• The World Health Organisation (WHO) has listed the Sinopharm COVID-19 vaccine for emergency use, giving the green light for this vaccine to be rolled out globally. 

• The Sinopharm vaccine is produced by Beijing Bio-Institute of Biological Products Co Ltd, subsidiary of China National Biotec Group (CNBG).

• A WHO emergency listing is a signal to national regulators that a product is safe and effective. It also allows it to be included in COVAX, a global programme to provide vaccines mainly for poor countries, which has hit supply problems. 

What is WHO’s Emergency Use Listing?

• 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.

• WHO’s EUL is a prerequisite for COVAX Facility vaccine supply. 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.

• The WHO had already given emergency approval to COVID-19 vaccines developed by Pfizer-BioNTech, AstraZeneca (AstraZeneca-SKBio, Republic of Korea and the Serum Institute of India), Johnson & Johnson and Moderna.

Sinopharm vaccine

• The Sinopharm product is an inactivated vaccine called SARS-CoV-2 Vaccine (Vero Cell). 

• Its easy storage requirements make it highly suitable for low-resource settings. 

• It is the also first vaccine that will carry a vaccine vial monitor, a small sticker on the vaccine vials that change color as the vaccine is exposed to heat, letting health workers know whether the vaccine can be safely used.

• WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) has also completed its review of the vaccine. 

• On the basis of all available evidence, WHO recommends the vaccine for adults 18 years and older, in a two-dose schedule with a spacing of three to four weeks. 

• Vaccine efficacy for symptomatic and hospitalised disease was estimated to be 79 per cent, all age groups combined.  

• Few older adults (over 60 years) were enrolled in clinical trials, so efficacy could not be estimated in this age group. 

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