Pfizer’s Comirnaty Becomes First Fully Approved Vaccine for the Prevention of COVID-19

The FDA has approved the Pfizer-BioNTech COVID-19 Vaccine (Comirnaty) for the prevention of the COVID-19 disease in individuals who are aged 16 years or older, marking the first full approval of a COVID-19 vaccine, according to a press release from the FDA.¹

The FDA analyzed efficacy data from a clinical trial that included approximately 20,000 individuals aged 16 years or older who received the vaccine and 20,000 who received placebo who did not demonstrate signs of infection within a week of receiving the second dose. Additionally, safety was evaluated in approximately 22,000 individuals who received the vaccine and 22,000 who were given placebo. Results from the clinical trial indicated that the vaccine had a 91% efficacy rate in preventing infection with COVID-19.

The emergency use authorization (EUA) that allows individuals aged 12 to 15 years to receive the vaccine is still in place. Additionally, on August 13, 2021, the FDA authorized the use of a third dose of the vaccine in immunocompromised individuals, such as those who have undergone a solid organ transplant or who have a condition that leaves them similarly immunocompromised.² According to the FDA, the approval represents an important key achievement for the betterment of public health and safety.

“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,” Janet Woodcock, MD, acting commissioner at the FDA, said in a press release. “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.”

The vaccine had a biologics license application that was built on extensive data and previous information that worked to support the EUA, including clinical and preclinical findings, details of the vaccine's manufacturing process, the results of vaccine testing, and site inspections. The FDA conducted its own analyses of the data within the BLA to ensure the vaccine’s safety and efficacy met the agency’s standards.

The FDA first issued an EUA on December 11, 2020, for Pfizer’s COVID-19 vaccine for individuals who were aged 16 years or older. The designation was based on the results of an ongoing, randomized, controlled, blinded clinical trial.³ Updated findings from the trial, which featured a longer duration of follow up and a larger study population, helped to pave the way for the full approval.

The FDA also notably conducted an in-depth evaluation of the post-authorization safety surveillance data that focused on myocarditis and pericarditis following administration of the vaccine. It was determined that there was an increased risk of developing these conditions, especially within 1 week of receiving the second dose. The risk was higher among men under the age of 40 vs women and older male patients. Men between the ages of 12 to 17 years had the highest observed risk.

“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. 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.,” Peter Marks, MD, PhD, director of the Center for Biologics Evaluation and Research at the FDA, concluded.

References

1. FDA approves first COVID-19 vaccine. News release. FDA. August 23, 2021. Accessed August 23, 2021. https://bit.ly/3ms0zEG
2. Coronavirus (COVID-19) update: FDA authorizes additional vaccine dose for certain immunocompromised individuals. News release. FDA. August 12, 2021. Accessed August 23, 2021. https://bit.ly/3g0dyJO
3. FDA takes key action in fight against COVID-19 by issuing emergency use authorization for first COVID-19 vaccine. News release. FDA. December 11, 2020. Accessed August 23, 2021. https://bit.ly/386Ph0f