Pfizer and BioNTech have concluded the Phase III study of their mRNA-based Covid-19 vaccine candidate, BNT162b2, which showed 95% efficacy rate and met all primary efficacy endpoints.
The final analysis data of the trial indicated that the vaccine had an efficacy rate of 95% in participants without prior SARS-CoV-2 infection, which was the first primary objective, in each case after seven days of administering second vaccine dose.
The trial also met the second primary objective with the vaccine showing similar efficacy rate in participants with and without prior infection.
As per the study protocol, the first primary objective analysis is based on 170 Covid-19 cases.
Data showed 162 cases occurred in the placebo group versus eight in the BNT162b2 group.
In adults aged over 65 years, the observed efficacy was over 94%, with consistent efficacy rates across age, gender, race and ethnicity demographics.
Also, results showed that ten severe Covid-19 cases were observed in the trial. Nine of them were observed in the placebo group and one in the BNT162b2 group.
No serious safety concerns related to the vaccine were reported by the study’s data monitoring committee.
The vaccine was shown to be well tolerated in a review of unblinded reactogenicity data from the final analysis. The analysis consisted of at least 8,000 adults in the Phase II/III study.
The randomised subset of participants were 18 years and older.
Pfizer and BioNtech noted that the safety milestone required by the US Food and Drug Administration (FDA) for emergency use authorisation (EUA) has been achieved.
The companies plan to submit a request to the FDA for a EUA soon.
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.”
Last week, Pfizer and BioNTech signed an agreement with the European Commission for the supply of 200 million doses of BNT162b2.