Pfizer's Phase 3 study of COVID-19 vaccine 95pc effective; to apply for FDA approval 'within days'

Global drugmakers Pfizer and BioNTech said on Wednesday their COVID-19 vaccine is 95 percent effective, including in adults over 65 years of age, a major announcement coming just two days after Moderna said its virus vaccine has an efficacy rate of 94.5 percent.

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 endpoints.

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.

With the safety milestone required by the US Food and Drug Administration (FDA) for Emergency Use Authorisation (EUA) being achieved, Pfizer and BioNTech plan to submit a request within days to the FDA for a 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.

Earlier this month, Pfizer and BioNTech had said their vaccine was found to be over 90 percent effective in preventing COVID-19 in participants.

Analysis of the data indicates a vaccine efficacy rate of 95 percent 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 company 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 eight 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 percent.

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COVID-19 vaccine developed by Pfizer and BioNTech demonstrates 90 pc effectiveness in preventing infection

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, Chairman and CEO, Pfizer.

"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," he added.

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, with still showing no signs of abating.

So far, the coronavirus pandemic has infected over 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.

The 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 to 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 side-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.

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 30g 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 as of November 13.

About 42 percent of global participants and 30 percent of US participants have racially and ethnically diverse backgrounds, and 41 percent of global and 45 percent 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 US, 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.