WASHINGTON – The results of a test in the United States with AstraZeneca’s COVID-19 vaccine may have used “outdated information,” US federal health officials said on Tuesday.
The Data and Security Monitoring Committee said in a statement that it was concerned that AstraZeneca had provided an incomplete view of the effectiveness data.
AstraZeneca reported on Monday that its COVID-19 vaccine offers strong protection among adults of all ages in a long-awaited American study, a finding that could help rebuild public confidence in injection worldwide and bring it it a step closer to US release.
In the study of 30,000 people, the vaccine was 79% effective in preventing symptomatic cases of COVID-19 – including in the elderly. There were no serious illnesses or hospitalizations among vaccinated volunteers, compared with five of these cases in participants who received false injections – a small number, but consistent with the findings in Britain and other countries that the vaccine protects against the worst of disease.
AstraZeneca also said that the study’s independent safety monitors found no serious side effects, including no increase in the risk of rare blood clots like those identified in Europe, a scare that prompted several countries to halt vaccines briefly last week.
The company plans to file an order with the Food and Drug Administration in the coming weeks, and external government consultants 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 determined by the Food and Drug Administration and the Centers for Disease Control and Prevention, after a complete review of the data by independent advisory committees.