As positive cases of COVID-19 continue to ratchet up across the nation, including in Minnesota, Pfizer announced on Monday that early data suggests its coronavirus vaccine looks to be 90% effective in preventing COVID-19.
“Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” said Dr. Albert Bourla, Pfizer Chairman and CEO in a statement.
The announcement comes as confirmed cases of COVID-19 across the U.S. are set to surpass 10 million on Monday, the most cases in the world. In Minnesota, the Health Department’s data for Nov. 9 show 3,930 new cases of the virus and 19 deaths.
Other key findings from the Pfizer study:
- Analysis evaluated 94 confirmed cases of COVID-19 in trial participants
- Study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; Safety and additional efficacy data continue to be collected
- Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November
- Clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints
Manufacturing of the vaccine is in the works, and Pfizer stated they expect to supply globally up to 50m doses in 2020 and up to 1.3bn doses in 2021. The determination of who receives the vaccine first will be made by each country.
Coming a week after the contentious presidential election, which produced a winner in President-elect Joe Biden, the timing of Pfizer’s announcement has caused some of President Trump’s supporters, including son Donald Trump, Jr., to suggest that the company timed the release of the vaccine news to help Biden.
But Pfizer representatives rejected this assertion on various news shows on Monday. Pfizer also countered the claim by Vice President Pence that the vaccine’s success was a result of his administration’s “Warp Speed” vaccine effort.
“We were never part of the Warp Speed,” Kathrin Jansen, a senior vice-president and the head of vaccine research and development at Pfizer, said in an interview with the New York Times. “We have never taken any money from the U.S. government, or from anyone.”
President-elect Biden noted on his transition website that Pfizer alerted him of the news last night: “Last night, my public health advisors were informed of this excellent news. I congratulate the brilliant women and men who helped produce this breakthrough and to give us such cause for hope,” Biden said in a statement.