AstraZeneca may have included outdated information from US vaccine trial – NIAID

AstraZeneca said a day earlier that its COVID-19 vaccine developed with the University of Oxford was 79% effective in preventing symptomatic disease in a large trial in the United States, Chile and Peru.

“The DSMB has expressed concern that AstraZeneca may have included outdated information from this trial, which may have provided an incomplete view of the efficacy data,” the US agency said, referring to Data Safety Independent Monitoring Board (DSMB).

“We urge the company to work with the DSMB to review the efficacy data and ensure that the most accurate and up-to-date efficacy data is made public as quickly as possible.”

The request has cast doubt on the company’s plans to seek a U.S. emergency use authorization for the vaccine in the coming weeks.

The authorization and guidelines for the vaccine’s use in the United States will be determined by the Food and Drug Administration and the Centers for Disease Control and Prevention after a thorough review of the data by independent advisory committees, said the NIAID, which makes part of the National Institutes of Health. .

AstraZeneca did not immediately respond to a request for comment from Reuters.

Hailed as a milestone in the fight against the COVID-19 pandemic when it emerged as a vaccine candidate last year, the AstraZeneca vaccine has been hampered by doubts about its efficacy, dosing regimen and side effects possible.