TwoSessions: Legalizing human challenge study suggested

▶ Testing to accelerate vaccine research but concerns rise over health risks

A political advisor suggested that China legalize human challenge study, a controlled human infection trial, for novel coronavirus and pathogens that have not been found in the country to enhance early research and development capability of vaccines, following the UK’s plan to run a COVID- 19 human challenge study.

Articles allowing human challenge study and clinical trials in the event of an emergency should be included in drug administration law and vaccine administration law to clarify the legal status of human challenge testing, Zhu Tongyu, a member of the National Committee of the Chinese People’s Political Consultative Conference ( CPPCC) and director of Shanghai Public Health Clinic Center, the designated hospital for COVID- 19 treatment and therapy in Shanghai, told the Global Times.

The drug regulatory authority should issue feasible ethical review guidelines for human challenge testing based on the related guidelines of the World Health Organization ( WHO), Zhu said.

It is of special significance at present to conduct clinical research on human challenge studies, establish an open national scientific research infrastructure and platform, and enhance early research and development capability of vaccines, Zhu said.

“It’s inevitable that the mutated coronavirus strains that have not been discovered in China but have spread abroad will enter China. In the long run, China cannot just rely on quarantine and travel restrictions to prevent the imported virus. Instead, we have to be scientifically prepared before the virus arrives,” Zhu said.

Human challenge testing is able to greatly accelerate the selection of vaccine candidates that are expected to enter phase II and III clinical trials, according to Zhu.

Beijing in January reported a new coronavirus variant previously found in the UK, when the ability of Chinese vaccines to protect against the variant remained unknown, and the response at that time was rather passive as we had not made early technological preparations for a variant, Zhu said.

Britain decided to launch COVID- 19 human challenge studies in February, targeting overseas variants that have not been imported into the country.

A working group from the WHO issued the guidance on COVID- 19 human challenge studies in May 2020, in which it outlined key criteria that would need to be satisfied in order for such studies to be ethically acceptable.

Human challenge studies must be carefully designed and conducted in order to minimize harm to volunteers and preserve public trust in research, and COVID- 19 challenge studies may involve higher levels of risk and uncertainty than other commonly accepted human challenge studies because the pathogenesis of COVID- 19 is currently poorly understood, the guidance said.

Prior to the UK’s COVID- 19 challenge study, human challenge studies have been used to develop treatments for diseases including malaria and cholera.

However, Chinese netizens are split over whether such studies should be carried out. Some objected to it, citing ethical issues and possible irreversible harm to participants, suggesting such studies can only be conducted to deepen understanding of diseases for which human beings have effective drugs to cure volunteers.