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Thursday, 19 November 2020 02:27 - - {{hitsCtrl.values.hits}}
Reuters: Pfizer Inc. will seek emergency US approval for its COVID-19 vaccine within days after final trial results showed its shot had a 95% success rate and no serious side effects, the drug maker said yesterday.
The efficacy of the vaccine, which could start being distributed in December, was found to be consistent across different ages and ethnicities – a promising sign given the disease has disproportionately affected the elderly and certain groups including black people.
The success rate of the vaccine developed by Pfizer and its German partner BioNTech is the highest of any candidate in late-stage clinical trials so far, and experts said it was a significant achievement in the race to end the pandemic.
Pfizer said 170 volunteers in its trial involving over 43,000 people contracted COVID-19 but 162 of them had only been given a placebo, 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, biologist at Temple University in Philadelphia. “Today is a special day.”
American drugmaker Pfizer said it would apply for the emergency authorisation “within days” and expected the US Food and Drug Administration’s vaccine advisory committee to discuss the data in a public meeting, likely to be held in December.
The FDA committee tentatively plans to meet on 8-10 December, a source familiar with the situation said, though the dates could still 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.
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 Pfizer-BioNTech shot was found to have 94% efficacy in people over 65 years, which experts said was crucial.
“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.
