China’s drug regulator says vaccines must have 50 percent efficacy to be approved

pharmafile | August 17, 2020 | News story | Sales and Marketing COVID, China, coronavirus, vaccines 

The Chinese Centre for Drug Evaluation (CCDE) has said that coronavirus vaccines must show 50 percent efficacy to be approved. 

The CCDE also said companies would have to prove their vaccines could provide immunity from the virus for a minimum of six months and be effective for 70 percent of the population. 

The regulatory body also has stated that vaccines must be free of the risk of antibody dependent enhancement. The concern is that infections may be worsened after inoculation as antibodies that are generated by the vaccine will bind to the COVID-19 virus without neutralising it and could actually enhance its ability to enter cells. 

Wang Huaqing, a leading immunologist at the CCDE, told the South China Morning Post  that it should be possible to identify these types of risks through the three phases of clinical trials. 

These guidelines are generally aligned with those put out by both the World Health Organization and the American FDA, and the CCDE said it collaborated directly with the WHO in putting out these rules. However, the FDA does not have a requirement for the minimum period of immunity. 

Four Chinese vaccines are currently in the final testing phase in Indonesia, United Arab Emirates, Brazil and Saudi Arabia, while 29 vaccines candidates are currently in clinical evaluations throughout the world. 

Conor Kavanagh

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