Pfizer and BioNTech announced their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 has demonstrated evidence of efficacy against coronavirus in participants without prior evidence of SARS-CoV-2 infection, 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.
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"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.
“I want to thank the thousands of people who volunteered to participate in the clinical trial, our academic collaborators and investigators at the study sites, and our colleagues and collaborators around the world who are dedicating their time to this crucial endeavor,” added Bourla. “We could not have come this far without the tremendous commitment of everyone involved.”
The Phase 3 clinical trial of BNT162b2 began on July 27 and has enrolled 43,538 participants to date, 38,955 of whom have received a second dose of the vaccine candidate as of November 8, 2020.
Approximately 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds.
The trial is continuing to enroll and is expected to continue through the final analysis when a total of 164 confirmed coronavirus cases have accrued.
The study also will evaluate the potential for the vaccine candidate to provide protection against coronavirus in those who have had prior exposure to SARS-CoV-2, as well as vaccine prevention against severe coronavirus disease.
In addition to the primary efficacy endpoints evaluating confirmed coronavirus cases accruing from 7 days after the second dose, the final analysis now will include, with the approval of the FDA, new secondary endpoints evaluating efficacy based on cases accruing 14 days after the second dose as well. ■