Find the latest COVID-19 news and guidance at Medscape’s Coronavirus Resource Center.
Officials at the US National Institute of Allergy and Infectious Diseases, the agency led by Anthony Fauci, MD, issued an overnight statement questioning the completeness of COVID-19 vaccine data that AstraZeneca shared in the interim results of the phase. 3 on efficacy and safety.
The reactions of the experts were quick. Some stand behind NIAID’s claims and want answers from the company, while others see this as a minor issue for a controversial company at almost every stage of vaccine development.
The NIAID statement states that when announcing the Phase 3 interim results on March 22, the company could have shared outdated information that “could have provided an incomplete picture of the effectiveness data”.
The questions came from members of the Data Monitoring and Safety Board (DSMB) tasked with reviewing the clinical trial. DSMB specifically criticized the company for “cherry picking” a more favorable overall effectiveness number, 79%, while more recent data examined by the council places the vaccine’s effectiveness between 69% and 74%, according to several media reports.
“What has happened is that the company has released a press release that provides data and makes some conclusions about effectiveness,” Fauci told ABC today Good morning America.
“The data and security monitoring council, when they saw that press release, were worried and wrote them a rather harsh note and a copy for me.
“They considered that the data in the press release were somewhat outdated and could, in fact, be misleading a bit and they wanted to correct them,” Fauci added.
The company’s response
AstraZeneca officials issued a brief statement today explaining that the interim results had been collected by a pre-specified date of 17 February. In addition, the company “will immediately engage with the Independent Data Security Monitoring Board (DSMB) to share our primary analysis with the highest efficacy data to date. “
“We intend to publish the results of the primary analysis within 48 hours,” the company added.
“Shocking, unprecedented”
Meanwhile, experts share their thoughts. “The situation is shocking. We have never seen such a statement before,” said Hilda Bastian, PhD, a clinical trial expert and co-founder of the Cochrane Collaboration, a nonprofit that promotes healthcare. Medscape medical news.
“It’s very difficult to understand what happened here,” Bastian said. The test protocol says that DSMB “will facilitate the interim analysis”, so if everything had been done as it should have been, DSMB would not have been blinded by a company press release. If making the press release in this particular way would have been a PR exercise, then it failed back. “
“It is not known that a DSMB disagrees with investigators on the interpretation of the results of the studies,” said Stephen Evans, MSc, professor of pharmacacoepidemiology at the London School of Hygiene and Tropical Medicine, in a comment provided by the Science Center UK.
However, he added, “It’s usually done in private, so this is unprecedented in my opinion.”
Other experts have criticized the NIAID statement for being vague. For example, the agency states in part: DSMB expressed concern that AstraZeneca could have included outdated information from the study, which could have provided an incomplete picture of the efficacy data.
“I find this problem in different ways. It reads as a sentence from the conclusions of a paper, but one that was presented out of context, without any explanation of why the conclusion was reached or what they think could have consequences either, “said Peter English, MD , retired consultant in communicable disease control and past chair of the Public Health Medicine Committee of the British Medical Association, in a commentary to Science Science Center.
“In my opinion, this is a shamefully poor communication of the NIH, because, with their lack of clarity, they have left room for speculation that could be harmful for the absorption of the vaccine,” the Englishman added.
“For me, this additional announcement by DSMB in response to yesterday’s AstraZeneca highlights the importance of providing data while publishing abstracts,” said Stephen Griffin, PhD, Associate Professor at the School of Medicine, University of Leeds, UK, said. for the Science Media Center.
“Of course, yesterday’s news was taken in good faith and the issues raised by the DSMB could be a simple technicality, however this will not be clear until we have a full disclosure,” he said. “However, we need to make sure that issues like this are dealt with properly and that inactive speculation is not taken advantage of by groups that want to undermine faith in vaccination programs.”
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 were available on how many of these cases were mild to moderate in the vaccine versus placebo groups.
“We don’t have the whole malfunction yet … these are the high-level results we just got this week,” Menelas Pangalos, executive vice president of biopharmaceutical research and development at AstraZeneca, told a news briefing on March 22. .
Pangalos said the company will have complete data available until it files an application with the U.S. Food and Drug Administration for authorization to use their vaccine urgently, probably 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 staff Miami-based journalist. It covers a wide range of medical specialties, including infectious diseases, gastroenterology and critical care. Follow Damian on Twitter: @MedReporter.
For more news, follow Medscape on Facebook, Twitter, Instagram, YouTube and LinkedIn