LONDON — A U.S. health agency on Tuesday said that AstraZeneca may have included outdated information in trial results of its Covid-19 vaccine, potentially casting doubt over published efficacy rates.
This was confirmed just a day after the results of a massive US trial that showed the vaccine is highly safe and effective and raises questions about whether AstraZeneca can request permission from the United States for a vaccine next month as planned.
The Data Safety Monitoring Board “expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data,” the U.S. National Institute of Allergy and Infectious Diseases said in a statement.
“We encourage the company to work with the DSMB to review event data and ensure that the most accurate and up-to-date event data is published as quickly as possible.”
The concerns were notified to NIAID late Monday, as were AstraZeneca and the Biomedical Advanced Research and Development Authority. And White House Medical Advisors, Dr. Anthony Fauci, NIAID is part of the National Institutes of Health.
And the results of the American trials showed, on Monday, that the Corona virus vaccine produced by AstraZeneca and the University of Oxford is 79% effective in preventing symptoms and 100% effective against severe diseases and hospitalization.
The results were hailed as “surprisingly positive” and “good news for the global community.” It was thought that the trial data could help boost public confidence in the footage and bring it a step closer to licensing emergency use in the United States.
AstraZeneca didn’t immediately respond to CNBC’s request for comment.
AstraZeneca shares were down 0.7% during Tuesday’s trading in London.
AstraZeneca said it plans to prepare for the preliminary analysis that will be submitted to the FDA to obtain permission for emergency use before mid-April.
Data from the study of late-stage human experiences was based on more than 32,000 volunteers across 88 pilot centers in the United States, Peru and Chile.