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WHO lists Sinopharm/CNBG COVID-19 vaccine for emergency use and issues interim policy recommendations

Geneva, 07 May 2021 - The Sinopharm COVID-19 vaccine was added to WHO Emergency Use Listing (EUL), providing the green light for this vaccine to be rolled out globally. WHO’s EUL is a prerequisite for COVAX Facility vaccine financing and supply. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.

The Sinopharm vaccine is produced by Beijing Bio-Institute of Biological Products Co Ltd, subsidiary of China National Biotec Group (CNBG). “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,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Health Products. “We urge the manufacturer to participate in the COVAX Facility and contribute to the goal of more equitable vaccine distribution.”

The Sinopharm vaccine assessment included on-site WHO inspections of the production facility. The Sinopharm product is an inactivated SARS-CoV-2 vaccine produced with Vero cells technology. Its easy storage requirements make it highly suitable for low-resource settings. It is also the 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 hospitalized disease was estimated to be 79%, all age groups combined.

More information available at https://www.who.int/teams/regulation-prequalification/eul/covid-19 ;
https://www.who.int/news/item/07-05-2021-who-lists-additional-covid-19-vaccine-for-emergency-use-and-issues-interim-policy-recommendations ;
https://www.bbc.com/news/world-asia-china-56967973 ;
https://www.reuters.com/world/middle-east/who-gives-emergency-approval-sinopharm-first-chinese-covid-19-vaccine-2021-05-07/

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