WASHINGTON – The results of a U.S. trial on AstraZeneca’s COVID-19 vaccine may have used “outdated information,” U.S. health officials said Tuesday.
The Data Control and Security Board said in a statement that it was concerned that AstraZeneca might provide an incomplete view of the efficacy data.
AstraZeneca reported Monday that its COVID-19 vaccine provided strong protection among adults of all ages in an expected study in the United States, a finding that could help rebuild public confidence in the shooting worldwide and bring it closer. one more step in liquidation in the US.
In the study of 30,000 people, the vaccine was 79% effective in preventing symptomatic cases of COVID-19, including older adults. There were no serious illnesses or hospitalizations among the vaccinated volunteers, compared with five such cases in participants who received false shots, a small number but consistent with the results of 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 an increased risk of rare blood clots like those identified in Europe, a scare that led many countries to briefly suspend vaccinations last week.
The company intends to submit an application to the Food and Drug Administration in the coming weeks and the government’s external advisers will publicly discuss the evidence before the agency makes a decision.
Authorization and guidelines for vaccine use in the United States will be determined by the Food and Drug Administration and the Centers for Disease Control and Prevention following a thorough review of the data by independent advisory committees.