Federal health officials said early Tuesday that the results of a US trial of AstraZeneca’s Kovid-19 vaccine may have relied on “outdated information” that “an announcement made on Monday may have provided skeptical data providing an incomplete view”. This was seen as good news for the British-Swedish company as well as the global vaccination campaign.
In a very unusual Statement Released after midnight, the National Institute of Allergy and Infectious Diseases said the Data and Safety Monitoring Board, an independent panel of medical experts under the National Institutes of Health that is helping oversee the US trial of AstraZeneca, Agencies and AstraZeneca were reported late. On Monday, it was “concerned” with information released by the company that morning.
The institute urged AstraZeneca to “review efficacy data with the monitoring board and make the most accurate, up-to-date efficacy data be made public as soon as possible.”
AstraZeneca did not immediately return a request for comment on Tuesday morning.
in News release Announcing the results of the US trial on Monday, the company said the vaccine, developed with the University of Oxford, was 79 percent effective against Kovid-19, which is higher than seen in previous tests, and the worst results from the disease. Prevents it completely. The long-awaited results were seen as encouraging global confidence in the vaccine, which was shaken this month when more than a dozen countries, mostly in Europe, Shot access temporarily suspended On concerns about possible rare side effects.
In recent times, the Monitoring Board’s analysis has been delayed several times as the board had to seek a revised report from the company dealing with trial data, according to a person familiar with the matter, who discussed it publicly. Was not authorized to do.
Companies that sponsor drug or vaccine trials typically wait for the monitoring board to run the analysis and conclude that the study provided an answer before announcing the results of the test. During testing, an unlimited statistical analysis group separated from the company acts as an intermediary to handle data requests and various other interactions with the monitoring request.
Company officials are monitored by the results of the study until the monitoring board sends the data of their study back to them. The Monitoring Board finally made AstraZeneca aware of the study’s results in a meeting over the weekend, leading to the company’s announcement on Monday morning.
A spokesperson for AstraZeneca, whom the company declined to name, said last week that it was “completely inaccurate” that the test data contained drafting problems or that they were not presented to the monitoring board in a clean fashion .
“As is often the case,” the spokesman said, monitoring boards “may request a new or explicit analysis of the data from the test. This will enable them to ensure the strength of their determination.”
Dr., a clinical trial specialist at Scripps Research in San Diego. Eric Topol said it was “highly erratic” to see such public displays of friction between the monitoring board and a study sponsor, which usually occur in close proximity.
“I have never seen this happen,” he said in an interview after the institute’s statement was released. “It’s very disturbing.”
AstraZeneca’s relations with US officials have worsened since last year, when senior health officials believed the company was not being corrected. Design of its clinical trials, its results and safety issues. This suspicion lasted until last week, when senior officials at several federal health agencies were skeptical about why AstraZeneca had not announced data from its US study.
The US trial, which involved more than 32,000 participants, was the largest test of its kind for Schott. The results released on Monday of AstraZeneca were from an interim look at the data after 141 Kovid-19 cases reported among volunteers.
The company did not disclose how the data is up-to-date. If the analysis was conducted on data one or two months ago, it is possible that a more current look would present a different picture of the vaccine’s effectiveness and safety. The company has said it will provide the Food and Drug Administration with a more comprehensive, more recent set of data than it reported on Monday. Although no clinical trial is sufficient to control very rare side effects, AstraZeneca reported that its study did not raise any serious safety issues.
Latest data it’s so late To make a lot of difference in the United States, where the vaccine is not yet authorized and is unlikely to be available before May. By then, federal officials predict, three of the vaccines will have enough vaccine doses for all adults in the nation that are already authorized: Pfizer-BioNotech, Modern and Johnson & Johnson.
Nevertheless, the better-than-expected results were seen as a heartbreaking turn for the shot of AstraZeneca, whose low cost and simple storage requirements have made it an important piece of the drive to vaccinate the world.
The results were also thought to ease concerns about the AstraZeneca vaccine in Europe. The regulator there Said last week The shot was “safe and effective”, reviewed after a small number of people with recently developed blood clots and abnormal bleeding. US testing gave no indication of such problems, although some safety issues can only be detected in the real world, once a drug or vaccine has been widely used.
Many millions of people worldwide have received AstraZeneca shots, including Britain and the European Union have more than 17 million, Almost all without serious side effects. In an effort to increase public confidence, Many European political leaders have received injections in recent times. The AstraZeneca vaccine has also been administered to leaders in South Korea, Taiwan and Thailand over the past week.
AstraZeneca said on Monday that it would continue to analyze the new data and prepare to apply for emergency authorization in the United States in the coming weeks. The vaccine has already been approved in more than 70 countries, but approval from US regulators will affect its global reputation.
The infectious disease comes after a series of statements from the institute Misunderstandings and communication faults AstraZeneca dating back over the past year has eroded the trust of American executives in the company.
Last summer, at least some top FDA officials only learned from the news that AstraZeneca had halted her Phase Britain vaccine trial in the UK after a partner developed neurological symptoms. Then in September, after another participant in a British study fell ill with similar symptoms, AstraZeneca halted its tests globally, but failed to notify US authorities immediately.
The US study was eventually halted for seven weeks, in part because AstraZeneca was slow to provide the FDA with evidence that the vaccine did not cause neurological symptoms. The investigators eventually concluded that the diseases could not be linked to the vaccine. Nevertheless, the delay was a major reason why AstraZeneca fell behind three other manufacturers whose vaccines have been granted emergency authorization in the United States.