The results of the companies' late-stage clinical trial showed that just 10% of almost 100 test subjects who tested positive for COVID-19 had received the vaccine rather than a placebo, according to what the firms said was an interim analysis of its third-stage trial.
The companies said their two-dose vaccine provided protection beginning seven days after the second dose and 28 days after the initial dose of the vaccine.
The companies said they will seek emergency use authorization from the Food and Drug Administration "soon after the required safety milestone is achieved," which it now expects as soon as next week.
"Today is a great day for science and humanity," Pfizer Chairman and CEO Dr. Albert Bourla said in a statement. "The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine's ability to prevent COVID-19."
"The first interim analysis of our global Phase 3 study provides evidence that a vaccine may effectively prevent COVID-19," added BioNTech CEO Ugur Sahin. "This is a victory for innovation, science and a global collaborative effort."
Pfizer and BioNTech have enrolled more than 43,000 volunteers in the third and final stage study, which began in late July. They said nearly 39,000 human subjects have received both doses.
Sahin said the trial will continue to collect data with goal of a examining the results after 164 confirmed COVID-19 cases have been accrued among participants.
The Pfizer-BioNTech vaccine is one of several candidates now in late-stage clinical trials worldwide, along with candidates being developed by AstraZeneca, Johnson & Johnson, Novavax and Moderna.
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