Abstract: Objective We explaine the considerations of "contraindications" "precautions" and "special groups" in vaccine instructions , to provide reference for vaccine enterprises and vaccine users; and analyze the problems with drafting, revision, management and use of vaccine instructions, to promote the improvement of the content of vaccine instructions in China, so as to guide the rational clinical use of vaccines. Results Based on the requirements of related regulations at home and abroad, given the current clinical research on vaccines and clinical practice in China, this paper explained the considerations of "contraindications" "precautions" and "special groups" in vaccine instructions, and explained the purpose of the safety section in the vaccine instructions is not to restrict the use of the vaccine, but to give full play the vaccine public health value under controllable security. Conclusion The improvement of vaccine instructions is not only a regulatory requirement, but also a process of continuously enriching scientific cognition. In order to change the problem of safety-related items in the vaccine instructions, it is necessary for all departments to make joint efforts.

Key words: vaccine, instructions, contraindication, precaution, special groups