AstraZeneca Plc may have released outdated information about its Covid-19 vaccine trial, giving an “incomplete” view of the efficacy of the shot, said the leading US agency on infectious diseases.
The Data and Safety Monitoring Board, charged with ensuring the safety and accuracy of the trial, has “expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data,” said the National Institute for Allergy and Infectious Diseases in a statement early Tuesday.
Read more: AstraZeneca vaccine found 79% effective in US trials: Key points
“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,” said the statement from the group headed by Anthony Fauci, the top US infectious disease official.
The disclosure comes as a setback to AstraZeneca, who earlier Monday said its vaccine was found 79% effective in preventing Covid-19 in a U.S. clinical trial of more than 30,000 volunteers.
{{/usCountry}}The disclosure comes as a setback to AstraZeneca, who earlier Monday said its vaccine was found 79% effective in preventing Covid-19 in a U.S. clinical trial of more than 30,000 volunteers.
{{/usCountry}}It’s preparing to seek approval from the Food and Drug Administration for use in the US; the shot has already been cleared in the U.K. and many other nations around the world.
AstraZeneca’s vaccine, developed with Oxford University, was once seen as a frontrunner to protect the world against Covid-19 but has been beset by a series of complications.
Read more: Explained: Why have some countries suspended use of AstraZeneca vaccine?
An error in dosing regimens during trials last year caused confusion over its efficacy, and it’s now at the center of a supply showdown with the European Union just days after concerns about blood clots prompted a dozen member states to suspend immunizations.