The COVID-19 vaccine from Pfizer-BioNTech has become the first to receive full approval from the U.S. Food and Drug Administration (FDA), the regulatory authority that oversees the safety, effectiveness and quality of vaccines that are used in the United States.
For the past eight months, the vaccine has been available to U.S. residents under Emergency Use Authorization (EUA) from the FDA. Hilary Babcock, MD, BJC infection prevention medical director and Washington University School of Medicine infectious diseases physician, says approval is primarily based on reviewing additional data.
“The FDA took several months to review all of the data before granting approval,” Dr. Babcock says. “We have good data on the safety and efficacy of the COVID-19 vaccine, and this confirms what we have seen over the past eight months since the vaccine became available — that it is working.”
Dr. Babcock says more than 40,000 people received the Pfizer vaccine during clinical trials leading up to EUA, and more than 92 million people in the U.S. have been fully vaccinated with the Pfizer vaccine since authorization.
“Studies of vaccine effectiveness after EUA was granted continue to show high effectiveness of the vaccines,” Dr. Babcock says. “And post-market surveillance has been reassuring. Most people experience only minor side effects, such as a sore arm or feeling ‘under the weather’ for a day or two.
“While the Pfizer mRNA vaccine has been associated with a very small increased risk of myocarditis in young men, that risk is lower than the rate of myocarditis after COVID-19 infection,” Dr. Babcock says, “and it is usually mild and easily treated.”
Dr. Babcock says FDA approval of the vaccine doesn’t change a whole lot from the EUA status that the FDA granted in December. “Both EUA and FDA approval are thorough processes that look at the safety and efficacy of a vaccine,” she says.
“A key difference between the two is that at least two months of follow-up data from phase 3 clinical trials is considered for EUA, versus at least six months of data that is needed for FDA approval,” Dr. Babcock says. “The safety and effectiveness of the COVID-19 vaccine was the same at two months versus six months, which is why it doesn’t change too much to go from EUA to FDA approval.”
For many, however, approval may bring additional peace of mind, especially to those who have been hesitant to get the vaccine.
“Having the COVID-19 vaccine FDA-approved is reassuring and provides an added layer of confidence that this vaccine has met all the required safety and effectiveness criteria, similar to other vaccines we get that are also FDA-approved,” Dr. Babcock says. “We hope this approval will ease the concerns of those who have not yet received the vaccine.
“And while we have all heard of occasional cases of COVID-19 occurring in vaccinated people, the risk of getting COVID-19, even with the delta variant, is much lower among the vaccinated — and the risk of ending up in the hospital or in the ICU is very low if fully vaccinated,” Dr. Babcock adds.
What does FDA approval mean to you?
See how a few team members from across BJC and Washington University feel about FDA approval of the Pfizer vaccine:
“The COVID vaccine’s FDA approval means liberation for me, my family, friends and my entire community to get back to a better, yet new, normal. It gives us the stamp of approval and takes away all excuses to not comply.”
— Tritobia Jones, MSW, LCSW, Christian Hospital case management social worker
“My hope is that the FDA approval will lead to an increased sense of confidence in the vaccine, that those who were previously on the fence will be more comfortable making the decision to get vaccinated.”
— Tara Manhart, RN, Missouri Baptist Sullivan Hospital occupational health nurse
“Coronavirus is real. The side effects of the vaccine are mild vs. the possible severe symptoms of the COVID-19 virus. Now that the vaccine has received full approval, it’s time to get back to life as we know it! It is our responsibility to be a part of the solution. Do your part — trust the scientists and get vaccinated!"
— Anita Wilson, ANP, FNP, Washington University School of Medicine, Division of Urologic Surgery, family nurse practitioner
Seeking FDA approval for a vaccine
The FDA expects vaccine developers to follow a specific process to generate the information it needs to assess the safety and effectiveness of a vaccine to prevent an infectious disease.
Once a manufacturing process is developed that ensures that a vaccine can be produced reliably and consistently, and the preclinical and clinical development programs have been successfully completed, companies submit a Biologics License Application (BLA) to the FDA. The FDA makes its decisions based on its analysis of the benefits and risks for the intended population who will receive the vaccine, as well as the disease(s) to be prevented. Learn more here.
How is emergency use authorization (EUA) different?
During public health emergencies, the FDA allows EUA to get vaccines/treatments to the public before full FDA approval.
In this process, vaccine manufacturers take on a development process that includes thousands of study participants to generate non-clinical, clinical and manufacturing information needed by the FDA to determine whether the known and potential benefits outweigh the known and potential risks of a vaccine.
When the phase 3 portion of the human clinical trials reaches a predetermined point that informs how well a vaccine works, a data safety monitoring board reviews the data and informs the manufacturer of the results. Based on the data and the interpretation of the data, manufacturers decide whether to submit an EUA request to the FDA, taking into consideration input from the FDA. See more about EUA here.