CanSino Biologics Inc. ("CanSinoBIO") (SEHK:6185, SHSE:688185) announced that the World Health Organization ("WHO") has granted Emergency Use Listing ("EUL") for Convidecia™, CanSinoBIO's Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector).
In addition to shortening the vaccination cycle by leveraging the advantages of its single-dose regimen, Convidecia™ can be stably transported and stored between 2°C and 8°C, making it more accessible to developing countries with insufficient storage facilities and medical resources, reducing the burden placed on healthcare systems and medical workers, and contributing to building broad immune protection globally.
"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. We are actively working with public and private organizations to grant access to Convidecia™. Looking ahead, we will continue to innovate and develop new products to further diversify our vaccine portfolio, including inhaled and mRNA vaccines."
The WHO's EUL procedure assesses novel health products during public health emergencies to make medicines, vaccines and diagnostics available as rapidly as possible to address the emergency while adhering to stringent criteria of safety, efficacy and quality. The EUL pathway involves rigorous assessment of late-stage clinical trial data as well as substantial additional data on safety, efficacy and quality by independent experts and WHO teams.
An 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 Technical Advisory Group for Emergency Use Listing, convened by the WHO and consisting of regulatory experts from around the world, determined that Convidecia™ meets WHO standards for protection against COVID-19 and that the benefits of the vaccine far outweigh risks.
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. CanSinoBIO's Phase III clinical trial was a global multicenter, randomized, double-blind and placebo-controlled study in Argentina, Chile, Mexico, Pakistan and Russia, and included approximately 45,000 volunteer participants globally, representing the same sample size as that of other leading global vaccine manufacturers. The results also proved the safety of Convidecia™ for a broad range of age groups above 18, including those over the age of 60.
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.
Convidecia™ is a genetically engineered vaccine with the replication-defective adenovirus type 5 vector that expresses the SARS-CoV-2 coronavirus spike protein. The vaccine is ready to use and does not contain preservatives, adjuvants nor substances of animal origin. So far, it 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 neutralizing antibody responses than those induced by a homologous inactivated vaccine booster or heterologous recombinant protein vaccine booster.