Vaccines safety guidelines

Prevention of influenza Safety and efficacy of zanamivir have not been established for prophylactic use to prevent influenza. Use of zanamivir should not affect the evaluation of individuals for annual influenza vaccination in accordance with guidelines of the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices. 

Essential medicines are those medicines and vaccines that satisfy the most common and important health care needs of the population. An essential medicines list (EML) makes medicine management easier in every respect - procurement, storage, distribution, prescribing and dispensing. The national EML should be determined by national treatment guidelines. Selection of essential medicines for the list is based on clear criteria of efficacy, safety, quality, cost and cost-effectiveness, and the list should be regularly updated. 

A safety assessment needs to be tailored to each individual investigational vaccine (case-by-case) and will need to consider the type of vaccine, its components (e.g., presence of a novel adjuvant), the clinical dose, and the schedule and route of administration. There are three key guidelines concerned with the safety of... 

In this respect, rDNA products are considered to be similar to biologicals produced by traditional methods, such as bacterial and viral vaccines, where adequate control of the starting materials and manufacturing procedure is just as necessary as that of the product. The guidelines therefore place considerable emphasis on in-process controls for ensuring the safety and effectiveness of the product, as well as on the comprehensive characterization of the final product itself. The validation of certain aspects of the manufacturing process, such as the ability of the purification procedure to remove unwanted materials, e.g., DNA, is also considered to be essential. 

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