The company is still awaiting its threshold for total COVID-19 infections in its 44,000-patient assessment. Nonetheless, they believe they have made history.
Coronavirus 2019 (COVID-19) vaccine development partners Pfizer and BioNTech are approximately 2 weeks away from being the first group to share phase 3 data for a pandemic prophylactic candidate.
They reported Monday morning that their vaccine candidate, BNT162, will have supporting data showing more than 90% efficacy in preventing COVID-19 infection.
Their statement—which added that no serious safety concerns were observed in its ongoing, real-world, phase 3 trial—would imply that their COVID-19 vaccine would be among the most effective childhood infection-risk vaccines on the market.
The 44,000-person, randomized, 1:1 trial is still seeking an endpoint when 164 volunteers develop COVID-19, according to Pfizer, and intends to assess its overall protection from even more severe forms of the virus, as well as how it may benefit patients previously infected.
This first analysis will include data with 94 volunteers who have developed COVID-19—though it’s currently not clear how many of this subpopulation were patients administered the vaccine or placebo.
As the COVID-19 pandemic has surged to new heights, with the first instances of 100,000-plus new daily cases being reported in the last week, investigators anticipate there will be a greater likelihood they will reached the 164-person infection count in the near future.
Pfizer now intends to request an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) later this month, upon their finalized collection of mandated two-month follow-up patient safety day.
It anticipates that by the end of the year, the company will have manufactured enough of the two-dose vaccine to immunize 15-20 million people.
Though actual, peer-reviewed data on the vaccine’s efficacy is yet to be shared, Pfizer leadership has expressed to major news outlets that these findings could alter the state, and hopes, of COVID-19 mitigation going forward.
William Gruber, Pfizer’s senior vice president of vaccine clinical research and development, told STAT News that he’s been in vaccine development for nearly 4 decades.
“I’ve seem some really good things,” he said. “This is extraordinary. This really bodes well for us being able to get a handle on the epidemic and get us out of this situation.”