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Just last week, Pfizer and BioNTech revealed that their experimental Covid-19 vaccine, called BNT162b2, was at least 90 percent effective in an early analysis. On Wednesday, the pharmaceutical and biotech companies reported that their vaccine was even more effective after it cleared more clinical trial benchmarks for safety and efficacy. And on Friday, they said they are requesting an emergency use authorization (EUA) from the Food and Drug Administration.
If granted an EUA, the BNT162b2 vaccine could be administered to certain high-risk groups in the United States — most likely health workers — as soon as mid-December. Pfizer and BioNTech are filing for similar approvals in other countries as well.
“Filing for Emergency Use Authorization in the US is a critical step in making our vaccine candidate available to the global population as quickly as possible,” said Ugur Sahin, CEO and cofounder of BioNTech, in a statement.
The companies are confident in their vaccine after showing strong results from their phase 3 clinical trial: Out of 170 Covid-19 cases, eight people that received the vaccine got Covid-19 versus 162 in the placebo group, an efficacy of 95 percent. They also say there are no “serious safety concerns related to the vaccine.”
A competitor, the vaccine developer Moderna, also recently reported that its vaccine was 94.5 percent effective in an early analysis.
It’s worth pausing to reflect on where we are: At the one-year anniversary of the first detection in China of the SARS-CoV-2 virus, the pathogen that causes Covid-19, there are now two highly effective vaccine candidates developed at a record pace, both using mRNA, a new vaccine technology that has never before been approved for use in humans.
The announcements are a breathtaking feat of science, international collaboration, and public investment. “The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic,” said Albert Bourla, Pfizer chair and CEO, in a statement.