WHO authorises Sinovac’s COVID-19 vaccine for emergency use

The World Health Organization (WHO) has validated Sinvoc’s COVID-19 vaccine for emergency use in adults aged 18 years and older in a two-dose schedule with a spacing of two to four weeks.

A WHO emergency use listing (EUL) is issued when a product meets international standards for safety, efficacy and manufacturing.

Sinovac’s jab was assessed by the WHO’s product evaluation group, which is comprised of regulatory experts and a Technical Advisory Group (TAG).

The TAG has responsibility for performing the risk-benefit assessment for an independent recommendation, to determine if a vaccine can be listed for an EUL and under which conditions.

For the Sinovac vaccine, this included on-site inspections of the facility where it is produced, the WHO said in a statement.

In addition to the EUL assessment, the WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) also completed its review of the vaccine.

Based on the available evidence for the jab, WHO has recommended the vaccine for use in adults aged 18 years and older in a two-dose regimen, with the time between doses to be between two to four weeks.

According to vaccine efficacy results, the Sinovac vaccine prevented symptomatic disease in 51% of vaccinated individuals and prevented severe COVID-19 and hospitalisation in 100% of study participants.

WHO is not recommending an upper age limit for the vaccine, although few older adults aged over 60 years were enrolled in clinical trials – subsequent data collected in multiple countries and supportive immunogenicity data suggests the jab is likely to have a protective effect in older adults, WHO said.

A WHO EUL is also a prerequisite for the COVAX Facility vaccine supply and international procurement.

"The world desperately needs multiple COVID-19 vaccines to address the huge access inequity across the globe," said Mariangela Simao, the assistant director general for access to health products at WHO

"We urge manufacturers to participate in the COVAX Facility, share their know-how and data and contribute to bringing the pandemic under control," she added.