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2021-05-10| ChinaCOVID-19

COVID-19: WHO Grants Worldwide Emergency Use Approval for First Chinese Vaccine

by Rajaneesh K. Gopinath
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On May 7th, the World Health Organization (WHO) approved the COVID-19 vaccine developed by China’s state-owned drugmaker Sinopharm for emergency use worldwide. This is the first instance of a vaccine developed by a non-Western country to receive the agency’s nod. It also became the first Chinese vaccine to notch emergency use authorization from WHO for any infectious disease.

“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.”

Sinopharm Vaccine Enters COVAX

The Sinopharm product is an inactivated vaccine called SARS-CoV-2 Vaccine (Vero Cell). The emergency approval allows it to be included in COVID-19 Vaccines Global Access (COVAX), which aims to supply vaccines mainly for poor countries. The global initiative already includes COVID-19 vaccines developed by Pfizer/BioNTech, Oxford/AstraZeneca, Johnson & Johnson, and Moderna.

“This expands the list of COVID-19 vaccines that COVAX can buy and gives countries confidence to expedite their own regulatory approval and to import and administer a vaccine,” said WHO Director-General Tedros Adhanom Ghebreyesus in a press briefing.

The WHO’s technical advisory group (TAG) assessed whether the vaccine’s clinical data and manufacturing practices met the required standards for emergency use recommendation. For Sinopharm’s vaccine, the assessment included on-site inspections of the production facility, the agency said in a statement.

“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.” the statement read.

The agency is also expected to decide on China’s other COVID-19 vaccine, made by Sinovac Biotech. Last week, the EMA’s Committee for Medicinal Products for Human Use (CHMP) initiated a rolling review of Sinovac’s COVID-19 vaccine. This also marked the first Chinese vaccine that the EMA is studying in real-time.

Related Article: India Approves Oral COVID-19 Drug for Emergency Use to Abate Oxygen Crisis

 

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