China's Anti-Novel Coronavirus Inactivated Vaccine Now World's First Goes into Clinical Trial

An inactivated vaccine for the novel coronavirus is now under clinical trial and is ready for emergency use as abide by the law, after received clinical trial permission from the National Medical Products Administration (NMPA) on April 12.

As the world's first of its kind put in clinical trial, the anti-novel coronavirus inactivated vaccine was developed by Wuhan Institute of Biological Products Co., Ltd. The institute is a subsidiary of China National Biotec Group (CNBG), which itself is controlled by China National Pharmaceutical Group Co., Ltd. (Sinopharm). 

With the newly developed vaccine, the company has added a strong support to reach the goal of "diagnosis, treatment and prevention" of the pandemic.

CNBG said that it will continue the research to complete the clinical trial as soon as possible and produce safe and effective vaccines for emergency use.

On that emergency basis the vaccine will be mass produced and put into the market to support the world-wide anti-pandemic battle, according to the company.

As early as Jan 19, CNBG launched a research team led by Yang Xiaoming, chief scientist of the Ministry of Science and Technology's vaccine project of China's "863 Program". 

Before the inactivated vaccine project was filed on Feb 1, a total of 1 billion yuan ($141.84 million) was invested as development funds and three institutes were arranged to work on the novel coronavirus vaccine via two technical methods – an inactivated vaccine and a genetic engineering vaccine.

The inactivated vaccine refers to vaccine containing a virus that has lost its ability to infect or to replicate via physical and chemical methods but still has the ability to make people's body develop an immune response.

What's more, compared with other types of vaccines, the inactivated ones have advanced development technologies, mature production procedures, controllable quality standards and more effective protection.

It is currently the most reliable vaccine development method to deal with unexpected epidemic outbreaks.

The newly permitted inactivated vaccine contains inert pathogenic microorganisms but still has immunogenicity and can be used for mass vaccinations. Its security and effectiveness also meet international standards.

The researchers consecutively worked out a series of vaccine production and quality-control techniques including screening the vaccine strains, establishing the virus seed bank, making and identifying the antibodies, testing detection methods, developing production approaches and quickly carrying out effectiveness and security assessment testing on animals.

A CNBG subsidiary institute has also succeeded in developing the nucleic acid test kits and promoted the treatment therapy of using recovered patients' plasma for treatment.

The nucleic acid test kit, developed by Shanghai Geneodx Biotechnology Co Ltd, was one of the first of its kind to obtain certification from NMPA and the European Union's CE marking. 

So far, enough kits for testing more than 1.3 million people have been delivered to many areas on the Chinese mainland, the Hong Kong and Macao special administrative regions as well as some other countries.

The plasma therapy was also recommended by the State Council and was listed as a national joint prevention and control mechanism as well as a National Health Commission diagnosis and treatment program.

By April 7, 2,169 plasma collections had been carried out and the therapy had been used and proven effective in 648 cases. The therapy has now been adopted in many countries.

Other CNBG institutes in Wuhan of Hubei province, Chengdu of Sichuan province, Lanzhou of Gansu province, Changchun of Jilin province as well as those in Beijing and Shanghai are also actively participating in related anti-pandemic medicine projects including test kits, plasma therapy, immune globulin and monoclonal antibody development.

With a mature inactivated vaccine development platform, CNBG introduced several kinds of such vaccines to the market, including those for poliomyelitis, hand-foot-mouth disease (HFMD), tick-borne encephalitis and hemorrhagic fevers, besides an inactivated SARS virus vaccine in 2003. The company's output capacity reached 700 million injections annually.

The world's first inactivated vaccine for the novel coronavirus is now in clinical trial after the authorities' permission on April 12, 2020. [Photo/sasac.gov.cn]

Researchers of the inactivated vaccine at the laboratory [Photo/sasac.gov.cn]

(Executive editor: Zhang Tianyuan)