The World Health Organisation (WHO) today, Friday 7 May 2021, 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, a subsidiary of China National Biotec Group (CNBG).
WHO Assistant-Director General for Access to Health Products Dr Mariângela Simão said:
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The addition of this vaccine has the potential to rapidly accelerate COVID-19 vaccine access for countries seeking to protect health workers and populations at risk.
We urge the manufacturer to participate in the COVAX Facility and contribute to the goal of more equitable vaccine distribution.
WHO’s Emergency Use Listing (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 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.
In the case of the Sinopharm vaccine, the WHO assessment included on-site inspections of the production facility.
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 the symptomatic and hospitalized disease was estimated to be 79%, all age groups combined.