AstraZeneca PLC may have released outdated information about its COVID-19 vaccine trial, giving an “incomplete” view of the efficacy of the shot, said the leading U.S. agency on infectious disease.
The Data and Safety Monitoring Board, charged with ensuring the safety and accuracy of AstraZeneca’s vaccine trial, has expressed concerns to the National Institute for Allergy and Infectious Diseases that the information released about the testing results included outdated information.
This “may have provided an incomplete view of the efficacy data,” the agency said in a statement early Tuesday, without elaborating.
“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 group headed by Anthony Fauci, the top U.S. infectious disease official.
AstraZeneca did not immediately respond to a request for comment made outside of office hours.
The DSMB, an independent panel, also raised its concerns about the outdated information to the British drugmaker and to the Biomedical Advanced Research and Development Authority, a U.S. agency that partially funded the shot’s development.
The disclosure comes as a setback to AstraZeneca, which 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.
It’s preparing to seek approval from the Food and Drug Administration for use in the U.S.; 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 front-runner to protect the world against COVID-19 but has been beset by a series of complications.
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.