According to US federal health officials, results from a US trial of AstraZeneca’s COVID-19 vaccine may have used “outdated information.”
The Data and Safety Monitoring Board expressed concern in a statement released early Tuesday that AstraZeneca may have provided an incomplete picture of effectiveness data.
In a long-awaited U.S. study, AstraZeneca’s COVID-19 vaccine offered strong protection among adults of all ages, a finding that could help restore public trust in the shot around the world and bring it closer to clearance in the United States.
The vaccine was found to be 79 percent effective in preventing symptomatic cases of COVID-19 in a study of 30,000 individuals, including older adults. There were no serious illnesses or hospitalizations among vaccinated volunteers, compared to five such cases among dummy shot participants — a small number, but consistent with findings from the United Kingdom and other countries that the vaccine protects against the disease’s worst symptoms.
AstraZeneca also stated that the study’s independent safety monitors discovered no serious side effects, such as an increased risk of rare blood clots like those seen in Europe, which prompted several countries to temporarily halt vaccinations last week.
The company plans to submit an application to the Food and Drug Administration in the coming weeks, and before the agency makes a decision, outside advisors to the government will discuss the evidence openly.
After a careful review of the data by independent advisory committees, the Food and Drug Administration and the Centers for Disease Control and Prevention will decide on authorization and guidelines for use of the vaccine in the United States.