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NEW YORK (Reuters) – Final results of Pfizer’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 ask a US emergency clearance within days, he said on Wednesday.
The vaccine’s efficacy rate, the highest of any candidate in advanced clinical trials so far, has been welcomed by experts who previously said interim results showing Pfizer’s vaccine to be effective over 90% were very encouraging.
Pfizer said there were 170 cases of COVID-19 in its trial involving more than 43,000 volunteers and that only eight people with the disease had received the vaccine rather than a placebo, meaning the vaccine had a rate efficiency of 95%. Of the 10 people who developed severe COVID-19, one had received the vaccine.
“The data is very strong,” said Ian Jones, professor of virology at the UK University of Reading. “Sounds like a real suitor.”
Pfizer said it expects the U.S. Food and Drug Administration’s vaccine advisory committee to review and discuss the data at a public meeting likely to be held in December.
“We continue to evolve at the speed of science, and we know that every day counts on our path to authorization,” said Albert Bourla, CEO of Pfizer.
The final analysis comes just a week after the first results of the trial showed that the vaccine, developed with German partner BioNTech, was over 90% effective. Moderna released preliminary data for its vaccine on Monday, showing an efficacy of 94.5%.
Better-than-expected results from the two vaccines, both developed with new messenger RNA technology, have raised hopes of ending a pandemic that has killed more than 1.3 million people and wreaked havoc on communities. savings and everyday life.
However, while some groups such as healthcare workers will be given priority in the United States for vaccinations this year, it will be months before large-scale deployments begin.
Dispensing a Pfizer shot is complicated by the need to store it in ultra-cold temperatures of -94 degrees Fahrenheit. It can, however, be stored in a normal refrigerator for up to five days, or up to 15 days in a thermal shipping box.
Pfizer said the efficacy of the vaccine was consistent across different ages and ethnicities, a sign that the vaccination could be used widely around the world.
The efficacy in adults over 65, particularly exposed to the virus, was over 94%.
“The 94% protection for the elderly is essential. This is the proof we need to ensure the protection of the most vulnerable, ”said Andrew Hill, Visiting Senior Fellow in the Department of Pharmacology at the University of Liverpool.
Stock markets strengthened slightly on the news from Pfizer. European futures STOXX 600 and US S&P 500 both rose around 0.3% to reach daily highs. The moves were modest, however, compared to the jump when Pfizer first announced that the vaccine was over 90% effective on November 9.
Shares of Pfizer rose 3% in pre-market trading while US-listed shares of BioNTech jumped 8%.
Pfizer said its two-dose vaccine, BNT162b2, was well tolerated, and side effects were mostly mild to moderate and went away 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 her 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 injection site at 2%.
Pfizer’s final results come as the virus is rampant around the world, putting enormous strain on health systems with a record number of new cases and hospitalizations.
The approach of winter in the northern hemisphere alongside the holiday season is expected to worsen the number of cases, as people spend more time indoors and have family reunions.
“With hundreds of thousands of people infected every day around the world, there is an urgent need to deliver a safe and effective vaccine to the world,” said Bourla of Pfizer.
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 plans to manufacture up to 50 million doses of the vaccine this year, enough to protect 25 million people, and then produce up to 1.3 billion doses in 2021.
Among the dozens of drugmakers and research groups rushing to develop COVID-19 vaccines, the next data release will likely come from AstraZeneca Plc with the University of Oxford in November or December. Johnson & Johnson say it is on track to provide data this year.
(Reporting by Michael Erman in Maplewood, NJ; Additional reporting by Ankur Banerjee in Bengaluru and Elizabeth Howcroft and Kate Kelland in London; Writing by David Clarke; Editing by Bill Berkrot, Peter Henderson, Edwina Gibbs and Pravin Char)
© Copyright Thomson Reuters 2020
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