The Food and Drug Administration has issued full approval to Pfizer for its two-dose COVID-19 vaccine.
The vaccine has previously been distributed under an Emergency Use Authorization since Dec. 11, 2020. The Pfizer vaccine was the first to be granted EUA and the first to work toward full approval.
Acting FDA Commissioner Dr. Janet Woodcock announced the approval Monday, Aug 23, calling it a pivotal moment in the fight against COVID-19. The vaccine will also have a new name: Comirnaty.
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“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 confident this vaccine meets the FDA’s gold standards for safety, effectiveness and manufacturing quality that we require for an approved product,” said Woodcock.
Dr. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research said, “We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities.”
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The FDA analyzed data from approximately 20,000 people who received the vaccine and 20,000 who received a placebo. Results from the clinical trials found the vaccine was 91% effective in preventing COVID-19. The full approval is for people aged 16 and older. The Pfizer vaccine remains under the EUA for children between the ages of 12 and 15.
Dr. Joshua B. Wyche, assistant vice president of Strategic Planning & Pharmacy Services at Augusta University Health said, “Today’s approval should be viewed as a tremendous accomplishment in the history of the United States of what is possible when a commitment to solve a problem, unparalleled investment and removal of government bureaucracy occurs.”
Dr. John Farr, Chief Medical Officer at Doctors Hospital called it excellent news that the medical community has been waiting to hear.
He said, “Hopefully, those who have been delaying getting the vaccine will be encouraged to get the vaccine now. This certainly opens the door for some businesses, companies and universities to mandate the vaccine. Approval was based on the FDA reviewing the data from tens of millions of doses of the vaccine that have been given; The review validated that the vaccines are very effective and have an excellent safety profile.”
Dr. Edward Simmer, director of the South Carolina Department of Health and Environmental Control, said this step underscores the safety and efficacy of the vaccines.
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“The key difference between full approval and an EUA is the length of time spent studying those who have received the vaccine, including a longer review period of data associated with any adverse events,” said Simmer. “Anyone who has remained hesitant about the vaccines should use this full approval as motivation to get the two-dose Pfizer vaccine as soon as possible.”
Simmer said the Moderna and Johnson & Johnson vaccines are also safe and effective. Those vaccines continue distribution under the EUA. Moderna officials have started submitting updated information to the FDA requesting full approval. Johnson and Johnson officials plan to file their request for full approval later this year.
Dana Lynn McIntyre is a Staff Reporter with The Augusta Press. You can reach her at dana@theaugustapress.com.
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