WASHINGTON – Results of a US trial of AstraZeneca’s COVID-19 vaccine may have used “outdated information,” US federal health officials said early Tuesday.
The Data and Safety Monitoring Board said in a statement it was concerned that AstraZeneca may have provided an incomplete picture of its efficacy data.
AstraZeneca reported Monday that its COVID-19 vaccine provided strong protection among adults of all ages in a highly anticipated US study, a finding that could help restore public confidence in the shot around the world and take it one step closer. to be brought with the approval in the US.
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 to five such cases in participants who received sham injections – a small number, but consistent with findings from 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 no increased risk of rare blood clots as identified in Europe, a scare that prompted many countries to briefly discontinue vaccinations 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 established by the Food and Drug Administration and Centers for Disease Control and Prevention after in-depth review of the data by independent advisory committees.