Find the latest COVID-19 news and guidance at the Medscape Coronavirus Resource Center.
Officials at the U.S. National Institute of Allergy and Infectious Diseases, the agency headed by Anthony Fauci, MD, issued a statement overnight questioning the integrity of COVID-19 vaccine data which AstraZeneca shared in its interim Phase 3 efficacy and safety results.
The reactions of the experts were quick. Some are behind NIAID’s claims and want company responses, while others see this as a minor issue for a company plagued by controversy in almost every step of vaccine development.
The NIAID statement states that when the provisional Phase 3 results were announced on March 22, the company may have shared outdated information that “may have provided an incomplete view of the efficacy data.”
Questions arose from members of the Data Control and Safety Board (DSMB) tasked with reviewing the clinical trial. The DSMB specifically criticized the company for “picking cherries” a more favorable overall effectiveness number, 79%, while the most recent data reviewed by the board placed the vaccine’s effectiveness at 69%. and 74%, according to various media reports.
“What happened was that the company issued a press release giving data and making some conclusions about effectiveness,” Fauci told ABC today Good morning America.
“The data and security control panel, when they saw that press release, they worried and wrote them a pretty hard note and with a copy for me.
“They believed the data in the press release was a bit outdated and in fact could be a bit misleading and they wanted it rectified,” Fauci added.
The company’s response
AstraZeneca officials issued a brief statement today explaining that provisional results were collected until a pre-specified date of February 17th. In addition, the company “will immediately collaborate with the Independent Data Security Surveillance Board (DSMB) to share the core analysis with the most up-to-date performance data.”
“We intend to issue the results of the primary analysis within 48 hours,” the company added.
“Shocking, unprecedented”
Meanwhile, experts share their views. “The situation is shocking. I’ve never seen a statement like this,” said Hilda Bastian, a doctor, clinical trial expert and co-founder of the Cochrane Collaboration, a nonprofit health advocacy organization. Medscape Medical News.
“It’s very hard to understand what happened here,” Bastian said. “The test protocol states that the DSMB will” facilitate the interim analysis, “so that if everything is done as it should have been, the DSMB would not be blinded by a company press release. in this particular way it was a PR to exercise and then there was a malfunction “.
“It is not uncommon for a DSMB to disagree with researchers on the interpretation of trial results,” said Stephen Evans, MSc, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, in a comment to the Science Media Center. Great Britain.
However, he added: “It’s usually done in private, so in my opinion this is unprecedented.”
Other experts criticized the NIAID statement for being vague. For example, the agency states in part: “The DSMB expressed concern that AstraZeneca could include obsolete information from this trial, which could provide an incomplete view of the efficacy data.”
“I find this problematic in several ways. It can be read as a sentence from the conclusions of a document, but it has been presented out of context, without any explanation of the reasons for drawing the conclusion, or what they believe they could have consequences, “said Peter English, MD, a retired consultant in communicable disease control and immediate chairman of the British Medical Association’s Committee on Public Health Medicine, in a comment to the Science Media Center.
“In my view, this is shamefully poor communication by the NIH, as with its lack of clarity they have left room for speculation that could be detrimental to vaccine uptake,” English added.
“For me, this new DSMB announcement in response to AstraZeneca’s publication yesterday highlights the importance of providing data while making abstracts public,” said Stephen Griffin, PhD, associate professor at the Faculty of Medicine from the University of Leeds, UK, told the Science Media Center.
“Naturally, yesterday’s news was taken in good faith and the issues raised by the DSMB may be mere technicality, but that will not be clear until we have full disclosure,” he said. “However, we need to make sure that issues like this are properly 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 were 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 just got this week,” Menelas Pangalos, executive vice president of biopharmaceutical research and development at AstraZeneca, told a news conference on May 22 of March.
Pangalos indicated that the company would have complete data available at the time it submitted an application to the U.S. Food and Drug Administration for authorization to use its vaccine in an emergency, probably in the first fortnight of April. .
He added that the trial is ongoing and that the FDA will receive information on more than 141 cases at that time.
Brenda Goodman, MA, contributed to this report.
Damian McNamara is 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