In a major development that helps ease tension in the country’s anti-Covid vaccination campaign, results from the much-awaited U.S. trial of the Oxford-AstraZeneca vaccine confirmed that it is both safe and highly effective.
“The AstraZeneca US Phase III trial of AZD1222 demonstrated statistically significant vaccine efficacy of 79% at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalisation,” the UK-based pharmaceutical and biotechnology giant said in a statement.
This interim safety and efficacy analysis was based on a trial in which more than 32,000 volunteers took part.
The independent data safety monitoring board (DSMB) found no increased risk of side effects such as blood clot and cerebral venous sinus thrombosis among the 21,583 participants receiving at least one dose of the vaccine.
Ann Falsey, Professor of Medicine, University of Rochester School of Medicine, US, and co-lead Principal Investigator for the trial, said, “These findings reconfirm
previous results observed in AZD1222 trials across all adult populations but it’s exciting to see similar efficacy results in people over 65 for the first time.
Mene Pangalos, Executive Vice President (BioPharmaceuticals R&D) at AstraZeneca, said, “These results add to the growing body of evidence that shows this vaccine is well-tolerated and highly effective against all severities of COVID-19 and across all age groups”.
The company will submit these findings to the US Food and Drug Administration to be considered for Emergency Use Authorization. If granted, it will pave the way for
the rollout of millions of doses across the United States.
The European Medicines Agency last week concluded that AstraZeneca’s COVID vaccine is “safe and effective”. An extraordinary meeting of the EU medicines regulator on Thursday gave the go-ahead on the continued use of the COVID-19 vaccine.
13 European countries had either temporarily halted AstraZeneca vaccine inoculations or delayed its rollout as a precaution following reports of patients developing blood clots after receiving AstraZeneca vaccine jabs.
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