The Food and Drug Administration announced Monday morning that it had granted full approval to Pfizer's mRNA two-shot vaccine to protect against the Wuhan coronavirus, a move that's sure to embolden leaders who seek to implement vaccine mandates.
"The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older," an FDA release explained of the first COVID vaccine to be granted full approval in most cases.
Today, FDA approved the first COVID-19 vaccine for the prevention of #COVID19 disease in individuals 16 years of age and older. https://t.co/iOqsxXV1fj
— U.S. FDA (@US_FDA) August 23, 2021
And while Pfizer's vaccine received full approval from the FDA for two doses among those 16 and up, it is still only available on an emergency use authorization (EUA) basis for those 12 to 15 or when used as a third booster dose.
To support the FDA’s approval decision today, the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population.
Specifically, in the FDA’s review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.
Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.
More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.
The FDA reported that the "most commonly reported side effects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever."
Despite receiving the green light for official approval in most cases, the FDA and CDC noted that they have continue to have "monitoring systems in place to ensure that any safety concerns continue to be identified and evaluated in a timely manner" and "is requiring the company to conduct postmarketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Comirnaty" to "include an evaluation of long-term outcomes among individuals who develop myocarditis following vaccination with Comirnaty."
The decision by the FDA to grant full approval to the Pfizer COVID-19 vaccine is expected to have significant implications nationwide. Many see it as a tipping point for private and public organizations on the fence about mandating vaccines for employees or students. https://t.co/vC8zcaX8hN
— Cayle Thompson (@CayleThompson) August 23, 2021
Already, New York City has begun implementation of its vaccine mandate for many activities and several companies and other jurisdictions have previously said they would require vaccination once FDA approval was granted.