Federal agency raises 'concern' about AstraZeneca vaccine trial data

The results of AstraZeneca’s latest Covid-19 vaccine study “may have contained out of date information” that “provided an incomplete view of the efficacy data,” a federal health institute said early Tuesday.

The National Institute for Allergies and Infectious Diseases made the unusual statement after AstraZeneca announced Monday that the study had no serious side effects and was 100 percent effective in stopping serious and fatal cases.

NIAID said it had been notified of the “concern” late Monday by the Data and Safety Monitoring Board, a body of independent experts that reviews safety and efficacy data for vaccines in the US.

“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 released as soon as possible,” says the acronym for the data and safety monitoring body.

The agency, which is part of the National Institutes of Health, has not suggested that the vaccine against the coronavirus, manufactured by AstraZeneca and Oxford University, is unsafe or ineffective. It has been recorded by tens of millions of people around the world and approved by dozens of regulators in other countries.

NBC News approached AstraZeneca for comment.

This is breaking news. You can find more updates here.

Leave a Comment