Early this morning, Pfizer and BioNTech issued a news release stating that the Phase 3 study of their MRNA-based COVID-19 vaccine met all primary efficacy endpoints. “Analysis of the data indicates a vaccine efficacy rate of 95% (p<0.0001) in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose,” stated the announcement. For those older than 65 years of age, the efficacy is reportedly over 94%.
No serious safety concerns have been reported by the Data Monitoring Committee for the study. According to the findings, “most solicited adverse events resolv[e] shortly after vaccination” – with 3.8% experiencing fatigue after their first or second dose and 2% recording headaches after their second dose. The FDA-required safety milestone for an EUA (Emergency Use Authorization) has been met, and thus, the two companies plan to submit an EUA request to the agency in the coming days.
Dr. Albert Bourla, Pfizer Chairman and CEO, issued a statement as per the news release: “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. 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.”
Expressing a concurring sentiment, Ugur Sahin, M.D., CEO and Co-founder of BioNTech stated: “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 power of BNT162 in providing early protection. These achievements highlight the potential of mRNA as a new drug class. Our objective 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 achieved 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.”
The news release added that Pfizer and BioNTech “expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021.”