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The World Health Organization (WHO) has licenced the use of Sinopharm, a Chinese COVID-19 vaccine, for emergency use.
Sinopharm is the WHO’s sixth vaccine approved against COVID-19; the WHO also lists Pfizer/BioNTech, Astrazeneca-SK Bio, Serum Institute of India, Janssen, and Moderna vaccines for emergency use.
The WHO announced the approval in a statement on Friday, saying it was part of attempts to increase access to vaccines in order to reduce the spread of the coronavirus.
According to the WHO, the emergency use listing (EUL) will also include more opportunities for countries involved in obtaining vaccines through the United Nations-led COVAX facility — African countries are obtaining vaccines through the COVAX facility.
Nigeria has also expressed interest in obtaining the COVID-19 vaccine from China, despite the fact that the AstraZeneca vaccine is currently being marketed in the region.
“WHO today 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),” the statement read.
“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.
“In the case of the Sinopharm vaccine, the WHO assessment included on-site inspections of the production facility. 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%, 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. Nevertheless, WHO is not recommending an upper age limit for the vaccine because preliminary data and supportive immunogenicity data suggest the vaccine is likely to have a protective effect in older persons.
“There is no theoretical reason to believe that the vaccine has a different safety profile in older and younger populations. WHO therefore recommends that countries using the vaccine in older age groups conduct safety and effectiveness monitoring to make the recommendation more robust.”