Solution Group Berhad’s the ASEAN manufacturing partner of CanSino Biologics Inc. announces that the World Health Organization has granted Emergency Use Listing (“EUL”) for Convidecia, CanSinoBIO’s Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for individuals aged 18 years and above.
“We are pleased to have obtained the issuance of an Emergency Use Listing, as well as the usage recommendation from the Strategic Advisory Group of Experts on Immunization Committee and the Good Manufacturing Practices certificate,” said Dr. Xuefeng YU, Chairman and Chief Executive Officer of CanSinoBIO. “This EUL will greatly contribute to the expansion of vaccine access to underserved populations around the globe, representing a significant milestone for CanSinoBIO and further demonstrating our efforts in the pandemic fight.
The WHO’s EUL procedure assesses novel health products during public health emergencies to make medicines, vaccines, and/or diagnostics available to address the emergency while adhering to stringent criteria of safety, efficacy, and quality. The EUL pathway involves a rigorous assessment of late-stage clinical trial data as well as data on safety, efficacy, and quality by independent experts and WHO teams. A EUL allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines and is a prerequisite to supply vaccines to the global COVAX Facility, a global mechanism for pooled procurement and equitable distribution of COVID-19 vaccines.
The WHO based its decision on the totality of scientific evidence provided by CanSinoBIO, including its Phase III clinical trial results on the safety and efficacy of Convidecia, which were published in The Lancet.
Currently, CanSinoBIO’s Convidecia has received approvals in more than 10 markets: China, Mexico, Ecuador, Chile, Argentina, Hungary, Kyrgyzstan, Pakistan, United Arab Emirates, Indonesia, and Malaysia. The company also established local partnerships for distribution in various countries, including setting up fill-and-finish facilities in Mexico, Pakistan, and Malaysia, allowing its COVID-19 vaccine access to more people in developing markets.
So far, Convidecia has been approved as a heterologous booster vaccine in China, Argentina, Malaysia and Indonesia. It is also the first and only adenovirus-vectored vaccine to be included in the heterologous vaccination program in China. Recent studies showed that using Convidecia as a heterologous booster, via either intramuscular injection or using the inhaled version, generated greater
