Vaccine 95% Effective in Final Trials, No Safety Concerns: Pfizer
Pfizer said there were no significant safety problems so far in a trial which included almost 44,000 participants.
Biotech company Pfizer on Wednesday, 18 November, said that a final analysis of clinical-trial data from its COVID-19 vaccine trial shows that the shot is 95 percent effective and that vaccine also protects older people from the infection, Bloomberg reported. T
The company also said that there had been no significant safety problems so far in a trial which included almost 44,000 participants.
“The Phase 3 study of our COVID-19 vaccine candidate has met all primary efficacy endpoints. The study reached 170 confirmed cases of COVID19, with the vaccine candidate BNT162b2 demonstrating 95 percent efficacy beginning 28 days after the first dose,” a statement from the company read, according to ANI.
The Pfizer-BioNTech data said that the vaccine’s efficacy in people older than 65 was more than 94 percent, according to Bloomberg.
One Step Closer Towards Emergency Use Authorisation
Wednesday’s announcement paves the way for Pfizer to apply for the first US regulatory authorisation for a coronavirus vaccine within days. In a statement, the companies announced that the safety milestone required by the US FDA for Emergency Use Authorisation (EUA) has been achieved and that they plan to submit a request within days to the FDA.
“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,”Dr. Albert Bourla, Pfizer Chairman and CEO.
An earlier preliminary analysis, results of which were announced on 9 November, had shown that the COVID-19 vaccine being developed by Pfizer Inc. and BioNTech SE prevented more than 90 percent of infections. Those findings were based on a preliminary analysis and Phase 3 trials of the vaccine were still underway at the time.
(With inputs from Bloomberg and ANI.)
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