Nov. 20 (UPI) — Pfizer and companion BioNTech will make an emergency request Friday to U.S. regulators in search of authorization to start distributing hundreds of thousands of doses of its COVID-19 vaccine, which it says is efficient in 95% of sufferers.
The businesses mentioned emergency use authorization from the Meals and Drug Administration will enable them to distribute their BNT162b2 vaccine to high-risk populations as quickly as subsequent month.
They’re able to make 50 million doses obtainable this 12 months and greater than a billion in 2021, officers have mentioned.
Pfizer mentioned Wednesday that it accomplished its final-stage human scientific trial for the vaccine, and outcomes confirmed that two photographs, given three weeks aside, had been efficient in blocking an infection in 95% of volunteers, with “no critical security issues.”
Pfizer and BioNTech have been engaged on the vaccine for months, which is the primary to achieve this level of the regulatory approval course of.
“Our work to ship a protected and efficient vaccine has by no means been extra pressing, as we proceed to see an alarming rise within the variety of circumstances of COVID-19 globally,” Pfizer Chairman and CEO Albert Bourla mentioned in an announcement Friday.
“Submitting within the U.S. represents a vital milestone in our journey to ship a COVID-19 vaccine to the world and we now have a extra full image of each the efficacy and security profile of our vaccine, giving us confidence in its potential.”
The businesses additionally mentioned they’ve begun rolling submissions for approval in different nations, together with Australia, Canada, Europe and Japan, and plan to submit functions instantly to different regulatory businesses worldwide.
“We intend to proceed to work with regulatory businesses worldwide to allow the speedy distribution of our vaccine globally,” BioNTech CEO Dr. Ugur Sahin mentioned.
“As an organization positioned in Germany within the coronary heart of Europe, our interactions with the European Medicines Company are of explicit significance to us and we now have constantly supplied information to them as a part of our rolling evaluate course of.”
Bourla mentioned Pfizer will meet quickly with the FDA’s Vaccines and Associated Organic Merchandise Advisory Committee.
Panel members have been requested to put aside Dec. 8-10 for potential conferences to debate the vaccine — a preliminary step within the FDA authorization course of — CNBC reported this week.
Biotech Moderna mentioned Monday it additionally will search emergency FDA authorization “inside weeks” for its vaccine. Interim information from final-stage testing present that it is also about 95% efficient.