Pfizer and BioNTech have announced that their BNT162b2 Covid-19 vaccine candidate has achieved all primary efficacy endpoints in the phase 3 study.
The data analysis showed a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection (primary infection), as well as in participants with and without prior SARS-CoV-2 infection (second primary objective).
The first primary objective analysis is based on 170 Covid-19 cases, of which 162 cases of Covid-19 have been observed in the placebo group versus eight cases in the BNT162b2 group.
A review of unblinded reactogenicity data from the final analysis, including a randomised subset of at least 8,000 participants 18 years and older in the phase 2/3 study showed the vaccine was well tolerated.
BioNTech CEO and co-founder Dr Ugur Sahin said: “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.”
Pfizer and BioNTech have also announced that the safety milestone needed by the US Food and Drug Administration (FDA) for emergency use authorisation (EUA) has been achieved.
The companies intend to submit for an EUA to the FDA based on the totality of safety and efficacy data collected to date, in addition to the manufacturing data relating to the quality and consistency of the vaccine.
The phase 3 clinical trial recruited 43,661 participants to date, of which 41,135 have secured a second dose of the vaccine candidate as of 13 November this year.
The patients have been recruited in around 150 clinical trials sites in the US, Germany, Turkey, South Africa, Brazil and Argentina. In addition, the study will continue to gather efficacy and safety data in participants for an additional two years.
Based on current projections, Pfizer and BioNTech expect to produce up to 50 million vaccine doses in this year and up to 1.3 billion doses by the end of 2021.
Pfizer chairman and CEO Dr Albert Bourla 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.”