In terms of scientific research and production, the state organizes vaccine marketing license holders, scientific research institutions and medical and health institutions to jointly tackle key problems and develop vaccines urgently needed for disease prevention and control; Encourage vaccine marketing license holders to increase investment in R&D and innovation, optimize production technology, improve quality control level, and promote vaccine technology progress; Encourage qualified medical institutions and disease prevention and control institutions to carry out clinical trials of vaccines according to law.
Judging from the review and approval, the Vaccine Management Law stipulates that the drug supervision and administration department of the State Council should give priority to the review and approval of vaccines and innovative vaccines urgently needed for disease prevention and control; The vaccine urgently needed to deal with major public health emergencies or other vaccines urgently needed as determined by the health authorities in the State Council, if the benefits outweigh the risks after evaluation, the drug supervision and administration department in the State Council can conditionally approve the application for vaccine registration; In the event of a particularly serious public health emergency or other emergencies that seriously threaten public health, the health authorities in the State Council put forward suggestions for emergency use of vaccines according to the needs of prevention and control of infectious diseases, which can be used urgently within a certain scope and time limit after being approved by the drug supervision and administration department in the State Council.
In addition, the Vaccine Management Law stipulates that vaccines that are urgently needed to prevent and control the epidemic situation of infectious diseases or respond to emergencies are exempted from batch issuance with the approval of the drug supervision and administration department of the State Council.
In ensuring the supply of vaccines. Article 69 of the Vaccine Management Law stipulates that when an infectious disease breaks out and is prevalent, the holder of the relevant vaccine marketing license shall timely produce and supply vaccines for the prevention and control of infectious diseases. Transport units should give priority to the transport of vaccines for the prevention and control of infectious diseases. The people's governments at or above the county level and their relevant departments shall do a good job in organization, coordination and guarantee. Article 65 stipulates that when there is a risk of vaccine supply shortage, the health authorities in the State Council and the drug supervision and administration departments in the State Council shall put forward suggestions, and the competent departments of industry and information technology in the State Council and the finance department in the State Council shall take effective measures to ensure vaccine production and supply.
Yuan Jie said that the vaccine management law also provides for ensuring vaccine quality and standardizing vaccination. COVID-19 should fully implement the provisions of the Vaccine Management Law and other laws and administrative regulations in vaccine development, production, circulation, vaccination and its supervision and management activities.
It is understood that five vaccine research and development technical routes are being carried out simultaneously, namely inactivated vaccine, recombinant subunit vaccine of genetic engineering, adenovirus vector vaccine, nucleic acid vaccine and attenuated influenza virus vector vaccine. At present, some projects have entered the animal experimental stage, and some vaccines can enter the clinical trial stage as early as April-May this year.