Pfizer said Monday its coronavirus vaccine, which was developed with BioNTech SE, showed promising results, preventing more than 90 percent of infections.
“This is about the best the news could possibly be for the world and for the United States and for public health,” William Gruber, Pfizer senior vice president for vaccine clinical research and development, said in a statement.
Pfizer CEO Albert Bourla said the findings mean “we are one step closer to potentially providing people around the world with a much-needed breakthrough to help bring an end to this global pandemic.”
The company may ask the Food and Drug Administration by the end of the month for emergency authorization of the two-dose vaccine.
Pfizer expects to seek broad U.S. emergency use authorization of the vaccine for people aged 16 to 85. To do so, it will need to have collected two months of safety data on around half of the study’s roughly 44,000 participants, expected in late November. [...]
Pfizer said the interim analysis was conducted after 94 participants in the trial developed COVID-19, examining how many of them received the vaccine versus a placebo.
The company did not break down exactly how many of those who fell ill received the vaccine. Still, over 90% effectiveness implies that no more than 8 of the 94 people who caught COVID-19 had been given the vaccine, which was administered in two shots about three weeks apart.
The efficacy rate is well above the 50% effectiveness required by the U.S. Food and Drug Administration for a coronavirus vaccine. (Reuters)
"It is a great day for science. It is a great day for humanity," says @Pfizer CEO @albertbourla on #COVID19 vaccine trial results. "I think we can see light at the end of the tunnel." $PFE pic.twitter.com/vN56J5PWSZ
— Squawk Box (@SquawkCNBC) November 9, 2020
President Trump called the report "such great news."
STOCK MARKET UP BIG, VACCINE COMING SOON. REPORT 90% EFFECTIVE. SUCH GREAT NEWS!
— Donald J. Trump (@realDonaldTrump) November 9, 2020
Joe Biden said he was informed of the results Sunday night. While he expressed his optimism, he added that it doesn't change the importance of masks and social distancing.
Joe Biden says his advisers were informed last night of Pfizer's vaccine progress. He calls it "cause for hope" but cautions that even if a Covid-19 vaccine is approved by late November, "it will be many more months before there is widespread vaccination in this country." pic.twitter.com/ahUd9JDBof
— Sahil Kapur (@sahilkapur) November 9, 2020
Update: Pfizer tries to distance itself from Operation Warp Speed.
"We were never part of the Warp Speed. We have never taken any money from the U.S. government, or from anyone," Kathrin Jansen, the head of vaccine research and development at Pfizer, told The New York Times.
But this is straight from a Pfizer press release from July:
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the execution of an agreement with the U.S. Department of Health and Human Services and the Department of Defense to meet the U.S. government’s Operation Warp Speed program goal to begin delivering 300 million doses of a vaccine for COVID-19 in 2021. Under the agreement, the U.S. government will receive 100 million doses of BNT162, the COVID-19 vaccine candidate jointly developed by Pfizer and BioNTech, after Pfizer successfully manufactures and obtains approval or emergency use authorization from U.S. Food and Drug Administration (FDA). (Pfizer)
“Expanding Operation Warp Speed’s diverse portfolio by adding a vaccine from Pfizer and BioNTech increases the odds that we will have a safe, effective vaccine as soon as the end of this year,” said HHS Secretary Alex Azar at the time. “Depending on success in clinical trials, today’s agreement will enable the delivery of approximately 100 million doses of this vaccine to the American people.”