The fight against Covid-19 has received a major boost after the World Health Organization approved China's Sinopharm vaccine for emergency use.
The WHO gave approval for it 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.
WHO says the vaccine can be stored at refrigerator — not freezer — temperatures, making it suitable for areas with limited resources.
The vaccine is the first with a vial monitor that changes colour when the vaccine is overheated and unusable.
“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,” Dr Mariângela Simao said.
Simao is the 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,” Simao added.
The listing makes the vaccine accessible through the Covax Facility vaccines supply platform. National regulatory agencies can develop their own regulations for approval to administer and import the vaccine.
Other vaccines approved by the WHO include AstraZeneca, Pfizer, Johnson and Johnson and Moderna.
The Emergency Use Listing assesses the quality, safety and efficacy of Covid-19 vaccines, as well as risk management plans and programmatic suitability, such as cold chain requirements.
WHO said the assessment is performed by its product evaluation group. It includes regulatory experts from around the world and a Technical Advisory Group that performs risk-benefit assessment for an independent recommendation on emergency use and required conditions.
“In the case of the Sinopharm vaccine, the WHO assessment included on-site inspections of the production facility," it said.
WHO recommends the vaccine for adults 18 years and older, in a two-dose schedule with a spacing of three to four weeks.
The vaccine efficacy was estimated to be 79 per cent among symptomatic and hospitalised patients in all age groups combined.
(Edited by V. Graham)
