Federal health officials said Tuesday that the encouraging results AstraZeneca announced about its Covid-19 vaccine may have been based on outdated and incomplete information about the vaccine’s effectiveness, which is an extraordinary setback for the credibility of an already vaccinated vaccine. wash.
In a statement released shortly after midnight, the National Institute of Allergy and Infectious Diseases said an independent panel of medical experts overseeing AstraZeneca’s US trial, ‘expressed concern that AstraZeneca may have included outdated information from the trial, which may have’ an incomplete overview of the effectiveness data. ”
The broadcast of a conflict between a pharmaceutical company and a board overseeing a clinical trial is very unusual. It is almost certain that the Food and Drug Administration and other regulators will conduct additional investigations into the vaccine if AstraZeneca wants emergency approval for the vaccine in the United States.
“This is really what you call an unforced error,” said Dr. Anthony S. Fauci, the country’s leading expert on infectious diseases, said on “Good Morning America” Tuesday morning. “Because the fact is: it’s most likely a very good vaccination, and these kinds of things do, as you say, nothing more than really doubt the vaccines and maybe contribute to the hesitation.”
The friction with the independent monitoring board revolved around how AstraZeneca determined whether participants in the clinical trial had possible or actual cases of Covid-19, according to a person familiar with the situation. The independent monitoring board has twice forced AstraZeneca to take a closer look, telling the company that it has sufficient information to determine how many participants in the trial have the disease. This could reduce the apparent efficacy of the vaccine.
But AstraZeneca on Monday announced its interim results without conducting a full board analysis, possibly putting the vaccine in an overly favorable light.
AstraZeneca defended the data it released on Monday, showing that the vaccine was 79 percent effective at preventing Covid-19. The company said on tuesday that the interim results appear to be “consistent” with more recent data collected during the trial. AstraZeneca has said it will share its latest effectiveness data with the monitoring board immediately. The company said it would issue full results within 48 hours.
The results announced by AstraZeneca on Monday were a much-needed dose of good news, especially as it came at a time when concerns about the safety of the vaccine had led to more than a dozen countries, mostly in Europe, temporarily suspend use of the shot due to concerns about possible rare side effects. The results not only confirm the safety of the vaccine, but also make the vaccine look more effective than it has been in previous trials.
But the members of the independent monitoring board were surprised by the company’s announcement. ‘They became concerned and wrote a rather harsh letter to them and told me in a copy that they actually believed that the information in the press release was somewhat outdated and perhaps a little misleading and wanted them to had to straighten it out, ”says dr. Fauci, who runs the National Institute of Allergy and Infectious Diseases.
This led to the overnight declaration of the Institute of Infectious Diseases, which is part of the National Institutes of Health.
Companies that sponsor drug or vaccine trials usually wait for the monitoring board to review analyzes and conclude that the study provided a response before announcing the trial results.
Business managers do not see the results of the study until the monitoring board returns their study data to the company. The monitoring board finally passed on the results of the study to AstraZeneca at a meeting over the weekend, which led to the company’s announcement Monday morning.
The slow progress of the monitoring board has aroused federal officials’ concern that AstraZeneca may have been sitting on the data or that the monitoring board was concerned about the way the data it reviewed was presented.
A spokesman for AstraZeneca, who did not want to name the company, said on Friday that it was “completely wrong” that the trial data had formatting problems or that it had not been submitted to the monitoring board in a clean slate.
“As is usually the case,” the spokesman said, monitoring boards could “request new or clearer analyzes of data from the trial. This will enable them to ensure the robustness of their provisions. ”
The statement from the National Institute, issued shortly after midnight, stunned experts. Dr. Eric Topol, a clinical trial expert at Scripps Research in San Diego, said it was “very irregular” to see such a public friction between a monitoring board and a study sponsor, which is usually consistent.
“I’ve never seen anything like it,” he said. “It’s so, so disturbing.”
AstraZeneca’s relationship with US authorities has been strained since last year, when senior health officials said the company did not speak directly about the design of its clinical trials, results and safety issues. The skepticism carried over to last week, when senior officials at a number of federal health agencies became suspicious of why AstraZeneca did not release data from its U.S. study.