Results from AstraZeneca's recent Covid-19 vaccine trial "may have included outdated information" that "provided an incomplete view of the efficacy data," a federal health institute said early Tuesday.
The unusual statement, issued just after midnight by the National Institute of Allergy and Infectious Diseases, came hours after AstraZeneca announced encouraging results from its Phase 3 trial based in the United States.
Interim analysis of the trial showed the vaccine made by AstraZeneca and Oxford University was safe and 100 percent effective in stopping severe and fatal cases of Covid-19, AstraZeneca said. After months of questions about the shot's safety and efficacy, these results were seen as a boost and the first step toward it being approved in the U.S., perhaps as early as April.
But later Monday, the NIAID said it was notified about a "concern" relating to the data included in this trial by the data and safety monitoring board, a panel of independent experts that reviews safety and efficacy data for vaccines in the United States.