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Breaking: FDA issues full approval for Pfizer vaccine
IBR Staff//August 23, 2021//
The U.S. Food and Drug Administration (FDA) has issued full approval of the Pfizer-BioNTech COVID-19 vaccine as of Aug. 23 for individuals aged 16 and older. The vaccine will retain its emergency authorization for ages 12 through 15, which was granted on May 16. A third dose of the vaccine for certain immunocompromised individuals will also retain its emergency authorization.
The Pfizer-BioNTech COVID-19 vaccine will now be marketed as the Comirnaty vaccine.
“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,” said acting FDA Commissioner Janet Woodcock, M.D. in the official announcement. “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 FDA issued its first emergency use authorization for the Comirnaty vaccine for those 16 or older on Dec. 11, 2020 based on the results of a randomized, controlled, blinded ongoing clinical trial of thousands of individuals. For full approval, the FDA reviewed updated data from the clinical trial, which included a longer duration of follow-up in a larger clinical trial population. 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 six 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 intended to be effective in preventing COVID-19 and potentially serious outcomes from it, including hospitalization and death.
