Chennai: Global pharma majors Pfizer and BioNTech have said that their Covid-19 vaccine was found 95 per cent effective in the final analysis of the Phase 3 trial.
They said the trial was conducted on people from various age groups including those aged over 65 years, paving the way for the companies to apply for emergency authorisation from US regulators within days.
Pfizer and its German partner BioNTech said they have concluded phase 3 study of their mRNA-based COVID-19 vaccine candidate BNT162b2, meeting all primary efficacy end points.
Based on current projections, the firms expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021.
Earlier in November, Pfizer and Biontech had said their Covid-19 vaccine candidate was found to be more than 90 per cent effective in preventing Covid-19 in participants.
Analysis of the data indicates a vaccine efficacy rate of 95 per cent 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 seven days after the second dose.
The companies said the first primary objective analysis is based on 170 cases of Covid-19, of which 162 cases of coronavirus were observed in the placebo group while 8 cases in the BNT162b2 group.
Vaccine efficacy was consistent across age, gender, race and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94 per cent, the firms said.
There were 10 severe cases of Covid-19 observed in the trial, with nine of the cases occurring in the placebo group and one in the BNT162b2 vaccinated group.
Dr Albert Bourla, Pfizer chairman and CEO, said, “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.”
Bourla added: “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. Pfizer said till date, the Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine.”