AstraZeneca insists its COVID-19 vaccine is highly effective even after counting additional illnesses in its US study, the latest in an extraordinary public dispute with US officials.
In a press release late Wednesday, the drugmaker said it had analyzed more data from that study and concluded that the vaccine is 76% effective in preventing symptomatic COVID-19, up from the 79% it had reported earlier in the year. week.
Just a day earlier, an independent panel overseeing the study had accused AstraZeneca of selecting data to promote the protection offered by your vaccine. The panel, in a tough letter to the company and US healthcare leaders, said the company had missed some COVID-19 cases that occurred in the study, a move that could erode trust in the science.
Some experts said that the new data provided by AstraZeneca was “reassuring” and that the information was likely strong enough for US regulators to authorize the vaccine.
“AstraZeneca may have been too hasty in submitting the previous and 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 associated with the research. He said the updated details did not look substantially different from what was released earlier this week.
Data disputes during ongoing studies generally remain confidential, but in an unusual step, the National Institutes of Health publicly asked AstraZeneca to correct the discrepancy.
AstraZeneca had relied on the findings of a predominantly American study of 32,000 people to help rebuild confidence in a vaccine that, despite being widely used in Britain, Europe and other countries, has had a troubled launch. Previous studies have yielded inconsistent data on its effectiveness, and then last week a scare over blood clots caused some countries to temporarily halt vaccines.
Most have since been restarted after the European Medicines Agency said the vaccine does not increase the overall incidence of blood clots.Although he did not rule out a connection to some rare clots. On Thursday, Denmark announced that it would continue to suspend the vaccine., and officials said they needed 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 dispute, experts had raised concerns that missteps in the vaccine launch could undermine confidence in the injection., which is crucial to global efforts to end the coronavirus pandemic as it is cheap, easy to store, and a mainstay of the COVAX initiative that aims to bring vaccines to low- and middle-income countries.
Earlier Wednesday, Dr. Anthony Fauci, America’s leading infectious disease expert, told reporters that he hoped that when all the data was publicly scrutinized by federal regulators, any doubts caused by the dispute would be dispelled. He predicted that “it would turn out to be a good vaccine.”
AstraZeneca’s most recent calculations were based on 190 COVID-19 cases that occurred during the study, 49 more than it had included earlier in the week. The vaccine appears especially protective against the worst outcomes, with no serious illnesses or hospitalizations among vaccinated study volunteers compared to eight severe cases among those who received sham injections, the company said. It did not provide a breakdown of the rest of the cases.
Some European authorities have questioned the degree of protection of the vaccine in older adults. In the US study, it was 85% effective in volunteers 65 and older, the company said. The study revealed no safety concerns.
The updated information “confirms that our COVID-19 vaccine is highly effective in adults, including those 65 and older,” AstraZeneca’s head of research Mene Pangalos said in a statement. He said the company expects “the launch of millions of doses throughout the United States.”
The study is not over, so additional COVID-19 cases may still accumulate. AstraZeneca cautioned that 14 additional possible cases are already being examined and could lead to additional changes to the data.
The company intends to request approval of the vaccine from the Food and Drug Administration in a few weeks. The FDA will publicly discuss all tests 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 spread to the public.
“Given the details given here, it seems like an unnecessary action to have raised concerns in public,” he said. “The results fluctuate as the data accumulates … it will be the FDA evaluation that counts and that will be done based on scrutiny of the full data and not on press releases.” He said that any vaccine with an efficacy rate greater than 60% is helpful.
He said it was unclear why there was “a breakdown in relations” between AstraZeneca and the independent US data experts monitoring the trial and were concerned it could undermine confidence in the vaccine.
“This vaccine is so important to global health and disputes do not promote global health,” he said. “At least in the short term, (this) will undermine confidence both in the United States and, more importantly, in the rest of the world.”
Associated Press medical writer Maria Cheng in London and Jan M. Olsen in Copenhagen contributed to this report.
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