For the 90th HGPI Seminar, we hosted Professor Satoshi Iwata, Chairman of the Expert Council on Promotion of Vaccination. Professor Iwata gave a lecture on the current status and issues of vaccination policy in Japan entitled, “Examining the Ideal Vaccination System for Japan and Current Efforts of the Expert Council on Promotion of Vaccination.”

In light of the situation surrounding COVID-19, the event was held online.

 

 

 

Key points of the lecture

• With vaccines, it is necessary to consider the balance between risks and benefits. For vaccine preventable diseases (VPDs), vaccines are key tools for infection control and for preventing severe cases from occurring.
• The Expert Council on Promotion of Vaccination was established in 2010 and continuously evaluates and examines vaccination policy to contribute to creating a domestic vaccination system in which people of all ages can receive the appropriate and necessary vaccinations in a safe manner. The Council has gathered various requests, opinions, and proposals concerning vaccination policy from academic societies across disciplines.
• While great improvements have been made in closing Japan’s vaccine gap, it is still prominent. Given the value and significance of vaccination, it is important that efforts to eliminate the vaccine gap are made as a matter of national risk management and policy.

 

■ The history of the Expert Council on Promotion of Vaccination and its current efforts
When the Expert Council on Promotion of Vaccination was established in 2010, there was still a significant gap between vaccinations provided in Japan and those provided abroad. It was created to establish an expert group like the Advisory Committee on Immunization Practices (ACIP) in the United States which would review vaccination policies and contribute to establishing a system to effectively provide the necessary vaccines to children and adults in Japan. Later, after a revision of the Immunization Act, the Subcommittee on Immunization and Vaccination of the Health Sciences Council was established to study Japan’s immunization and vaccination system. The Council’s goal shifted in response to this development and it now works to continuously evaluate and examine vaccination policy to contribute to the creation of a domestic vaccination system in which people of all ages can receive the appropriate and necessary vaccinations in a safe manner.

The Expert Council on Promotion of Vaccination has submitted various proposals and requests. To combat VPDs, it presented a proposal to the Welfare Science Council Infectious Diseases Subcommittee’s Vaccination Subcommittee on the need to create a system that allows all who wish to be vaccinated to be able to receive vaccinations regardless of income or earnings. It also released a statement on the urgent need to make a new, permanent system of public subsidies for the human papillomavirus (HPV) vaccine and other vaccines. Other than proposals submitted to the Ministry of Health, Labour and Welfare (MHLW), recognizing the importance of education, the Council has also submitted a request to the Ministry of Education, Culture, Sports, Science and Technology (MEXT) that vaccine information be added to educational materials for promoting cancer education.

Current topics of discussion at the Expert Council on Promotion of Vaccination include vaccinating preschool-aged children with pertussis vaccine and inactivated poliovirus vaccine (IPV), vaccination as a countermeasure against the spread of infectious diseases at mass gatherings like the Tokyo Olympics and Paralympics, and specific methods to communicate risk during vaccination.

 

■ The significance of introducing vaccines and issues facing vaccine introduction
The significance of vaccine introduction can be classified several ways, such as (1) the fundamental principle of infection control is to prevent VPDs through vaccination; (2) vaccines can be used for diseases that likely to cause epidemics or that affect few people but are severe, difficult to treat, or fatal; (3) while the fundamental principle of vaccination is individual defense, accumulating individual defense creates societal protection; (4) vaccinations prevent nosocomial infections; (5) vaccination provides pharmacoeconomic benefits; and (5) vaccination is worth promoting as a national policy to prevent infectious diseases, to provide risk management against infectious diseases, and to maintain and promote public health.

Despite growing public understanding of the significance of introducing vaccines, there is still a vaccine gap. One reason for this is the prolonged process of adding vaccines to the routine vaccination schedule. In Japan, there are two types of vaccinations: voluntary and routine. It is important that vaccines crucial for protecting public health are added to the routine vaccination schedule so that immunization becomes widespread. In recent years, however, deliberations on adding vaccines to the routine vaccination schedule have had the tendency to become drawn-out. Uncertainty towards prospects for approval and addition to the routine vaccination schedule lowers motivation towards vaccine development among members of industry. In the U.S., vaccine evaluation is conducted by working groups centered around the ACIP and begins during the late stages of development. After official approval, discussions on the possibility of adding a vaccine to the routine vaccination schedule can begin. Said discussions also consider public funding. Compared to the flexible U.S. system, in Japan, various studies on vaccines are conducted independently by the Health Sciences Council of the MHLW. This means there are significant delays before decisions to add vaccines to the routine schedule are reached. For example, although the mumps vaccine has been on the market for 27 years, deliberations on adding it to the routine vaccination schedule have been ongoing for seven years and have yet to reach a conclusion.

 

■ Developments around the HPV vaccine
It is well-known that cervical cancer has a high incidence and mortality rate among young women. According to a report presented by National Cancer Center Japan, about 10,000 women develop cervical cancer and about 3,000 die from it every year. Furthermore, the incidence and mortality rates for cervical cancer among women in their 20s and 30s are increasing. Although the HPV vaccine is known to be effective for preventing cervical cancer, as of December 2020, active efforts to promote HPV vaccination in Japan have stopped due to various events that occurred after it was added to the routine vaccination schedule in 2013.

In the future, we must ensure that people vaccinated against HPV and their guardians are provided appropriate information. There is a strong need for the academic community to provide information that is backed by scientific evidence; for the government (both the national and municipal governments) to provide appropriate information on the HPV vaccine as a routine vaccination (through individual notices); for family doctors to provide appropriate information regarding HPV vaccination and to promote vaccination; for appropriate information on HPV vaccine to be provided during education; and for proactive Government efforts to promote HPV vaccination to resume. Although recent Government efforts have helped improve the HPV vaccination rate, we also believe it is necessary to continue to monitor the situation closely.

It is also important we study the situation surrounding the HPV vaccine as an example of vaccine hesitancy. Vaccine hesitancy occurs when parents with children hesitate or refuse to vaccinate themselves or their children. In Japanese culture and society, people tend to decide the necessity of a vaccination based on the behavior of their friends, acquaintances, and the people around them. Although there is a small segment of the population that is determined to never be vaccinated, as we see in Europe and the U.S., it is important that the significance of vaccination is communicated while information on the risks and benefits of vaccines is provided. This includes information on both side effects and effectiveness. To that end, I believe advice from experts will grow more important in the future. Expert advice will be needed to reduce the influence of ignorance and prejudice and to ensure that the media reports on vaccines in as neutral and scientific a manner as possible, without exaggerating side effects or effectiveness.

 

■ Necessary steps for future vaccination policy reform
A system has been established in the U.S. in which the ACIP can begin evaluating vaccines from the later stages of development and make decisions concerning their prompt addition to the routine vaccination schedule after approval. In Japan, the discussion and deliberation processes required for a vaccine to be added to the routine vaccination schedule may require improvements in places the existing system and methods are not functioning effectively and efficiently. Furthermore, to ensure vaccines can be added to the routine vaccination schedule, it is important that smooth discussions can be held with the Ministry of Internal Affairs and Communications (MIC), which provides support to municipal governments and other such bodies that implement routine vaccinations; and with the Ministry of Finance (MOF), which allocates the budget for routine vaccinations.

In light of the above, in addition to clear guidelines and an overview of the process for addition to the routine vaccination schedule that spans the development stages to inclusion in the schedule, future vaccine policies must also include measures for the continuous collection of the epidemiological data needed for new vaccine development and inclusion in the routine vaccination schedule. Focus should be placed on high-priority vaccines and efforts should be made to promote their development. Furthermore, from the perspective of national crisis management and ensuring societal safety and security, it is important for the relevant ministries and agencies to hold discussions in parallel to speed up deliberations on topics like the introduction of a vaccine to the routine schedule. Strong collaboration with academia and industry is also desirable, particularly in policy planning.

With vaccines, it is important to balance the various risks and benefits while maintaining public health. At the individual and societal levels, vaccine benefits include disease prevention and reduced medical costs, while vaccine risks are side effects and cost. It is said that the cost of vaccinating against a disease is generally lower than the cost of treatment. However, as vaccine use becomes more widespread and eventually yields results in terms of disease prevention and lower medical costs at the individual and societal levels, it becomes more difficult to see those benefits at a glance. This means it is important to build understanding of vaccine risks and benefits through risk communication strategies that use accurate information, and to then connect that understanding to decision-making concerning vaccination.

The fundamental principle of infection control is to prevent VPDs using vaccines. Since public funding for vaccination will lead to more opportunities for vaccination and risk communication, I believe it is important to promote efforts to see vaccination implemented as part of national policy.

 

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■ Profile

Prof. Satoshi Iwata (Chairman, Expert Council on Promotion of Vaccination; Department of Infectious Diseases, National Cancer Center Hospital)
Professor Satoshi Iwata graduated from Keio University School of Medicine in 1976. That same year, he joined the Department of Pediatrics at Keio University School of Medicine. Later, he studied at St. Louis University and Columbia University in the United States for a brief period in 1996. After returning to Japan, he assumed the post of Chief Pediatrician at Tokyo Medical Center in 1999. His other roles at Tokyo Medical Center have included Director of Education and Training, Director of General Medical Services, Director of Medical Safety Management, and Director of the Clinical Trial Management Office. In 2010, he became a professor at Keio University School of Medicine’s Division of Infectious Diseases and Infection Control. In 2013, he became a professor at the Keio University School of Medicine’s Department of Infectious Diseases. He has served as Director of the Department of Infectious Diseases at the National Cancer Center Hospital since 2017 and as Visiting Professor at Keio University School of Medicine since 2018.

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