Pfizer and its collaborator BioNTech released early study results Monday indicating that their vaccine, BNT162b2, prevented more than 90% of infections with the virus that causes COVID-19. This conclusion was based on the first interim efficacy analysis conducted on November 8, 2020 by an external, independent Data Monitoring Committee (DMC) from the Phase 3 clinical study.
Details of the announcement include:
— The vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis.
— The analysis evaluated 94 confirmed cases of COVID-19 in trial participants.
— 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.
— Submission for Emergency Use Authorization to the U.S. Food and Drug Administration is planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November.
— 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.
Pfizer and BioNTech are continuing to accumulate safety data and currently estimate that a median of two months of safety data following the second (and final) dose of the vaccine candidate – the amount of safety data specified by the FDA in its guidance for potential Emergency Use Authorization – will be available by the third week of November.
Additionally, participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose.
Dr. Albert Bourla, Pfizer Chairman and CEO said “We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen. With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough.”
Along with the efficacy data generated from the clinical trial, Pfizer and BioNTech are working to prepare the necessary safety and manufacturing data to submit to the FDA to demonstrate the safety and quality of the vaccine product produced.
Based on current projections it expects to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021. Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-review publication.