Pfizer concludes phase 3 study of Covid-19 vaccine with 95 per cent efficacy rate

 Company to apply for emergency US authorisation within days

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 8 cases in the BNT162b2 group.

Agencies   |  TT   |   18.11.20 :  Global drugmakers Pfizer and BioNTech on Wednesday said they have concluded phase 3 study of their mRNA-based Covid-19 vaccine candidate with 95 per cent efficacy rate, adding that they would apply for emergency US authorization within days.

The companies said the vaccine had no major side effects and its efficacy was consistent across all demographics, 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.

"Additionally, the safety milestone required by the US FDA (Food and Drug Administration) for Emergency Use Authorization (EUA) has been achieved. To date, no serious safety concerns related to the vaccine candidate have been reported," it said.

"Within days, we plan to submit a request to the US FDA  for an EUA based on the totality of safety and efficacy data collected, as well as manufacturing data relating to the quality and consistency of the vaccine candidate," it added.

This week, leading biotechnology company Moderna said its Covid-19 vaccine had shown to be 94.5 per cent effective. 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 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 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.

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.