New York, Nov 20 (efe-epa).- Pfizer Inc and partner BioNTech SE on Friday asked the Food and Drug Administration (FDA) to allow their Covid-19 vaccine to be administered to high-risk people in the United States.
The FDA is expected to decide within weeks on the request for an Emergency Use Authorization for the drug, BNT162b2, meaning that vaccinations could begin as soon as the middle of next month.
Pfizer, which is based in the US, and Germany’s BioNTech said earlier this week that the latest data from Phase 3 clinical trials involving nearly 44,000 people worldwide showed BNT162b2 to be 95 percent effective at preventing infection with the coronavirus.
The vaccine, which is given in two doses, was 94 percent effective among test subjects older than 65, the demographic at the highest risk of dying from Covid-19, the companies said.
The US remains the epicenter of the global pandemic, with 252,000 fatalities and 11.8 million confirmed cases. New infections are running at 200,000 per day, while the death toll is mounting every 24 hours by 2,000.
“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,” Pfizer Chairman and CEO Albert Bourla said.
“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,” he said.
The firms said they are simultaneously seeking regulatory approval from health authorities in Australia, Canada, Japan, Europe and the United Kingdom.
“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,” the CEO of BioNTech, Dr. Ugur Sahin, said.
All but eight of the 170 participants in the clinical trials who tested positive for Covid-19 received the placebo, while 41,135 had gotten a second dose of BNT162b2 as of Nov. 13.
The monitoring committee appointed by the US National Institutes of Health for the study has not raised any serious safety concerns.
The submission to the FDA includes safety data on some 100 children between the ages of 12 and 15.
Roughly 42 percent of test subjects were of diverse racial and ethnic backgrounds and more than 40 percent were in the 56-85 age bracket.
Observers have pointed out that the handling requirements for the Pfizer/BioNTech drug, which must be maintained at a temperature of minus 70C (minus 94F), could represent a challenge for less-developed countries.
But Pfizer, the world’s second-biggest pharmaceutical firm, said it was “confident in its vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world.”
Pfizer and BioNTech said they have the capacity “to supply up to 50 million vaccine doses globally in 2020 and up to 1.3 billion doses by the end of 2021.”
Founded in 1849 and with more than 88,000 employees, Pfizer is vying with tiny Moderna, a 10-year-old firm with a staff of fewer than 900, to be the first to introduce a coronavirus vaccine in the US.
Moderna said Monday that its vaccine candidate demonstrated 94 percent effectiveness in clinical trials.
The company noted that its formula can be transported and stored at temperature in the range of 2-8C (36-46F), “the temperature of a standard home or medical refrigerator.”
Moderna said it will approach the FDA “in the coming weeks” to request Emergency Use Authorization for its vaccine.