The US federal health officials said that results from a US trial of AstraZeneca’s COVID-19 vaccine may have used “outdated information”.
In a statement early Tuesday, the US federal health officials said that results from a US trial of AstraZeneca’s COVID-19 vaccine may have used “outdated information”.
The Data and Safety Monitoring Board, last Monday, had said in a statement that it was concerned that AstraZeneca may have provided an incomplete view of the efficacy data.
On Monday, AstraZeneca reported 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.
The vaccine, in the study of 30,000 people, was 79% effective at preventing symptomatic cases of COVID-19 including in older adults.
Among vaccinated volunteers, there were no severe illnesses or hospitalizations, compared with five 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.
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, AstraZeneca said.
In the coming weeks, the company aims to file an application with the Food and Drug Administration, and the government’s outside advisers will publicly debate the evidence before the agency makes a decision.
After thorough review of the data by independent advisory committees, 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.
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