AstraZeneca may have included “outdated information” in touting the effectiveness of its COVID-19 vaccine in a U.S. study, federal health officials said Tuesday.
In response, AstraZeneca said it is working on providing more up-to-date information and promised an update within 48 hours.
The unprecedented rift came just hours after AstraZeneca released information it hoped would help settle lingering questions about the effectiveness of a vaccine that is being widely used in Europe and other parts of the world and is about to be considered for use in the U.S.
The company announced on Monday that a predominantly U.S. study of 32,000 volunteers showed its vaccine was 79 percent effective in preventing symptomatic COVID-19.
It also said there were no severe illnesses or hospitalizations among volunteers given the vaccine, compared with five cases among those given dummy shots.
But shortly after midnight, the National Institutes of Health issued a statement saying the independent monitors that oversee the study had “expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data.”
The NIH urged the company to “ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.”
Anthony Fauci told ABC’s “Good Morning America” that the incident “really is what you call an unforced error” and that he expects the discrepancy to be straightened out.
On Tuesday, AstraZeneca said that the data it first released included COVID-19 cases that occurred up to Feb. 17 and that it is continuing to analyze cases that have occurred since then.
Every vaccine trial is overseen by a “data and safety monitoring board,” or DSMB. These boards include scientists and statisticians who have no ties to either the government or the vaccine makers.
It was the NIH-appointed DSMB that raised the concerns about AstraZeneca’s data.
The AstraZeneca vaccine is used widely in Britain, across the European continent and in other countries, but its rollout has been marred by repeated missteps and scares.
Partial results from its first major trial — which Britain used to authorize the vaccine — were clouded by a manufacturing mistake that researchers didn’t immediately acknowledge.
Insufficient data about how well the vaccine protected older people led some countries to initially restrict its use to younger populations before reversing course.
U.S. officials suspended an AstraZeneca study for six weeks while they sought details about problems reported in Britain before deciding the vaccine wasn’t to blame.
Then last week, more than a dozen countries temporarily halted their use of the shot following reports of rare blood clots in some people who received it. The European Medicines Agency concluded the shot did not increase the overall incidence of clots.
AstraZeneca’s shot is cheaper and easier to store than many of its rivals’ and thus is expected to be widely used in the developing world.
The company has said it aims to file an application with the FDA in the coming weeks.
The Western Journal has reviewed this Associated Press story and may have altered it prior to publication to ensure that it meets our editorial standards.
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