CanSino Biologics gets WHO emergency use listing for COVID vaccine Convidecia

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.

The emergency use listing (EUL) procedure assesses the suitability of novel health products during public health emergencies. The objective is 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.

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.

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 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.

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