Pfizer and BioNTech could secure emergency US and European authorization for their COVID-19 vaccine next month after final trial results showed it had a 95 percent success rate and no serious side effects, the drugmakers said on Wednesday.
The vaccine’s efficacy was found to be consistent across different ages and ethnicities, which shows a promising sign given the disease has disproportionately hurt the elderly and certain groups including black people.
The US Food and Drug Administration could grant emergency-use by the middle of December, BioNTech Chief Executive Ugur Sahin said. Conditional approval in the European Union could be secured in the second half of December.
“If all goes well I could imagine that we gain approval in the second half of December and start deliveries before Christmas, but really only if all goes positively,” he added.
The success rate of the vaccine developed by the US drugmaker and German partner BioNTech was far higher than what regulators had said would have been acceptable.
Of the 170 volunteers who contracted COVID-19 in Pfizer’s trial involving over 43,000 people, 162 had received a placebo and not the vaccine, meaning the vaccine was 95 percent effective. Of the 10 people who had severe COVID-19, one had received the vaccine.
The final trial analysis comes a week after initial results showed the vaccine was more than 90 percent effective.
BioNTech’s Sahin said US emergency use authorization would be applied for on Friday.