A U.S. health agency on Tuesday said that AstraZeneca’s recent COVID-19 vaccine trial report “may have included outdated information” that “provided an incomplete view of the efficacy data.”
The U.S. National Institute of Allergy and Infectious Disease expressed concerns just one day after the drugmaker announced that data from its U.S.-based clinical trial show the vaccine was 79 percent effective in preventing symptomatic disease and 100 percent effective against severe disease and hospitalization.
The Data Safety Monitoring Board “expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data,” the NIAID said in a statement.
“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 adds.
However, the institute did not suggest the vaccine is unsafe or ineffective. The vaccine has been administered to tens of millions of people globally and approved or given emergency approval in more than 70 countries.
The trial data revealed Monday was seen as “surprisingly positive.” Experts did not find any safety concerns related to the vaccine in the trial conducted in the U.S., Chile and Peru that included more than 32,000 adult volunteers.
Though trial data for the vaccine has been promising, a number of European countries, including Norway, France and Denmark, have temporarily suspended distribution of the vaccine in recent weeks following reports of blood clotting in patients who had received the shots.
However, in addition to the new Phase 3 trial’s findings, an emergency investigation by the European Medicines Agency (EMA) last Thursday found that the vaccine is “safe and effective” in preventing coronavirus and “not associated with an increase in the overall risk of thromboembolic events, or blood clots.”
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