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AstraZeneca insisted its COVID-19 vaccine offers strong protection even after counting additional illnesses in its US study, as the drugmaker responded to concerns raised by US officials in an unusually public rebuke that threatened to further erode confidence in the shot.
In a press release late Wednesday evening, AstraZeneca said it analyzed more data from this study and concluded that the vaccine was 76% effective in preventing symptomatic COVID-19, instead of the 79% it reported earlier in the week.
Some experts called the new analysis reassuring and said the updated details did not appear significantly different from what had been announced earlier. A full data snapshot won’t come for at least a few weeks, once the Food and Drug Administration begins its own rigorous review. For now, it is not clear whether the new figures will be enough to restore the credibility of a vaccine which, despite being widely used in Britain, Europe and other countries, has experienced a difficult deployment.
Earlier this week, an independent panel overseeing the US vaccine trial accused AstraZeneca of collecting data. to praise the protection offered by his cliché. The panel, in a stern letter to the company and U.S. health executives, said AstraZeneca had omitted some cases of COVID-19 that arose in the study.
The drugmaker responded that the results it reported included cases up to mid-February, as agreed in the study rules, and that it was preparing a more comprehensive analysis of cases since then – which he published on Wednesday.
“AstraZeneca may have been too hasty in submitting an earlier incomplete interim analysis rather than waiting to analyze and submit the full dataset,” said Julian Tang, a virologist at the University of Leicester who was not connected to research. He said the updated details were likely strong enough for US regulators to clear the vaccine.
Ahead of the release of the new findings, Dr.Anthony Fauci, America’s leading infectious disease expert, told reporters he hoped that when all the data was publicly approved by the FDA, it would allay any hesitation caused by the spat. He predicted it would be “a good vaccine.”
AstraZeneca was relying on the results of a predominantly American study of 32,000 people to help restore confidence in its shot, which is crucial for global efforts to end the coronavirus pandemic because it is cheap, easy. to stockpile and a pillar of the COVAX initiative to bring vaccines to low- and middle-income countries. Despite the evidence from trials and actual use that it protects, previous studies have found inconsistent data on how effective it is.
Then last week, fear of blood clots led some countries to temporarily suspend inoculations. Most have since restarted after the European Medicines Agency said the vaccine did not increase the overall incidence of blood clots., although this does not exclude a connection to some rare clots. Denmark announced on Thursday that it will continue its suspension of the vaccine.
AstraZeneca’s latest efficacy calculations were based on 190 cases of COVID-19 that occurred during the US study, 49 more than what it included earlier in the week. The vaccine appeared particularly protective against the worst outcomes, without serious illness or hospitalization among the vaccinated study volunteers, against eight severe cases among those who received dummy injections, the company said. He did not provide a breakdown of the other cases.
Some European authorities have questioned the degree of protection of the vaccine in the elderly. In the US study, it was 85% effective in volunteers 65 and older, the company said. The study did not raise any safety concerns.
The updated information “confirms that our COVID-19 vaccine is highly effective in adults, including those aged 65 and over,” AstraZeneca Chief Research Officer Mene Pangalos said in a statement. He said the company looks forward to “the deployment of millions of doses across America.”
The study is not complete, so additional cases of COVID-19 could still accumulate. AstraZeneca has warned that 14 other possible cases are already under review and that could lead to further data changes.
The company intends to seek FDA clearance for the vaccine in a few weeks. The agency will publicly discuss all evidence with its outside advisers before making a decision.
Stephen Evans, a vaccine expert at the London School of Hygiene and Tropical Medicine, said it was difficult to understand why the dispute between AstraZeneca and US officials has spread to the public. Such divisions during ongoing studies generally remain confidential.
“Given the details given here, it seems unnecessary to raise concerns in public,” he said. “The results fluctuate as the data accumulates … what matters will be the FDA’s assessment and this will be based on a careful review of the full data and not press releases. ” He said any vaccine with an efficacy rate greater than 60% is helpful.
He said it was not clear why there was “a breakdown in relationship” between AstraZeneca and the independent US data experts overseeing the trial and feared it could undermine confidence in the vaccine.
“This vaccine is so important to global health, and disputes don’t promote global health,” he said. “At least in the short term, (it) will undermine confidence both in the United States and, more importantly, the rest of the world.”
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Associated Press medical editor Maria Cheng in London and Jan M. Olsen in Copenhagen contributed to this report.
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The Associated Press’s Department of Health and Science receives support from the Department of Science Education at the Howard Hughes Medical Institute. The AP is solely responsible for all content.
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