Pfizer Inc and BioNTech could make sure about emergency U.S. also, European approval for their COVID-19 vaccine one month from now after final trial results showed it had a 95% success rate and no serious side effects, the drugmakers said on Wednesday.
The vaccine’s viability was discovered to be predictable across various ages and identities – a promising sign given the infection has excessively harmed the older and certain groups including Black people.
The U.S. Food and Drug Administration could concede emergency-use by the middle of December, BioNTech Chief Executive Ugur Sahin disclosed to Reuters TV. Conditional approval in the European Union could be made sure about in the second 50% of December, he added.
“If all goes well I could imagine that we gain approval in the second 50% of December and start deliveries before Christmas, however truly just if all goes positively,” he said.
The success rate of the vaccine developed by the U.S. drugmaker 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.”
BioNTech’s Sahin said U.S. emergency use authorization (EUA) would be applied for on Friday.
An FDA advisory committee tentatively plans to meet on Dec. 8-10 to discuss the vaccine, a source familiar with the situation said, though the dates could change. The FDA did not respond to requests for comment.
The final trial analysis comes a week after initial results showed the vaccine was more than 90% effective. Moderna Inc on Monday released preliminary data for its vaccine showing 94.5% effectiveness.
“We now have two safe and highly effective vaccines that could be authorized by the Food and Drug Administration and ready to distribute within weeks,” U.S. Health and Human Services Secretary Alex Azar said.
The Moderna vaccine is likely to be authorized within seven to 10 days of Pfizer receiving its EUA, U.S. officials said, with states ready to begin distribution within 24 hours.
The better-than-expected results from the two vaccines, both developed with new messenger RNA (mRNA) technology, have raised hopes for an end to a pandemic that has killed more than 1.3 million people and wreaked havoc upon economies and daily life.
The news was especially welcome with the virus again running rampant around the world, setting records for new infections and hospitalizations almost daily.
The Pfizer-BioNTech shot was found to have 94% efficacy in people over age 65, a particularly high-risk group.
“This is the evidence we needed to ensure that the most vulnerable people are protected,” said Andrew Hill, senior visiting research fellow at the University of Liverpool’s department of pharmacology.
Global shares rose as the trial results countered concerns around the soaring infection rate. Pfizer shares were up 1.6% while BioNTech jumped 3.8% in the United States. Moderna shares fell 3.6%.
Investors have treated vaccine development as a race between companies, although there is likely to be global demand for as much vaccine as can be produced for the foreseeable future.
