WHO today, June 1, 2021 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. We urge manufacturers to participate in the COVAX Facility, share their knowhow and data and contribute to bringing the pandemic under control”.
Dr Mariângela Simão, WHO Assistant-Director General for Access to Health Products
Assessment of COVID-19 vaccines
The 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. It also assesses risk management plans and programmatic suitability, such as cold chain requirements. The product evaluation group, composed of regulatory experts from around the world and a Technical Advisory Group (TAG), performs such assessments. The group is composed of regulatory experts from around the world and a Technical Advisory Group (TAG).
As part of the EUL process, the company producing the vaccine must commit to continue to generate data to enable full licensure and WHO prequalification of the vaccine.
However, 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 very manageable and particularly suitable for low-resource settings.
Moreover, WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) has also completed its review of the vaccine. WHO recommends the vaccine for use in adults 18 years and older in a two-dose schedule. It advices people to take this vaccine with a spacing of two to four weeks.
Vaccine efficacy test results
Vaccine efficacy results showed that the vaccine prevented symptomatic disease in 51% of those vaccinated. It also prevented severe COVID-19 and hospitalization in 100% of the studied population. Meanwhile, WHO indicated that it has enrolled few older adults (over 60 years) in clinical trials, so efficacy could not be estimated in this age group.
Nevertheless, WHO stated that it is not recommending an upper age limit for the vaccine. This is because data collected during subsequent use in multiple countries and supportive immunogenicity show that it is likely to have a protective effect in older persons. COVID-19 vaccine COVID-19 vaccine COVID-19 vaccine
“There is no reason to believe that the vaccine has a different safety profile in older and younger populations. WHO recommends that countries using the vaccine in older age groups conduct safety and effectiveness monitoring to verify the expected impact”.
According to the WHO, such monitoring will contribute to making the recommendation more robust for all countries. Meanwhile, the WHO indicated that its prequalification process will assess additional clinical data generated from vaccine trials and deployment on a rolling basis. This will ensure the vaccine meets the necessary standards of quality, safety and efficacy for broader availability
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