G42 Healthcare, subsidiary of Abu Dhabi-based Group 42 and a strategic partner of China's Sinopharm in its Covid-19 vaccine programme, has termed the commercial licensing of the vaccine in China as a milestone in the fight against the pandemic.
The same vaccine was officially registered by the UAE Ministry of Health and Prevention (MOHAP) on December 9, 2020, on the basis of Sinopharm interim analysis showing 86% efficacy in preventing Covid-19 in the Phase III trial volunteers, the company said in a statement.
Today's approval was based on updated Sinopharm interim results submitted in China showing 79.34% efficacy. The efficacy variance in the two interim analysis reports is due to two factors - time period and case definition, the statement said.
The analysis submitted to the UAE was in early December and based on the Food and Drug Administration (FDA) case definition, while in China it was submitted at the end of December and based on the Chinese Center for Drug Evaluation (CDE) case definition. The CDE defines Covid-19 case in more stringent terms than the FDA. Both reports are correct and valid, it said.
Very importantly, the core results of the two interim analyses are consistent - the positive conversion rate is above 99% and the protection rate is 100% against moderate to severe cases, it added.
In addition, the vaccine has established a robust safety profile throughout the large-scale global trials and widespread emergency use programs.
"With the regulatory approvals now in place, we are working with our colleagues at Sinopharm and in other trial countries to publish the detailed results in peer reviewed journals, both domestically and internationally," it added. - TradeArabia News Service
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