WHO, in a statement, said that the validation gives
countries, funders, procuring agencies and communities the assurance that it
meets international standards for safety, efficacy and manufacturing.
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.
Sinovac-CoronaVac vaccine is produced by the Beijing-based
pharmaceutical company, Sinovac.
WHO has earlier listed the Pfizer/BioNTech, Astrazeneca-SK
Bio, Serum Institute of India, Astra Zeneca EU, Janssen, Moderna and Sinopharm
vaccines for emergency use.
The statement quoted Dr Mariângela Simão, WHO
Assistant-Director General for Access to Health Products, as saying, “The world
desperately needs multiple COVID-19 vaccines to address the huge access
inequity across the globe.
“We urge manufacturers to participate in the COVAX Facility,
share their knowhow 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 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), 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. Its
easy storage requirements make it manageable and particularly suitable for
low-resource settings.
WHO’s Strategic Advisory Group of Experts on Immunisation
(SAGE) has also completed its review of the vaccine.
Vaccine efficacy results show that the vaccine prevents
symptomatic disease in 51 per cent of those vaccinated and prevents severe
COVID-19 and hospitalisation in 100 per cent of the studied population.
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