The WHO’s EUL procedure assesses the quality, safety and efficacy of COVID-19 vaccines as a prerequisite for COVAX vaccine supply: thus allowing countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.
As with other vaccines, Convidecia (a single dose vaccine which is based on a modified human adenovirus that expresses the spike S protein of SARS-CoV-2) was assessed based on a 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,” notes the WHO.
Clinical trials have demonstrated 64% efficacy against symptomatic disease and 92% against severe COVID-19.
The WHO issued its first emergency use validation in December 2020, with the Pfizer/COVID-19 vaccine. The other vaccines with EUL from the WHO come from Moderna (mRNA-1273); AstraZeneca (AZD1222); Serum Institute of India (branded Covishield from AstraZeneca); J&J (Ad26.COV2.5); SinoPharm (Covilo / BBIBP-CorV); Sinovac (CoronaVac); Bharat Biotech (Covaxin); Novavax (NVX-CoV2373) and Serum Institute of India (branded Covovax from Novavax).