Publications by authors named "Shin Okuda"
Routine vaccinations help prevent the outbreak and spread of infectious diseases; however, it can take up to ten years from vaccine approval to introduction into routine vaccination schedules in Japan. Here, we investigate the information required to introduce an approved vaccine into routine vaccination schedules and the reasons why it takes so long. Based on the published data of the Immunization and Vaccine Committee of the Health Science Council, we set out to explore ways to facilitate discussion on this topic.
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- - The study explores the unique challenges in vaccine development, particularly in Japan, highlighting the need for distinct approaches compared to therapeutics, due to the preventive nature of vaccines and their administration to healthy individuals.
- - Through a survey and comparison of guidelines, key issues identified include the need for protective efficacy trials, challenges in evaluating combination vaccines, and the complexities of conducting multiregional trials, especially for older adults and immunocompromised patients.
- - The paper suggests evaluating new vaccines through multiregional trials, utilizing licensed combination vaccines as comparators, and proposing methods to assess the efficacy of vaccines in non-major groups by correlating immunogenicity with known protective effects.
Article Synopsis
- - The effectiveness and safety of vaccines are primarily assessed by their ability to generate an immune response, rather than the dosage used, indicating the need for specific considerations in vaccine development according to Japanese guidelines.
- - Recent global developments in vaccine creation, including the introduction of foreign vaccines and a broader international approach, have highlighted the necessity to update these guidelines.
- - A study revealed challenges in Japan's vaccine development process, particularly around non-clinical studies, and recommended aligning Japan's guidelines with international standards to facilitate more efficient and rational vaccine development.
Tactile sensation is one type of valuable feedback in evaluating a product. Conventionally, sensory evaluation is used to get direct subjective responses from the consumers, in order to improve the product's quality. However, this method is a time-consuming and costly process.
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