Pfizer final analysis of Phase 3 study indicates COVID-19 vaccine efficacy rate of 95%
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Pfizer final analysis of Phase 3 study indicates COVID-19 vaccine efficacy rate of 95%

NEW YORK: The Pfizer and BioNTech on Wednesday (November 18, 2020) introduced that after conducting the ultimate efficacy evaluation within the Phase three research, their COVID-19 vaccine, BNT162b2, met all the research’s major efficacy endpoints. They mentioned that the evaluation of the info signifies a vaccine efficacy charge of 95% in individuals with out prior SARS-CoV-2 an infection (first major goal) and likewise in individuals with and with out prior SARS-CoV-2 an infection (second major goal), in every case measured from 7 days after the second dose. 

“The first primary objective analysis is based on 170 cases of COVID-19, as specified in the study protocol, of which 162 cases of COVID-19 were observed in the placebo group versus 8 cases in the BNT162b2 group. Efficacy was consistent across age, gender, race and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94%,” mentioned Pfizer.

There have been 10 extreme instances of COVID-19 noticed within the trial, with 9 of the instances occurring within the placebo group and one within the BNT162b2 vaccinated group.

 

Also learn | COVID-19: Centre makes large announcement over procurement of Pfizer vaccine

 

Pfizer said that up to now, the Data Monitoring Committee for the research has not reported any severe security considerations associated to the vaccine. 

“A review of unblinded reactogenicity data from the final analysis which consisted of a randomized subset of at least 8,000 participants 18 years and older in the phase 2/3 study demonstrates that the vaccine was well tolerated, with most solicited adverse events resolving shortly after vaccination. The only Grade 3 (severe) solicited adverse events greater than or equal to 2% in frequency after the first or second dose was fatigue at 3.8% and headache at 2.0% following dose 2. Consistent with earlier shared results, older adults tended to report fewer and milder solicited adverse events following vaccination,” added Pfizer.

The corporations introduced that the protection milestone required by the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) has been achieved and the Pfizer and BioNTech plan to submit a request inside days to the FDA for a EUA primarily based on the totality of security and efficacy information collected up to now, in addition to manufacturing information regarding the standard and consistency of the vaccine. 

“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,” mentioned Dr Albert Bourla, Pfizer Chairman and CEO. 

He added, “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.”

“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,” mentioned Ugur Sahin, M.D., CEO and Co-founder of BioNTech. 

He added, “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. 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.”

This is to be famous that the Phase three medical trial of BNT162b2 started on July 27 and has enrolled 43,661 individuals up to now, 41,135 of whom have acquired a second dose of the vaccine candidate as of November 13, 2020. 

Approximately 42% of worldwide individuals and 30% of U.S. individuals have racially and ethnically various backgrounds, and 41% of worldwide and 45% of U.S. individuals are 56-85 years of age. A breakdown of the range of medical trial individuals will be discovered right here from roughly 150 medical trials websites within the United States, Germany, Turkey, South Africa, Brazil and Argentina.

“The trial will continue to collect efficacy and safety data in participants for an additional two years,” mentioned Pfizer.

They said that primarily based on present projections, Pfizer and BioNTech count on to supply globally as much as 50 million COVID-19 vaccine doses in 2020 and as much as 1.three billion coronavirus doses by the top of 2021. 

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