CanSino Biologics Inc. 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. 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. 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[1] 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.