Results from a US trial of AstraZeneca’s Covid-19 vaccine may have used "outdated information" and that could mean the company provided an incomplete view of efficacy data, U.S. federal health officials said in a statement early on March 23.
The Data and Safety Monitoring Board said in a statement that it was concerned that AstraZeneca may have provided an incomplete view of the efficacy data.
AstraZeneca reported on Monday that its COVID-19 vaccine provided strong protection among adults of all ages in a long-anticipated U.S. study, a finding that could help rebuild public confidence in the shot around the world and move it a step closer to clearance in the U.S.
In the study of more than 30,000 people, the company reported the vaccine was found to be 79% effective at preventing symptomatic cases of Covid-19 -- including in older adults. There were no severe illnesses or hospitalizations among vaccinated volunteers, compared with 5 such cases in participants who received dummy shots -- a small number, but consistent with findings from Britain and other countries that the vaccine protects against the worst of the disease.
AstraZeneca also said the study’s independent safety monitors found no serious side effects, including no increased risk of rare blood clots like those identified in Europe, a scare that led numerous countries to briefly suspend vaccinations last week.
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