The World Health Organization added China’s Sinopharm to its list of COVID-19 vaccines approved for emergency use on Friday, providing the COVAX Facility with another option for broadening access to vaccines globally.
It is the sixth shot that the United Nations health agency has added to an international arsenal of medicines, vaccines and diagnostics against the coronavirus pandemic. The emergency use listing helps expedite regulatory approval processes and enables international organizations to distribute vaccine in places where it is most needed.
WHO’s announcement sends a signal that China’s vaccine is safe to use, though the emergency listing is not meant to replace the approval process of national regulators. The Sinopharm COVID-19 vaccine is produced by the Beijing Bio-Institute of Biological Products, a subsidiary of the China National Biotec Group. WHO said it is estimated to be 79 percent effective against patients who have symptoms or are hospitalized.
“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, a Brazilian pediatrician and WHO’s 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 emergency use listing procedure assesses the quality, safety & efficacy of #COVID19 vaccines, as well as risk management plans & programmatic suitability, such as cold chain requirements. For the Sinopharm vaccine, on-site inspections of the production facility were conducted pic.twitter.com/p7eM9wHZ8a
— World Health Organization (WHO) (@WHO) May 7, 2021
The emergency use listing looks at the quality, safety and efficacy of COVID-19 vaccines, along with risk management plans and other factors, WHO said. It is conducted by a product evaluation group that includes regulatory experts and technical advisers.
WHO’s first such listing since the pandemic began was on December 31 for Pfizer-BioNTech’s two-shot coronavirus vaccine Comirnaty®. Then on February 15 it listed two more two-shot vaccines for emergency use, both from AstraZeneca, as a further step towards broadening access to vaccines globally. On March 12 it listed another shot, Johnson & Johnson’s Janssen COVID-19 vaccine. And on April 30 it listed the Moderna vaccine for emergency use. Both the Pfizer-BioNTech and Moderna two-dose vaccines use the brand-new messenger RNA, or mRNA technology. Neither were made with the coronavirus itself, so no one could catch COVID-19 from them.
This sixth listing expands the number of COVAX Facility vaccines that can be distributed to low-income and developing countries. COVAX, co-led by WHO, Gavi, the Vaccine Alliance and the Coalition for Epidemic Preparedness Innovations, is part of the Access to Covid-19 Tools (ACT) Accelerator, a global collaboration among 10 international organizations to provide coronavirus tests, medicines and vaccines worldwide.
With the Sinopharm vaccine, WHO said its assessment included on-site inspections of the production facility. It also is the first vaccine that will carry a small sticker on vaccine vials that changes color as the vaccine is exposed to heat. That is used to let health workers know whether it is safe to use. WHO recommended China’s COVID-19 two-dose vaccine for adults 18 years and older, though it noted a paucity of data on patients older than 60 “so efficacy could not be estimated in this age group.”