AstraZeneca may have provided an incomplete view of efficacy data on its Covid-19 vaccine from a large scale US trial, the US National Institute of Allergy and Infectious Diseases (NIAID) said on Tuesday.
AstraZeneca said a day earlier that its Covid-19 vaccine developed with Oxford University was 79% effective in preventing symptomatic illness in a large trial in the United States, Chile and Peru.
“The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data,” the US agency said, referring to the independent Data Safety Monitoring Board (DSMB).
“We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.”
The request cast doubts over the company’s plan to seek US emergency use authorisation for the vaccine in the coming weeks.
Authorisation and guidelines for use of the vaccine in the United States will be determined by the Food and Drug Administration and Centres for Disease Control and Prevention after thorough review of the data by independent advisory committees, said the NIAID, part of the National Institutes of Health.
AstraZeneca did not immediately respond to a Reuters request for comment.