NIGERIA: More countries would be able to access more vaccines as the World Health Organization (WHO) has validated the Sinovac-CoronaVac COVID-19 vaccine for emergency use.
This, according to the Health body, will address the shortage of vaccine and go further to bring the pandemic under control.
In a statement made available to Transcontinental Times, the WHO assured countries, funders, procuring agencies and communities that the vaccine meets international standards for safety, efficacy and manufacturing.
The vaccine is produced by the Beijing-based pharmaceutical company Sinovac.
The WHO Assistant-Director General for Access to Health Products, Dr Mariângela Simão while urger manufacturers to participate in the COVAX Facility by sharing their knowhow and data and contribute to bringing the pandemic under control.
“The world desperately needs multiple COVID-19 vaccines to address the huge access inequity across the globe,” Simão said .
WHO Emergency Use Listing (EUL)
The WHO’s Emergency Use Listing (EUL) is a prerequisite for COVAX Facility vaccine supply and international procurement which 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 emergency use listing (EUL) procedure assesses the suitability of novel health products during public health emergencies.
The objective is to make medicines, vaccines and diagnostics available as rapidly as possible to address the emergency, while adhering to stringent criteria of safety, efficacy and quality.
The assessment weighs the threat posed by the emergency as well as the benefit that would accrue from the use of the product against any potential risks.
The assessment is performed by the product evaluation group which has 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.
For the Sinovac-CoronaVac vaccine, the WHO assessment included on-site inspections of the production facility.
WHO Strategic Advisory Group of Experts (SAGE) on Immunization
The WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) has also completed its review of the vaccine.
It is based on the available evidence that 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.
SAGE is the principal advisory group to WHO for vaccines and immunization.
It is charged with advising WHO on overall global policies and strategies, ranging from vaccines and immunization technology, research and development, to delivery of immunization and its linkages with other health interventions.
Vaccines approved for use
The WHO has already listed the Pfizer/BioNTech, Astrazeneca-SK Bio, Serum Institute of India, Astra Zeneca EU, Janssen, Moderna and Sinopharm vaccines for emergency use.
SAGE had issued recommendations on Pfizer on the 8 January 2021, Moderna on 25 January 2021, AstraZeneca on 21 April 2021, Janssen COVID on 17 March 2021 and Sinopharm on 7 May 2021.