AstraZeneca may have included “outdated information” when it disclosed the effectiveness of its COVID-19 vaccine in a study in the United States, federal health officials said Tuesday, in a rare public disagreement that public confidence in the vaccine could continue. undermine.
In response, AstraZeneca noted that it is working on more up-to-date information and that the most recent findings are consistent with the original announcement that the vaccine offers strong protection. The company promised to provide an update within 48 hours.
In an unusual rebuke just hours after AstraZeneca announced on Monday that its vaccine was performing well in its US trial, an independent panel overseeing the study accused the company of picking out data, according to a senior government official.
The panel wrote to AstraZeneca and federal health officials that it was concerned that the company would choose to use outdated and potentially misleading data in place of the most recent and comprehensive findings, said the government official, who spoke on condition of anonymity due to the vulnerability of the topic.
“Such decisions undermine public confidence in the scientific process,” the letter added.
The trial in the United States was intended to help answer outstanding 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 administration in the U.S. population .
AstraZeneca tried to regain confidence in its vaccine with Monday’s report, when it announced that a trial of 32,000 volunteers, mostly in the United States, showed that its vaccine was 79% effective in preventing symptomatic COVID-19 cases, and that none of the vaccinated volunteers suffered from serious illness or had to be hospitalized.
Shortly after midnight, however, the National Institutes of Health (NIH) released a statement noting that the independent agencies overseeing the study “ expressed concern that AztraZeneca may have included outdated information from the study, which may be an provided an incomplete picture of the efficacy data ”.
The NIH urged the company to “ensure that the most accurate and current efficacy data is released as soon as possible.”
External experts were shocked and perplexed by the reprimand. But they stressed that it will ultimately be the Food and Drug Administration (FDA) that will analyze all of the data before deciding whether the AstraZeneca vaccine can be used in the United States.
“At the end of the day, the data will have to speak for itself, no matter what this miscommunication may be,” said Dr. Jesse Goodman of the University of Goergetown and former FDA director of vaccination.
NIH Dr. Anthony Fauci told ABC’s “Good Morning America” that the incident “is really what can be defined as a casual error,” and that he expects the discrepancy to be resolved.
Fauci also noted that the episode shows that the US regulatory system is working. “The fact that the security board noticed this discrepancy was an example.”
But the public is rarely able to see those practical details, which have now been revealed by the extraordinary analysis applied to the development of COVID-19 vaccines around the world.
Every vaccine trial is monitored by “a data and safety monitoring board.” These panels include scientists and statisticians who are experts in their field, but independent of the government or the companies that produce the vaccine.
AstraZeneca’s vaccine is widely used in Britain, on the European continent and in other countries, but its application was hampered by inconsistent reports from efficacy studies and then by reports of thrombosis last week. Causing some countries to temporarily stop using it. .