New York: Pfizer Inc PFE.N and BioNTech 22UAy.DE could get emergency US and European approval for their COVID-19 vaccine in December after final trial results showed a resounding 95 per cent success rate without serious side effects, the drugmakers said on Wednesday, according to news agency Reuters.
The efficacy of the vaccine was found to be consistent across different ages and ethnicities — a promising sign.
The US Food and Drug Administration could approve emergency-use by the middle of December, BioNTech Chief Executive Ugur Sahin was quoted as saying by Reuters TV. Conditional approval in the European Union could come in the second half of December, Sahin added.
“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,” Sahin was quoted as saying by the agency.
Of the 170 volunteers who were infected by 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 per cent effective. Of the 10 people who had severe COVID-19 infection, one had received the vaccine.
“A first in the history of mankind: less than a year from the sequence of the virus to the large-scale clinical trial of a vaccine, moreover based on a whole new technique,” Enrico Bucci, a biologist at Temple University in Philadelphia, was quoted by the agency. “Today is a special day,” Bucci said.
