The Food and Drug Administration (FDA) has approved the Pfizer-BioNTech COVID-19 vaccine, making it the first COVID-19 vaccine to receive full approval. The vaccine is marketed as Comirnaty.
Comirnaty is indicated for the prevention of COVID-19 in people aged 16 and over; however, the vaccine will remain available under the Emergency Authorization (EUA) for people aged 12 to 15 years and for the administration of a third dose in certain immunocompromised individuals.
Comirnaty’s approval was based on a review of updated data from an ongoing, randomized, controlled, blinded clinical trial involving approximately 44,000 participants aged 16 and over, as well as previously submitted data in support of the EEA, such as clinical data. The results of the study support the vaccine’s 91% effectiveness for Comirnaty in preventing COVID-19 disease. The FDA does its own analysis of the information in the biologics filing to ensure that the vaccine is safe and effective.
In terms of safety, the prescribing information for Comirnaty includes post-marketing data indicative of an increased risk of myocarditis and pericarditis, especially within 7 days of the second dose. The most commonly reported side effects in people aged 16 years and over were pain, redness and swelling at the injection site, tiredness, headache, muscle or joint pain, chills, and fever.
Comirnaty contains mRNA that is used by the body to mimic one of the proteins in the virus that causes COVID-19. In its press release, the FDA noted that the mRNA in Comirnaty is only present in the body for a short time and is not incorporated into or altered in an individual’s genetic material.
Comirnaty is the same formulation as the EUA vaccine and is given in a series of 2 doses 3 weeks apart.
In addition, a booster dose of the vaccine will be available to the wider population pending FDA approval and recommendation from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP). The companies are also currently evaluating the vaccine in studies on children aged 6 months to 11 years; Study results for the age group 5 to 11 are initially expected in September.
Regarding today’s approval, Acting FDA Commissioner Janet Woodcock, MD said, “While millions of people have safely received COVID-19 vaccines, we recognize that FDA approval of a vaccine may now instill additional confidence for some to get vaccinated. Today’s milestone brings us one step closer to changing the course of this pandemic in the United States. “
- FDA approves first COVID-19 vaccine. Press release. U.S. Food and Drug Administration. Accessed August 23, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine.
- Comirnaty [package insert]. Mainz, Germany and New York, NY: BioNTech and Pfizer, Inc .; 2021.
This article originally appeared on MPR