November 9, 2020 – Pfizer Inc. (New York, NY) and BioNTech SE announced its vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants who did not have evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis.
Based on current projections, Pfizer expects to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.
The study was conducted November 8, 2020 by an external, independent Data Monitoring Committee (DMC) from the Phase 3 clinical study.
The study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; Safety and additional efficacy data continue to be collected. The final analysis evaluated 94 confirmed cases of COVID-19 in trial participants.
Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November.
Pfizer says the clinical trial will continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints
“Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”