Pfizer and BioNTech’s mRNA-based COVID-19 vaccine candidate – BNT162b2 – has achieved an efficiency rate of 95% after hitting all primary endpoints in a Phase 3 study.
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.
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%.
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.
To date, the Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine.
In addition, the companies announced that the safety milestone required by the US FDA for Emergency Use Authorization (EUA) has been achieved.
Pfizer and BioNTech plan to submit a request within days to the FDA for an 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.”
Pfizer and BioNTech plan to submit the efficacy and safety data from the study for peer-review in a scientific journal once analysis of the data is completed.
The news follows days after Moderna’s vaccine candidate achieved an almost identical efficiency rate.