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U.S. health officials expressed concerns on Tuesday morning that positive results that AstraZeneca announced on Monday for its Covid-19 vaccine may have been based on “an incomplete view of ‘efficacy data’ from a clinical trial and relying on ‘outdated information’, throwing another curve in the company’s vaccine saga.
In a statement issued shortly after midnight Tuesday morning, The National Institute of Allergy and Infectious Diseases said it was briefed on data issues by the Data and Safety Oversight Committee that audited the trial. DSMBs are comprised of independent medical experts who provide an additional screen of data produced from clinical trials.
“We urge the company to work with the DSMB to review efficacy data and ensure that the most accurate and up-to-date efficacy data is released to the public as quickly as possible,” said NIAID.
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In a Tuesday morning interview with STAT, Anthony Fauci, the head of NIAID, said the DSMB had expressed concern because it believed AstraZeneca’s results published in a press release on Monday appeared more favorable than the more recent data from the AstraZeneca vaccine.
“I was kind of stunned,” Fauci said. “The Data Safety and Oversight Committee was concerned that the data in AZ’s press release was not the most accurate and up-to-date data. This is what the DSMB communicated to AZ in a rather stern note. After seeing this letter, we couldn’t just leave it unanswered.
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As to why the NIAID released its unusual statement, Fauci said, “We just felt we couldn’t stay silent. Because if we were to remain silent, we could naturally be accused of covering something up. And we certainly didn’t want to be in that position.
He added: “In my mind, this is an unforced error of the company.”
The results published Monday by AstraZeneca come from an interim analysis of a trial of 32,000 volunteers through February 17. In a statement released on Tuesday, the company said it would “immediately engage” with the DSMB “to share our core analysis with those in higher positions. up-to-date efficacy data. The company said it plans to announce the results of the primary scan within 48 hours.
“We reviewed the preliminary assessment of the primary analysis and the results were consistent with the interim analysis,” the company said. “We are now completing the validation of the statistical analysis.”
NIAID’s two-paragraph statement opened another chapter in the path of the AstraZeneca vaccine, which was developed with researchers at the University of Oxford. It didn’t even happen 24 hours after the company announced in a press release on Monday that its vaccine was 79% effective in preventing symptomatic Covid-19 in a US trial, a result that was better than expected on the based on previous trials and seemed to help resolve some questions about vaccine robustness. The company also said that the vaccination reduces severe Covid-19 and hospitalization by 100%.
The results were seen as a final step before the company seeks clearance from U.S. regulators for its shot, which is already approved in other countries.
The company’s vaccine came under scrutiny most recently after European countries suspended deployment last week due to safety concerns over blood clots, but the European Medicines Agency has par The sequel said the vaccine’s benefits outweighed its risks and that campaigns have restarted.
Based on test data released on Monday, AstraZeneca said the study did not identify any new safety issues. A specific examination did not reveal any risk of blood clots. The study also did not see a specific type of clot in blood vessels near the brain that the EMA said could be associated with the vaccine. However, this type of clot, called cerebral venous sinus thrombosis, is so rare that it should not occur even in a large clinical trial.
The NIAID statement on Tuesday cited only the DSMB’s concerns about efficacy data and did not mention safety concerns.
The two-dose AstraZeneca vaccine is seen as a great hope to help expand access to the vaccine globally because it is cheaper than other Covid-19 vaccines and easier to manufacture and distribute than some others. It is widely used in Europe and increasingly in Asia.
But the company’s vaccination efforts have been hampered by incidents and questions about its public announcements. At the start, the American study was stopped for a month and a half due to a brain hemorrhage in a patient who was subsequently determined to be unrelated to the vaccine. In the results of the initial trials announced earlier, the data seemed to suggest at one point that the second dose of the vaccine had reduced its effectiveness. Some a previous confusion arose the company’s unusual strategy of pooling clinical trial data in its analyzes.
The ups and downs of AstraZeneca’s vaccines have heightened fears the public may shy away from a vaccination that could help tame the Covid-19 pandemic, at a time when public health officials are urging people to get vaccinated when they get the chance. Fauci said on “Good Morning America” on Tuesday that the frustration was that “this is most likely a very good vaccine” and that he hoped people would understand that the DSMB’s concerns were an example of one of the numerous guardrails guaranteeing the quality of the vaccine development process. .
“If you look at it the data is really, really good, but when they put it in the press release it wasn’t completely accurate,” Fauci said. “We must continue to do everything possible to make people understand that safeguards are in place.”
When asked if he’s worried about people’s confidence in the AstraZeneca vaccine and others, Fauci told STAT: “Obviously it’s a concern whenever something like this happens. product, because it could erode public trust, yes. “
But he stressed that the FDA, when it reviews AstraZeneca’s vaccine for authorization, will make an independent decision.
Helen Branswell and Matthew Herper contributed reporting.
This story has been updated with comments from AstraZeneca and Anthony Fauci.
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