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The Vaccines and Related Biological Products Advisory Committee approved the vaccine, BNT162b2, paving the way to emergency use authorization.
Emergency use authorization (EUA) seems imminent for BNT162b2, the COVID-19 coronavirus vaccine candidate from Pfizer and BioNTech.
After the Vaccines and Related Biological Products Advisory Committee gave their approval for the drug to be considered for the EUA, there seem to be few hurtles to cross before it can be distributed.
In a statement, Dec. 11, FDA Commissioner Stephen M. Hahn, MD, and Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research say the vaccine is moving through the process.
“Following yesterday’s positive advisory committee meeting outcome regarding the Pfizer-BioNTech COVID-19 vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization,” they say. “The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution.”
According to documents released by the Food and Drug Administration (FDA) for the committee meeting, Dec. 10, the vaccine has hit the efficacy and safety benchmarks to receive the EUA.
The common belief was that the EUA was likely to come Dec. 12, but The New York Times reports that the authorization is likely to come this evening though it doesn't seem that this make the vaccine available sooner.
Earlier this week, Canada’s drug regulatory body announced they’d approved the vaccine for use with patients in the country, according to Reuters.
This came a day after the U.K. began vaccinating the elderly members of their population including one named William Shakespeare. The euphoria of vaccinations beginning was tempered though by two healthcare workers developing allergic reactions which led the country’s regulatory agency to warn people with significant vaccine, medicine, or food allergies not to receive the vaccine, according to The Washington Post.
Health and Human Services Secretary Alex Azar told CNN that he predicts 20 million Americans will be vaccinated in the next several weeks saying the Trump administration was in negotiations with Pfizer in an effort to get more doses of BNT162b2.
In July, the U.S. Department of Health and Human Services placed an initial order for 100 million doses of BNT162b2 for $1.95 billion after it is manufactured and either obtains approval or emergency use authorization from the FDA. The federal government will also be able to acquire up to an additional 500 million doses and American patients will receive the vaccine free.