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The World Health Organisation (WHO) has granted approval to the Covid-19 vaccine made by the Chinese state-owned company Sinopharm.
WHO has listed the Sinopharm Covid-19 vaccine for emergency use, giving the green light for its global roll-out.
The Sinopharm vaccine is produced by Beijing Bio-Institute of Biological Products Co Ltd, a 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.”
WHO’s Emergency Use Listing (EUL) is a prerequisite for COVAX Facility vaccine supply.
The UN health agency has previously granted emergency use approval to vaccines made by Pfizer, AstraZeneca, Johnson & Johnson and Moderna.
The WHO assessment of the Sinopharm vaccine included on-site inspections of the production facility. It is an inactivated vaccine called SARS-CoV-2 Vaccine (Vero Cell).
“Its easy storage requirements makes it highly suitable for low-resource settings. It is also the first vaccine that will carry a vaccine vial monitor, a small sticker on vaccine vials that change colour as the vaccine is exposed to heat, letting health workers know whether the vaccine can be safely used,” WHO said in an official release.
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,” it said.
The efficacy of the vaccine for symptomatic and hospitalised patients 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. Nevertheless, WHO is not recommending an upper age limit for the vaccine because preliminary data and supportive immunogenicity data suggests the vaccine is likely to have a protective effect in older persons,” it said.
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