AstraZeneca’s Covid-19 vaccine corrupt

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U.S. health officials question results from AstraZeneca’s vaccine trial, less than a day after they’re released. I’ve never seen anything like this,” he said. “It’s so, so troubling.” AstraZeneca’s relationship with the U.S. authorities has been fraught since last year, when senior health officials believed the company was not being forthright about the design of its clinical trials, its results and safety issues. That skepticism carried over to last week, when senior officials at a number of federal health agencies grew suspicious about why AstraZeneca had not announced data from its U.S. study. March 23, 2021 Federal health officials said Tuesday that the encouraging results that AstraZeneca announced about its Covid-19 vaccine may have been based on outdated and incomplete information about the vaccine’s effectiveness, an extraordinary blow to the credibility of an already embattled vaccine. In a statement released after midnight, the National Institute of Allergy and Infectious Diseases said that an independent panel of medical experts that has been helping to oversee AstraZeneca’s U.S. trial had “expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data.” The exact nature of the institute’s concerns — and the effect they might have on how effective the vaccine appears to be — was unclear. But it is highly unusual for such a dust-up about the integrity of a clinical trial, especially one as high-profile as this, to occur in public. “This is really what you call an unforced error,” Dr. Anthony S. Fauci, the nation’s leading infectious-disease expert, said on “Good Morning America” on Tuesday morning. “Because the fact is: This is very likely a very good vaccine, and this kind of thing does, as you say, do nothing but really cast some doubt about the vaccines and maybe contributes to the hesitancy.” AstraZeneca defended the data that it released on Monday, which showed the vaccine was 79 percent effective at preventing Covid-19. The company said in a statement on Tuesday that the interim results, which were current as of Feb. 17, appeared to be “consistent” with more recent data collected during the trial. AstraZeneca said it would immediately share its latest efficacy data with the monitoring board. The company said it would reissue fuller results within 48 hours. The results that AstraZeneca announced on Monday seemed encouraging — especially because they came at a moment when concerns about the vaccine’s safety had led more than a dozen countries, mostly in Europe, to temporarily suspend the shot’s use over concerns about possible rare side effects. But the statement from the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health, raised the prospect that the company was presenting an overly optimistic interpretation of the data. In recent days, the independent monitoring board’s analysis was delayed several times because the board had to ask for revised reports from those handling trial data on behalf of the company, according to a person familiar with the matter who was not authorized to discuss it publicly. Companies sponsoring drug or vaccine trials typically wait for the monitoring board to review analyses and conclude that the study has yielded an answer before they announce trial results. Company executives do not see the results of the study until the monitoring board reports their study data back to the company. The monitoring board ultimately conveyed the results of the study to AstraZeneca in a meeting over the weekend, leading to the company’s announcement Monday morning. The monitoring board’s slow progress fueled concerns among federal officials that AstraZeneca may have been sitting on the data or that the monitoring board had concerns about the way the data it was reviewing had been presented. An AstraZeneca spokeswoman, whom the company declined to name, said on Friday that it was “completely incorrect” that the trial data had formatting problems or had not been submitted to the monitoring board in a clean fashion. “As is often the case,” the spokeswoman said, monitoring boards “can request new or clarifying analyses of data from the trial. This would enable them to ensure the robustness of their determinations.” The national institute’s statement, issued shortly after midnight, stunned experts. Dr. Eric Topol, a clinical trials expert at Scripps Research in San Diego, said it was “highly irregular” to see such a public display of friction between a monitoring board and a study sponsor, which are typically in close concordance. “I’ve never seen anything like this,” he said. “It’s so, so troubling.” AstraZeneca’s relationship with the U.S. authorities has been fraught since last year, when senior health officials believed the company was not being forthright about the design of its clinical trials, its results and safety issues. That skepticism carried over to last week, when senior officials at a number of federal health agencies grew suspicious about why AstraZeneca had not announced data from its U.S. study.