WHO Validates Sinovac COVID-19 Vaccine for Emergency Use and Issues Interim Policy Recommendations

Original from WHO official website

June 1st, WHO validated the Sinovac-CoronaVac COVID-19 vaccine for emergency use, giving countries, funders, procuring agencies and communities the assurance that it meets international standards for safety, efficacy and manufacturing. The vaccine is produced by the Beijing-based pharmaceutical company Sinovac.

China currently has two vaccines that have been given emergency authorization from the WHO. The previously authorized one is Sinopharm vaccines.

The Sinovac-CoronaVac product is an inactivated vaccine. Its easy storage requirements make it very manageable and particularly suitable for low-resource settings.

WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) has also completed its review of the vaccine. On the basis of available evidence, WHO recommends the vaccine for use in adults 18 years and older, in a two-dose schedule with a spacing of two to four weeks. Vaccine efficacy results showed that the vaccine prevented symptomatic disease in 51% of those vaccinated and prevented severe COVID-19 and hospitalization in 100% of the studied population.

Few older adults (over 60 years) were enrolled in clinical trials, so efficacy could not be estimated in this age group. Nevertheless, WHO is not recommending an upper age limit for the vaccine because data collected during subsequent use in multiple countries and supportive immunogenicity data suggest the vaccine is likely to have a protective effect in older persons. There is no reason to believe that the vaccine has a different safety profile in older and younger populations. WHO recommends that countries using the vaccine in older age groups conduct safety and effectiveness monitoring to verify the expected impact and contribute to making the recommendation more robust for all countries.

Sinovac COVID-19 vaccine has been directly or indirectly supplied to nearly 40 countries and regions in the world. The global cumulative supply exceeds 600 million doses (including semi-finished products). According to incomplete statistics, more than 430 million doses of Sinovac vaccine have been inoculated globally.

WHO emergency use listing

WHO has already listed the Pfizer/BioNTech, Astrazeneca-SK Bio, Serum Institute of India, Astra Zeneca EU, Janssen, Moderna and Sinopharm vaccines for emergency use.