FDA gives full approval of first COVID-19 vaccine
The Pfizer-BioNTech COVID-19 Vaccine known as Comirnaty has full FDA approval.
CAPE GIRARDEAU, Mo. (KBSI) – The U.S. Food and Drug Administration gave full approval of the first COVID-19 vaccine Monday. This is the first vaccine given full approval by the FDA.
The Pfizer-BioNTech COVID-19 Vaccine will now be marketed as Comirnaty for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine was 91% effective in preventing COVID-19 disease, based on results from the clinical trial.
Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under emergency use authorization (EUA) in those 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. This vaccine continues to be available under (EUA), including for people ages 12 through 15 and for the administration of a third dose in certain immunocompromised individuals.
FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products. The FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA) which is submitted to the agency providing very specific requirements.
Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into – nor does it alter – an individual’s genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart.
“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.,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research, in a press announcement issued by the FDA.
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. 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.
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 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. The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death.
The approval was granted to BioNTech Manufacturing GmbH.