Pfizer said Wednesday that the COVID-19 vaccine it is developing with BioNTech SE proved to be more than 95% effective in preventing new coronavirus infections in a study of thousands of volunteers.
The company also said its Phase 3 trial involving more than 40,000 volunteers showed no safety concerns.
During the trial, 170 volunteers became infected with the novel coronavirus. Of the 170, 162 positive COVID-19 cases were among people who received a placebo while only eight were among those who received the experimental vaccine.
“Efficacy was consistent across age, race and ethnicity demographics,” Pfizer and BioNTech said in a joint statement. “The observed efficacy in adults over 65 years of age was over 94%.”
More than 10 millions Americans have contracted COVID-19 since the beginning of the pandemic and more than 230,000 U.S. residents have died with the disease.
Pfizer’s vaccine calls for two doses, and the company said “protection is achieved 28 days after the initiation of the vaccination.”
The phase 3 study enrolled 43,538 participants, with 42% having diverse backgrounds, according to the company.
Pfizer hopes to apply for emergency use authorization with the U.S. Food and Drug Administration as early as this month.
Pfizer expects to have 50 million doses produces this year and an additional 1.3 billion next year.