Pfizer says COVID-19 shot 95% effective, seeking clearance soon
Trial results have not been analyzed by independent experts yet
Pfizer said Wednesday that new test results show its coronavirus vaccine is 95 per cent effective, is safe and also protects older people most at risk of dying. The new results are part of the last data the company needed to seek emergency use of limited shot supplies as the catastrophic outbreak worsens across the globe.
The vaccine is among seven that Canada has pre-ordered.
The announcement, just a week after Pfizer first revealed promising preliminary results, comes as the company is preparing within days to formally ask U.S. regulators to allow emergency use of the vaccine.
They have also begun "rolling submissions" for the vaccine with regulators in Europe, the U.K. and Canada, and soon will add this new data.
Pfizer initially had estimated its vaccine, developed with German partner BioNTech, was more than 90 per cent effective after 94 infections had been counted. With Wednesday's announcement, the company now has accumulated 170 infections in the study — and said only eight of them occurred in volunteers who got the actual vaccine rather than a dummy shot. One of those eight developed severe disease, the company said.
"This is an extraordinarily strong protection," Dr. Ugur Sahin, BioNTech's CEO and co-founder, told The Associated Press.
The companies have not yet released detailed data on its study, and results have not been analyzed by independent experts. Also still to be determined are important questions such as how long protection lasts and whether people might need boosters.
But all eyes are on the progress of potential vaccines as the grim infection rate jumps in the U.S. and abroad as winter weather forces people indoors, in the close quarters that fuel viral spread.
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Effective on older adults
Pfizer said its vaccine was more than 94 per cent effective in adults over age 65, though it is not clear how the company determined effectiveness in older adults, with only eight infections in the vaccinated group to analyze and no breakdown provided of those people's ages.
Sahin said there were enough older adults enrolled in the study and among the placebo recipients who became infected that he is confident "this vaccine appears to work in the higher-risk population."
Earlier this week, Moderna, Inc. announced that its experimental vaccine appears to be 94.5 per cent effective after an interim analysis of its late-stage study.
Similar results from two vaccines both made with a brand-new technology — using a snippet of the genetic code of the coronavirus to train the body to recognize if the real virus comes along — likely will add to experts' reassurance about the novel approach.
While initial supplies will be scarce and rationed, as the supply grows, Sahin said the companies have a responsibility to help ensure access for lower-income countries as well.
Pfizer and BioNTech also say they now have the required data on the vaccine's safety needed to seek emergency authorization from the U.S. Food and Drug Administration.
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Company says no serious side effects reported
The company didn't disclose safety details but said no serious vaccine side effects have been reported, with the most common problem being fatigue after the second vaccine dose, affecting about four per cent of participants.
The study has enrolled nearly 44,000 people in the U.S. and five other countries. The trial will continue to collect safety and efficacy data on volunteers for two more years.
Pfizer and BioNTech said they expect to produce up to 50 million vaccine doses globally in 2020 and up to 1.3 billion doses in 2021.
U.S. officials have said they hope to have about 20 million vaccine doses each from Moderna and Pfizer available for distribution in late December. The first shots will be offered to vulnerable groups like medical and nursing home workers, and people with serious health conditions.