On March 22, AstraZeneca said the vaccine demonstrated 79 percent efficacy at preventing symptomatic COVID-19 and 100 percent efficacy at preventing severe disease and hospitalization in its U.S. phase 3 trial.
NIAID’s statement, issued just after midnight on March 23, said that its data and safety monitoring board expressed concern that AstraZeneca’s announcement was based on “outdated information from that trial, which may have provided an incomplete view of the efficacy data.” The data and safety monitoring board notified AstraZeneca and the Biomedical Advanced Research and Development Authority of its concerns.
NIAID urged AstraZeneca to work with its data and safety monitoring board to review the efficacy data and ensure it quickly makes the most accurate and up-to-date efficacy data available.
AstraZeneca’s vaccine is authorized for emergency use in dozens of countries, but it has not yet been aproved in the U.S. The drugmaker is expected to apply for FDA emergency approval within weeks.
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