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(Reuters) – Final results from Pfizer Inc’s COVID-19 vaccine trial showed its injection had a 95% success rate and two months of safety data, paving the way for the drugmaker to apply for an emergency clearance. in the United States in a few days, he said Wednesday. .
The vaccine’s efficacy rate, the highest of all late-stage clinical trial candidates to date, pleased experts who had already said that interim results showing Pfizer’s injection was more than 90 effective. % were very encouraging.
Pfizer said there were 170 cases of COVID-19 in its trial of more than 43,000 volunteers and that only eight people with the disease had received the injection instead of a placebo, meaning the vaccine had a 95% efficacy rate. . Of the 10 people who developed severe COVID-19, one had received the vaccine.
“The data is very strong,” said Ian Jones, a professor of virology at Britain’s University of Reading. “He seems like a real contender.”
Pfizer said it expects the US Food and Drug Administration’s vaccine advisory committee to review and discuss the data at a public meeting likely to be held in December.
The final analysis comes just a week after the initial trial results showed the vaccine to be more than 90% effective. Moderna Inc released preliminary data for its vaccine on Monday, showing an effectiveness of 94.5%.
The better-than-expected results of the two vaccines, both developed with new messenger RNA (mRNA) technology, have raised hopes of ending a pandemic that has killed more than 1.3 million people and wreaked havoc on the economies and daily life.
However, while some groups, such as healthcare workers, will have priority in the United States for vaccines this year, it will be months before large-scale deployments begin.
Pfizer said the efficacy of the vaccine developed with German partner BioNTech SE was consistent across different ethnic and age groups, a sign that immunization could be used widely around the world.
Efficacy in adults over 65, who are at particular risk from the virus, was greater than 94%.
Equity markets strengthened slightly on the news from Pfizer. Europe’s STOXX 600 and US S&P 500 futures were up 0.3% to hit highs for the day. However, the moves were small compared to the jump when Pfizer first announced that the vaccine was more than 90% effective on November 9. The reaction in European government bonds and currencies was muted.
Pfizer shares were up 3% in pre-market trading, while BioNTech shares traded in the US were up 8%.
SLIGHT SIDE EFFECTS
Pfizer said its vaccine, BNT162b2, was well tolerated and that the side effects were mostly mild to moderate and disappeared quickly.
The only serious adverse event that affected more than 2% of those vaccinated was fatigue, which affected 3.7% of recipients after the second dose. Older adults tended to report fewer and milder adverse events.
Moderna named five categories of serious side effects experienced by at least 2% of those who received their vaccine. He listed fatigue at a frequency of 9.7%, muscle pain at 8.9%, joint pain at 5.2%, headache at 4.5%, pain at 4.1%, and redness around the site of the 2% injection.
Pfizer’s bottom line comes as the virus spreads rampant around the world, putting enormous pressure on healthcare systems with a record number of new cases and hospitalizations.
The arrival of winter in the Northern Hemisphere along with the Christmas season is expected to worsen the number of cases as people spend more time indoors and have family gatherings.
“With hundreds of thousands of people around the world infected every day, we urgently need to bring a safe and effective vaccine to the world,” said Pfizer CEO Albert Bourla.
Pfizer and BioNTech also said they plan to submit the data to other regulatory agencies around the world and submit the study data to a peer-reviewed scientific journal.
Pfizer reiterated that it expects to produce up to 50 million doses of vaccines this year, enough to protect 25 million people, and then produce up to 1.3 billion doses in 2021.
Of the dozens of drug manufacturers and research groups competing to develop COVID-19 vaccines, the next data release will likely be from AstraZeneca Plc with the University of Oxford in November or December. Johnson & Johnson says it is on track to release data this year.
(Information by Michael Erman in Maplewood, NJ; additional information by Ankur Banerjee in Bengaluru and Elizabeth Howcroft and Kate Kelland in London; written by David Clarke; edited by Bill Berkrot, Peter Henderson, Edwina Gibbs and Pravin Char)
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