Less than a day after AstraZeneca released clinical trial data that showed its coronavirus vaccine has an efficacy of 79%, health officials raised concerns about the data the company provided.
The National Institute of Allergy and Infectious Diseases issued a rare statement in the middle of the night saying that the Data and Safety Monitoring Board (DSMB) alerted them of potential issues with the clinical trial.
"The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data," the agency wrote. "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."
AstraZeneca said that the analysis released on Monday (March 22) used data from before February 17. The pharmaceutical company said it would provide the DSMB with the most up-to-date data within 48 hours.
This isn't the first time concerns have been raised with AstraZeneca's vaccine. Several countries briefly stopped distributing it after reports that people who received it developed blood clots. They resumed a few days later after the European Medicines Agency said they found no evidence linking the vaccine to the development of blood clots.
AstraZeneca's vaccine has been approved by a number of countries and the World Health Organization but has not been granted an emergency use authorization by the U.S. Food and Drug Administration. It is unknown if the latest issue will delay approval in the United States.
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