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Officials with the U.S. National Institute of Allergy and Infectious Diseases, the agency led by Anthony Fauci, MD, issued a statement overnight in which they questioned the integrity of the COVID-19 vaccine data that AstraZeneca shared in its interim phase 3 efficacy and safety findings.
The experts’ reactions were swift. Some back NIAID’s claims and want answers from the company, while others see this as less of an issue for a controversial company at almost every step of its vaccine development.
The NIAID statement states that by announcing the interim results of phase 3 on March 22, the company may have shared outdated information that “may have provided an incomplete view of the effectiveness data.”
Questions came from members of the Data and Safety Monitoring Board (DSMB) tasked with reviewing the clinical trial. The DSMB specifically criticized the company for “choosing” a more favorable overall efficacy number, 79%, while the most recent data reviewed by the board places the vaccine’s efficacy between 69% and 74%, according to multiple reports. of the media.
“What happened is that the company published a press release giving data and drawing some conclusions about the effectiveness,” Fauci said today on ABC. Good morning america.
“The data and security monitoring board, when they saw that press release, they got worried and wrote them a pretty tough note and with a copy for me.
“They felt that the data that was in the press release was somewhat out of date and could actually be a bit misleading, and they wanted clarification,” Fauci added.
The company’s response
AstraZeneca officials released a brief statement today explaining that the interim results were compiled up to a pre-specified date of February 17. In addition, the company “will immediately engage with the independent data security monitoring board (DSMB) to share our main analysis with most -effectiveness data to date.”
“We intend to publish the results of the primary analysis within 48 hours,” the company added.
Meanwhile, the experts share their thoughts. “The situation is shocking. I’ve never seen a statement like that before,” said Hilda Bastian, PhD, clinical trials expert and co-founder of the Cochrane Collaboration, a nonprofit health advocacy organization. Medscape Medical News.
“It’s very difficult to understand what happened here,” Bastian said. “The test protocol says that the DSMB ‘will facilitate the interim analysis’, so if everything were done as it should have been, the DSMB would not be caught off guard by a company press release. in this particular way off a PR exercise, then it has gone wrong. “
“It is not uncommon for a DSMB to disagree with researchers on the interpretation of the trial results,” said Stephen Evans, MSc, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, in a comment provided to Science. Britain’s Media Center.
However, he added, “it is usually done in private, so this is unprecedented in my opinion.”
Other experts criticized the NIAID statement for being vague. For example, the agency states in part: “The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data.”
“I find this problematic in various ways. It reads like a sentence from the conclusions of an article, but one that has been presented out of context, with no explanation of the reasons for drawing the conclusion, or what they think they might be. consequences. be, “said Peter English, MD, retired communicable disease control consultant and immediate past chair of the British Medical Association’s Committee on Public Health Medicine, in a comment provided to the Science Media Center.
“In my opinion, this is embarrassingly bad communication from the NIH, as their lack of clarity has left room for speculation that it could be detrimental to vaccine acceptance,” added English.
“For me, this new DSMB announcement in response to yesterday’s AstraZeneca launch highlights the importance of data being provided at the same time abstracts are released,” said Stephen Griffin, PhD, associate professor at the School of Medicine. from the University of Leeds, UK, to the Science Media Center.
“Naturally, yesterday’s news was taken in good faith and the issues raised by the DSMB may be a mere technicality, but this will not be clear until we have a full disclosure,” he said. “However, we must ensure that issues like this are adequately addressed and that groups seeking to undermine faith in vaccination programs do not take advantage of idle speculation.”
More data planned for the FDA
The placebo-controlled clinical trial with 32,449 participants revealed 141 cases of symptomatic COVID-19. However, no data are available on how many of these cases were mild to moderate in the vaccine versus placebo groups.
“We don’t have the full breakdown yet … these are the high-level results we got this week,” said Menelas Pangalos, executive vice president for biopharmaceutical research and development at AstraZeneca, during a press conference on March 22.
Pangalos indicated that the company would have complete data available by the time it submits an application to the US Food and Drug Administration for emergency use authorization for its vaccine, likely in the first half of April.
He added that the trial is ongoing and the FDA will receive information on more than 141 cases at that time.
Brenda Goodman, MA, contributed to this report.
Damian McNamara it’s a cane Miami-based journalist. Covers a wide range of medical specialties, including infectious diseases, gastroenterology, and intensive care. Follow Damian on Twitter: @MedReporter.
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