Pfizer Inc. and BioNTech SE's coronavirus vaccine is 95% effective at preventing COVID-19 infection, a final analysis of a phase 3 trial has shown.
A total of 170 cases of COVID-19 were assessed across the 43,000-person study, 162 in the placebo group and eight in the vaccine group, Pfizer said in a Nov. 18 news release. It marks the first time any pharmaceutical company has produced a final analysis of a phase 3 trial of a coronavirus vaccine.
Efficacy of the vaccine, called BNT162b2, was consistent across gender, race, ethnicity and age, with observed efficacy among over-65s of 94%, the U.S. pharmaceutical giant said. The data has not been peer reviewed, a standard practice for published clinical trial results.
This means the safety data milestone required by the U.S. Food and Drug Administration for emergency use authorization has been achieved, Pfizer reaffirmed, adding that it intends to submit the request to the regulator "within days."
Of the 10 severe cases of COVID-19 observed in the trial, nine occurred in the placebo group and one in the vaccinated group, the company added.
The study's data monitoring committee did not report any serious safety concerns related to the vaccine. A review of a randomized subset of over 8,000 adult participants demonstrated that the vaccine was well tolerated, with most solicited adverse events resolving shortly after vaccination, Pfizer said.
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Highlighting mRNA's potential
"We are grateful that the first global trial to reach the final efficacy analysis mark indicates that a high rate of protection against COVID-19 can be achieved very fast after the first 30-microgram dose, underscoring the power of BNT162 in providing early protection," said BioNTech CEO and co-founder Ugur Sahin. "These achievements highlight the potential of mRNA as a new drug class."
The companies plan to produce as many as 50 million doses of the vaccine in 2020 and 1.3 billion in 2021, with each person requiring two doses. Pfizer and BioNTech have already agreed to supply millions of doses to the U.S., the EU, the U.K. and Japan.
The latest findings follow interim results from the study released Nov. 9 that showed the vaccine was more than 90% effective after 94 confirmed cases of COVID-19 were reported among study participants.
Pfizer's interim analysis was followed a week later by interim phase 3 results from Moderna Inc. showing 94% efficacy and a higher storage temperature for that company's vaccine candidate. The extreme temperatures needed to ship Pfizer's product has been seen as a possible barrier to efficient distribution.