It took less than a day after AstraZeneca touted its COVID-19 vaccine was 79 percent effective at preventing symptomatic COVID-19, that the National Institute for Allergy and Infectious Diseases (NIAID) issued a statement indicating the drugmaker’s announcement may have been based on outdated data.
On March 22, AstraZeneca claimed their 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 issued a statement just after midnight on March 23, saying its data and safety monitoring board expressed concern that AstraZeneca’s announcement was based on “outdated information from that trial, which may have provided an incomplete view of the efficacy data.”
AstraZeneca’s vaccine is authorized for emergency use in dozens of countries, but it has not yet been approved in the U.S. The drugmaker is expected to apply for FDA emergency approval within weeks.
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.