China’s First COVID-19 Vaccine Listed for Emergency Use

The World Health Organization (WHO) announced it listed the Sinopharm COVID-19 vaccine for emergency use, enabling this vaccine to be rolled out globally.

WHO’s Emergency Use Listing (EUL) is a prerequisite for COVAX Facility vaccine supply. It also allows countries to expedite their regulatory approval to import and administer COVID-19 vaccines. 

The Sinopharm COVID-19 vaccine is the first to 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.

The Sinhopharm (BBIBP-CorV) vaccine works by teaching the immune system to make antibodies against the SARS-CoV-2 beta coronavirus. Inactivated virus vaccines have been used for several decades, such as vaccines against rabies and hepatitis A. 

“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, in a press release. 

“We urge the manufacturer to participate in the COVAX Facility and contribute to the goal of more equitable vaccine distribution.”

The EUL assesses the quality, safety, and efficacy of COVID-19 vaccines and risk management plans and programmatic suitability, such as cold chain requirements. In the case of the Sinopharm vaccine, the WHO assessment included on-site inspections of the production facility.

WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) has also completed its vaccine review.

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. 

The WHO emergency use listing (EUL) procedure assesses the suitability of novel health products during public health emergencies. As part of the EUL process, the company producing the vaccine must generate data to enable full licensure and WHO prequalification. 

The WHO prequalification process will assess additional clinical data generated from vaccine trials and deployment on a rolling basis to ensure the vaccine meets the necessary standards of quality, safety, and efficacy for broader availability.

The Sinopharm vaccine is produced by Beijing Bio-Institute of Biological Products Co Ltd, a subsidiary of China National Biotec Group (CNBG). 

The WHO also listed the Pfizer - BioNTech vaccine for emergency use on 31 December 2020; two AstraZeneca/Oxford COVID-19 vaccines on 15 February 2021, produced by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India; and COVID-19 vaccine Ad26.COV2.S was developed by Janssen (Johnson & Johnson) on 12 March 2021.

The SAGE Interim Recommendations can be found on this webpage.  

Note: Headline edited for clarity and added further vaccine description: 'The Sinhopharm (BBIBP-CorV) vaccine works by teaching the immune system to make antibodies against the SARS-CoV-2 beta coronavirus. Inactivated virus vaccines have been used for several decades, such as vaccines against rabies and hepatitis A.'

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