Coronavirus: FDA report looks good for Pfizer vaccine EUA

December 9, 2020
Keith A. Reynolds

The report came out as the U.K. has started vaccinating patients.

The vaccine candidate from Pfizer and BioNTech is getting closer to emergency use authorization (EUA).

According to documents released by the Food and Drug Administration (FDA) for the Vaccines and Related Biological Products Advisory Committee Meeting, the vaccine candidate, BNT162b2, has hit the efficacy and safety benchmarks to receive the EUA which is expected to come any day.

The same day, Canada’s drug regulatory body announced they’d approved the vaccine for use with patients in the country, according to Reuters.

“Canadians can feel confident that the review process was rigorous and that we have strong monitoring systems in place,” the agency said in a news release. “Health Canada and the Public Health Agency of Canada will closely monitor the safety of the vaccine once it is on the market and will not hesitate to take action if any safety concerns are identified.”

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.