WASHINGTON – (AP) The results of a US trial of the AstraZenecas COVID-19 vaccine may have included outdated information and that could mean the company has provided an incomplete view of efficacy data, federal officials said on Tuesday. American health.
AstraZeneca said in a statement that the data released on Monday included cases up to February 17, as specified in the study rules, and that it was continuing to analyze cases that have arisen since then. The company said a preliminary analysis of the data that continued to flow was in line with what it had previously said. He promised an update within 48 hours.
AstraZeneca reported on Monday that its COVID-19 vaccine offered strong protection to adults of all ages in a long-awaited U.S. study, a finding that some experts hoped would help restore public confidence in shooting around the world and to bring it closer to the clearance. in the USA
In the study of more than 30,000 people, the company reported that the vaccine was found to be 79% effective in preventing symptomatic cases of COVID-19, including in the elderly. There were no serious illnesses or hospitalizations among the vaccinated volunteers, compared to five such cases in participants who received a small number of dummy vaccines, but in accordance with the findings of Great Britain and other countries say the vaccine protects against the worst of the disease.
AstraZeneca also said that independent safety monitors from the studies found no serious side effects, including any increased risk of rare blood clots like those identified in Europe, a fear that has led many countries to briefly suspend vaccinations. last week.
But just hours after the publication of these encouraging results, the US National Institute of Allergy and Infectious Diseases issued an unusual statement.
The agency said the Data and Safety Oversight Committee has expressed concern that AstraZeneca may have included outdated information from this trial, which may have provided an incomplete view of efficacy data.
We urge the company to work with the DSMB to review efficacy data and ensure that the most accurate and up-to-date efficacy data is made public as quickly as possible, the statement added.
In previous vaccine trials, as is the case here, cases continued to increase, even as companies began to release their data. But the AstraZeneca circumstance is unusual because it is of concern to the data watchdog.
The Food and Drug Administration examines the results of the most recent trials when evaluating vaccines.
The company has announced its intention to file an application with the FDA in the coming weeks, and the government’s external advisers will then publicly debate the evidence.
Authorization and guidelines for the vaccine’s use in the United States will be determined by the FDA and the Centers for Disease Control and Prevention after a thorough review of the data by independent advisory committees.
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