Pfizer and BioNTech Will Apply for Emergency Use Authorization to the U.S. FDA for COVID-19 Vaccine

Pfizer and BioNTech announced earlier today that they are submitting a request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization of their coronavirus vaccine candidate.

Less than two weeks ago, Pfizer had announced that the vaccine it is developing with BioNTech SE to combat the novel coronavirus “was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis.”

If approved by the FDA, it is possible that the vaccine can be distributed to high-risk populations in the U.S. by the middle to end of December 2020.

“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. 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,” said Dr. Albert Bourla, Pfizer chairman and CEO, in a written statement.

“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.”

“Filing for Emergency Use Authorization in the U.S. is a critical step in making our vaccine candidate available to the global population as quickly as possible,” said Ugur Sahin, M.D., CEO and co-founder of BioNTech.

“We intend to continue to work with regulatory agencies worldwide to enable the rapid distribution of our vaccine globally. As a company located in Germany in the heart of Europe, our interactions with the European Medicines Agency (EMA) are of particular importance to us and we have continuously provided data to them as part of our rolling review process.”

The Phase 3 clinical trial of the vaccine, which is based on BioNTech’s proprietary mRNA technology, started earlier on July 27 and has enrolled 43,661 participants, 41,135 of whom received a second dose of the vaccine candidate as of November 13. Those who have participated will continue to be monitored for long-term protection and safety for two more years after their second dose.