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Hind Al Soulia - Riyadh - GENEVA — The World Health Organisation (WHO) on Friday gave an emergency use listing to Sinopharm, China's COVID-19 vaccine, making it the sixth vaccine to receive WHO validation for safety, efficacy and quality, the UN health agency said in a press release.
“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 is produced by Beijing Bio-Institute of Biological Products Co Ltd, a subsidiary of China National Biotec Group (CNBG).
Commenting on the WHO's nod to the vaccine, Director-General Dr. Tedros Adhanom Ghebreyesus tweeted on Friday, saying: "WHO urges governments to offer incentives to manufacturers to share technology & know-how. And we encourage countries with the most vaccines to donate doses through COVAX, which is the fastest & most equitable way to increase the distribution of vaccines globally."
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 by 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.
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.
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