China’s drug regulator the National Medical Products Administration approved on Thursday the registration application of a domestically produced recombinant COVID-19 vaccine with conditions.
The vaccine was developed by a research team under the Academy of Military Sciences and CanSino Biologics Inc., a Chinese high-tech biopharmaceutical company.
Led by Chen Wei, a researcher at the academy’s Institute of Military Medicine, the team developed the recombinant COVID-19 vaccine with the modified defective adenovirus as the vector.
The National Medical Products Administration requires Chen’s team to continue its relevant research work, fulfill the requirements for conditional marketing approval, and submit follow-up research results in a timely manner.
“Among the COVID-19 vaccines granted market approval by China, our vaccine is the only such product to require a single dose instead of two. With a single dose inoculation, both the cellular and humoral immunity of the human body will be activated. It will achieve good protection results after only 14 days. Besides, the vaccine can be transported and stored at two to eight degrees Celsius,” said Hou Lihua, Chen’s colleague.
On March 16, 2020, the vaccine started Phase I clinical trials in Wuhan City, central China’s Hubei Province. At that time, it was the world’s first COVID-19 vaccine candidate to enter clinical trials. On February 8, 2021, an interim analysis of Phase III trial data was completed for the vaccine.
In Phase III trials conducted in Pakistan, the vaccine showed a 100 percent efficacy rate in preventing severe COVID-19 cases 28 days after a single dose inoculation, and the overall efficacy rate stood at 74.8 percent.
The vaccine has already obtained emergency use approval from Pakistan and Mexico.
Chen hopes that the new vaccine will help not only China, but the world in its efforts to contain the spread of COVID-19.
“I want to thank every volunteer and relevant departments who worked with us around the clock to develop the COVID-19 vaccine. The battle against the virus is a test for our team. We hope that China’s scientific and technological innovations will make a strong contribution to world pandemic control efforts,” said Chen.
China has granted conditional market approval to four self-developed COVID-19 vaccines, Minister of Science and Technology Wang Zhigang said Friday.
China has adopted five technological approaches in developing COVID-19 vaccines. China now has 17 self-developed COVID-19 vaccines undergoing clinical trials, with seven undergoing phase-3 clinical trials, Wang told a press conference held in Beijing.
China has also included 11 drugs and treatment methods in its diagnosis and treatment plan for COVID-19, Wang added. (CCTVPlus)