New vaccine gets thumbs-up from WHO

THE World Health Organisation (WHO) recently 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.

“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 know-how and data and contribute to bringing the pandemic under control.”

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 coldchain requirements.

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. Its easy storage requirements make it manageable and 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 recommended 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 hospitalisation 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. However, the WHO said it was not recommending an upper age limit for the vaccine because data collected during subsequent use in multiple countries and supportive immunogenicity data suggested that the vaccine was likely to have a protective effect in older persons.