China approves three COVID-19 vaccines for clinical trials

The second phase will recruit 500 volunteers and introduce the placebo control group to further evaluate the immunogenicity and safety of the vaccine. As of 5 p.m. on April 13, 273 volunteers had been vaccinated.

An inactivated vaccine candidate developed by the Wuhan Institute of Biological Products under the China National Pharmaceutical Group (Sinopharm) and the Wuhan Institute of Virology under the Chinese Academy of Sciences was approved for clinical trials on April 12, Wu said.

Another inactivated vaccine candidate developed by Sinovac Research and Development Co., Ltd., a company based in Beijing, was approved on April 13, he added.

Using killed pathogenic microorganisms to enhance the immunogenicity, inactivated vaccines have advantages of mature production process, controllable quality standards and wide protection range, according to Wang Junzhi, an academician with the Chinese Academy of Engineering.

To produce the vaccine, researchers cultivate live viruses on a large scale in P3 laboratories, which have relatively high biosafety standards, Wang said.

Experts have been invited to give whole-process direction in the preclinical animal experiments of the vaccines, including acute toxicity experiments, repeated toxicity experiments and immunogenicity experiments, he said.

Sample vaccines for clinical trials have passed inspections by the Food and Drug Administration and the National Institutes for Food and Drug Control, he added.
China has laid a solid foundation for research into inactivated vaccines over recent years. Inactivated vaccines have been widely used to fight hepatitis A, influenza, hand-foot-and-mouth disease and poliomyelitis, he said.

The safety and effectiveness of inactivated vaccines can be judged by internationally accepted standards, Wu said.

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Source: Xinhua