An mRNA-based vaccine candidate against the SARS-CoV-2 being developed by Pfizer and BioNTech has shown promising results 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.
According to the findings of the first interim report, the vaccine was over 90 percent effective in preventing this deadly infection.
The Phase 3 study of the BHT162b2 experimental shot enrolled 43,538 volunteers, and no major safety concerns were noted in any of them. According to the press release of Pfizer, the participants will also be monitored for long-term protection and safety for 2 years after the second dose.
“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. “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.”
Pfizer and BioNTech are working to submit the necessary safety and manufacturing data to the FDA to demonstrate the safety and quality of the vaccine product produced.
Based on current projections they expect to produce up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021 globally.