Coronavirus: Pfizer submits vaccine candidate EUA application

Pfizer and BioNTech say they will submit a request for emergency use authorization (EUA) of the COVID-19 coronavirus vaccine candidate BNT162b2 from the U.S. Food and Drug Administration (FDA) today.

According to a news release, the companies have already initiated rolling submissions in Australia, Canada, Europe, and Japan for authorization. The plan is to produce 50 million doses of the drug by the end of the year and up to an additional 1.3 billion doses by the end of 2021.

Earlier this week, the companies announced the candidate showed 95 percent efficacy in patients not previously infected with COVID-19 and also those who have previously been infected beginning 28 days after the first dose which meets all of the study’s primary efficacy standpoints.

“Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of COVID-19 globally,” Dr. Albert Bourla, Pfizer chairman and CEO, says in the release. “Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential. We look forward to the upcoming Vaccines and Related Biological Products Advisory Committee discussion and continue to work closely with the FDA and regulatory authorities worldwide to secure authorization of our vaccine candidate as quickly as possible.”

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.

Officials with Operation Warp Speed announced that about 40 million doses of BNT162b2 another promising vaccine candidate manufactured by Moderna could be available for distribution by the end of December, according to a report from Drug Topics.