World Health Organization (WHO) on Thursday issued an emergency use listing (EUL) for CONVIDECIA, a vaccine manufactured by CanSino Biologics, China, adding to a growing portfolio of vaccines validated by WHO for the prevention of COVID-19 caused by SARS-CoV-2.
WHO’s EUL procedure assesses the quality, safety and efficacy of COVID-19 vaccines as a prerequisite for COVAX vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.
“CONVIDECIA was assessed under the WHO EUL procedure based on the review of data on quality, safety, efficacy, a risk management plan, programmatic suitability and a manufacturing site inspection conducted by WHO. The Technical Advisory Group for Emergency Use Listing, convened by WHO and made up of regulatory experts from around the world, has determined that the vaccine meets WHO standards for protection against COVID-19 and that the benefits of the vaccine far outweigh risks,” said the global health organisation in a press statement.
According to WHO, CONVIDECIA is based on a modified human adenovirus that expresses the spike S protein of SARS-CoV-2. It is administered as a single dose. CONVIDECIA was also reviewed earlier this month by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), which formulates vaccine specific policies and recommendations for vaccines’ use in populations (i.e. recommended age groups, intervals between shots, specific groups such as pregnant and lactating women).
The advisory group SAGE recommends use of the vaccine as a single (0.5ml) dose, in all age groups 18 and above. CONVIDECIA was found to have 64% efficacy against symptomatic disease and 92% against severe COVID-19.