China grants conditional market approval for Sinopharm CNBG’s COVID-19 vaccine

The inactivated COVID-19 vaccine developed by Beijing Institute of Biological Products of Sinopharm CNBG has been granted conditional registration by the NMPA of China, Chinese equivalent of FDA, according to a press conference of the State Council Joint Prevention and Control Mechanism on December 31, 2020,

Over 60,000 volunteers of 125 nationalities have participated in the Phase III clinical trial of Sinopharm CNBG in countries outside China including UAE and Bahrain. The vaccine’s efficacy rate based on interim analysis is higher than the target set at the beginning, and its safety and effectiveness performances also exceed the standard level of both WHO for market approval and the Chinese regulatory authority for conditional market approval, which entitles the vaccine a general public use in China.

Aside from China, Sinopharm CNBG’s COVID-19 vaccine was announced to be officially registered in UAE and Bahrain on December 9 and 12 respectively, based on the results of Phase III clinical trials indicating 86% efficacy rate, 99 % seroconversion rate of neutralizing antibody and 100% effectiveness in preventing moderate and severe cases of COVID-19.

Because the standards of diagnosis of infection cases and review process of Phase III clinical trial vary in different countries, the 86% efficacy rate announced by UAE and 79.34% by China are both real and valid.

A vaccine against COVID-19 should be evaluated comprehensively in various aspects such as safety, effectiveness, accessibility and affordability. Safety is undoubtedly the premise, on which the performance in effectiveness also matters to a large extent. Others including manufacturing capacity, storage and logistics conditions, targeted population should also be considered.

Generally speaking, Sinopharm CNBG’s COVID-19 vaccine has shown comprehensive strengths. A large sample of injection and data prove its safety and effectiveness. Besides, the vaccine doesn’t require freezing temperatures for storage, making transport and distribution much easier for most of the countries in the world. Its capacity is also large enough for massive inoculation.

The Chinese approved COVID-19 vaccine adds to the world’s faith in beating the pandemic. As defined by the Chinese government to be a global public good, Sinopharm CNBG COVID-19 vaccine will make its own contribution to the global fight against the coronavirus disease in the future.

About Sinopharm
China National Pharmaceutical Group Co., Ltd. (Sinopharm) is a large healthcare group directly under the State-owned Assets Supervision and Administration Commission (SASAC) of the State Council, with 128,000 employees and a full chain in the industry covering R&D, manufacturing, logistics and distribution, retail chains, healthcare, engineering services, exhibitions and conferences, international business and financial services.

Sinopharm owns over 1,100 subsidiaries and 6 listed companies which are Sinopharm Group Co., Ltd. (Sinopharm Holding), China National Medicines Corporation Ltd., China National Accord Medicines Corporation Ltd., Beijing Tiantan Biological Products Co., Ltd., Shanghai Shyndec Pharmaceutical Co., Ltd., and China Traditional Chinese Medicine Holdings Co., Ltd.