WHAT YOU NEED TO KNOW:
- The Oxford/AstraZeneca (AZ) COVID-19 vaccine is found to be highly safe and effective against COVID-19 and its severe symptoms, according to a large human trial study done in the U.S., Peru, and Chile.
- The company further stated that in the U.S. trial, no cases of cerebral venous sinus thrombosis (CVST) were detected among the more than 20,000 participants.
- The results, which are noted as consistent with the Oxford-led trials with regards to its efficacy, are regarded as great news as the company begins its application for U.S. approval.
Results of a large phase 3 trial conducted in the U.S., Chile, and Peru showed the Oxford/AstraZeneca (AZ) COVID-19 vaccine to be 79 percent effective against the disease and 100 percent effective in stopping critical cases and hospitalizations across all age groups, the company said on Monday in a news release.
The partners added that in the U.S. trial, an independent safety committee’s review of the rare blood clot cases in the brain, called cerebral venous sinus thrombosis (CVST), found “no increased risk of thrombosis or events characterized by thrombosis” among the 21,583 participants receiving at least one dose of the vaccine.
The news comes after nearly a dozen countries resumed administering the shot after temporarily halting its use over concerns regarding blood-clotting effects in people who received the jab.
“These results are great news as they show the remarkable efficacy of the vaccine in a new population and are consistent with the results from Oxford-led trials,” said lead investigator of the Oxford Vaccine Group, Andrew Pollard.
AstraZeneca further announced that it will now begin working on its application to the Food and Drug Administration for emergency use authorization.
While AstraZeneca’s vaccine efficacy, per the European Union’s drugs regulator in its December recommendation, is listed at more than 60 percent, it is consistent with Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) maximum efficacy, based on a 3-month gap between the first and second dose.
The latest trial involved giving participants either two doses of the Oxford-AstraZeneca vaccine or a placebo vaccine within a four-week interval.
Of the 32,000 participants involved, 79% were white/Caucasian, 8% black/African American, 4% Native American, 4% Asian, and 22% Hispanic. Twenty percent consisted of volunteers aged 65 years and older while roughly 60 percent had chronic diseases related to higher risks of progression to severe COVID-19.