WASHINGTON (AP) – AstraZeneca may have included “obsolete information” in disseminating the effectiveness of its COVID-19 vaccine in a US study, federal health officials said Tuesday in an unusual public outcry that could further erode confidence in the shot.
In response, AstraZeneca said it works on more up-to-date information and that the latest findings are consistent with previous ones. He promised an update in 48 hours.
It was not clear exactly what U.S. health officials were concerned about. But unprecedented tension erupted just hours after AstraZeneca released information it hoped would help resolve lingering questions about the effectiveness of a vaccine that is widely used in Europe and other parts of the world and is about to be considered. for use in the US.
The company announced Monday that a predominantly U.S. study of 32,000 volunteers showed its vaccine was 79% effective in preventing symptomatic COVID-19 disease. He also stressed that there were no serious illnesses or hospitalizations among the volunteers who received the vaccine, compared to five cases among those who received fake shots.
But shortly after midnight, the National Institutes of Health issued a statement stating that the independent monitors overseeing the study “expressed concern that AstraZeneca could include obsolete information from this trial, which could have provided an incomplete view. of the efficiency data ”.
The NIH urged the company to “ensure that the most accurate and up-to-date performance data is made public as quickly as possible.”
External experts were surprised and baffled by the spitting. But they noted that, ultimately, the Food and Drug Administration will examine all the data before deciding whether the AstraZeneca vaccine can be deployed in the United States.
“It looks like whatever that communication error is, in the end the data will have to be represented by themselves,” said Dr. Jesse Goodman of Georgetown University, a former head of vaccines at the FDA.
NIH Dr. Anthony Fauci told ABC’s “Good Morning America” that the incident “really is what you call an unforced error” and that he hopes the discrepancy will be rectified.
Fauci also said the episode shows that the U.S. regulatory system works: “The data control and security board that picks up this discrepancy was an example of safeguarding.”
But this fact is rarely seen by the public, which is now exhibited with the extraordinary microscope applied to the development of COVID-19 vaccines in the world.
All vaccine trials are overseen by a “data control and safety board” or DSMB. These councils include scientists and statisticians who are experts in their fields but who have no ties to either the government or vaccine manufacturers.
In the AstraZeneca study, like the studies on the other vaccines used, some participants receive the actual vaccine and the rest receive fake shots, neither they nor their doctors know what it is. Only the DSMB has the power to unlock the code of who has obtained what information and see how the volunteers are before the study is over.
The DSMB looks after safety issues and also considers that the study has met some predetermined final criteria that show that it is time to make an efficiency calculation. It was the NIH-designated DSMB that raised concerns about AstraZeneca data.
On Tuesday, AstraZeneca said the data it first published included cases of COVID-19 that occurred through Feb. 17, as specified in the study’s rules, and that it continues to analyze cases that have occurred. Since then. He said a preliminary analysis of more recent data was consistent with what he had already reported.
It is common for companies developing COVID-19 vaccines to publish early data and continue to study the results as they arrive.
Some experts had hoped Monday’s AstraZeneca announcement would help rebuild public confidence in shooting around the world.
The vaccine is widely used in Britain, across the European continent and other countries, but its release was affected by inconsistent study reports on its effectiveness and, last week, a scare about blood clots. which caused some countries to temporarily pause inoculations.
The results of the US study announced by AstraZeneca coincided with studies from other places (and real-world use in Britain) that found the vaccine to offer good protection against the worst it can offer. the COVID-19. But company executives rejected repeated requests from reporters to provide a breakdown of the 141 COVID-19 cases it used to argue the effectiveness of the shooting.
The company has said it intends to file an application with the FDA in the coming weeks.