Pfizer announced today the successful conclusion of their mRNA-based BNT162b2 vaccine for SARS-CoV-2 produced in partnership with BioNTech. This news comes shortly after the announcement of findings of 95% efficacy followed by claims by the Trump administration the partnership's work were attributed to the Operation Warp Speed program.
“The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic. We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world.”
Of the ten cases of COVID-19 within the study group, nine ocurred within the placebo participants. The vaccine was deemed safe after studying more than 8,000 participants aged 18 years and above. According to the Phase 2/3 study, "The only Grade 3 (severe) solicited adverse events greater than or equal to 2% in frequency after the first or second dose were fatigue at 3.8% and headache at 2.0% following dose 2" with fewer and less severe symptom reported in older adults.
“We are grateful that the first global trial to reach the final efficacy analysis mark indicates that a high rate of protection against COVID-19 can be achieved very fast after the first 30 µg dose, underscoring the potential of BNT162 to provide early protection,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “These achievements highlight the potential of mRNA as a new drug class. Our goal from the very beginning was to design and develop a vaccine that would generate rapid and potent protection against COVID-19 with a benign tolerability profile across all ages. We believe we have successfully accomplished this with our vaccine candidate BNT162b2 in all age groups studied so far and look forward to sharing further details with the regulatory authorities. I want to thank all the devoted women and men who contributed to this historically unprecedented achievement. We will continue to work with our partners and governments around the world to prepare for global distribution in 2020 and beyond.”