Global drugmakers Pfizer and BioNTech said on Wednesday that their COVID-19 vaccine was found 95 per cent effective in the final analysis of the Phase 3 trial, including in people aged over 65 years, paving the way for the companies to apply for emergency authorisation from United States regulators within days.
American pharmaceutical giant Pfizer and its German partner BioNTech said they have concluded phase 3 study of their mRNA-based COVID-19 vaccine candidate BNT162b2, meeting all primary efficacy end points.
Based on current projections, the companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021.
The major announcement comes just two days after leading biotechnology company Moderna said on Monday its virus vaccine had an efficacy rate of 94.5 per cent.
Earlier this month, Pfizer and Biontech had said their COVID-19 vaccine candidate was found to be more than 90 per cent effective in preventing COVID-19 in participants.
Analysis of the data indicates a vaccine efficacy rate of 95 per cent 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 seven days after the second dose.
The companies said the first primary objective analysis is based on 170 cases of COVID-19, of which 162 cases of coronavirus were observed in the placebo group while 8 cases in the BNT162b2 group.
Vaccine efficacy was consistent across age, gender, race and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94 per cent, they said.
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.
"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," Bourla said.
The announcements about the vaccines and their potential availability for use among the general population in the coming weeks and months has offered hope to millions around the world in a year that has seen the COVID-19 pandemic devastate lives and economies and still showing no signs of abating.
So far, the coronavirus pandemic has infected more than 55 million people around the world and killed more than 1.3 million people even as governments implemented strict lockdowns and restrictions to slow the spread of the virus that originated in the Chinese city of Wuhan.
A second wave of infections is threatening to derail economies and impact lives again as countries had gradually begun to ease restrictions and open up.
Pfizer said till date, the Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine.
A randomised subset of at least 8,000 participants 18 years and older in the phase 2/3 study found that the vaccine was well tolerated and any side effects resolved shortly after vaccination.
The sides-effects noticed after the first or second dose was fatigue, and headache. Further, older adults tended to report fewer and milder side-effects following vaccination.
With the safety milestone required by the US Food and Drug Administration for Emergency Use Authorization being 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.
BioNTech MD, CEO and Co-founder Ugur Sahin said the final efficacy analysis indicates that a high rate of protection against COVID-19 can be achieved very fast after the first 30 µg dose.
"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. 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," Sahin said.
The Phase 3 clinical trial of BNT162b2 began in July and has enrolled 43,661 participants to date, 41,135 of whom have received a second dose of the vaccine candidate as of November 13.
Approximately 42 per cent of global participants and 30 per cent of US participants have racially and ethnically diverse backgrounds, and 41 per cent of global and 45 per cent of US participants are 56-85 years of age.
Four of Pfizer's facilities are part of the manufacturing and supply chain; St. Louis, Andover, and Kalamazoo in the U.S and Puurs in Belgium. BioNTech's German sites will also be leveraged for global supply.
Pfizer said it is confident in its vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world. The companies have developed specially designed, temperature-controlled thermal shippers utilising dry ice to maintain temperature conditions of -70°C±10°C.
