Washington: Pfizer and BioNTech could secure emergency US and European authorisation for their COVID-19 vaccine next month. This development comes after final trial results of the COVID-19 vaccine showed it had a 95 per cent success rate and no serious side effects. This information was given by both the drugmakers here Wednesday. The vaccine’s efficacy was found to be consistent across different ages and ethnicities. It is 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, he added.
“If all goes well I could imagine that we gain approval in the second half of December and start deliveries before Christmas. However, this will happen really only if all goes positively,” Sahin stated.
The success rate of the vaccine developed by Pfizer and German partner BioNTech was far higher than what regulators had said would have been acceptable. Experts said it was a significant achievement in the race to end the pandemic.
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% effective. Of the 10 people who had severe COVID-19, 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,” said Enrico Bucci, a biologist at Temple University in Philadelphia. “Today is a special day,” he added.
Sahin said US emergency use authorisation (EUA) would be applied for on Friday.
An FDA advisory committee tentatively plans to meet December 8-10 to discuss the vaccine, a source familiar with the situation said.
The final trial analysis comes a week after initial results showed the vaccine was more than 90% effective. Moderna released Monday preliminary data for its vaccine showing 94.5% effectiveness.
“We now have two safe and highly effective vaccines that could be authorised by the Food and Drug Administration. Then they will be ready to distribute within weeks,” US Health and Human Services Secretary Alex Azar said.
Pfizer said vaccine was well-tolerated and that side effects were mostly mild to moderate, and cleared up quickly. The only severe adverse events experienced by volunteers were fatigue (3.8%) and headaches (2%) after the second dose. Older adults tended to report fewer and milder adverse events.
“These are extraordinary results, and the safety data look good,” said David Spiegelhalter. He is a professor and expert in risk and evidence communication at the University of Cambridge.