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Interim efficacy data suggests the Pfizer/BioNTech mRNA-based vaccine has an efficacy rate above 90%.
Pfizer and BioNTech SE announced on Nov. 9, 2020 that interim efficacy analysis data from a Phase III clinical trial of BNT162b2, the mRNA-based COVID-19 vaccine candidate, showed the vaccine had an efficacy rate above 90%, at seven days after a second required dose.
The analysis, conducted by an external, independent Data Monitoring Committee (DMC), was based on an evaluable case count of 94 people split between vaccinated individuals and those who received a placebo, the companies reported in a press statement. The final vaccine efficacy percentage may vary as the study continues, the statement noted.
The Phase III clinical trial has enrolled 43,538 participants to date; 38,955 have received a second dose of the vaccine candidate 21 days after the initial dose, as of Nov. 8, 2020. Pfizer and BioNTech reported the trial is expected to continue through the final analysis when 164 confirmed COVID-19 cases have accrued.
The study also will evaluate the potential for the vaccine to protect against COVID-19 in those who have had prior exposure to SARS-CoV-2, and against severe COVID-19 disease.
The companies estimate that a median of two months of safety data following the second dose of the vaccine candidate—required by FDA for Emergency Use Authorization—will be available by the third week of November.
Participants will be monitored for an additional two years after receiving the second dose. The companies said in the statement that they expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.