AstraZeneca insists that its COVID-19 vaccine is highly effective even after counting additional diseases in its US study, the most recent in an extraordinary public dispute with US officials.
In a press release on Wednesday, the doctor said he analyzed more data from the study and concluded that the vaccine is 76% effective in preventing symptomatic COVID-19, instead of the 79% it reported earlier this week. .
Just a day earlier, an independent group overseeing the study accused AstraZeneca of cherry picking data to promote the protection afforded by his vaccine. The group, in a harsh letter to the company and US health leaders, said the company had omitted some COVID-19 cases that took place in the study, a move that could erode confidence in science.
Some experts said that the new data provided by AstraZeneca is “reassuring” and that the information is probably strong enough for US regulators to authorize the vaccine.
“AstraZeneca may have been in too much of a hurry to send in the incomplete previous interim analysis, rather than wait to analyze and present the full set of data,” said Julian Tang, a non-University of Leicester virologist. connected to research. He said the updated details do not look substantially different from those published earlier this week.
Disputes over data from ongoing studies usually remain confidential, but in an unusual move, the National Institutes of Health has publicly asked AstraZeneca to remedy the discrepancy.
AstraZeneca relied on the results of a predominantly US study of 32,000 people to help rebuild confidence in a vaccine that, despite being widely used in the UK, Europe and other countries, has had a troubled launch. Previous studies have shown inconsistent data on its effectiveness, and last week, a scare on blood clots caused some countries to temporarily stop inoculation.
Most have restarted after the European Medicines Agency said the vaccine does not increase the overall incidence of blood clots., although it did not rule out a connection with some rare clots. On Thursday, Denmark announced that it would continue to suspend the vaccine, officials say they need more information before making a decision.
The question now is whether the company’s latest calculations can end the tension in the United States. Even before the latest spit, experts had expressed concern that the wrong steps in vaccine implementation could undermine confidence., which is crucial for global efforts to end the coronavirus pandemic because it is cheap, easy to store and a pillar of the COVAX initiative to bring vaccines to low- and middle-income countries.
Earlier Wednesday, Dr. Anthony Fauci, the leading infectious disease expert in the United States, told reporters that he hopes that when all data is publicly verified by federal regulators, it will dispel any hesitation caused by spitting. He predicted that “it will prove to be a good vaccine.”
The latest AstraZeneca calculations were based on 190 COVID-19 cases that occurred during the study, 49 more than included during the week. The vaccine appears to be particularly protective against the worst results, with no serious illness or hospitalization among vaccinated study volunteers, compared to eight severe cases of those who were given inactive photos, the company said. It did not provide a breakdown of the rest of the cases.
Some European authorities have questioned how protective the vaccine is in older adults. In the US study, it was 85% effective in volunteers age 65 and older, the company said. The study showed no safety concerns.
The updated information “confirms that our COVID-19 vaccine is extremely effective in adults, including those aged 65 and over,” AstraZeneca head of research Mene Pangalos said in a statement. He said the company is looking forward to “launching millions of doses in America.”
The study was not completed, so additional cases of COVID-19 may accumulate. AstraZeneca warned that an additional 14 possible cases are already being examined and could lead to further changes to the data.
The company intends to request the elimination of the vaccine by the Food and Drug Administration in a few weeks. The FDA will publicly discuss all evidence with its external advisors 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 had spread in public.
“Given the details given here, it seems unnecessary to have raised concerns in public,” he said. “Results fluctuate as data accumulates … what matters is the FDA’s assessment, which will be based on an examination of the complete data and not the press releases.” He said that any vaccine with an efficacy rate of more than 60% is useful.
He said it was unclear why there was a “breakdown in relations” between AstraZeneca and independent US experts monitoring the process and worried it could undermine confidence in the vaccine.
“This vaccine is so important to global health, and the disputes do not promote global health,” he said. “At least in the short term, (this) will undermine confidence in both the United States and, more importantly, the rest of the world.”
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Associated Press medical writer Maria Cheng of London and Jan M. Olsen of Copenhagen contributed to the report.
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