WASHINGTON – U.S. health officials said AstraZeneca possibly “included outdated information” in the latest analysis of the U.S. clinical trial of its coronavirus vaccine.
According to The Associated Press, the U.S. National Institute of Allergy and Infectious Diseases shared the news in a statement early Tuesday.
“Late Monday, the Data and Safety Monitoring Board (DSMB) notified NIAID, [the Biomedical Advanced Research and Development Authority] and AstraZeneca that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial,” the statement read. “The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data.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 statement continued: “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.”
An AstraZeneca spokesman told the AP that the company is “looking into” the claim.
The news came hours after AstraZeneca said its two-dose COVID-19 vaccine was 79% effective at preventing symptomatic COVID-19 in a Phase 3 clinical trial conducted in the United States, Peru and Chile, according to an interim analysis of the data. The company said in a news release that the shot, AZD1222, also demonstrated “100% efficacy at preventing severe disease and hospitalization” for COVID-19 in the trial, which included more than 32,000 participants. Additionally, the vaccine was 80% effective among participants age 65 and older, the release said.
“The vaccine was well-tolerated, and the independent data safety monitoring board (DSMB) identified no safety concerns related to the vaccine,” the release said, adding that a review found “no increased risk” of “thrombotic events,” otherwise known as blood clots.
Although more than 50 countries have authorized AstraZeneca’s vaccine for emergency use, it has not yet been approved in the United States, according to the AP.
Several European countries, including Germany, Spain, France and Italy, recently agreed to resume administering the AstraZeneca vaccine after temporarily suspending its use because a small number of recipients had reported blood clots, The New York Times reported. After conducting a review, the European Medicines Agency last week deemed the shot safe but said the vaccine will now include a warning label, according to the newspaper.
– The Associated Press contributed to this report.
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