The primary efficacy analysis in 170 confirmed cases of Covid-19 showed that BNT162b2 is 95% effective in preventing Covid-19, compared to placebo
Pfizer and BioNTech’s mRNA-based Covid-19 vaccine candidate BNT162b2 has met all the primary efficacy endpoints in the ongoing Phase 3 study, following the final efficacy analysis.
The data analysis demonstrated 95% vaccine efficacy rate in participants without prior SARS-CoV-2 infection, which is the first primary objective.
Also, the vaccine showed same efficacy in participants with and without prior SARS-CoV-2 infection, which is the second primary objective, as measured seven days after the second dose.
Pfizer chairman and CEO 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.
“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.”
The first primary objective analysis was conducted based on 170 confirmed Covid-19 cases, of which 162 Covid-19 cases were observed in the placebo group, compared to eight cases in the BNT162b2 vaccinated group.
BNT162b2 demonstrated a consistent efficacy across age, gender, race and ethnicity demographics, with more than 94% efficacy observed in adults aged 65 years and above.
The Phase 3 trial reported 10 severe Covid-19 cases, of which nine cases occurred in the placebo group and one in the BNT162b2 vaccinated group.
Also, the vaccine did result in any serious safety concerns and consistent with earlier shared results, as reported by the independent Data Monitoring Committee (DMC) for the Phase 3 study. older adults experienced mild adverse events after vaccination.
BioNTech CEO and co-founder 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.
“These achievements highlight the potential of mRNA as a new drug class. 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.”
Pfizer and BioNTech designed temperature-controlled thermal shippers for vaccine
Pfizer and BioNTech have specially designed temperature-controlled thermal shippers that leverage dry ice to maintain -70°C±10°C temperature.
The GPS-enabled thermal sensor in shippers would help to track the location and temperature of each vaccine shipment across their pre-set routes. Shippers can be used as temporary storage units for 15 days with refilled dry ice.
Pfizer and BioNTech announced that the vaccine has achieved the safety milestone required by the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA).
The companies intend to seek an EUA from the FDA within few days, based on the totality of safety and efficacy data till date, along with quality and consistency data of the vaccine.
Sahin added: “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.
“I want to thank all the devoted women and men who contributed to this historically unprecedented achievement. We will continue to work with our partners and governments around the world to prepare for global distribution in 2020 and beyond.”