Pfizer, BioNTech seek 'milestone' FDA approval for COVID-19 vaccine

Nov. 20 (UPI) -- Pfizer and partner BioNTech made an emergency request Friday to U.S. regulators seeking authorization to begin distributing millions of doses of its COVID-19 vaccine, which they say is effective in 95% of patients.

The companies said emergency use authorization from the Food and Drug Administration will allow them to distribute their BNT162b2 vaccine to high-risk populations as soon as next month.

Pfizer Chairman and CEO Albert Bourla called the submission a "historic day for science."

"It is with great pride and joy -- and even a little relief -- that I can say that our request for emergency use authorization for our potential COVID-19 vaccine is now in the FDA's hands," he said in a statement.

The companies are ready to make 50 million doses available this year and more than a billion in 2021, officials have said.

Pfizer said Wednesday that it completed its final-stage human clinical trial for the vaccine, and results showed that two shots, given three weeks apart, were effective in blocking infection in 95% of volunteers, with "no serious safety concerns."

Pfizer and BioNTech have been working on the vaccine for months, which is the first to reach this point in the regulatory approval process.

"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," Bourla said Friday.

"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."

The companies also said they have begun rolling submissions for approval in other nations, including Australia, Canada, Europe and Japan, and plan to submit applications immediately to other regulatory agencies worldwide.

"We intend to continue to work with regulatory agencies worldwide to enable the rapid distribution of our vaccine globally," BioNTech CEO Dr. Ugur Sahin said.

"As a company located in Germany in the heart of Europe, our interactions with the European Medicines Agency are of particular importance to us and we have continuously provided data to them as part of our rolling review process."

Bourla said Pfizer will meet soon with the FDA's Vaccines and Related Biological Products Advisory Committee.

Panel members have been asked to set aside Dec. 8-10 for potential meetings to discuss the vaccine -- a preliminary step in the FDA authorization process -- CNBC reported this week.

Biotech Moderna said Monday it also will seek emergency FDA authorization "within weeks" for its vaccine. Interim data from final-stage testing show that it also is about 95% effective.