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Coronavirus | AstraZeneca may have used outdated info in vaccine trial: U.S.

The logo for AstraZeneca is seen outside its North America headquarters in Wilmington, Delaware, U.S. on March 22, 2021.   | Photo Credit: Reuters

Results from a U.S. trial of AstraZeneca’s COVID-19 vaccine may have used “outdated information,” U.S. federal health officials said in a statement early on March 23.

Also read: U.S. data shows AstraZeneca's vaccine is effective for all ages

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 on Monday that its COVID-19 vaccine provided strong protection among adults of all ages in a long-anticipated U.S. 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 U.S.

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 hospitalisations 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.

Also read: The Hindu Explains | How safe is AstraZeneca’s COVID-19 vaccine?

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.

Authorisation and guidelines for use of the vaccine in the United States will be determined by the Food and Drug Administration and Centres for Disease Control and Prevention after thorough review of the data by independent advisory committees.

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Printable version | May 17, 2021 5:54:15 AM | https://www.thehindu.com/news/international/astrazeneca-may-have-used-outdated-info-in-vaccine-trial-us/article34139052.ece

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