People all over the world received good news as Pfizer announced that a vaccine candidate has been successful.
The vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis.
The analysis evaluated 94 confirmed cases of COVID-19 in trial participants. The study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; Safety and additional efficacy data continue to be collected. Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November. A clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints
The development is a significant step toward combating the global pandemic at a time when many areas are seeing a rise in cases. The heads of Pfizer and BioNTech celebrated their breakthrough as a reason for hope.
“Today is a great day for science and humanity. 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,” Pfizer Chairman and CEO Dr. Albert Bourla said in a statement. “We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity, and economies struggling to reopen. With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis.”
BioNTech CEO and co-founder Ugur Sahin called the trial’s result “a victory for innovation, science and a global collaborative effort,” and that “in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality.”
The companies expect to produce as many as 50 million doses of the vaccine this year and up to 1.3 billion next year.