Chinese biopharmaceutical firm CanSino Biologics Inc announced on Monday that a recombinant novel coronavirus vaccine (Ad5-nCoV) the company developed with a military research team has received special one-year military drug approval.
The approval for the military use of Ad5-nCoV was granted by the Health Bureau of the Logistics Support Department of the Central Military Commission on June 25, for one year, the company said in a statement sent to the Global Times on Monday. Ad5-nCoV is currently limited to military use and cannot be expanded to a broader vaccination range without the approval of the Logistics Support Department, the statement said.
Ad5-nCoV is being jointly developed by CanSino and a team led by military infectious disease expert Chen Wei from the Institute of Biotechnology under the Academy of Military Medical Sciences.
The vaccine was approved for clinical trials in March. Phase one and two clinical trials for Ad5-nCoV have been conducted in China, with phase two trials were unveiled on June 11, 2020, according to CanSino. Data from the clinical trials showed a good safety profile and high levels of humoral and cellular immune responses. The overall clinical results indicate Ad5-nCoV has the potential to prevent diseases caused by SARS-CoV-2. According to regulations of the Chinese People’s Liberation Army (PLA) covering drugs, special military drugs are those that the military uses to prevent and treat war injuries and diseases in special military environments.
Such drugs are limited to military use. Local medical institutes have to obtain the approval of local provincial-level governments and the military logistics support department to use such drugs, according to the regulations.
Li Daguang, a professor at the National Defense University of the PLA, told the Global Times on Monday that the approval process for Ad5-nCoV to become a special military drug followed the normal procedures.
The move is mainly intended to encourage and promote COVID-19 vaccine research and development (R&D) amid the current tough pandemic situation, according to Li.
Global infections reached 10,180,816 as of press time after the number topped 10 million on Sunday, according to Johns Hopkins University’s tracking of the data.
Li noted that the status of “special military drug” would not affect the normal R&D procedure and marketing process of the vaccine.
Special military drugs have to obtain the approval of the military logistics support department and China’s national drug supervision department before being used for civilians, according to the regulations.
CanSino announced in May that it had obtained approval from the Canadian National Research Council to conduct clinical trials for Ad5-nCoV, though it didn’t disclose further details.
Source: Global Times