With the listing, WHO said countries, funders, procuring agencies and communities receive assurance that the vaccines meet international standards for safety, efficacy and manufacturing. The Emergency Use Listing (EUL) is a prerequisite for supply through the Covax facility and international procurement. It also allows countries to expedite their own regulatory approval to import and administer Covid-19 vaccines.

The organization said it grants the EUL following a “rigorous assessment” of late Phase 2 and 3 clinical trial data as well as substantial additional data on safety, efficacy, quality and a risk management plan with a focus on low- and middle-income countries. The assessment considers quality, safety and efficacy of Covid-19 vaccines, as well as risk management plans and “programmatic suitability”, such as cold chain requirements.

The Sinovac-CoronaVac doses, based on an inactivated virus, are said to be easy to store and especially suited for countries with poor resources. On the basis of available evidence, WHO is recommending the vaccine for use in adults 18 years and older, in a two-dose schedule with a spacing of two to four weeks.

Efficacy results from the assessment showed that the vaccine prevented symptomatic disease in 51% of recipients and prevented severe Covid-19 and hospitalization in 100% of the studied population. As few adults over 60 years were enrolled in clinical trials, the health agency said it could not estimate efficacy in this age group. Nevertheless, it is not recommending an upper age limit as it said data collected during subsequent use in multiple countries and suggest that it is likely to have a protective effect in older adults. 

Author: Dede Williams, Freelance Journalist