WASHINGTON (AP) – Results of a U.S. trial of AstraZeneca’s COVID-19 vaccine may have used “outdated information,” U.S. federal health officials said early Tuesday.
The Data and Security Monitoring Board said in a statement that it was concerned that AstraZeneca may have provided an incomplete review of the effectiveness data.
AstraZeneca reported on Monday that the COVID-19 vaccine provides strong protection among adults of all ages in a long-awaited US study, a finding that could help rebuild public confidence in the shot around the world and a step closer to approval in the usa
In the study of 30,000 people, the vaccine was 79% effective in preventing symptomatic cases of COVID-19 – including in older adults. There were no serious illnesses or hospitalizations among vaccinated volunteers, compared with five such cases in participants who received dummy shots – a small number, but in line with the findings of Britain and other countries that the vaccine protects against the worst disease word.
AstraZeneca also said the study’s independent safety monitors found no serious side effects, including no increased risk of rare blood clots such as those identified in Europe, a shock that led many countries to briefly vaccinate last week. suspended.
The company plans to file an application with the Food and Drug Administration in the coming weeks, and the government’s external advisers will discuss the evidence in public before the agency decides.
Authorization and guidelines for the use of the vaccine in the United States will be determined by the Food and Drug Administration and Centers for Disease Control and Prevention after thorough review of the data by independent advisory committees.