Pfizer Inc. and BioNTech SE announced today that after conducting the last analysis of the effectiveness of their ongoing Phase 3 study, their COVID-19 vaccine candidate, the messenger RNA-based BNT162b2, met all of the primary efficacy endpoints of the study.
Data analysis specifies that the efficacy rate of the vaccine's 95 percent in participants without prior COVID-19 infection, as well as in participants with and without prior COVID-19 infection, in each case gauged from 28 days from the initial dose, seven days following the second dose.
The initial primary goal assessment is based on 170 COVID-19 cases, as indicated in the study protocol, of which more than 160 cases of the virus were detected in the "placebo group against eight cases in the BNT162b2 group."
The study found efficiency was consistent across demographics, including gender, age, ethnicity, and race. The observed efficiency among adults more than 65 years old was more than 94 percent.
A Novel Strategy
Results of the study are almost identical to the initial findings which Moderna earlier reported from its ongoing trial for its vaccine candidate's efficacy.
Reports on this latest development said that both Moderna's vaccine and the Pfizer and BioNTech candidate comprise mRNA "that codes for the surface protein of SARS-CoV-2, the surface protein of SARS-CoV-2, the virus that causes COVID-19."
The strategy, reports indicated, is novel that no drug made from mRNA has been approved for general human use.
Pfizer and BioNTech also announced a plan to submit a request within days to the US Food and Drug Administration for an Emergency Use Administration or EUA, based on the entirety of safety and efficacy data gathered to date, including the manufacturing data associated with the vaccine's quality and consistency. The same data is also set for submission to other regulatory agencies all over the world.
Meanwhile, according to Trudie Lang, who directs the Global Health Network at the University of Oxford, "This is a remarkable and very reassuring situation that we find ourselves in."
He added, to go from determining a new virus to having numerous vaccines at the point of seeking regulatory approval is such an "incredible milestone for science."
Hoping to End the Devastating Pandemic
Pfizer chairman and CEO Albert Bourla said the study findings mark a vital step "in this historic eight-month journey to bring forward a vaccine" that can help end the devastating pandemic.
He also added, "We continue at the speed of science" to gather all the data collected thus far and share with regulators all over the world.
BioNTech CEO and co-founder Ugur Sahin, MD sad, "We are grateful that the first global trial to reach the final efficacy analysis mark" specifies that a high protection rate from COVID-19 can be attained very fast, following the initial 30 µg dose, highlighting the potential of BNT162 "to provide early protection."
The said achievement, the BioNTech official added, underscores "the potential of mRNA as a new drug class.
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