Rotavirus in National Immunization Program(NIP) began in October 2020.Mumps vaccine still remains voluntary. In addition, as another gap, among the “vaccines with high development priority” requested by the Ministry of Health, Labor and Welfare(MHLW), Herpes Zoster vaccine has been launched on the market, but discussions on NIP have been stalled, and MMR vaccine (a combination of Mumps, Measles, and Rubella), a five-combo and six-combo vaccines (a vaccine in which hepatitis B vaccine and Hib vaccine are added to the DTaP-IPV), High-dose influenza vaccines have not been introduced in Japan. The EFPIA Vaccine Working Group is committed to reducing regulatory issues and policy-related barriers while promoting Life Course Immunization to enable early adoption and NIP adoption of these vaccines.
On the other hand, due to the downgrade of the SARS-Cov-2 virus to a Class 5 infectious disease in Japan, work that should be done in a routine such as deliberation on NIP and consultation with trade associations has temporarily resumed. In addition to the issues that have been appealed by the four vaccine-related trade associations so far, some members of the MHLW council have made remarks in the review of the “Immunization Basic Plan ” which calls for a review of vaccination policies that are difficult for the public, such as the difference between NIP vaccination and voluntary vaccination, the classification of NIP vaccination (A/B), and the obligation to make efforts to immunize.
The immunization basic plan is scheduled to be reviewed by the end of 2023 fiscal year, and EFPIA aims to realize it by strengthening its efforts with national stakeholders and authorities in collaboration with other trade associations.
As the public’s awareness of the prevention of infectious diseases increases, the vaccination rate of the elderly, such as seasonal influenza and elderly pneumococcus, has increased compared to before the COVID-19 pandemic. Adequate communication between healthcare professionals and vaccinated persons, which is fundamental to the spread of Life Course Immunization, is becoming increasingly important. In 2020, EFPIA Japan agreed to fully cooperate with the Academia Advisory Board to create this information, in addition to providing an environment where people can be vaccinated with peace of mind, and disseminating infection prevention measures at medical institutions, as well as the need for guidance for healthcare professionals to lead mutual communication with vaccinated persons. The EFPIA Vaccine Subcommittee published the first edition of the “Communication Guidance on Vaccination” in 2021 and the second edition in 2022 as a stepping stone to promote the spread of Life Course Immunization, and is working to disseminate it with the cooperation of each academic society.
In the review of the immunization basic plan this time, discussions are progressing while institutional studies related to NIP category A and B have not begun, and the MHLW has announced that trade associations requested to improve the predictability of NIP process, to incentivise vaccines with high development priority, and to digitize vaccination historyl, as the next theme of the consultation between the four trade associations. They mutually agreed to formulate guidelines for the stable supply of vaccines, and some topics are being discussed. EFPIA and PhRMA will exchange dialogues on the above four issues from the perspective of global companies, and if the four trade associaitons cannot reach a consensus, they are prepared to express their opinions with the cooperation of foreign-affiliated trade associations.
Key issues and recommendations
Vaccine Working Team, EFPIA Japan
(Senior Expert, Janssen K.K.)
c/o Janssen K.K.
3-5-2 Nishikanda, Chiyoda-ku, Tokyo 101-0065
EBC Medical Equipment and Diagnostics Committee Secretariat contact:
GE Healthcare Japan
Ipsen Pharma Japan
Nippon Boehringer Ingelheim
Novo Nordisk Pharma