Health and Global Policy Institute (HGPI) held the seventh installment of “30-minute Health Policy Update,” a series of briefings for Diet Members on the most pressing health policy issues of today.

This installment was titled “Issues in Japan’s Immunization and Vaccination Policy and the COVID-19 Pandemic” and its featured speaker was Dr. Mugen Ujie (Director, Immunization Support Center, National Center for Global Health and Medicine (NCGM)). Dr. Ujie spoke on the characteristics of vaccines and what is needed to utilize them effectively within society. After the lecture, the attending Diet Members asked many questions and a lively opinion exchange session was held.

This installment of the 30-minute Health Policy Update series was held with the goal of increasing the number of Diet Members who are informed on the characteristics of existing vaccines and on trends and issues in Japan’s immunization and vaccination policies.

■ Key Points of the Lecture

• Vaccines are the most cost-effective tool.
• The benefits and risks of vaccines must be understood as knowledge.
• Based on scientific knowledge with a long-term perspective from when a vaccine is used until its use shows effects in the real world, political priorities must be made clear and continuous support must be provided even in non-emergency periods.

 

[Program]

Explanatory introduction:
Joji Sugawara (Manager, HGPI)

Opening remarks:
Noriko Furuya (Member, House of Representatives)

Lecture:
“Issues in Japan’s Immunization and Vaccination Policy and the COVID-19 Pandemic”
Mugen Ujie (Director, Immunization Support Center, NCGM)

Closing remarks:
Kiyoshi Kurokawa (Chairman, HGPI)

Question and answer session

 

■ Overview

The Characteristics of Vaccines

Vaccines have been called the greatest invention in medicine and public health of the 20th century. In the early 20th century, when infectious diseases were becoming a significant problem, the introduction of vaccines greatly reduced the number of people infected. In addition to preventing illness in vaccinated people, vaccination has other benefits that make it a highly cost-effective intervention. For example, vaccinated children do not miss as much school, so vaccines improve education. Vaccines also increase productivity in society by reducing the burden of care placed on families and by lowering healthcare expenses. Even compared to investments in public infrastructure, school education, and local healthcare professionals, vaccination has been shown to provide the greatest returns. It is estimated that vaccines save the public 40 trillion yen, which is the equivalent of investing 6 million yen per person.

Because vaccinated people are unaware when they have been protected from infection, vaccine effectiveness must be understood as knowledge gained through scientific evaluation. Furthermore, because vaccination is an intervention conducted when people are already healthy, there are also many times people believe any health effects they experience after a vaccination are side effects of the vaccine, even for unrelated symptoms. Problems resulting from vaccine interventions tend to surface more easily as a result.

Currently, many people around the world are becoming sick or dying due to Coronavirus Disease 2019 (COVID-19), which has created a great amount of interest in vaccines. Looking at policy responses taken to similar events in the past, we see many common elements. When the Immunization Act was enacted in 1948, many infectious diseases were running rampant at the time. As a public health measure, vaccinations were made mandatory for 12 targeted diseases and punishments were put in place for those who refused vaccination. However, when infection numbers began to decrease due to vaccines and it became more difficult for people to see the effects of vaccines, they grew more vocal toward vaccine side effects. In response, the punishments for refusing vaccination were gradually removed. Instead of being mandatory, people were “obligated to endeavor to receive vaccinations” or vaccines were granted more generous insurance coverage. In this manner, the more progress there is on immunization and vaccination policy, the harder it becomes to enjoy the benefits of vaccines.

 

Necessary Steps for Enabling the Effective Use of Vaccines

Vaccines operate in a cycle that includes development, manufacturing, creating a system for administration, administration, recording, and evaluation. The problem is the strength of demand for vaccines from society. The fact that people in Japan have always had little trust in vaccines has been pointed out for years. In spite of the ongoing COVID-19 pandemic, a survey of 15 countries found that Japan had the fewest respondents who wanted their family and friends to be vaccinated (around 47%). It is likely results like these may be having significant impacts on vaccine policy.

In 1989, the Government enacted a policy of vaccinating children with measles, mumps, and rubella (MMR) vaccine at age one, but there were more cases of aseptic meningitis caused by mumps than originally anticipated. This resulted in a great amount of criticism toward the vaccine. Other factors at the time meant that its use was essentially halted. These included violations of the Pharmaceutical Affairs Law by the pharmaceutical company producing the vaccine. Currently, among the 37 members of the Organisation for Economic Co-operation and Development (OECD), Japan is the only country that does not use the MMR vaccine. Although mumps has become exceedingly rare around the world, it is estimated there are tens of thousands of cases of mumps in Japan almost every year, with hundreds of people experiencing complications including mumps-induced hearing loss. If this situation is allowed to continue, it will be difficult to identify which health problems can be prevented by vaccinating. Progress cannot be made on immunization and vaccination policy unless society as a whole agrees to accept responsibility for the actions that have not been taken.

Japan has made large investments in vaccine development in response to the current pandemic. However, vaccines cannot be developed immediately just because investments have been made. Compared to other countries, Japan tends to take a different social approach to vaccines and this may be one reason for the delay in development. In addition, the fact that Japan took longer to deploy the vaccine than certain other countries was because vaccines were not approved until domestic clinical trials were completed. This was the influence of Japan’s policies, which emphasize safety even in emergencies. The ideal form of regulations for responding to emergencies like these must be discussed in the future in addition to how all of society can cooperate with companies to develop critical pharmaceuticals.

The Cabinet recently approved a proposal to reinforce systems for vaccine development and production. I think we must take a broad approach to examining vaccine development and why the system for effectively using vaccines is not operating well in society. That should include a look at past recommendations while keeping in mind various aspects like long-term vision and social tolerance.

 

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■ Question and answer session with parliamentarian

Q1

Toward the end of the presentation, you mentioned that it is also necessary to increase social tolerance (or acceptance) toward pharmaceuticals, and I think politics has certain responsibilities in that regard. This is also true for booster vaccinations, which are expected to be scientifically necessary. I think that right now, people are going through the vaccination process expecting it to be over when they get vaccinated. However, there is no system in place to manage information on those who have been vaccinated. How should we think about the need for follow-ups or tracing? I think we need to manage information on how people are after vaccination, including their medical history, but there is no nationwide system for doing so whatsoever. I would like to know how you evaluate these points from a medical standpoint.

A1

As you pointed out, COVID-19 vaccines have only been in widespread use for about six months, so we do not actually have data on their long-term safety and effectiveness yet. Current analyses predict that vaccine-induced immunity in the form of antibodies will be effective for up to six months and will gradually decline, probably over the course of a few years. A similar trend has been seen with other diseases. In all likelihood, the effects of immune memory and cellular immunity will keep people from developing severe cases of COVID-19 for longer, so decreases in antibodies will not necessarily mean that everyone will lose immunity. Rather, like current influenza vaccines, we expect that a certain number of vaccinated people will become infected but they will be less likely to experience severe symptoms. Pfizer and Moderna are conducting clinical trials for booster vaccinations that will allow those who were vaccinated in December of last year to receive a third dose in September of this year, but from a medical perspective on safety and effectiveness, results on the need for booster shots are still inconclusive. So, I think we will continue holding technical, scientific discussions on if it is best to give booster shots after one year, or after two or three years.

As for the domestic information system for tracing vaccinated and infected people that you mentioned, we have a system called the Vaccination Record System (VRS) which was established under the leadership of the Cabinet Secretariat’s National Strategy Office of Information and Communication Technology. The VRS allows municipalities to manage information on vaccinated people under the Immunization Act’s temporary vaccination framework. The VRS is meant to replace municipal vaccination ledgers to enable each municipality to trace who has been vaccinated, when they were vaccinated, and what vaccine they received. However, that information is not being linked on who has been infected with a disease and when. For some time, it has been pointed out that being able to obtain such information in a uniform manner would make it easier to evaluate vaccines and diseases. However, the system has not yet been put to use in such a way. Careful discussions are being held from the perspectives of personal information protection and cross-municipality information sharing. It is not considered to be against anyone’s interest if information on whether or not they have been vaccinated is made public, and it is believed the widespread use of such a system would result in significant productivity gains. I think there is an indirect relationship between the use of scientific technology and systems and the creation of public trust in vaccines, the Japanese government, and attitudes based on scientific thinking. Progress on society’s attitudes on such topics is unlikely to happen overnight, so I think our approach should be to gradually build understanding among society as a whole. This should be done by disseminating information based on scientific perspectives regarding topics like failures and problems and by holding wide-ranging discussions on those topics over long periods of time.

Q2

The minimum age for the Pfizer vaccine was recently lowered from 16 to 12 and it was approved for longer refrigerator storage times. This will promote individual vaccinations. On the other hand, the people who will have to respond to these changes in medical settings are healthcare professionals. I would like to ask your opinion on how to increase coverage when understanding among parents does not improve. Similar issues apply to the vaccine for human papillomavirus (HPV), the virus that causes cervical cancer.

A2

Compared to elderly people, adolescents are less likely to develop severe cases of COVID-19. This is one reason that vaccination has not advanced. In the U.S., it is rare for adolescents to be hospitalized for COVID-19, but about one-third of those who are hospitalized end up being placed in Intensive Care Units (ICUs),[1] and some of them die. In addition, adolescents who are infected with COVID-19 are two to three times more likely to require hospitalization than those infected with influenza.[2] Meanwhile, the benefits of preventive measures to overall public health are being demonstrated scientifically and publicized. Can’t this approach be used as a reference in Japan?

The U.S. has already lowered the minimum age for vaccination to 12 and has begun vaccinating children. Previously, for other vaccines to be administered, there was a mandatory minimum interval of two weeks before or after COVID-19 vaccination so safety could be evaluated accurately. However, the U.S. has removed the provision for an interval between these vaccinations so as not to interfere with routine vaccinations. There have been no findings that suggest close intervals between COVID-19 vaccines and other vaccines cause issues for safety or effectiveness, so we should consider discussing eliminating the intervals between vaccines in Japan to further encourage vaccination.

Q3

Children tend to contract more respiratory infections in autumn and winter. As the parties who administer vaccines, pediatricians are extremely concerned if it is possible to administer routine vaccinations simultaneously with influenza vaccines. Technically, is it possible to administer two vaccines to one person in the same visit?

Regarding differences between races, there have been reports of myocarditis in children following vaccination with the Pfizer and Moderna vaccines, but some people in Europe and the U.S. are advocating for vaccination because of Kawasaki disease-like symptoms in infected children. I wonder if evidence from Europe and the U.S. is applicable when vaccinating children in Japan. There is also talk of conducting mass vaccinations in schools, but I think the medical community must sort these issues out first. After doing that, there should be some way to communicate to parents to reassure them.

A3

It is no exaggeration to say that there was almost no influenza season last year because infectious disease control measures were followed all throughout society. On the other hand, some specialists are worried that the lack of an influenza season caused people to miss opportunities to boost their immune systems, and that will have effects after people stop following those measures. That means we must continue following basic infectious disease control measures like hand washing and respiratory hygiene even after the COVID-19 situation settles down. The simultaneous administration of vaccines is also an extremely important issue. Making multiple hospital visits for vaccinations is not only inconvenient, in terms of time and cost, they also cause significant cumulative losses for society. Some findings suggest that certain live attenuated vaccines have decreased effectiveness when administered simultaneously, but in theory, there should be no problem administering COVID-19 vaccines at the same time as other vaccines. However, without data, it is impossible to confirm that doing so is actually safe, so simultaneous administration is not being practiced at this point in time. In the future, once assessment results have been reported, we will have to decide whether to conduct simultaneous administration after considering the balance between its advantages and disadvantages. Also, if it becomes possible to administer COVID-19 vaccines simultaneously with other vaccines administered regularly, like influenza vaccine, we can increase coverage for both. That is another key aspect.

Regarding cases of myocarditis among young people, although exceedingly rare, the Ministry of Health of Israel has reported such cases have been associated with mRNA vaccines. Those findings have also been recognized in the U.S. and Europe. At this point, we have concluded that in theory, going unvaccinated carries greater risk because myocarditis is extremely rare and because inflammatory complications such as multisystem inflammatory syndrome and myocarditis, which you mentioned, are known to occur even in cases of natural infection. Although there may be some regional variation in the incidence of these complications, we must achieve social consensus on the indications for vaccination through quantitative assessment based on surveillance, and then advance countermeasures.

Q4

Vaccines have already been developed, but I think people are still waiting for vaccines that are made in Japan. During their development, however, I think getting participants for randomized controlled trials to study placebo effects may pose a challenge when there are already vaccines produced overseas. In addition, mothers feel reluctant to let anyone do anything to their babies. That applies to pharmaceuticals as well as vaccines. The mass media also has tremendous influence. No matter how much politicians advocate for vaccination, the way the mass media portrays vaccines makes promotional efforts difficult. In other words, unlike in the West, it is difficult to exercise leadership through politics in Japan. What steps can be taken to address these problems?

A4

As you pointed out, greater coverage will make it more difficult to conduct randomized controlled trials, which are considered to be the most reliable form of scientific evidence when assessing the validity of tests and treatments. Some major global pharmaceutical companies have already moved large-scale clinical studies to areas where vaccination rates are still low, like South America and South Asia, due to the difficulty of conducting them in Europe and the U.S. I think we are already near the end of the period during which we can conduct large-scale, randomized controlled trials in their purest form. This means Japanese pharmaceutical companies which are not conducting large-scale, randomized controlled trials right now may face very challenging situations in the future. Also, when assessing immunogenicity, it may be difficult to demonstrate non-inferiority to mRNA vaccines from Pfizer and other companies, which have already generated very good results. There are examples from the U.K. of infection tests being conducted as challenge studies to efficiently assess pharmaceuticals with small sample groups. Although we have to discuss ethical considerations, we may have to consider alternative evaluation methods.

In addition, mothers tend to be reluctant to allow pharmaceuticals and vaccines that may cause adverse reactions to be administered to their children, even ones they would take themselves. With the HPV vaccine, it has been shown that women with higher educational backgrounds tend to be more hesitant toward the vaccine. I think people feel that way partially because of the idea that vaccines are not from nature. However, vaccines themselves are not extra things that are added to the body. Rather, they are treasures that protect us from diseases by inducing immunity through the body’s own mechanisms. I think widely disseminating these ideas will be one way to overcome hesitancy.

The mass media, medical professionals, and politicians are all extremely important stakeholders. I think that some people in the media view building interest as their main objective instead of prioritizing scientific facts or benefits to society. There was once a measles outbreak at Disneyland in the U.S. and a certain doctor questioned the effectiveness of the measles vaccine. Rather than taking it as an opportunity to get attention, the media responded by criticizing that doctor. As a result, the California Medical Association suspended that doctor’s medical license in court. In Japan, we must reexamine the literacy and ethical views of society as a whole and advance with the goal of spreading accurate information throughout society. I think there are no shortcuts we can take to achieve that. I think every stakeholder must continuously work to do what they can. For example, there must be communication from politicians and healthcare professionals working on health problems.

 

[1] https://www.cdc.gov/mmwr/volumes/69/wr/mm6932e3.htm
[2] https://www.cdc.gov/mmwr/volumes/70/wr/mm7023e1.htm?s_cid=mm7023e1_w

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■ Immunization and Vaccination Policy Promotion Project Overview

Health and Global Policy Institute (HGPI) launched the Immunization and Vaccination Policy Promotion Project in FY2020. In the project’s first year, we established an advisory board to grasp the current situation and identify problems facing Japan’s immunization and vaccination policy through discussions with specialists in Japan from industry, Government, academia, and civil society. We then held a global expert meeting in December 2020. There, discussions were held with experts from overseas together with advisory board members. The issues raised over the course of those discussions were synthesized into policy recommendations and presented in “A Life Course Approach to Immunization and Vaccination Policy,” which outlined specific actions to take under five perspectives.

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