WASHINGTON – The results of a study conducted in the US with the AstraZeneca COVID-19 vaccine could have used “outdated information”, US health officials said on Tuesday.
The Data and Safety Monitoring Board said in a statement that it was concerned that AstraZeneca could have provided an incomplete picture of the efficacy data.
AstraZeneca reported on 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 public confidence in the film around the world and bring it closer to one step closer to US clearance
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 injections – a small number, but in line with findings in the UK and other countries that the vaccine protects against the most serious illness.
AstraZeneca also said that the study’s independent safety monitors found no serious side effects, including an increased risk of rare blood clots, such as those identified in Europe, a scare that led many countries to briefly suspend vaccinations last week. .
The company plans to file an application with the Food and Drug Administration in the coming weeks, and government external advisers will publicly debate the evidence before the agency makes a decision.
Authorization and guidelines for the use of the vaccine in the United States will be established by the Food and Drug Administration and the Centers for Disease Control and Prevention, after thorough examination of the data by independent advisory committees.