AstraZeneca may have used “outdated information” to arrive at the conclusion that its vaccine was 79 percent effective against COVID-19 in a U.S. trial that involved more than 32,000 people, American federal health officials said in a statement on Tuesday.
The Data and Safety Monitoring Board said it was concerned that AstraZeneca may have provided incomplete view of the efficacy data.
“Late Monday, the Data and Safety Monitoring Board (DSMB) notified NIAID, BARDA, and AstraZeneca that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine 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 The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data. 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,” the United States National Institutes of Health said in a statement.
“Authorization and guidelines for use of the vaccine in the United States will be determined by the Food and Drug Administration and Centers for Disease Control and Prevention after thorough review of the data by independent advisory committees.”
In a statement on Monday, AstraZeneca claimed its vaccine was highly effective against the deadly virus and prevented severe disease and death.
The statement by U.S. officials on Tuesday has now cast doubt on the results.