By Jonathan Springston, Editor, Relias Media
The FDA on Monday gave full approval to the Pfizer-BioNTech COVID-19 vaccine, the first such solution to receive the agency’s complete support.
“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,” Acting FDA Commissioner Janet Woodcock, MD, said in a statement.
Now marketed under the brand name Comirnaty, the solution is approved for anyone older than age 16 years. The agency said the vaccine will remain under an emergency use authorization (EUA) for young people age 12 to 15 years and as a third booster shot for certain immunocompromised patients.
The FDA issued an EUA for the Pfizer-BioNTech vaccine on Dec. 11, 2020, based on an ongoing randomized, controlled trial that included more than 40,000 participants age 16 years and older. To reach its decision to give full approval, the FDA examined updated data from the trial, observing that this vaccine was 91% effective against the virus. Researchers have followed-up with several thousand participants for several months, noting some mild side effects after receiving the second dose (e.g., fatigue, headache, injection site pain). The agency noted post-safety surveillance is ongoing to monitor rare side effects, such as myocarditis and pericarditis.
“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. 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,” Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research, said in a statement. “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. 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.”
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