WHO validates new COVID vaccine by Sinovac

June 2, 2021

The World Health Organization (WHO) validated the Sinovac-CoronaVac COVID-19 vaccine for emergency use. The vaccine is produced by the Beijing-based pharmaceutical company Sinovac.

WHO’s Emergency Use Listing (EUL) is a prerequisite for COVAX Facility vaccine supply and international procurement. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.

The EUL assesses the quality, safety, and efficacy of COVID-19 vaccines, as well as risk management plans and programmatic suitability, such as cold chain requirements. The assessment is performed by the product evaluation group, composed by regulatory experts from around the world and a technical advisory group (TAG), which is in charge of performing the risk-benefit assessment for an independent recommendation on whether a vaccine can be listed for emergency use and, if so, under which conditions.

In the case of the Sinovac-CoronaVac vaccine, the WHO assessment included on-site inspections of the production facility.

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

On the basis of available evidence, the 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.

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