New data from a final efficacy analysis of Pfizer and BioNTech's BNT162b2 vaccine shows that it is 95% effective at preventing COVID-19.
The mRNA-based vaccine met all of the phase III study’s primary efficacy endpoints, demonstrating a vaccine efficacy rate of 95%.
This was observed in participants both without prior SARS-CoV-2 infection and in participants with and without prior SARS-CoV-2 infection, seven days after the second dose was administered.
The first primary objective analysis is based on 170 cases of COVID-19, of which 162 cases of COVID-19 were observed in the placebo group compared to the BNT162b2 group.
In addition, Pfizer and BioNTech reported that this efficacy was consistent across age, gender, race and ethnicity demographics, with the observed efficacy rate in adults over the aged of 65 reaching 94%.
“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,” said Ugur Sahin, chief executive officer and co-founder of BioNTech.
“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,” he added.
The companies also announced that the vaccine has hit the safety milestone required by the US Food and Drug Administration (FDA) for Emergency Use Authorisation (EUA) submission.
As a result, Pfizer and BioNTech expect to submit a request 'within days' to the FDA for an EUA, based on the safety and efficacy data collected to date.
“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,” said Albert Bourla, Pfizer chairman and chief executive officer.
“We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world,” he added.