AstraZeneca Plc may have provided an incomplete view of efficacy data on its COVID-19 vaccine from a large scale U.S. trial, a U.S. health agency said Tuesday in a fresh setback for the shot.
The news comes just one day after interim data from the drugmaker showed better-than-expected results from the trial and casts doubt on its plan to seek U.S. emergency use authorization for the vaccine in the coming weeks.
The vaccine developed with Oxford University was 79% effective in preventing symptomatic illness in a large trial in the United States, Chile and Peru, and, crucially, posed no increased risk of blood clots, according to the data.
The Data Safety Monitoring Board (DSMB) has “expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data,” the U.S. National Institute of Allergy and Infectious Diseases (NIAID) said in a statement.
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