Pharmaceutical company Pfizer and BioNTech SE ‘s vaccine candidate BNT162b2 has been found to be 95% effective, the company announced on Wednesday, November 18.
In a statement, Pfizer announced that the vaccine prevented mild and severe forms of COVID-19, and was 94% effective in adults over 65 who are more vulnerable to developing COVID-19.
The Phase 3 clinical trial began on July 27 and has enrolled 43 661 participants to date, 41 135 of whom have received a second dose of the vaccine candidate as of November 13, 2020. Trial sites were located in the United States, Germany, Turkey, South Africa, Brazil and Argentina.
Approximately 42% of global participants and 30% of US participants have racially and ethnically diverse backgrounds, and 41% of global and 45% of US participants are 56-85 years of age.
“Analysis of the data indicates a vaccine efficacy rate of 95% 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,” said the company.
“The first primary objective analysis is based on 170 cases of COVID-19, as specified in the study protocol, of which 162 cases of COVID-19 were observed in the placebo group versus 8 cases in the BNT162b2 group. Efficacy was consistent across age, gender, race and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94%.”
To date, the Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine.
Pfizer and BioNTech plan to submit a request within days to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) based on the totality of safety and efficacy data collected to date, as well as manufacturing data relating to the quality and consistency of the vaccine.
“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.”
Ugur Sahin, MD, CEO and Co-founder of BioNTech added: “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.”
Based on current projections, the companies expect to produce up to 50-million vaccine doses globally in 2020 and up to 1.3-billion doses by the end of 2021.