health System. He tells Scary Mommy his thoughts on how the FDA approval will impact future vaccine numbers. “My hope of course is we will see a meaningful uptick in the number of individuals getting a vaccine now that we have FDA approval,” he says. “Ultimately though, only time will tell. I’ve treated several patients in the hospital with COVID-19 who were unvaccinated. Oftentimes I would ask what their concern was and usually it had nothing to do with the fact that the vaccine wasn’t officially FDA approved, but more from a concern with how quickly the vaccine was developed and they weren’t sure what the long term side effects would be because it was a new vaccine.”

Cherian says this is “anecdotal” based on his own conversations with patients and stresses that he’s “sure there are individuals out there who have been holding off getting the vaccine pending FDA approval, and frankly I hope there are a lot of them because I want to get millions of more Americans vaccinated as soon as is humanly possible!”

The FDA was sure to let the public know that just because the vaccine was quickly approved for emergency use doesn’t mean it hasn’t gone through rigorous testing. “Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”

Cherian thinks we will start seeing vaccine mandates “fairly soon” noting that some companies and universities have already enacted vaccine mandates prior to the FDA’s approval of Pfizer’s vaccine. “What people need to keep in mind is that this is nothing new. Schools for example already require proof of update vaccinations including Tdap (diphtheria, tetanus and pertussis) and Hepatitis B to name just a few. The reason for this is not only does this help protect individuals but those around them as well,” he explains.

Pfizer submitted their vaccine for emergency approval back in May and more than 204 million doses of the shot have been administered so far via emergency use authorization. With FDA approval, more businesses, schools, and other venues will be able to mandate vaccines for their employees and guests. Let’s hope this exciting news means hundreds of thousands more so a return to “normal” might happen even sooner.