U_S_ federal health officials say the results of a U_S_ trial of AstraZeneca’s COVID-19 vaccine may have used “outdated information.”
The Safety and Data Monitoring Board said in a statement that it was concerned that AstraZeneca may have provided an incomplete view of the efficacy data.
AstraZeneca reported Monday that its COVID-19 vaccine provided strong protection among adults of all ages in a long-awaited US study, a finding that could help rebuild and bring public confidence in the vaccine around the world. one more step to approval in the US.
In the study of 30,000 people, the vaccine was 79% effective in preventing symptomatic cases of COVID-19, even in older adults. There were no serious illnesses or hospitalizations among the vaccinated volunteers, compared to five such cases in participants who received dummy injections – a small number, but consistent with the findings from Britain and other countries that the vaccine protects against the worst. of the illness.
AstraZeneca also said that the study’s independent safety monitors found no serious side effects, including an increased risk of rare blood clots like those identified in Europe, a scare that led many countries to briefly suspend vaccines last week.
The company aims to file an application with the Food and Drug Administration in the coming weeks, and the government’s outside advisers will publicly debate the evidence before the agency makes a decision.
Authorization and guidelines for use of the vaccine in the United States will be determined by the Food and Drug Administration and the Centers for Disease Control and Prevention after a thorough review of the data by independent advisory committees.