Pfizer and BioNTech said Wednesday that a final data analysis indicated that their coronavirus vaccine is 95% effective in preventing COVID-19 among trial participants. With the new analysis and the conclusion of Pfizer and BioNTech's Phase 3 trial, the companies said they have achieved the safety milestone required to the Food and Drug Administration's Emergency Use Authorization.
The new numbers improve on the preliminary trial data that the companies shared earlier this month indicating that the vaccine's efficacy was roughly 90%. They also follow news from Moderna earlier this week that its vaccine candidate is 94.5% effective in preventing the illness.
The vaccine candidate, BNT162b2, was highly effective against the virus 28 days after the first dose, and the companies said that its effectiveness was consistent across all ages, races and ethnicities. Among elderly patients 65 years old and older, the observed efficacy was 94%.
In the trial, 10 severe cases of COVID-19 were observed, with nine of them coming from the placebo group and one occuring in the vaccinated group, suggesting the vaccine also can fend off severe cases. Overall, the study saw 170 COVID-19 cases among the study's more than 43,000 participants, with 162 coming fromt he placebo group and eight cases among the vaccinated group.
“The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic. We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world,” said Dr. Albert Bourla, Pfizer chairman and CEO. “With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world.”
Pfizer's and BioNTech's vaccine, like Moderna's uses messenger RNA, or mRNA technology, a newer approach to vaccines that leverages genetic material to trigger and immune response. BioNTech CEO and co-founder Ugur Sahin said that besides offering a potential protection against the novel coronavirus, the vaccine candidate showcases the capabilities of mRNA vaccines.
“These achievements highlight the potential of mRNA as a new drug class," Sahin said. “Our objective from the very beginning was to design and develop a vaccine that would generate rapid and potent protection against COVID-19 with a benign tolerability profile across all ages. We believe we have achieved this with our vaccine candidate BNT162b2 in all age groups studied so far and look forward to sharing further details with the regulatory authorities.”
The companies said they would submit a reuest within days to the FDA for Emergency Use Authorization based on the efficacy and safety data, as well as manufacturing data related to the vaccine candidate's quality and consistency.
By the end of the year, the companies said they expect to produce as many as 50 million vaccine doses globally, and as many as 1.3 billion doses by the end of 2021.