China is steadily moving forward with research and development of COVID-19 vaccines in a safe and effective manner, with several potential solutions reaching final clinical trials and expected to be launched later this year, experts said.
These comments follow an official statement by drug supervision authorities on Friday regarding the technical guidelines for the novel coronavirus preventive vaccine development, which outline the conditions for vaccines to be released to market.
In order to speed up the vaccine development and listing process, changes to clinical trials and immunity programs post-listing may be considered, according to the statement by the National Medical Products Association.
Vaccine efficiency should be evaluated through phase III clinical trials. Safety risks of vaccine products and the risks associated with vaccination should also be assessed. If the vaccine is sufficiently effective and reaches an acceptable level of safety, it will be eligible for market approval, the statement said.
After a vaccine is marketed, the safety and clinical efficacy of the vaccine should be continuously observed in the context of large-scale vaccination, and protection persistence should continue to be studied.
Other countries are also accelerating their market launch of vaccines.
Russia has received a request for the production of one billion doses of a COVID-19 vaccine from 20 nations, said Kirill Dmitriyev, head of the Russian Direct Investment Fund that finances the vaccine project, AFP reported on August 11.
Meanwhile, Indian Prime Minister Narendra Modi announced on the country’s Independence Day celebrations on Saturday that India has made plans for mass-producing a COVID-19 vaccine once scientists give the green light, Hindustan Times reported.
Despite recognizing Russia’s encouraging approach to accelerated vaccine approval, Chinese experts noted that it is unlikely Chinese companies would follow Russia’s process, as China has effectively suppressed its domestic epidemic, allowing sufficient time to ensure safety and efficacy in vaccine development.
China’s first COVID-19 vaccine patent, jointly filed by PLA major general Chen Wei and CanSino Biologics Inc, has been granted. The patent was filed on March 18 and authorized on August 11, according to a report by the State Intellectual Property Office, Jiemian News reported Sunday.
Tian Hongjian, a director with the China Medicinal Biotech Association, told the Global Times that a Chinese-developed vaccine will likely enter the market by the end of this year, ahead of schedule.
“Now the production line for the vaccine in China is already in place, but we want to ensure the safety and clinical efficacy of the vaccine before launching it on the market,” Tian said, noting that China is already speeding up the process and cannot go faster in order to guarantee its safety.
Once phase III is complete, it can be listed on the market, he said.
Zhong Nanshan, a renowned respiratory disease expert, said while attending the China-Russia COVID-19 academic exchange conference, held in South China’s Guangdong Province, that the fatality rate in Russia is low, about 1.7 percent, and some of its technologies and strategies are worth learning. China has its own unique methods of fighting the epidemic, especially in traditional Chinese medicine, the 21jingji.com reported on Sunday.
China and Russia have plans to jointly carry out clinical trials of vaccines, noted Zhong.
According to China’s Ministry of Industry and Information Technology (MIIT), as of July 23 a total of 13 enterprises in China have launched construction of assembly lines for the production of COVID-19 vaccines, while nine Chinese enterprises have received regulatory approval to start vaccine clinical trials.
vaccine Photo:VCG
