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Saturday, July 24th, 2021

WHO approves China’s Sinopharm COVID-19 vaccine for emergency use globally

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The World Health Organization (WHO) added the Sinopharm COVID-19 vaccine produced by Beijing Bio-Institute of Biological Products Co Ltd. to the list of vaccines approved for emergency use worldwide last week, giving a potential new source and new boost for efforts by the COVAX initiative.

“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 Simão, WHO Assistant-Director General for Access to Health Products, said. “We urge the manufacturer to participate in the COVAX Facility and contribute to the goal of more equitable vaccine distribution.”

Countries will now be able to hasten their own regulatory approval to import and administer the Sinopharm COVID-19 vaccine as a result. The emergency use listing followed assessments of quality, safety and efficacy, risk management plans, and the ability to follow things like cold chain requirements. On-site inspections of the vaccine production facility were conducted, and the whole process was pursued by regulatory experts and the Technical Advisory Group, which conducted a risk-benefit assessment.

The WHO Strategic Advisory Group of Experts on Immunization (SAGE) recommended the vaccine for adults aged 18 years and older, issued in two doses. Comparative to some other COVID-19 vaccines, those doses should be spaced approximately three to four weeks apart. All told, the vaccine has an efficacy of approximately 79 percent, lower than vaccines from Pfizer and Moderna, for example, but higher than those put out by Johnson and Johnson and AstraZeneca.

While a potential bolster for the WHO’s global vaccination efforts, it is also a watershed moment for China, marking the first time a Chinese-produced vaccine has ever received emergency authorization from the WHO and the global recognition for its pharmaceutical research that comes with that fact.

Sinopharm is an inactivated vaccine that can be easily stored even in low-resource settings. It also comes with a vaccine vial monitor that changes color based on the vaccine’s exposure to heat to immediately and easily notify health workers whether it’s safe for use. However, due to lack of sufficient data, WHO recommends countries using the vaccine in older age groups conduct safety and effectiveness monitoring to further bolster the vaccine’s recommendation.