Updated Nov 20, 2020, 08:13am EST
Pfizer and BioNTech will apply for emergency regulatory approval in the U.S. Friday for their Covid-19 vaccine—as the companies announced they would earlier this week—days after a clinical trial showed the vaccine to be 95% effective at preventing the disease.
This is the first time a company has sought regulatory approval for a Covid-19 vaccine which, if approved, will mark the first time a vaccine built using mRNA technology has made it to market.
The application comes days after the companies announced a 95% efficacy rate for the vaccine based on an extensive Phase 3 clinical trial involving more than 40,000 volunteers.
The results show the highest efficacy rate of any late-stage Covid-19 vaccine in development — far higher than the 50% U.S. regulators had been willing to accept — and the companies report “no serious safety concerns” with the vaccine.
Source: Forbes – Business