China’s Sinovac vaccine gets greenlight for WHO emergency use
The World Health Organization has approved Sinovac-CoronaVac COVID-19 vaccine for emergency use.
The global health organization has assured countries, funders, procuring agencies and communities that the Beijing made vaccine has met the international standards for safety, efficacy and manufacturing, and is therefore safe for emergency use.
“The world desperately needs multiple COVID-19 vaccines to address the huge access inequity across the globe,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Health Products.
“We urge manufacturers to participate in the COVAX facility, share their knowhow and data and contribute to bringing the pandemic under control.”
Other vaccines already listed for emergency use by WHO are Pfizer/BioNTech, AstraZeneca, Moderna and Sinopharm.
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WHO’s Emergency Use Listing (EUL) is a prerequisite for the vaccine access platform, COVAX, and international drug procurement practices. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 shots in the arms of the people.
The EUL evaluates the quality, safety and efficacy of COVID-19 vaccines, as well as risk management plans such as requirements for cold chain storage.
The drug evaluation is done by regulatory experts globally and a technical advisory group (TAG) that determines the risk-benefit assessment before recommending whether a vaccine can be listed for emergency use.
For the Sinovac-CoronaVac vaccine, the WHO assessment included on-site inspections of the production facility for the inactivated vaccine.
The China made vaccine easy storage requirements makes it manageable and suitable for poor countries.
On account of the 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.
The shot’s efficacy showed that the vaccine prevented symptomatic disease in 51 per cent of those inoculated and prevented severe COVID-19 and hospitalization in 100 per cent of the population surveyed.
