(Fighting against New Coronary Pneumonia) Chinese experts: Emergency approval of New Coronavirus vaccine will not reduce safety standards
China News Agency, Beijing, April 14 (Reporter Sun Zifa) At the press conference of the Joint Defense and Joint Control Mechanism of the State Council on the 14th, Wang Junzhi, an academician of the Chinese Academy of Engineering, pointed out that even in the case of emergency approval, it is safe and effective for the new coronavirus vaccine Nor can the evaluation criteria for sex be reduced.
Recently, two new inactivated vaccines against coronavirus in China have been approved by the National Drug Administration for phase one or two combined clinical trials, and related clinical trials have started simultaneously. This is China's first batch of new inactivated coronavirus vaccines that have received clinical research approvals.
"Our country has a relatively good foundation in the preparation of inactivated vaccines." Wang Junzhi said that at the beginning of the New Coronary Pneumonia epidemic, China was the first to isolate virus strains, and coordinated R & D units through joint defense and joint control mechanisms, using high biological safety Production conditions (P3 laboratory), a large number of live virus cultivation, so that the basic conditions for vaccine development.
He also introduced that experts from various departments had early intervention and full guidance, especially guiding enterprises to complete pre-clinical animal experiments, including safety-related acute toxicity experiments, repeated toxicity experiments, immunogenicity experiments, and animal challenge protection Test etc. After the above work is completed, the three batches of clinical trial samples produced will also be subject to inspection by the China Food and Drug Administration.
In this process, all the application materials are submitted for rolling at the same time, in accordance with the special approval procedures of the State Food and Drug Administration, and in accordance with the relevant technical requirements for approval. After meeting the requirements of the emergency approval clinical trial, it is approved to enter the clinical trial.
It is known that three new coronavirus vaccines have been approved for clinical trials in China. In addition to the speed of emergency approval, the safety and effectiveness of vaccines are also highly concerned by society.
Wang Junzhi said that the vaccine is a special product for healthy people, "safety is the first priority." The emergency approval process always respects science and follows the rules, with safety and effectiveness as the fundamental policy. Many R & D steps are changed from series to parallel, research and review are linked, and R & D materials are submitted on a rolling basis, followed by review and evaluation. On the premise of not lowering the standards, the efficiency of R & D and review has been greatly improved.
He also said that the safety of vaccines is mainly determined by pre-clinical research. Related animal experiments must be completed in accordance with relevant regulations and technical requirements. Only after reaching the prescribed requirements can they be approved for clinical trials to fully ensure the safety of the subjects. Even in the case of emergency approval, the evaluation criteria for the safety and effectiveness of vaccines cannot be reduced. (Finish)