September 4, 2020
EFPIA Japan

Statement on the Vaccination System under COVID-19 pandemic
Due to the COVID-19 pandemic, many people around the world continue to lose their healthand lives.
In addition, we will enter the 2020-2021 infectious disease season with no established COVID19 vaccines or treatment. If respiratory infections, such as influenza, becomes an epidemic at
the same time as COVID-19, the impact on the medical system will be significant due toincreased burden on the medical site that undertakes diagnosis and treatment. In order toprotect the health of the people and the medical site, we must urgently promote thedevelopment of an environment in which all people from children to the elderly understand thesignificance of vaccination and receive vaccination (Life course immunization).
⚫

Propose to develop a system that promotes fundamental understanding of theeffectiveness, safety, and necessity of vaccination.
Promote the establishment of a system to promptly and comprehensively evaluate
the efficacy and safety of vaccines⚫

Under such emergency state never experienced before, COVID-19 vaccine development byEFPIA member companies is proceeding at a rapid pace with unprecedented collaboration
between industry, government and academia. （Introduction of member companies' efforts for COVID-19：
http://efpia.jp/covid-19/index.html）
EFPIA aims to distribute vaccines promptly and equitably around the world, once COVID-19
vaccine obtains manufacturing approval. However, there are several issues that impede theintroduction of imported vaccines to Japan, which we believe needs to be considered inadvance in order to promptly deliver COVID-19 vaccines to the Japanese people.
⚫

Promote international harmonization of domestic regulations related to quality(test items and standard setting by the Japanese Pharmacopoeia and MRBP) .
Propose a system that allows vaccination to start immediately after COVID-19
vaccine manufacturing approval by establishing operational standards that clarify
the roles of vaccination personnel⚫

EFPIA Japan will strengthen cooperation with all stakeholders involved in infectious disease
control based on four urgent proposals.

Propose to develop a system that promotes fundamental understanding of the effectiveness,safety, and necessity of vaccination, rather than a temporary epidemic prevention boom dueto the COVID-19 pandemic. Improving the understanding of vaccination for adults and theelderly is particularly urgent.
-Enhancing awareness of vaccination for the public
Preventing infectious diseases means not only protecting one's own health, but also__________________________________________________________________
c/o Nippon Boehringer Ingelheim Co., Ltd.
ThinkPark Tower, 2-1-1, Osaki, Shinagawa-ku, Tokyo 141-6017
Tel: 03-6417-2032 Fax: 03-6685-4870

family and society. As vaccination is not “non-essential and non-urgent”, stakeholders
need to work together to disseminate the importance of not missing vaccination
opportunities. However, it is generally not easy to access the right information about
vaccines and diseases, so there is an urgent need to take measures to connect
physicians who are partners in preventive medicine with every citizen.
- Formulation of two-way communication guidelines for physicians
Vaccination is the most effective measure to prevent infectious diseases, but at thesame time, all vaccines that have shown effectiveness also have side reactions. We
will initiate industry-government-academia discussions to develop guidelines for a
two-way communication between physicians and vaccine recipients for the recipient'sunderstanding. To start, we will summarize the minimum required communication
guidance under emergency.
- Enhancing infection prevention measures at clinics for vaccination
Many pediatrics have already taken infection prevention measures in clinics bydistinguishing the time and place of medical consultation and vaccination. Due toongoing concerns over COVID-19, clinics need further control over infections. Clinics
such as internal medicine that vaccinate adults and elderly need to take new infection
control measures. However, as internal medicine conduct a much smaller number ofvaccinations than pediatrics, it is desirable to secure a budget to support strengthen
the vaccination efforts at medical institutions.
- Enhancing awareness of vaccination information for physicians
In order to promote vaccination of adults and the elderly, it is necessary for doctors,
nurses, pharmacists, and other physicians who prepare and inoculate to understandthe basic knowledge of vaccines and points to note when performing vaccinations. Inorder to support this, we have to develop an educational mechanism for physicians toreconfirm their knowledge.

Promote the establishment of a system to promptly and comprehensively evaluate theefficacy and safety of vaccines.
- Enhancing of epidemiological survey system
In order to evaluate the efficacy and safety of vaccinations, there is an urgent need toenhance epidemiological surveys. In addition, it is required to construct a databasethat maintains vaccination records, medical receipt information and side reaction
reports. This allows for large scale post-market monitoring at all times. Databaseenhancement will effectively support the vaccine development needed in Japan evenat normal times.
- Establishment of an organization directly controlled by the Government makecomprehensive vaccination decisions
In the event of a life-threatening situation, economic crisis or a great amount of social
loss or burden due to the rapid spread of infectious diseases, it is necessary toestablish an organization directly controlled by the Cabinet that is organized acrossindustry, government, academia and ministries. Based on comprehensive verificationof social situations, it is desirable to make swift political decisions regarding theestablishment of vaccine R&D/manufacturing system and the setting of vaccination
recommendations.
- Establishment of vaccination centers in all prefectures
Enhancing communication between companies and physicians and between__________________________________________________________________
c/o Nippon Boehringer Ingelheim Co., Ltd.
ThinkPark Tower, 2-1-1, Osaki, Shinagawa-ku, Tokyo 141-6017
Tel: 03-6417-2032 Fax: 03-6685-4870

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physicians and vaccination recipients is important for safe vaccination. In addition, it isnecessary to clarify the contact point for various consultations (including sidereactions) regarding vaccination. The establishment of vaccination centers in eachprefecture that plays a role in leading regional vaccinations not only during normal
times but also during emergencies should be promoted.

Promote international harmonization of domestic regulations related to quality (test itemsand standard setting by the Japanese Pharmacopoeia and MRBP) in order to shorten thelead time that occurs after importing the COVID-19 vaccine.
- Harmonize Japanese original test items and standards (i.e. abnormal toxicitytest) with international standards
Due to the increasing demand for COVID-19 vaccines worldwide, it is necessary to
promote harmonization of regulations, which is a major obstacle in considering thesupply of vaccines to Japan. In particular, by making the standard test items
consistent with overseas standards, additional tests to obtain test results for new
applications and after importation becomes unnecessary. Most self-tests weresignificantly reduced when MRA became applicable for vaccines. However as it is stillnecessary to conduct an additional self-test in Japan for items set by the requirementsof Japan only, its consideration should be done immediately.
Due to the existence of Japan's unique standards, it will take substantial time tocomply when there are any changes in international or overseas standards.
- Allow batch release testing of imported vaccines by inspecting only SLP
documents
For products that have received a certificate after being tested by EU member stateauthorities, we recommend exempting the region test and performing only SLP-based
document inspection. Currently, many of the COVID-19 vaccines are in thedevelopment stage and it is estimated that the effective period of the vaccine will belimited when it is introduced into Japan. By adopting the aforementioned method,lead-time in units of several months can be shortened while still maintaining quality
standards. As such, it becomes possible to stably supply products with a longer shelf
life to the Japanese population.

Propose a system that allows vaccination to start immediately after COVID-19 vaccine
manufacturing approval by establishing operational standards that clarify the roles ofvaccination personnel.
- Preparation of vaccination system in emergency situations
Emergency vaccination is different from usual, as it is necessary to establish a system
for many people to be vaccinated across the country in a short period of time. For
example, it is necessary to urgently prepare a vaccination system manual, such as
establishing a vaccination system for group vaccination and establishing a vaccine
supply/distribution method.
- Clarification of vaccination policy in emergency situations
Even if the total volume of COVID-19 vaccines can be secured for all Japanese
population, there are restrictions due to amount of vaccine that can be supplied at atime and the vaccination environment. As such, it is necessary to determine the__________________________________________________________________
c/o Nippon Boehringer Ingelheim Co., Ltd.
ThinkPark Tower, 2-1-1, Osaki, Shinagawa-ku, Tokyo 141-6017
Tel: 03-6417-2032 Fax: 03-6685-4870

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priority of vaccination in consideration of these factors and to obtain a sufficientunderstanding of the people in advance with clear reasons.
- Securing budget for emergency vaccination
When performing emergency vaccination, it is necessary to establish a system that isdifferent from the usual. The government should secure the budget necessary forsystem development in order to maintain fairness among local governments.
- Support for health hazards caused by emergency approved vaccines
The government should create or leverage existing no-fault compensation systems toprovide speedy, accessible and effective compensation to parties suffering serious
physical injury or death validly attributable to a COVID-19 vaccine, and provide
protection from civil liability (not indemnification) to all parties involved in thedevelopment, manufacturing, distribution, funding, procurement and deployment for
vaccines administered during the pandemic period.

About EFPIA Japan (http://efpia.jp/)
Established in April 2002, EFPIA Japan represents 21 R&D-based European pharmaceuticalcompanies operating in Japan. In 2019, combined sales from the member companies
accounted for roughly 23% of the pharmaceutical market in Japan. The mission of EFPIA
Japan is to “Contribute to healthcare and patients in Japan through the early introduction of
innovative medicines and vaccines”. EFPIA Japan aims to strengthen dialogue with decisionmakers in order to improve Japanese healthcare for all.
About EFPIA (European Federation of Pharmaceutical Industries and Associations)(http://www.efpia.eu)
EFPIA, EFPIA Japan’s partner organisation, is headquartered in Brussels and represents thepharmaceutical industry operating in Europe. Through its direct membership of 36 national ass
ociations and 39 leading pharmaceutical companies, EFPIA provides the voice of companies c
ommitted to researching, developing and bringing new medicines to improve health and qualit
y of life around the world.

__________________________________________________________________
c/o Nippon Boehringer Ingelheim Co., Ltd.
ThinkPark Tower, 2-1-1, Osaki, Shinagawa-ku, Tokyo 141-6017
Tel: 03-6417-2032 Fax: 03-6685-4870

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