Vaccines

Rotavirus vaccination was launched in October 2020 as the National Immunization Program (NIP). However, Mumps vaccine remains voluntary. Other existing gaps include the “high-priority development vaccines” requested by MHLW, MMR vaccine (mumps, measles and rubella), the 5- or 6-in-1 combination vaccine (where hepatitis B and/or Hib vaccines are added to the 4-in-1 DTaP-IPV-diphtheria, tetanus, pertussis and inactivated polio) and high dose Quadrivalent Influenza vaccine are still not available in Japan. EFPIA Vaccine Working Team continues to work to reduce regulatory and policy-related barriers for early adoption and NIP of those vaccines as well as strongly promote “Life Course Immunization (Prevent all vaccine-preventable diseases from infants to the elderly)”.

In 2020, due to the global COVID-19 pandemic, almost administrative resources were invested for the COVID-19 countermeasure, and all the work was suspended such as NIP review and discussion between industry groups and MHLW. On the other hand, the importance of vaccines has become widely recognized by the general public and with the delay of the COVID-19 vaccine development in Japan, discussions on the current vaccine development and production system and the ideal industrial structure have become active, and the government has begun to consider future solutions. In this discussion, politicians mentioned that it is necessary to involve global companies from the perspective of “All Japan” instead of “Only Japan” to rebuild the vaccine industry in Japan.

As in our statement issued in September 2020, “Proposal of vaccination system under COVID-19 pandemic”, to promote this movement as a permanent move rather than a temporary one, EFPIA Japan has worked with other industry groups to reach out to national stakeholders and authorities to re-building the vaccine industry.

Amid growing public awareness of the prevention of infectious diseases, vaccinations for the elderly, such as seasonal influenza and pneumococcus pneumoniae in the elderly, were vaccinated more than usual. Adequate communication between healthcare professionals and recipients, 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 the guidance, in addition to providing an environment where people can able to 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 recipients. 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 2022, as COVID-19 countermeasures continued to be the top priority from the previous year, no institutional studies related to NIP A and B were started. However MHLW announced that the next theme of the discussion with the four industry organizations was to improve the predictability of NIP, handle vaccines with high development priority, digitize vaccination record and guidelines for the stable vaccines supply. Some topics are being discussed and agreed to formulate. EFPIA will exchange dialogue on the above four issues from the perspective of global companies aligned with PhRMA, and if the four organizations cannot reach a consensus, we are preparing to express our opinions with the cooperation of foreign-affiliated industry associations.

Key issues and recommendations

Chairman

Mr. Shinji Matsumoto
Vaccine Working Team, EFPIA Japan
(Senior Expert, Janssen K.K.)
c/o Janssen K.K.
3-5-2 Nishikanda, Chiyoda-ku, Tokyo 101-0065
Phone 03-4411-7700

EBC Medical Equipment and Diagnostics Committee Secretariat contact:
E-mail:  EBC-MDX@ebc-jp.com

Members

Alexion Pharma
AstraZeneca
Bayer Yakuhin
Bracco-Eisai
Chugai Pharmaceutical
CSL Behring
Ferring Pharmaceuticals
GE Healthcare Japan
Genmab
GlaxoSmithKline
Guerbet Japan
Idorsia Pharmaceuticals
Ipsen Pharma Japan
Janssen Pharmaceutical
LEO Pharma
Lundbeck Japan
Merck Biopharma
Nihon Servier
Nippon Boehringer Ingelheim
Novartis Pharma
Novo Nordisk Pharma
Sanofi
UCB Japan