The World Health Organization (WHO) granted emergency use approval (EUL) for Convidecia™, CanSinoBIO’s new recombinant coronavirus vaccine (adenovirus type 5 vector) for people aged 18 years and older. or more, according to a company statement.
“In addition to shortening the vaccination cycle by taking advantage of its single-dose regimen, Convidecia™ can be stably transported and stored at 2°C to 8°C, making it more accessible to developing countries with insufficient storage facilities and medical resources,” the text indicated. “This in turn reduces the burden on health systems and medical workers, and contributes to building broad immune protection globally,” he added.
As explained, the WHO based its decision on the entirety of the scientific evidence provided by CanSinoBIO, including the results of its Phase III clinical trial on the safety and effectiveness of Convidecia™, which were published in The Lancet. The CanSinoBIO Phase III clinical trial was a global multicenter, randomized, double-blind, placebo-controlled study in Argentina, Chile, Mexico, Pakistan and Russia, and included 45,000 volunteer participants worldwide, representing the same size of sample than that of other leading vaccines worldwide. The results also demonstrated the safety of Convidecia™ for a wide range of age groups over 18 years of age, including those over 60 years of age.
An EUL allows countries to accelerate their own regulatory approval to import and administer COVID-19 vaccines, and is a prerequisite for supplying vaccines to the global COVAX Facility, a global mechanism for the joint procurement and equitable distribution of COVID-19 vaccines. virus
Currently, CanSinoBIO’s Convidecia™ has received approvals in more than 10 markets, including China, Mexico, Ecuador, Chile, Argentina, Hungary, Kyrgyzstan, Pakistan, United Arab Emirates, Indonesia and Malaysia. The company also established local partnerships for distribution in several countries, including launching fill-finish facilities in Mexico, Pakistan and Malaysia, making its COVID-19 vaccines accessible to more people in developing markets. .
So far, Convidecia™ has been approved as a heterologous booster in China, Argentina, Malaysia and Indonesia. It is also the first and only adenovirus-vectored vaccine included in the heterologous vaccination program in China.
“Recent studies demonstrated that the use of Convidecia™ as a heterologous booster, either with intramuscular injection or inhaled version, generated greater neutralizing antibody responses than those induced by the homologous inactivated vaccine booster or the heterologous recombinant protein vaccine booster,” the statement ended.
