China COVID-19 Vaccine Authorized by the WHO
The World Health Organization (WHO) validated the CoronaVac COVID-19 inactivated vaccine for emergency use on June 1, 2021.
This WHO authorization gives countries, funders, procuring agencies, and communities the assurance that the CoronaVac vaccine meets international standards for safety, efficacy, and manufacturing.
CoronaVac 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, in a press statement.
WHO’s Emergency Use Listing (EUL) empowers countries to expedite their regulatory approval to import and administer COVID-19 vaccines.
The EUL assesses the quality, safety, and efficacy of COVID-19 vaccines and risk management plans and programmatic suitability, such as cold chain requirements. The CoronaVac vaccine storage requirements make it very manageable and particularly suitable for low-resource settings.
The assessment is performed by the product evaluation group, composed of 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.
The WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) has also completed its vaccine review.
Based on the available evidence, the 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. Vaccine efficacy results showed that the vaccine prevented symptomatic disease in 51% of those vaccinated and prevented severe COVID-19 and hospitalization 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.
Nevertheless, WHO is not recommending an upper age limit for the vaccine because data collected during subsequent use in multiple countries and supportive immunogenicity data suggest the vaccine is likely to have a protective effect in older persons.
There is no reason to believe that the vaccine has a different safety profile in older and younger populations, says the WHO.
The WHO recommends that countries using the vaccine in older age groups conduct safety and effectiveness monitoring to verify the expected impact and make the recommendation more robust for all countries.
WHO emergency use listing procedure assesses the suitability of novel health products during public health emergencies.
Sinovac Biotech Life Sciences Ltd. is a Beijing, China-based biopharmaceutical company that focuses on the research, development, manufacturing, and commercialization of vaccines that protect against human infectious diseases.
PrecisionVaccinations publishes research-based vaccine news.