China’s First Recombinant Protein Subunit COVID-19 Vaccine Received Conditional Marketing Approval

On March 1, 2022, the Recombinant COVID-19 Vaccine (CHO Cell) developed by Zhifei Longcom has received Conditional Marketing Authorization (CMA) from the National Medical Products Administration (NMPA). It is China’s first approved recombinant protein subunit vaccine for preventing diseases caused by COVID-19.  

（Source：NMPA Website） 

Recombinant COVID-19 Vaccine (CHO Cell)

The vaccine is jointly developed by Zhifei Longcom Biopharmaceutical Co., Ltd. and the Institute of Microbiology, Chinese Academy of Sciences. By using genetic engineering, the Recombinant COVID-19 Vaccine (CHO Cell) expresses and purifies pathogen antigen protein in engineering cells.

Data analysis of overseas phase III clinical trials as of June 30, 2021 shows that:

•  7 days after the three doses, the vaccine efficacy in people over 18 years old is 81.43% against COVID-19 of any severity. (95% confidence interval 73.35% to 87.38%). The vaccine efficacy against COVID-19 including severe and critical disease cases is 92.87%.  Analysis of variants of COVID-19 showed that, the vaccine efficacy 7 days after full vaccination was 81.38% against Delta variant.    

The Recombinant COVID-19 Vaccine (CHO Cell) has received marketing authorization or emergency use approval in many countries:

• On March 1, 2021, it received marketing authorization in Uzbekistan, became the world’s first approved recombinant COVID-19 vaccine.
• On March 10, 2021, it received Emergency Use approval (EUA) in China.
• On October 7, 2021, it received EUA in Indonesia.
• On January 10, 2022, it received approval as heterologous booster for inactivated COVID-19 vaccine in Indonesia.
• On January 22, 2022, it received EUA in Colombia.
• On February 19, 2022, it received approval as heterologous booster for inactivated COVID-19 vaccine in China.
• On March 1,2022, it received CMA in China.   

What is the difference between emergency use and conditional approval?

Emergency use   

According to Article 20 of the Law of the People’s Republic of China on Vaccine Administration, in the event of a public health emergency of special importance or other emergencies that seriously threaten public health, the competent health department of the State Council may propose the emergency use of vaccines according to the needs for the prevention and control of infectious diseases, and may use them within a certain scope and period of time after the State Council's drug supervision and management department has organized and approved the demonstration.

Conditional approval  

According to Article 20 of the Law of the People’s Republic of China on Vaccine Administration, if the benefits of vaccines urgently needed in response to major public health emergencies or other vaccines urgently needed as determined by the competent health department of the State Council outweigh the risks after assessment, the State Council's drug supervision and management department may approve the application for vaccine registration with conditions.
There are also relevant provisions in the Law of the People’s Republic of China on Drug Administration. Article 26 stipulates that for the treatment of diseases that are seriously life-threatening and have no effective means of treatment, as well as drugs urgently needed in public health, if the data of drug clinical trials have shown the curative effect and can predict its clinical value, approval may be granted with conditions, and the relevant matters shall be set forth in the drug registration certificate.