Immunization Office, Health Service Division, Health Service Bureau, Ministry of Health, Labour and Welfare of Japan, 1-2-2, Kasumigaseki, Chiyoda-ku, Tokyo 100-8916, Japan.
Influenza Technical Committee, The Japan Association of Vaccine Industries, 2-14-4, Uchikanda, Chiyoda-ku, Tokyo 101-0047, Japan.
Vaccine. 2023 Jul 12;41(31):4625-4631. doi: 10.1016/j.vaccine.2023.05.070. Epub 2023 Jun 7.
In Japan, the Ministry of Health, Labour and Welfare (MHLW) designates one specific virus strain for each component of the quadrivalent seasonal influenza vaccine, and four domestic manufacturers produce egg-based influenza vaccines with the same formulation (inactivated, split-virus) using uniform vaccine strains. Thus, discussions of the development of effective seasonal influenza vaccines so far has focused solely on the antigenic match between the vaccine strains and epidemic viruses. However, in 2017, the Japanese selection system of vaccine viruses demonstrated that even a candidate vaccine virus that is antigenically similar to the predicted circulating viruses is not necessarily suitable for vaccine production, given lower productivity of the vaccine. Taking this experience into account, the MHLW reformed the scheme of vaccine strain selection in 2018, and instructed the Vaccine Epidemiology Research Group created by the MHLW to probe how the virus strains for the seasonal influenza vaccine should be selected in Japan. In this context, a symposium, entitled "Issues of the Present Seasonal Influenza Vaccines and Future Prospects", was held as part of the 22nd Annual Meeting of the Japanese Society for Vaccinology in 2018, and subjects related to the influenza vaccine viruses were discussed among relevant administrators, manufacturers, and researchers. This report summarizes the presentations given at that symposium in order to convey the present scheme of vaccine virus selection, the evaluation of the resulting vaccines, and the efforts at new vaccine formulation in Japan. Notably, from March 2022, the MHLW has launched a discussion of the merits of the seasonal influenza vaccines produced by foreign manufacturers.
在日本，厚生劳动省 (MHLW) 为四季流感疫苗的每个组份指定了一种特定的病毒株，并且有四家国内制造商使用相同的疫苗株（灭活、分裂病毒）生产基于鸡蛋的流感疫苗。因此，到目前为止，有关季节性流感疫苗开发的讨论仅集中在疫苗株与流行病毒之间的抗原匹配上。然而，在 2017 年，日本的疫苗病毒选择系统表明，即使候选疫苗株与预测的流行病毒具有抗原相似性，由于疫苗的生产效率较低，也不一定适合用于疫苗生产。考虑到这一经验，MHLW 在 2018 年改革了疫苗株选择方案，并指示由 MHLW 成立的疫苗流行病学研究小组探讨日本应如何选择季节性流感疫苗的病毒株。在这种情况下，作为 2018 年日本疫苗学会第 22 届年会的一部分，举办了一次题为“当前季节性流感疫苗的问题和未来展望”的专题讨论会，相关管理人员、制造商和研究人员讨论了与流感疫苗病毒相关的主题。本报告总结了该专题讨论会上的演讲，以传达日本目前的疫苗病毒选择方案、对由此产生的疫苗的评估以及新疫苗配方的研究进展。值得注意的是，自 2022 年 3 月以来，MHLW 已经开始讨论外国制造商生产的季节性流感疫苗的优点。
