US federal health officials concerned company may have provided an incomplete view of efficacy data; FDA to rule on authorization in coming weeks

WASHINGTON — Results from a US trial of AstraZeneca’s COVID-19 vaccine may have used “outdated information,” US federal health officials said early Tuesday.

(FILES) A file photo taken on February 6, 2021 shows a box containing vials of the AstraZeneca Covid-19 vaccine at the Foch hospital in Suresnes, on the start of a vaccination campaign for health workers with the AstraZeneca/Oxford vaccine. – The World Health Organization gave emergency use approval to AstraZeneca’s Covid-19 vaccines on February 15, 2021, allowing distribution to some of the world’s poorest countries to begin. “The WHO today listed two versions of the AstraZeneca-Oxford Covid-19 vaccine for emergency use, giving the green light for these vaccines to be rolled out globally through Covax,” a WHO statement said, referring to the programme aimed at equitable distribution of inoculations. (Photo by Alain JOCARD / AFP)

The Data and Safety Monitoring Board said in a statement that it was concerned that AstraZeneca may have provided an incomplete view of the efficacy data.

AstraZeneca reported Monday that its COVID-19 vaccine provided strong protection among adults of all ages in a long-anticipated US study, a finding that could help rebuild public confidence in the shot around the world and move it a step closer to clearance in the US.

In the study of 30,000 people, the vaccine was 79% effective at preventing symptomatic cases of COVID-19 — including in older adults. There were no severe illnesses or hospitalizations among vaccinated volunteers, compared with five such cases in participants who received dummy shots — 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 like those identified in Europe, a scare that led numerous countries to briefly suspend 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 determined by the Food and Drug Administration and Centers for Disease Control and Prevention after thorough review of the data by independent advisory committees.

*Source: The Times of Israel