FDA Grants Pfizer COVID-19 Vaccine ‘Comirnaty’ Full Approval In Nine Months
The Food and Drug Administration (FDA) on Monday granted full approval to Pfizer’s COVID-19 vaccine for individuals 16 years and older.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” Acting FDA Commissioner Janet Woodcock said in a statement issued Monday. “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.”
Editor’s Note: It usually takes 3 -6 years for full approval of a drug, but the FDA gave this level of approval to the Pfizer vaccine that was introduced less than 9 months ago. This vaccine is still in clinical trials when this post was published with an Estimated Primary Completion Date of April 1, 2022 and Estimated Study Completion Date of July 30, 2023.
COVID-19 vaccines developed by Pfizer, Moderna and Johnson & Johnson have all previously been granted emergency use authorization (EUA) after meeting the FDA’s safety and efficacy requirements. The full licensure announced Monday stems from a so-called biologics license application, building on previously-submitted pre-clinical and clinical data, information relating to the manufacturing process, vaccine quality data and site inspections.
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
“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine,” Dr. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, said in a statement. “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.”
He later added, in part, “although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”
The approval on Monday also paves the way for the Pentagon to mandate the vaccine among 1.3 million active-duty service members. Full licensure has been widely anticipated to boost confidence in those otherwise hesitant to receive the shot under emergency approval. U.S. Surgeon General Vivek Murthy told Chris Wallace on “Fox News Sunday” that full approval might lead to an increase in vaccination rate.
“There are universities and businesses that have been considering putting in vaccine requirements in order to create a safer workplace or learning environment,” Murthy said. “And I think this announcement from the FDA would likely encourage them and make them feel more comfortable.”
Excerpt from the FDA 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.
Sources:
https://www.foxbusiness.com/healthcare/fda-grants-pfizer-covid-19-vaccine-full-approval
https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine
