Pfizer said Wednesday that a final assessment of trial data on the COVID-19 vaccine it developed in conjunction with German company BioNTech showed it was 95% effective, and that it would apply for emergency use authorization with the U.S. Food and Drug Administration “within days.” It was the latest hopeful news for a world desperate to turn the tide on the coronavirus pandemic that has killed more than 1.3 million people globally, and almost 250,000 in the U.S. alone.
In a statement released early Wednesday, Pfizer said the efficacy of its vaccine was consistent “across age, gender, race and ethnicity demographics,” and that trial data after two months had met the criteria laid out by the FDA to demonstrate both the safety and function of the vaccine.
“Pfizer and BioNTech plan to submit a request within days to the FDA for an EUA [Emergency Use Authorization] based on the totality of safety and efficacy data collected to date,” the U.S. pharmaceuticals giant said.
Pfizer became the first vaccine maker to claim an extremely high efficacy for its formula last week, saying preliminary data showed it to be more than 90% effective at preventing new coronavirus infections. Wednesday’s announcement cemented those results with final data, and made them even more optimistic by matching preliminary efficacy data reported by Moderna, another American vaccine maker that hopes to seek EUA in the U.S. soon.
Pfizer said the Phase 3 human trials, which involved more than 43,000 people, showed the vaccine “was well tolerated across all populations,” with “no serious safety concerns observed.” The only notable side effects, according to Pfizer, were fatigue in 3.8% of vaccine recipients and headaches in about 2%.
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