Vaccination andChildren's Health2023 Version

Written and edited by: The Review Committee for Vaccination Guidelines
Publisher:

Public Foundation of the Vaccination Research Center

Introduction
Children are often ill and sometimes become extremely sick; vaccination canprotect them from several serious illnesses.
This brochure has been created to provide you with information about vaccinationand to allow you to have your child vaccinated safely.
We hope that this brochure will enhance the health and growth of your child.

Table of Contents

1. Get your child vaccinated!

1

Get your child vaccinated!.................................................................................. 2

2

What is vaccination?........................................................................................... 2

3

Vaccination validity............................................................................................. 2

4

Routine vaccination and voluntary vaccination.................................................. 3

5

Let's make a vaccination plan for your child...................................................... 4

6

Before having your child vaccinated.................................................................. 10

7

Diseases preventable by vaccination and vaccines............................................. 14
Rotavirus infection........................................................................................................ 14
Hepatitis B..................................................................................................................... 16
Hib infection.................................................................................................................. 17
Pneumococcal infection in children.............................................................................. 19
Diphtheria, pertussis, tetanus, and polio (acute poliomyelitis)..................................... 21
Tuberculosis................................................................................................................... 26
Measles and rubella....................................................................................................... 27
Varicella (chickenpox)................................................................................................... 30
Japanese encephalitis..................................................................................................... 31
Human papillomavirus infection (protection against cervical cancer).......................... 34

8What to do if your child experiences an adverse reaction to a vaccination........ 38[Reference 1] Novel coronavirus (COVID-19) and its vaccines........................................... 40[Reference 2] Diseases preventable by voluntary vaccination and overview of vaccines.... 42
Seasonal influenza vaccine............................................................................................ 42
Mumps vaccine.............................................................................................................. 43[Reference 3] Vaccine screening questionnaire..................................................................... 45[Reference 4] Post-vaccination health survey........................................................................ 48
The 2023 edition is based on revisions as of January 2023.
You can receive the latest information from your municipality (including special wards; the same
applies below). This information is also available from the websites of the
Ministry of Health, Labour and Welfare (https://www.mhlw.go.jp/english/) and theInfectious Disease Surveillance Center, National Institute of Infectious Diseases(https://www.niid.go.jp/niid/en/).
If amendments are made to national laws or systems, notifications and other information will be
published on the website of the Public Foundation of the Vaccination Research Center(https://www.yoboseshu-rc.com).

1

1. Get your child vaccinated!

1. Get your child vaccinated!
The immunity to diseases which mothers give their infants almost completely
disappears 3 months after birth for pertussis and 12 months after birth for measles.
Consequently, after these periods, infants must ward off disease by producing their own
immunity. Vaccination supports this defense.
Children go outside more often and interact with more people as they grow;consequently, they are at higher risk of infection. We recommend that you learn about
vaccination and have your child vaccinated for his/her health.

● Infections
Infections are caused by pathogens, including viruses and bacteria,
which invade the body and multiply. Symptoms may include fever,cough, and headache, depending on the type of pathogen.

2. What is vaccination?
Vaccination is the administration of attenuated forms of viruses and bacteria or of
their toxins which cause infectious diseases such as measles and pertussis. Giving theseattenuated forms produces immunity against these diseases. A “vaccine” is a preparation
used for vaccination.
Vaccines cannot be prepared for all infectious diseases. Due to their nature, vaccines
cannot be produced for some viruses and bacteria.

3. Vaccination validity
Vaccination is performed to prevent a target disease or reduce its severity in the event
it is contracted; however, immunity is not established in some children because of theircharacteristics and physical condition. If there is a desire to confirm whether immunity has
been established, there are blood tests which measure the levels of antibodies in the blood.
24. Routine vaccination and voluntary vaccination

In addition, with some vaccines, immunity gradually diminishes even after it has been
established, and such vaccines require boosters at specific intervals to maintain long term
immunity. (See 5. (3) Vaccine types and characteristics on page 4)

4. Routine vaccination and voluntary vaccination
Vaccination includes routine vaccination and voluntary vaccination. With regard toroutine vaccination, the Preventive Vaccination Law defines the target diseases, subjects andvaccination schedules.
Vaccination is carried out during periods appropriate to each disease. Please refer to“List of recommended periods for routine vaccination (Category A disease)” on page 8
for recommended vaccination periods (standard vaccination periods).

Routine vaccination
Routine vaccinations are the vaccinations stipulated by the “Preventive Vaccination Law” andare divided into vaccinations for Category A and Category B diseases. As a general rule, thecost is paid by the local governments for those subject to vaccination against Category A
diseases, so they can be vaccinated at public expense. Vaccination against Category B
diseases may be partly covered by public expense. From January 30, 2013, special
measures have been set for children who were unable to receive routine vaccination due to along-term serious illness. For details, please check the information of your health center/municipal office.

Category A
diseaseThe main focus is on mass prevention and prevention of serious illnesses.
The person (guardian) is obliged to make an effort and is recommended to
be vaccinated by the government.

・Rotavirus

・Hepatitis B

・Hib infection

・Diphtheria

・Pertussis

・Tetanus

・Pneumococcal infection in children

・Polio (Acute poliomyelitis) ・Tuberculosis (BCG)

・Measles・Rubella・Varicella・Japanese encephalitis・Human papillomavirus (HPV) infection

Category B
diseaseThe main focus is on personal prevention.
The person (guardian) is not obliged to make an effort and is notrecommended to be vaccinated by the government.

・Seasonal influenza infection* ・Pneumococcal infection in elderly*Vaccination against seasonal influenza for children is voluntary.

35. Let’s make a vaccination plan for your child

Voluntary vaccination
Voluntary vaccinations are vaccinations other than the “routine vaccinations” stipulated in
the “Preventive Vaccination Law”. As a general rule, the cost required for vaccinations isborne by the individual. Some local governments pay part or all of the cost depending on theneed for vaccination. Please check the information of your health center/municipal office.

5. Let’s make a vaccination plan for your child(1) Notice of vaccination
Routine vaccination is carried out by the municipal office in accordance with thePreventive Vaccination Law. A notice of vaccination is usually sent to parents/guardiansindividually. Since the notice is sent on the basis of the Basic Resident Register and the
Residence Card, make sure to report when a baby is born or when you move.
（2）Set a rough schedule for vaccination
Routine vaccinations are, in principle, given individually. Determine a specific scheduleand order for vaccinations after considering municipal programs, the physical condition
your child, and the state of disease provenance, and consulting with your family doctor.
Note that some municipalities may give the BCG vaccine as a mass vaccination(provided at a designated time and place such as healthcare center).
(3) Vaccine types and characteristics
Vaccines are classified into two categories: live and inactivated vaccines.
Live vaccine
Live vaccines are made of attenuated live bacteria and viruses (live bacteria and viruses
whose pathogenicity has been weakened). Resistance (immunity) to the disease isestablished similarly to actually being infected by it. After vaccination, attenuatedbacteria and viruses (bacteria and viruses whose pathogenicity has been weakened) start
multiplying; consequently, vaccines can cause mild symptoms, including fever and rash,depending on the vaccine. It takes about one month to establish sufficient resistance(immunity). However, some vaccines require boosters because their resistance (immunity)
may gradually decline and weaken.
45. Let’s make a vaccination plan for your childTypes oflive vaccines

・Rotavirus vaccine ・BCG
・Measles-rubella (MR) vaccine ・Measles vaccine
・Rubella vaccine ・Varicella (chicken pox) vaccine
・Mumps vaccine ・Yellow fever vaccine

Inactivated vaccine
Inactivated vaccines are made by killing the virus or bacteria, extracting the components
required to develop resistance (immunity) and eliminating their virulence (pathogenicity).
The bacteria and viruses do not multiply, and several shots are required to establish resistance(immunity). Two or three vaccine shots are given at certain intervals to establish a basic
resistance (immunity), after which a booster is given several months to one year later toenhance resistance (immunity) to a sufficient level. However, the resistance (immunity)
declines gradually. To keep the resistance (immunity) for a long time, a booster isrequired at certain intervals, depending on the characteristics of the vaccine.

・Hepatitis B vaccine ・Hib vaccine ・Pediatric pneumococcal vaccine
・Diphtheria-pertussis-tetanus and inactivated polio vaccine (DPT-IPV)

Types ofinactivatedvaccines

・Diphtheria-pertussis-tetanus vaccine (DPT)・Diphtheria-tetanus vaccine (DT)・Inactivated poliovirus vaccine (IPV) ・Japanese encephalitis vaccine
・Human papillomavirus vaccine ・Seasonal influenza vaccine
・Meningococcal vaccine ・Hepatitis A vaccine ・Rabies vaccine
・Tetanus vaccine (T)55. Let’s make a vaccination plan for your child(4) Intervals at which diﬀerent vaccines are given
On October 1, 2020, the vaccination intervals when receiving different vaccines wererevised.
Vaccines are classified as live or inactivated vaccines, and when receiving injected live
vaccines, the appropriate intervals must be maintained.
In certain cases, more than one kind of vaccine may be received at the same time.
Consult with your doctor thoroughly.
If your child is to be vaccinated several times with the same vaccine, please make surethat the specified intervals are adhered to.

65. Let’s make a vaccination plan for your childInjected live vaccine
Routinevaccination

Voluntary
vaccination

BCG, MR,Interval of 27 daysor moreInjected live vaccine

Measles, Rubella, Varicella
Mumps, Yellow fever

No interval specified

Oral live vaccine
Inactivated vaccine*The interval from the day after vaccination with an injected live vaccine to the day of another injected live vaccine shall be 27 days or more.
*The interval from the day after vaccination with an injected live vaccine to the day of vaccination with a live oral vaccine or inactivatedvaccine is not specified.

Oral live vaccine
Routinevaccination

Rotavirus

Injected live vaccine
No interval specified

Inactivated vaccine
Routinevaccination

Hepatitis B, Hib infection, Pneumococcal
infection in children (13-valent), DTP-IPV, DPT,

Oral live vaccine

Inactivated vaccine

DT, Polio, Japanese encephalitis, Human papillomavirus
infection, Seasonal influenza infection and Pneumococcal
infection in elderly
Voluntary
vaccination

Hepatitis A, Rabies, Tetanus, Adult diphtheria
infection, Meningococcal infection, Herpes zoster(Caution)・Symptoms such as fever and swelling at the injection site may occur over a period of several days after vaccination.
Regardless of whether it is within the period in which additional vaccination is allowed, only proceed with vaccination
after verifying that there are no physical health issues, such as fever or swelling at the injection site.
・Different vaccinations may be given at the same time when specially approved by a doctor.
・For vaccines which require multiple inoculations, please follow the provisions outlined in package inserts, etc., regarding
vaccination intervals.

7

5. Let’s make a vaccination plan for your child

List of recommended periods for routine vaccination (Category A disease)

Rotavirus
infection(see page 14)

Oral live attenuated humanrotavirus vaccine(monovalent vaccine)*

5-valent oral live attenuatedhuman rotavirus vaccine(5-valent vaccine)*

7-month-old
32 weeks
0 daysafter birth
8-month-old

5-month-old
24 weeks
0 daysafter birth
6-month-old

3-month-old
14 weeks
6 daysafter birth
4-month-old

1-month-old
6 weeks
0 daysafter birth
2-month-old[Note] The starting date for calculating the vaccination interval is the day following the day of vaccination.

19-year-old
20-year-old

9-month-old
1-year-old
2-year-old
3-year-old
4-year-old
5-year-old
6-year-old
7-year-old
8-year-old
9-year-old
10-year-old
11-year-old
12-year-old
13-year-old
14-year-old
15-year-old
16-year-old
17-year-old
18-year-old

3-month-old
6-month-old*The standard vaccination period for the initial vaccination is between 2 months after birth and 14 weeks 6 days after birth.

Hepatitis B(See page 16)

Hib infection(See page 17)

Pediatric pneumococcal
infection(See page 19)

Phase 1Diphtheria (D)(DPT-IPV•
Pertussis(P)DPT•DT•IPV)
Tetanus (T)Phase 2
Polio (IPV)(DT)(See page 21)

3 shots are given at intervals of 20 days or more (usually 20-56
days), the initial vaccination, with the booster given at least 6 months(usually 1 year to 1 year and 6 months) after the completion of theinitial vaccination.

BCG/BacilleCalmette-Guérin(See page 26)
Measles (M)Rubella (R)(MR•M•R) (See page 27)
Varicella (chickenpox)(See page 30)

Japanese encephalitis(See page 31)
Human papillomavirus
infection(See page 34)*1
2 shots are given at intervals of at least 6 days (usually 6-28 days), as
the initial vaccination, with the booster given at least 6 months(usually about 1 year) after the completion of the initial vaccination.
*Women born between 1997 and 2007 who did not get vaccinatedduring the period of suspension of active recommendation canreceive a catch-up vaccination only for the three years between 2022
and 2024 (Please refer to page 37).

*2*

*1: Persons born between April 2, 2007 and October 1, 2009 may receive the phase 1 vaccine as a routine vaccination if
aged 6 months to no later than 90 months, or 9 years old to no later than 13 years old.
*2: Persons born between April 2, 1995 and April 1, 2007 who were unable to receive the phase 1 and 2 vaccine are able toreceive the vaccine as a routine vaccination if under the age of 20.

8

5. Let’s make a vaccination plan for your childThe
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a congenitalabnormality of the gastrointestinal tract (except for・ Children with a congenital abnormality of the gastrointestinal tract (except forchildren who have completed treatment for said abnormality)
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any subsequent
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The lengthof vaccinationintervals
are establishedin laws in
andordinances.
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The lengthof vaccinationintervals
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means
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・ Have pertussis before
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pages 23-25.
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see
pages
28-29.
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9

6. Before having your child vaccinated

6. Before having your child vaccinatedPlease confirm the following before vaccination
1

Is your child in good health?

2

Do you understand the necessity for vaccination and the benefits
and possible risks (adverse reactions) of the vaccine that will begiven to your child today?
If you have any questions, please write them down.

3

Did you bring your maternal and child health handbook with you?

4

Did you complete a vaccination screening questionnaire?

(1) General precautions
Vaccination should be performed when your child is in good health. Always take noteof the physical condition and characteristics of your child. If you have any concerns, do
not hesitate to consult your family doctor, healthcare center, or the municipal office incharge, in advance.
To have your child vaccinated safely, we recommend that you make the decision
whether to receive the vaccination on the appointed day after taking the following into
consideration:a) Observe your child carefully from the morning on the day of vaccination, andconfirm that he/she is well.
Even if vaccination is scheduled, if your child appears sick, consult your family
doctor and decide whether your child should be vaccinated or not.
b) Thoroughly read the information about vaccination provided by the municipal
office so that you fully understand the necessity and possible adverse effects of thevaccines.
If you have any questions, ask the doctor who is to vaccinate your child before
vaccination.
c) Make sure to bring your maternal and child health handbook.
d) The screening questionnaire contains important information for the doctor in
charge of vaccination. Please fill in the form completely and accurately.
10

6. Before having your child vaccinatede) We recommend that the child being vaccinated be accompanied by a parent/
guardian who is familiar with the child’s usual physical condition.
A child can only be vaccinated if a parent/guardian fully understands the benefits ofand possible adverse reactions to vaccination and agrees to have the child vaccinated.

(2) The following persons cannot receive vaccination:a) A child with an obvious fever (37.5°C or higher)b) A child with a severe acute illness
As a general rule, children with acute, severe illnesses should not be vaccinated onthat day, as the course of such illness can be unpredictable.
c) A child who has had anaphylaxis to any component of the vaccine preparation to
be given on that day“Anaphylaxis” is an acute, severe systemic allergic reaction, usually within 30 minutes
after vaccination, including excessive sweating, a swollen face, systemic severe
urticaria, nausea, vomiting, hoarseness, and respiratory distress, resulting in shock.
d) Women eligible for the measles, rubella, varicella (chickenpox), and mumps
vaccination and are known to be pregnant
This is a regulation not directly concerning children but important for persons whowill receive voluntary vaccination.
e) As concerns the BCG vaccination, a child with a predisposition to keloidsf)Persons who are eligible for the hepatitis B vaccination and who have received
the hepatitis B vaccine after birth as part of the mother-to-infant transmission
prevention programg) Children eligible for rotavirus vaccination who have a clear history of intussusception,
who have a congenital abnormality of the gastrointestinal tract (except for children
who have completed treatment for said abnormality), or who have been found tohave a severe combined immunodeficiency diseaseh) Other conditions that a doctor considers inappropriate
Even if your child does not meet the above criteria a) to f), he/she cannot be
vaccinated if a doctor decides that doing so would be inappropriate.

11

6. Before having your child vaccinated(3) Children who require careful consideration in receiving a vaccination
Parents/guardians to whom the following may apply should have their child seen by
their family doctor in advance to determine whether the child can be vaccinated.
If vaccination is to take place, it should be performed by the family doctor, or at anothermedical institution provided a note or letter, etc. can be obtained from the family doctor.
a) A child who is being treated for a heart, kidney, liver, or blood disease, or adevelopmental disorder.
b) A child who has had a fever within 2 days of a previous vaccination or an allergic
reaction, including rash and urticaria.
c) A child who has had a seizure in the past.
The decision of whether a child should be vaccinated depends on the age at which
the seizure occurred, the presence or absence of fever, subsequent seizures, and thetype of vaccine. Please consult the child’s doctor before vaccination.
d) A child who has been diagnosed with immunodeficiency in the past or has a family
member or relative with immunodeficiency (for example, a person who repeatedly
had perianal abscesses as a baby).
e) A child who is allergic to the vaccine’s components, such as eggs, antibacterial
agents, and the stabilizers used in any step of vaccine production.
f)

In the case of BCF vaccination, a child who is suspected to have been infected withtuberculosis in the past, such as having had extended contact with a tuberculosis
patient in the family.

g) In the case of rotavirus vaccination, a child with an active gastrointestinal illness
or gastrointestinal disorder such as diarrhea.

(4) General precautions after receiving vaccinationa) For 30 minutes after the vaccination, observe your child at the medical institution(facility) or ensure that a doctor can be contacted immediately. Acute adverse
events often develop during that time.
b) Watch for possible adverse reactions for up to 4 weeks (for live vaccines) or
1 week (for inactivated vaccines) after vaccination.
c) Keep the vaccination site clean. Bathing is allowed, but avoid rubbing thevaccination site.
d) Avoid strenuous physical activity on the day of vaccination.

12

6. Before having your child vaccinatede) If a child experiences an abnormal reaction at the vaccination site or has a change
in physical condition after vaccination, consult a doctor immediately.

13

7. Diseases preventable by vaccination and vaccines

7. Diseases preventable by vaccination and vaccines
Each child has a unique physiological makeup. In rare cases, varying degrees ofadverse reactions may occur. It is important for you to decide whether to have your childvaccinated after detailed consultation with your doctor, who understands the physicalstatus of your child.

◆ Rotavirus infection(1) Cause and course
Rotavirus is a cause of acute gastroenteritis seen around the world and often seen
primarily in infants and children under the age of 5 years old. Primary symptoms include
diarrhea, vomiting, and fever and may also occasionally be accompanied by dehydration,
spasms, liver dysfunction, and renal failure, and, rarely, acute encephalopathy. It can
infect and cause illness any number of times, regardless of age, but first-time infection
during infancy causes the most serious illness, with repeated infection thereafter resulting
in more and more mild illness.

(2) Rotavirus vaccines (live vaccines)
There are two rotavirus vaccines – the oral live attenuated human rotavirus vaccine(Rotarix®; hereafter referred to as the monovalent vaccine), which uses attenuated rotavirus;
and the 5-valent oral live attenuated human rotavirus vaccine (RotaTeq®; hereafterreferred to as the 5-valent vaccine), which uses reassortant rotavirus. Both vaccines
provide about 80% protection from gastroenteritis caused by rotavirus infection, andabout 95% protection from serious rotavirus infection.
Rotavirus can infect and cause illness any number of times, regardless of age, but firsttime infection during infancy causes the most serious illness, with repeated infection
thereafter resulting in more and more mild illness. Accordingly, with the primary aim ofpreventing such first-time infection, vaccination is administered in early infancy.
With the first rotavirus vaccine introduced in the United States, it was found that
intussusception, a serious illness in infants and young children, frequently occurred as
an adverse reaction, and sales of this product were halted. Both of the two varieties ofrotavirus vaccine in use around the world today have been confirmed to have a lower
risk of intussusception than the first rotavirus vaccine introduced in the United States via
large-scale clinical trials.

14

7. Diseases preventable by vaccination and vaccines

The risk of intussusception is increased during the week after receiving the firstrotavirus inoculation.
In comparing the risks (the occurrence of adverse reactions such as intussusception) andbenefits (prevention of serious rotavirus infection) of rotavirus vaccination, it is believed thatpreventing rotavirus infection is more beneficial to children, and more and more countries
around the world are introducing the rotavirus vaccines.
If you notice even one of the following in your child after rotavirus vaccination, consider
the possibility of intussusception and consult with a doctor immediately: periodic dysphoria,
abdominal pain, repeated vomiting, intense crying, or bloody stool.
Rotavirus was made a routine vaccination on October 1, 2020.
Eligibility for the routine vaccination is children born on or after August 1, 2020.
The inoculation ages and number of inoculations are 2 inoculations separated by aninterval of 27 days or more for children between 6 weeks 0 days after birth and 24 weeks
0 days after birth for the monovalent vaccine (Rotarix®); and 3 inoculations separated byintervals of 27 days or more for children between 6 weeks 0 days after birth and 32 weeks
0 days after birth for the 5-valent vaccine (RotaTeq®). Note that in order to avoid theperiod in which there is a high incidence of intussusception, it is considered desirable tocomplete the initial inoculation by 14 weeks 6 days after birth.
The incidence of severe cases (cases deemed to be serious by the reporter) amongsuspected cases of adverse reactions (adverse events) reported by medical institutions
was 0.003% for the monovalent vaccine (Rotarix®) and 0.0020% for the 5-valent vaccine(RotaTeq®). (The incidence reported from April 1, 2013 to September 30, 2022. Source:
January 2023 documents 2-22 and 2-23 from the 90th Working Group Meeting on Adverse
Events, the Subcommittee on Vaccination and Vaccines of the Health Sciences Council.)

Oral live attenuatedhuman rotavirus
vaccineRotavirus (monovalent vaccine)*

5-valent oral live
attenuated humanrotavirus vaccine(5-valent vaccine)*

infection

7-month-old
32 weeks
0 daysafter birth
8-month-old

5-month-old
24 weeks
0 daysafter birth
6-month-old

4-month-old

3-month-old
14 weeks
6 daysafter birth

2-month-old

1-month-old
6 weeks
0 daysafter birth(3) Vaccination schedule*The standard vaccination period for the initial vaccination is between 2 months after birth and 14 weeks 6 days
after birth.

15

7. Diseases preventable by vaccination and vaccines◆ Hepatitis B
Since October 2016, the hepatitis B vaccine has been given as a routine vaccination to all
children born on or after April 1, 2016. The cost of vaccinations to newborns of hepatitis
B-positive (HBs antigen positive) mothers will continue to be covered by health insurance,
and in the case of accidental exposure to hepatitis B positive blood etc., the cost of the
inoculation will continue to be covered by workers’ compensation or health insurance.

(1) Cause and course
When a person is infected by the hepatitis B (HB) virus, he or she may develop acutehepatitis and recover, or progress to chronic hepatitis. In some cases, fulminant hepatitis
may occur with severe symptoms which may result in death. In other cases, the virus
may hide in the liver without causing any obvious symptoms, and develop into chronic
hepatitis, cirrhosis, or hepatic cancer after a period of years. It is known that the younger
the patient, the less clear the symptoms of acute hepatitis and the more likely the virus
will hide, resulting in persistent infection. Infections occur through mother-infanttransmission from an HB virus positive (HBs antigen positive) mother to her newborn,
through direct contact with HB positive blood or bodily fluids, or through sexual contact
with an individual who is HB positive.

(2) Hepatitis B vaccine (inactivated vaccine)
Vaccination with the hepatitis B (HB) vaccine, especially in children, is aimed
primarily at preventing persistent infection by the virus and the future potential occurrenceof chronic hepatitis, cirrhosis, or hepatic cancer, rather than at preventing hepatitis in the
short term.
Previously, newborn infants of HB virus positive mothers were given the hepatitis B
vaccine plus hepatitis B immunoglobulin as soon as possible after birth to prevent motherto-child transmission. Now, however, in order to have more people receive the hepatitis
B vaccine and reduce the number of future sufferers of chronic hepatitis, cirrhosis, andhepatic cancer, routine vaccination began in October 2016 for all children born on or after
April 1, 2016, in addition to the mother-to-child transmission prevention program.
Note that the mother-to-child transmission prevention program will continue to becovered by health insurance.
Children eligible for routine HB vaccination are those born on or after April 1, 2016 andunder 1 year of age. The standard schedule is between the time the child turns 2 months
and up to 9 months, in which two subcutaneous injections are given with an interval of atleast 27 days between the first and second injections, and another subcutaneous injection
16

7. Diseases preventable by vaccination and vaccines

given after an interval of at least 139 days after the first injection.
Adverse reactions to the HB vaccine have been reported in about 10% of people who
received the vaccine to date, and include lethargy, headache, and swelling/redness/painat the vaccination site, etc. However, the vaccine is being given to newborns and infants
without problems. The incidence of severe cases (cases deemed to be serious by thereporter) among suspected cases of adverse reactions (adverse events) reported by medical
institutions was 0.0008%. (The incidence reported from April 1, 2013 to September 30, 2022.
Source: January 2023 documents 2-21 from the 90th Working Group Meeting on Adverse
Events, the Subcommittee on Vaccination and Vaccines of the Health Sciences Council.)

20-year-old

19-year-old

18-year-old

17-year-old

16-year-old

15-year-old

14-year-old

13-year-old

12-year-old

11-year-old

10-year-old

9-year-old

8-year-old

7-year-old

6-year-old

5-year-old

4-year-old

3-year-old

2-year-old

1-year-old

9-month-old

3-month-old

6-month-old(3) Vaccination schedule

Hepatitis B◆ Hib infection(1) Cause and course
Haemophilus influenzae, especially Haemophilus influenzae type b, is a problematic
pathogen for infants and small children, causing not only superficial infections such as
otitis media, sinusitis, and bronchitis, but also deep (systemic) infections (also calledinvasive infections) such as meningitis, sepsis, and pneumonia. Prior to 2010, the incidenceof meningitis caused by Hib was 7.1-8.3 out of a population of 100,000 aged less than
5 years. It was estimated that about 400 become infected with meningitis per year andabout 11% of those experience poor outcomes*. Children aged 4 months or more and lessthan 1 year accounted for a half of total patients. (*Cited from material provided by the
Vaccination Working Group, Section of Infectious Diseases, Health Science Council of
MHLW.) Now that the Hib vaccine is widely used, invasive Hib disease is nearly unseen.
(2) Freeze-dried Haemophilus b conjugate vaccine (Hib vaccine)(inactivated vaccine)
Haemophilus influenzae is classified into 7 categories, with type b being the main cause
of serious disease; consequently, type b is used for vaccination. This vaccine is used
extensively throughout the world, and was authorized for use in Japan in December 2008
and made a routine vaccination in April 2013.
17

7. Diseases preventable by vaccination and vaccines

This vaccine may be given simultaneously with other vaccines when the physician
determines it to be necessary and the child’s guardian gives consent. Each vaccine canalso be given separately.
In Europe and the United States, invasive Hib infections decreased dramaticallyafter the vaccine was introduced. Reduction has been similarly dramatic in Japan after
introduction of routine vaccination, and Hib infections are now nearly unseen. The World
Health Organization (WHO) highly recommended routine Hib vaccinations for infants
and children in 1998; consequently, Hib vaccination has been introduced in more than
110 nations and its efficacy has been evaluated highly.
Adverse reactions are mainly local reactions including redness (44.2%), swelling(puffiness) (18.7%), induration (lump) (17.8%), and pain (5.6%); as well as systemic
reactions including fever (2.5%), dysphoria (14.7%), and loss of appetite (8.7%) (Seepackage insert [1st ver.] revised in August 2022).
The incidence of severe cases (cases deemed to be serious by the reporter) among suspectedcases of adverse reactions (adverse events) reported by medical institutions was 0.0019%.
(The incidence reported from April 1, 2013 to September 30, 2022. Source: January2023 documents 2-18 from the 90th Working Group Meeting on Adverse Events, theSubcommittee on Vaccination and Vaccines of the Health Sciences Council.)
Vaccination against Hib infection is conducted per the following procedures by age inmonths at the time of initiating the initial vaccination. The standard vaccination procedure
is as described in (a) below:a) A child aged 2 to 7 months (not exceeding the first day of 7 months) at the time ofinitiating the initial vaccination
The initial vaccination is conducted using a Hib vaccine provided three times atintervals of 27 days or more (20 days if required by a physician), with the standard
interval being 27 (20 if required by a physician) to 56 days. The booster is conducted
once at an interval of 7 months or more (usually 7 to 13 months) after the initial
vaccination. It should be noted that the second and third injections of the initial
vaccination are to be given by the time the child is 12 months of age, and are not to begiven if the child exceeds 12 months. One booster may be given after an interval of atleast 27 days (20 days if required by a physician) after the last vaccination of phase 1.
b) A child aged 7 months (the second day of 7 months) to 12 months (not exceeding thefirst day of 13 months) at the initiation of the initial vaccination
The initial vaccination is conducted using a Hib vaccine provided twice at intervalsof 27 days or more (20 days if required by a physician), with the standard interval
18

7. Diseases preventable by vaccination and vaccines

being 27 (20 if required by a physician) to 56 days. The booster is conducted once at
an interval of 7 months or more (usually 7 to 13 months) after the initial vaccination.
It should be noted that the second injection of the initial vaccination is to be givenby the time the child is 12 months of age, and is not to be given if the child exceeds
12 months. One booster may be given after an interval of at least 27 days (20 days if
required by a physician) after the last vaccination of phase 1.
c) A child aged 12 months (the second day of 12 months) to 60 months (not exceeding thefirst day of 60 months) at the initiation of the initial vaccination.
The vaccination is conducted using a Hib vaccine provided once.
A child who could not be vaccinated due to disease requiring long-term care is also
vaccinated in this manner.

20-year-old

19-year-old

18-year-old

17-year-old

16-year-old

15-year-old

14-year-old

13-year-old

12-year-old

11-year-old

10-year-old

9-year-old

8-year-old

7-year-old

6-year-old

5-year-old

4-year-old

3-year-old

2-year-old

1-year-old

9-month-old

3-month-old

6-month-old(3) Vaccination schedule

Hib infection◆ Pneumococcal infection in children(1) Cause and course
Streptococcus pneumoniae is one of two major causes of bacterial pediatric infections.
This is a bacterium carried deep in the noses of many children and occasionally causes
bacterial meningitis, bacteremia, pneumonia, sinusitis, and otitis media.
Prior to the introduction of the vaccine, the prevalence of purulent meningitis causedby Streptococcus pneumoniae was 2.6-2.9 out of a population of 100,000 aged less than
5 years. It was estimated that about 150 experience meningitis per year*. Case fatality
rate and frequency of secondary complications (e.g. hydrocephalus, deafness, mental
disabilities) are higher than that of Hib-induced meningitis, with about 21% experiencing
a poor prognosis. (*Cited from material provided by the Vaccination Working Group,
Section of Infectious Diseases, Health Science Council of MHLW.) Now that thepneumococcal conjugate vaccine is in wide use, invasive infections such as pneumococcal
meningitis have decreased dramatically.
(2) Adsorbed 13-valent pneumococcal conjugate vaccine(13-valent pneumococcal conjugate vaccine) (inactivated vaccine)
The pediatric pneumococcal conjugate vaccine (13-valent pneumococcal conjugate
19

7. Diseases preventable by vaccination and vaccines

vaccine) was developed to prevent bacterial meningitis in children, including 13 serotypes
causing serious conditions in children.
This vaccine was first used in the United States as a 7-valent vaccine in 2000, andswitched to a 13-valent vaccine in 2010, which is currently used as the standard vaccine
in over 100 countries. It has been reported in many countries that inoculation with this
vaccine reduces bacterial meningitis and bacteremia. In Japan, the vaccine was authorized
for use in November 2013, and the incidence of invasive pneumococcal disease has
decreased similarly.
This vaccine may be given simultaneously with other vaccines when the physician
determines it to be necessary and the child’s guardian gives consent. Each vaccine canalso be given separately.
Adverse reactions include local reactions such as erythema (67.8-74.4%) and swelling(47.2-57.1%), and systemic reactions including fever of over 37.5°C (32.9-50.7%). (Seepackage insert [3rd ver.] revised in September 2021.)
The incidence of severe cases (cases deemed to be serious by the reporter) amongsuspected cases of adverse reactions (adverse events) reported by medical institutions was
0.0019%. (The incidence reported from October, 2013 to September 30, 2022. Source:
January 2023 documents 2-17 from the 90th Working Group Meeting on Adverse Events,
the Subcommittee on Vaccination and Vaccines of the Health Sciences Council.)
Vaccination against pediatric pneumococcal infection is provided per the following
procedures by age in months at of the time of initiating the initial vaccination. The
standard vaccination procedure is as described in (a) below:a) A child aged 2 to 7 months (not exceeding the first day of 7 months) at the time ofinitiating the initial vaccination.
The initial vaccination is conducted using a 13-valent pneumococcal conjugate
vaccine provided three times at intervals of at least 27 days usually by the time thechild is 12 months of age. The booster is conducted once at an interval of at least
60 days after the initial vaccination, given no earlier than one day after the child turns
12 months (the standard vaccination period is between 12-15 months after birth).
However, the second and third injections of the initial vaccination are to be given by
the time the child is 24 months of age, and are not to be given if the child exceeds
24 months (the booster is allowed after this time). The second injection of the initial
vaccination is to be given by the time the child is 12 months of age, and is not to begiven if the child exceeds 12 months (the booster is allowed after this time).
20

7. Diseases preventable by vaccination and vaccinesb) A child aged 7 (the second day of 7 months) to 12 months (not exceeding the first dayof 12 months) at the time of initiating the initial vaccination.
The initial vaccination is conducted using a 13-valent pneumococcal conjugate
vaccine provided twice at intervals of at least 27 days usually by the time the child is
12 months of age. The booster is conducted once at an interval of at least 60 days after
the initial vaccination 12 months after birth. However, the second injection of the initial
vaccination is to be given by the time the child is 24 months of age, and is not to begiven if the child exceeds 24 months (the booster is allowed after this time).
c) A child aged 12 (the second day of 12 months) to 24 months (not exceeding the firstday of 24 months) at the initiation of the initial vaccination.
The vaccination is conducted using a 13-valent pneumococcal conjugate vaccine
provided twice at intervals of at least 60 days.
d) A child aged 24 (the second day of 24 months) to 60 months (not exceeding the firstday of 60 months) at the initiation of the initial vaccination.
The vaccination is conducted using a 13-valent pneumococcal conjugate vaccine
provided once.
A child who could not be vaccinated due to disease requiring long-term care canalso be vaccinated in this manner.

20-year-old

19-year-old

18-year-old

17-year-old

16-year-old

15-year-old

14-year-old

13-year-old

12-year-old

11-year-old

10-year-old

9-year-old

8-year-old

7-year-old

6-year-old

5-year-old

4-year-old

3-year-old

2-year-old

1-year-old

9-month-old

3-month-old

6-month-old(3) Vaccination schedulePneumococcal
infectionin children◆ Diphtheria, pertussis, tetanus, and polio (acute poliomyelitis)(1) Cause and course(a) Diphtheria
Diphtheria is caused by Corynebacterium diphtheriae and is spread by droplet infection.
The improved diphtheria-pertussis-tetanus vaccine (DPT) (acellular) was introduced tothe market in 1981. Today, the annual incidence of diphtheria in Japan has been zero (0)for many consecutive years, but in the Asian region, epidemic outbreaks have been seen.
The bacterium infects mainly the throat but also the nasal cavity. Even when infection21

7. Diseases preventable by vaccination and vaccines

occurs, diphtheria causes symptoms in only about 10% of people, while the rest of
those infected become asymptomatic carriers who can transmit the disease to otherpeople. Symptoms include high fever, sore throat, a barking cough, and vomiting; afalse membrane may also form in the throat which can cause asphyxia. Patients must
be monitored carefully because the bacterium produces a toxin that can cause a serious
myocardial disorder or paralysis two to three weeks after the development of symptoms.
(b) Pertussis
Pertussis is caused by Bordetella pertussis and is spread by droplet infection.
Since pertussis vaccination was begun in 1950, the number of patients has decreased,
but in recent years, there have been cases of pertussis in children ranging from school age
to adolescence as well as in adults characterized by persistent coughing. Such people arepotential sources of infection to small children, and require caution since the disease canbecome serious, especially in newborns and infants.
Prototypical pertussis begins with symptoms mimicking a common cold. The child thenbegins to cough violently and repeatedly, with a flushed face. After coughing, the patient
is forced to inhale rapidly, creating a whooping sound similar to a whistle. Usually, fever
does not develop. Infants sometimes present with blue lips (cyanosis), seizures (fits)
or suddenly stop breathing because they are unable to breathe due to coughing. Severe
complications such as pneumonia or encephalopathy are likely to develop, and these
diseases may lead to death in newborns or infants.

● Droplet infection
Droplet infection is the transmission of viruses and bacteria throughcoughing, sneezing, conversation, etc. Viruses and bacteria envelopedin sprays of saliva and airway secretions are spread through the air topeople within one meter.
(c) Tetanus
Clostridium tetani does not spread from person to person. The bacteria are usuallyfound in soil and enter the body through wounds in the skin. The bacteria multiply in the
body and produce a toxin, causing tonic muscle spasms. Half of all patients are infected
through a small skin wound not noticed by themselves or the people around them. As thebacteria are found in soil, opportunities for infection are constant. If a pregnant motherhas immunity, the newborn is protected from tetanus during delivery.
22

7. Diseases preventable by vaccination and vaccines(d) Polio (acute poliomyelitis)
Polio (acute poliomyelitis) is also known as “infantile paralysis.” Pandemics occurred
repeatedly in Japan until the early 1960s. Owing to vaccination, the last occurrence of apatient paralyzed by a wild strain of the polio virus was in 1980. The WHO declared theeradication of poliomyelitis from the Western Pacific Region including Japan in 2000.
At present, there are only two polio-endemic countries, Pakistan and Afghanistan, andglobal polio eradication seems no longer a dream, but the world remains vigilant against
polioviruses.
The polio virus infects through the mouth and proliferates in the cells of the pharynx
and small intestine. The polio virus is said to multiply for 4 to 35 days (mean: 7-14 days)in the cells of the small intestine. Viruses thus multiplied are excreted in feces and taken
through the mouth of a person with no resistance (immunity) to the polio virus, resulting
in infection from person to person. Most people who are infected with the polio virus
are asymptomatic and gain lifelong protection (lifelong immunity). In some people
who experience symptoms, the viral infection spreads via the blood to the brain andspinal cord, thereby causing paralysis. Out of 100 children infected with the polio virus,
5-10 experiences symptoms like those of the common cold, accompanied by fever, andfollowed by headache and vomiting.
About 1 of 1,000-2,000 people infected with the polio virus experiences paralysis of
the limbs. Some are permanently paralyzed or suffer from progression of symptoms,
sometimes dying of respiratory distress.

(2) Diphtheria-pertussis-tetanus and inactivated polio vaccine (DPT-IPV),
Diphtheria-pertussis-tetanus vaccine (DPT), and diphtheria-tetanus
vaccine (DT) (inactivated vaccine)
The phase 1 initial vaccination is given after 2 months of age, three times in the case of
DPT-IPV and DPT and twice in the case of DT, allowing an interval of at least 20 days
with the standard interval being 20 to 56 days. The phase 1 booster vaccination is given
at least 6 months (usually about 1 year to 1 year and 6 months) after the completion of theinitial vaccination. Take care not to miss a vaccination, as multiple injections are required.
Phase 2 vaccination (diphtheria-tetanus vaccine) is given once at the age of 11-12 years.
Although a voluntary vaccination, it is also possible to have your child receive the DPT
vaccine at this time, strengthening their immunity to pertussis.
To acquire sufficient immunity, your child must be vaccinated according to fixedintervals. However, even in the event the interval between injections becomes longer than23

7. Diseases preventable by vaccination and vaccinesthat specified, there are several methods which can be taken, so please consult with yourfamily doctor and the municipal office.
The DPT-IPV can be used even with children who have already contracted one or moreof pertussis, diphtheria, poliomyelitis (acute poliomyelitis), or tetanus.
Since November 2012, the combined DPT (diphtheria, pertussis, tetanus) and IPV(inactivated polio) quadruple vaccines Quattrovac® (produced by KM Biologics) andTetrabik ® (produced by the Research Foundation for Microbial Diseases of Osaka
University) have been used. In December 2015, the DPT-IPV quadruple vaccine,
Squarekids® subcutaneous injection syringe (produced by Daiichi Sankyo Vaccine Co.,
Ltd.), was introduced to the market.
The incidence of serious cases (cases deemed to be serious by the reporter) among suspectedcases of adverse reactions (adverse events) reported by medical institutions was 0.0012% for
the DPT-IPV, 0.0017% for the DPT vaccine and 0.0002% for the DT vaccine. (The incidence
reported from April 1, 2013 to September 30, 2022. Source: January 2023 documents 2-16,
2-11 and 2-12 from the 90th Working Group Meeting on Adverse Events, the Subcommittee
on Vaccination and Vaccines of the Health Sciences Council.)Even in the absence of a serious adverse reaction, if your child is cranky or swelling
occurs, consult with a doctor.
Although the incidence of diphtheria, pertussis, tetanus, and polio (acute poliomyelitis) has
decreased, these diseases are all associated with serious complications, disabling sequelae, oreven death. Therefore, it is recommended to receive vaccination for their prevention.

(3) Polio vaccine (inactivated vaccine)
An oral polio vaccine (OPV) had been used to eradicate polio in Japan and this state had
been maintained up until August 2012; however, the OPV was replaced with an inactivatedpoliovirus vaccine (IPV) as a routine vaccination on September 1, 2012 in order to avoid
vaccine-associated paralytic poliomyelitis (VAPP), a rare but serious adverse reaction
to the OPV which develops in about one out of one million vaccine recipients. The IPVIMOVAX POLIO® subcutaneous injection (produced by Sanofi K.K.) has been used since
September 2012.
The IPV includes antigens of three types of polio viruses (I, II and III). Resistance(immunity) to these three types of polio viruses reaches almost 100% with three
IPV vaccinations; however, the fourth vaccination is needed because IPV maintains
immunocompetence for a shorter time than the OPV.
A domestic clinical trial of IMOVAX POLIO® showed that pain (18.9%), erythema (77.0%),24

7. Diseases preventable by vaccination and vaccines

swelling (54.1%), fever of 37.5°C or more (33.8%), drowsiness (35.1%), and irritability(41.9%) were observed after the third vaccination. Precautions of shock and anaphylaxis(frequency unknown) and against convulsions as they were observed in 1.4% are described in
the package insert. (See package insert [2nd ver.] revised in December 2022).
The incidence of severe cases (cases deemed to be serious by the reporter) among suspectedcases of adverse reactions (adverse events) reported by medical institutions was 0.0010%.
(The incidence reported from April 1, 2013 to September 30, 2022. Source: January 2023
documents 2-15 from the 90th Working Group Meeting on Adverse Events, the Subcommittee
on Vaccination and Vaccines of the Health Sciences Council.)
The switch from OPV to IPV is taking place all over the world. However, there aremany cases that OPV-derived viruses (circulating vaccine derived Polio, virus: cVDPV)
still lurking in sewage and river water infect non-vaccinated individuals and cause
paralysis in regions where vaccination rates are low. As cases of OPV-derived virus
infection have recently been reported in the United States, Israel, the United Kingdom,
and Indonesia, there is a need to improve polio vaccination coverage in these countries.
In Japan, the DPT-IPV vaccination rate is high, and cVDPV has not been detected, so therisk is extremely low. However, there is a possibility that the virus will be brought into
Japan from overseas, so it is recommended to receive a vaccine containing IPV.
15-year-old

14-year-old

13-year-old

12-year-old

11-year-old

10-year-old

9-year-old

8-year-old

7-year-old

6-year-old

5-year-old

4-year-old

3-year-old

2-year-old

1-year-old

9-month-old

3-month-old

Phase 1:DPT-IPV,
DPT, DTand IPV(See Notes 1
and 2)

6-month-old(4) Vaccination schedule

3 shots are given at intervals of 20 days or more (usually 20-56 days) as the initial
vaccination, with a booster (once) given at least 6 months (usually 1 year to 1 year
and 6 months) after the completion of the initial vaccination.

DTphase 2
Note 1: The DPT-IPV, DPT, and DT can also be given to children who have already experienced pertussis. If the
DT is given, the initial vaccination is conducted with 2 shots. The DPT-IPV, DPT, and DT can also begiven to children who have already experienced any of the diseases of diphtheria, tetanus, or polio.
Note 2: In the phase 1 initial vaccination, the same type of vaccine is usually given the required number of times.

25

7. Diseases preventable by vaccination and vaccines◆ Tuberculosis(1) Cause and course
Tuberculosis is caused by infection from Mycobacterium tuberculosis. Although
the number of tuberculosis patients has markedly decreased in Japan, approximately
20,000 people are newly diagnosed with tuberculosis every year and the disease can betransmitted to children from adults. Immunity against tuberculosis cannot be acquiredin the womb, so newborn babies are also at risk of contracting the disease. Infants
and children have low immunity against tuberculosis; as a result, they sometimes
contract systemic tuberculosis or tuberculous meningitis, resulting in severe secondary
complications.
It is recommended to receive a BCG vaccination within 1 year after birth as the BCG
vaccine has the effect of preventing serious tuberculosis, such as meningitis and miliary
tuberculosis, in infants.
The standard vaccination period is from 5 to 8 months after birth.
(2) BCG vaccine (live vaccine)
The BCG vaccine is made from attenuated Mycobacterium bovis.
The method used to administer the BCG vaccination in Japan is a percutaneous
injection using an apparatus with multiple needles that is pressed into two locations on
the upper arm. The vaccine should not be given elsewhere on the body due to possible
adverse reactions, including keloid formation. The vaccination site should be allowed todry away from light for about 10 minutes.
Red pockmarks appear on the vaccination site around 10 days after vaccination,and some may discharge a small amount of pus (fester). This reaction peaks about
4 weeks after vaccination; subsequently, the pockmarks are covered with scabs and heal
completely by three months after vaccination, leaving only tiny scars. This scarring is not
an abnormal reaction but evidence that a person has acquired immunity through the BCG
vaccination. As the vaccination site will heal naturally, keep it clean and do not cover itwith a bandage or plaster. However, if the vaccination site is still oozing three months
after vaccination, please consult a doctor.
One rare adverse reaction is swelling in the lymph nodes below the armpit on thesame side as the vaccination. This reaction can generally be left untreated; however,occasionally the area can grow tender, severely swollen, or, rarely, may fester andnaturally tear. Should such a reaction occur, please consult a doctor.
The incidence of severe cases (cases deemed to be serious by the reporter) amongsuspected cases of adverse reactions (adverse events) reported by medical institutions was
0.0028%. (The incidence reported from April 1, 2013 to September 30, 2022. Source:26

7. Diseases preventable by vaccination and vaccines

January 2023 documents 2-19 from the 90th Working Group Meeting on Adverse Events,
the Subcommittee on Vaccination and Vaccines of the Health Sciences Council.)
In cases where a child is infected with tuberculosis due to transmission from afamily member etc., within 10 days of the injection the vaccination site may show an
inflammatory reaction called Koch’s phenomenon (redness, swelling, and suppuration at
the vaccination site, generally followed in 2 to 4 weeks by decreased redness, swelling,
and inflammation, after which the wound scarifies [leaves a scar] and heals). Unlike theusual reaction time (generally about 10 days after vaccination), the Koch phenomenon
appears at an early stage, within several days of vaccination. If your child develops areaction which suggests the Koch phenomenon, promptly consult your municipality or aphysician, as your child may require treatment. In such cases, family members and otherindividuals close to the child who may have transmitted tuberculosis will also require a
medical examination.

15-year-old

14-year-old

13-year-old

12-year-old

11-year-old

10-year-old

9-year-old

8-year-old

7-year-old

6-year-old

5-year-old

4-year-old

3-year-old

2-year-old

1-year-old

9-month-old

3-month-old

6-month-old(3) Vaccination schedule

BCG◆ Measles and rubella(1) Cause and course(a) Measles
Measles is caused by infection by the measles virus. Measles is highly contagious andspreads not only through droplets and contact but also through airborne transmission.
Without vaccination, many people will contract the disease and there is risk of an
epidemic. The main symptoms of prototypical measles are fever, cough, runny nose,
bloodshot eyes, eye discharge, and rash. For the first 3 to 4 days, patients have a fever of
38°C, which appears to decline but increases again to 39°C to 40°C, with a rash over theentire body. The fever goes down within 3 to 4 days, and the rash gradually disappears.
The parts affected by the rash may remain darker for a while.
The main complications are bronchitis, pneumonia, otitis media, and encephalitis. About 7
to 9 out of 100 people with measles also get otitis media and about 1 to 6 get pneumonia. 1 to
2 out of 1,000 experiences encephalitis. One or two out of 100,000 measles patients develops
subacute sclerosing panencephalitis (SSPE), a chronic progressive form of encephalitis.
A serious disease, even in advanced countries with sophisticated medical care, around 1 out
27

7. Diseases preventable by vaccination and vaccinesof 1,000 measles patients dies. In Japan, approximately 20 to 30 people died annually during
the epidemic which occurred in the years around 2000. Globally, cases of measles are once
again on the rise, and many children, primarily in developing countries, die from measles.

● Airborne infection (droplet nuclei infection)
With an airborne infection, the virus or bacterium is discharged into the
air and infects people in open spaces. Measles, varicella (chickenpox), andtuberculosis are airborne diseases.
(b) Rubella
Rubella is caused by the rubella virus and is spread by droplet infection. The incubation
period is 2 to 3 weeks. Prototypical rubella develops with mild cold-like symptoms, andthe main symptoms are rash, fever, and posterior cervical lymphadenopathy (lymph nodes
swelling in the back of the throat). Conjunctival congestion also occurs. Older children
and adults experience a high frequency of arthritis. The prognosis is generally good, butthrombocytopenic purpura and encephalitis may also be observed, and, rarely, hemolytic
anemia. According to the National Epidemiological Surveillance of Infectious Diseases,
during the rubella outbreak from 2018 to 2019 (with a total of 5,239 cases), there were 21
reported cases of thrombocytopenic purpura and 2 reported cases of encephalitis. Adult
patients experience severe symptoms.
When a pregnant woman is infected by the rubella virus before around the 20th weekof pregnancy, there is a very high risk of her infant being born with congenital rubella
syndrome which may include heart abnormalities, cataracts, hearing impairment, anddelayed growth and development.

(2) Combined measles-rubella (MR) vaccine, measles (M) vaccine, rubella (R)vaccine (live vaccine)
The MR live vaccine contains attenuated measles and rubella viruses.
Once your child turns 1 year old, you should have him or her receive the phase 1
vaccination as soon as possible.
Both the measles and rubella vaccines give 95% or more of children immunity after one
injection, but out of caution in case of non-response to the first dose and to prevent agerelated decline of immunity, a second injection (phase 2 vaccination) is now performed.
Even if your child received the measles and rubella vaccine before his or her firstbirthday, it is not counted in the number of vaccinations received because vaccination
under one year of age is insufficient for acquiring immunity. Have him or her receive theroutine phase 1 vaccination once he or she turns 1 year old, and the phase 2 vaccination
once the appropriate age is reached.
28

7. Diseases preventable by vaccination and vaccines

Eligibility for the phase 2 vaccination is the year before admission into elementary
school, that is, children in their final year of kindergarten or nursery school.
For the phase 1 and 2 vaccinations, the combined measles-rubella (MR) vaccine is used.
The combined measles-rubella (MR) vaccine can also be used for individuals who havealready contracted measles or rubella.
If your child has received a gamma globulin injection for the purpose of treating or
preventing illness, please consult your physician for the appropriate timing of vaccination.
The data concerning adverse reactions to the measles and the rubella vaccines showsthat anaphylaxis, thrombocytopenic purpura, encephalitis, and seizure may occur rarely.
Febrile seizures (seizures caused by a fever) have occasionally (about 1 child in 300
children) been reported after measles vaccination. In addition, there have been reports ofchildren experiencing encephalitis/encephalopathy in extremely rare cases (1 child or lessin 1-1.5 million children).
The incidence of severe cases (cases deemed to be serious by the reporter) amongsuspected cases of adverse reactions (adverse events) reported by medical institutions was
0.0010%. (The incidence reported from April 1, 2013 to September 30, 2022. Source:
January 2023 documents 2-1 from the 90th Working Group Meeting on Adverse Events,
the Subcommittee on Vaccination and Vaccines of the Health Sciences Council.)
Although the rubella vaccine is a live vaccine and the rubella virus multiplies in the bodysimilarly to the measles vaccine, a vaccinated person does not infect those around him or her.
Measles causes severe symptoms and may result in sequelae or death. When a pregnant
woman contracts rubella, her infant may be born with congenital rubella syndrome
which may include heart abnormalities, cataracts, retinopathy, hearing impairment, andintelligence impairment. Make sure you are vaccinated so as to prevent contracting these
diseases or transmitting them to others.
19-year-old

18-year-old

17-year-old

15-year-old

16-year-old

14-year-old

13-year-old

12-year-old

11-year-old

10-year-old

9-year-old

8-year-old

7-year-old

6-year-old

5-year-old

4-year-old

3-year-old

2-year-old

9-month-old

1-year-old

3-month-old

6-month-old(3) Vaccination schedule

Measles/Rubella(MR/M/R)(See Notes 1 and 2) MR phase 1: It is recommended to receive vaccination as soon as possible after the first birthday.
MR phase 2: 1 year (from April 1 to March 31) before entering elementary school. It is recommended
to receive vaccination as soon as possible after a child reaches the age for accination.

Note 1: A simultaneous vaccination for measles and rubella in phase 1 and 2 is given using the combined
measles-rubella (MR) vaccine.
Note 2: Individuals who have experienced either measles or rubella before can receive the vaccine for the disease
they have not experienced or the measles-rubella (MR) vaccine and are normally given the MR vaccine.
* Men born between April 2, 1962 and April 1, 1979 have been added to the list of those eligible for routine
vaccination concerning rubella (phase 5 routine vaccination for rubella).

29

7. Diseases preventable by vaccination and vaccines◆ Varicella (chickenpox)(1) Cause and course
Varicella (chickenpox) is an acute infectious disease caused by initial infection with thevaricella-zoster virus (“VZV”). It is one of the most infectious diseases, spread by directcontact, droplets, and airborne infection. Once a person is infected, the virus remains
dormant in the body (in the trigeminal ganglia and other cerebral ganglia, and in the dorsal
root ganglia) and reactivates to cause herpes zoster (shingles) when the person ages, orwhen the immune system is compromised.
The incubation period of varicella (chickenpox) is generally about 2-3 weeks (10-21days). The main symptom of prototypical varicella (chickenpox) is a characteristic rashwith itching. There may also be a fever. The rash begins as raised red spots, progressing
in 3 or 4 days to blisters that crust over and form scabs before healing. Although the rashtends to be distributed on the abdomen, back, and face, it also characteristically appearson the scalp and other parts which are covered with hair.
Varicella usually clears spontaneously in about 1 week, but in rare cases it can beaccompanied by encephalitis, pneumonia, or liver function abnormality. Antiviral
medication (e.g. Acyclovir) is sometimes used. It is not unusual for bacterial infections
to develop via the skin and lead to purulence. In some cases, complications such as
sepsis and other severe bacterial infections may occur. High-risk patients (patientswith malignant tumors such as acute leukemia or patients who are or may be
immunosuppressed due to treatment) are particularly likely to develop severe symptoms.
In accordance with regulations such as the Enforcement Regulations for the School
Health and Safety Act, children are to refrain from attending nursery school, kindergarten,
or elementary/middle/high school until all of the rash has crusted over (formed scabs).
When adults develop varicella (chickenpox), symptoms tend to become more severe
compared to children.
(2) Varicella (chickenpox) vaccine (live vaccine)This is a live vaccine containing attenuated VZV. It was developed in Japan aheadof the rest of the world. About 20% of the individuals who receive this vaccine once
experience varicella (chickenpox) later, but in a milder form. The vaccine is given twice
to ensure that infection does not occur.
It has been shown that vaccine administration within 3 days of exposure to a varicellapatient is effective in preventing disease. This kind of vaccination is also used to prevent
hospital-acquired infection.
Almost no adverse reactions are observed in healthy children and adults; however, fever
and rash occasionally develop, and local redness, swelling (puffiness), and induration (stiffness)
are observed in rare cases. High-risk patients (patients who may be immunosuppressed due30

7. Diseases preventable by vaccination and vaccines

to the effects of treatment for acute lymphatic leukemia or nephrotic syndrome) may
receive the vaccination, provided that certain conditions are met. However, the patient
may develop a fever with raised red spots and blisters 14 to 30 days after vaccination. (Seepackage insert [3rd ver.] revised in January 2022)
The incidence of severe cases (cases deemed to be serious by the reporter) amongsuspected cases of adverse reactions (adverse events) reported by medical institutions was
0.0010%. (The incidence reported from April 1, 2013 to September 30, 2022. Source:
January 2023 documents 2-5 from the 90th Working Group Meeting on Adverse Events,
the Subcommittee on Vaccination and Vaccines of the Health Sciences Council.)
After being made a routine vaccination on October 2014, the incidence of varicella(chickenpox) decreased dramatically. The varicella vaccine can be given at the sametime as the MR vaccine. Children aged 12 months to no later than 36 months are given afreeze-dried live attenuated varicella vaccine, with the first injection given when the childis 12 months to no later than 15 months and the second injection given after an intervalof at least 3 months with the standard interval being between 6 to 12 months. Children
who already received the varicella vaccine as a voluntary vaccination are deemed to havereceived the number of injections he or she has already undergone.

20-year-old

19-year-old

18-year-old

17-year-old

16-year-old

15-year-old

14-year-old

13-year-old

12-year-old

11-year-old

10-year-old

9-year-old

8-year-old

7-year-old

6-year-old

5-year-old

4-year-old

3-year-old

2-year-old

1-year-old

9-month-old

3-month-old

6-month-old(3) Vaccination schedule

Varicella(chickenpox)◆ Japanese encephalitis(1) Cause and course
Japanese encephalitis is caused by the Japanese encephalitis virus. The Japanese encephalitis
virus is transmitted by mosquitoes carrying viruses that have multiplied in pigs and otherhosts. After an incubation period of 7 to 10 days, it may develop into acute encephalitis
with symptoms such as high fever, headache, vomiting, disturbance of consciousness, andconvulsions. Japanese encephalitis does not spread from person to person.
One in 100-1,000 people infected with the virus develops encephalitis, etc. Some people
develop meningitis, while others may only experience symptoms like a summer cold. The
fatality rate of encephalitis is about 20-40%, but many people suffer from nervous systemsequelae after recovering from the disease.
In Japan, the disease occurs mainly in the western areas, but the Japanese encephalitis
virus is found throughout the nation and especially in western Japan. Japanese encephalitis
31

7. Diseases preventable by vaccination and vaccines

outbreaks among domesticated pigs occur yearly from June to around October, during
which time approximately 80% of pigs are infected in some geographical areas. In thepast, the disease was prevalent among small and school-age children, but due to thewider use of vaccination and changes in living environments, the number of patients has
decreased. In recent years, patients have mostly been elderly, but in 2015, a 10-months old
infant in Chiba prefecture was determined to have Japanese encephalitis. There were also
11 reported incidents in 2016, mostly in elderly people. This was the first time the numberof patients exceeded 10 per year since 1992.

(2) Freeze-dried Japanese encephalitis vaccine (inactivated vaccine)
The freeze-dried cell culture-derived Japanese encephalitis vaccine in use in Japan
today is created by growing the virus in Vero cells and killing (inactivating) the virus witha substance such as formalin, after which it is refined.
The incidence of severe cases (cases deemed to be serious by the reporter) amongsuspected cases of adverse reactions (adverse events) reported by medical institutions was
0.0007%. (The incidence reported from April 1, 2013 to September 30, 2022. Source:
January 2023 documents 2-20 from the 90th Working Group Meeting on Adverse Events,
the Subcommittee on Vaccination and Vaccines of the Health Sciences Council.)
Eligibility for the phase 1 routine vaccination is children between 6 and 90 months after
birth. The standard schedule is to give two injections separated by an interval of 6 to 28
days from the day the child turns 3 and before his or her fourth birthday, and one injection
from the fourth birthday to before the child turns 5. Eligibility for the phase 2 routine
vaccination is children from 9 years to before he or she turns 13. The standard schedule is
to give one injection between the child’s ninth and tenth birthdays.

20-year-old

19-year-old

18-year-old

17-year-old

16-year-old

15-year-old

14-year-old

13-year-old

12-year-old

11-year-old

10-year-old

9-year-old

8-year-old

7-year-old

6-year-old

5-year-old

4-year-old

3-year-old

2-year-old

1-year-old

9-month-old

3-month-old

6-month-old(3) Vaccination schedule*1

Japanese
encephalitisTwoinjections are given
at intervals of 6 days or more (usually 6-28 days)追加接
as the initial
初回接種は6日以上、標準的には6日から28日までの間隔をおいて2回行い、vaccinationof phase 1, and a booster
is given at least 6 months (usually about 1 year) after the
種は初回接種終了後6月以上、標準はおおむね1年を経過した時期に1回行います。
completion of the initial vaccination of phase 1 (2 injections).
*2*1: Persons born between April 2, 2007 and October 1, 2009 may receive the phase 1 vaccine as a routine
vaccination if aged 6 months to no later than 90 months, or 9 years old to no later than 13 years old.
*2: Persons born between April 2, 1995 and April 1, 2007 who were unable to receive the phase 1 and 2 vaccine
are able to receive the vaccine as a routine vaccination if under the age of 20.

32

7. Diseases preventable by vaccination and vaccines(4) Special consideration for vaccination (to secure opportunities for
vaccination for children who were unable to receive the vaccine due tosuspension of active recommendation in 2005)
A. Children born between April 2, 2007 and October 1, 2009 who have not received theirphase 1 (3 injections) Japanese encephalitis vaccination by March 31, 2010 are eligible
for the following measures to secure opportunities for vaccination for children who areeither between 6 to 90 months of age or from 9 years to under 13 years.
(A) Children who received the first injection of phase 1 and who have 2 injections
remaining are to be given two injections of freeze-dried cell culture-derived Japanese
encephalitis vaccine separated by an interval of at least 6 days. The first injection andthe 2 injections mentioned herein are to be separated by an interval of at least 6 days.
(B) Children who received the first 2 injections of phase 1 and who have 1 injection
remaining are to be given 1 injection of freeze-dried cell culture-derived Japanese
encephalitis vaccine. The first 2 injections and the 1 injection mentioned herein are to
be separated by an interval of at least 6 days.
(C) Children who have not received any of the phase 1 injections are to be given 2
injections of freeze-dried cell culture-derived Japanese encephalitis vaccine separated
by an interval of at least 6 days, with the standard interval being 6 to 28 days, followedby 1 booster at least 6 months after the second injection, with the standard schedule forthe booster being about 1 year after the second injection.
(D) According to (A), (B), and (C) above, children 9 years to under 13 years who havereceived all of the phase 1 injections and have yet to receive the phase 2 injection,
are to be given 1 injection of freeze-dried cell culture-derived Japanese encephalitis
vaccine after an interval of at least 6 days.
B. Children under the age of 20 who were born between April 2, 1995 and April 1, 2007
and who may not have received the phase 1 (three injections) and phase 2 (one injection)
vaccine due to suspension of active recommendation on May 30, 2005 are eligible forthe following measures to secure opportunities for vaccination.
(A) Children who have 3 injections remaining of phase 1 and 2 (children who received
1 injection of the initial vaccination in phase 1 [children who received the first
injection]) are to be given 2 injections of freeze-dried cell culture-derived Japanese
encephalitis vaccine separated by an interval of at least 6 days, with the fourth injection
for children at least 9 years to age to be given after an interval of at least 6 days after
the third injection.
(B) Children who have 2 injections remaining of phase 1 and 2 (children who received
two injections of the initial vaccination in phase 1 [children who received the second
injection]) are to be given the third injection of freeze-dried cell culture-derived
33

7. Diseases preventable by vaccination and vaccines

Japanese encephalitis vaccine after an interval of at least 6 days, with the fourth
injection for children at least 9 years to age to be given after an interval of at least
6 days after the third injection.
(C) Children who are to receive phase 2 of the vaccination (children who havecompleted phase 1 injections [children who received the third injection]) are to begiven the fourth injection for children at least 9 years to age after an interval of at least
6 days after the third injection.
(D) Children who have not received any of the phase 1 injections are to be given
2 injections of freeze-dried cell culture-derived Japanese encephalitis vaccine separated
by an interval of at least 6 days, with the standard interval being 6 to 28 days, followedby 1 booster at least 6 months after the second injection, with the standard schedule
for the booster being about 1 year after the second injection. The fourth injection forchildren at least 9 years to age is to be given after an interval of at least 6 days after thethird injection.
Because there was insufficient recommendation of phase 2 vaccination for persons
who will turn 18 between 2017 and 2024 (persons born between April 2, 1999 and April
1, 2007) due to suspension of active recommendation from May 30, 2005 to March 31,
2010, the measures in (4) were adopted for the purpose of active recommendation of thevaccine to persons turning 18 in every applicable year.
A pregnant or possibly pregnant woman aged 13 years or more is not allowed to receive
vaccination in principle and can receive vaccination only if the advantage of vaccinationis confirmed to be superior to the risk.
You can ask questions on vaccination and receive latest information from yourmunicipality. A Q&A is available from the website of the Ministry of Health, Labour andWelfare: “Q&A on Japanese encephalitis vaccination” (Japanese)(https://www.mhlw.go.jp/bunya/kenkou/kekkakukansenshou21/dl/nouen_qa.pdf)◆ Human papillomavirus infection (protection against cervical cancer)(1) Cause and course
The human papillomavirus (HPV) is a common virus which infects many people, of whomsome women develop cervical cancer. Out of the more than 100 types of HPV, types 16
and 18 are considered to be causal for approximately 50 to 70% of cases of cervical cancer.
Most HPV infections clear spontaneously and the virus becomes undetectable. However,in some women, over the course of up to 20 years, precancerous lesions and then cervicalcancer will develop. Every year, about 11,000 women develop cervical cancer in Japan, andan estimated 2,900 die from the disease (source: “Cancer Information Service,” Center for34

7. Diseases preventable by vaccination and vaccines

Cancer Control and Information Services, National Cancer Center). In addition to vaccines
to prevent HPV infection, early detection and early treatment of precancerous lesions
through cervical cancer screening tests hold promise for decreasing incidence and mortality
rates of this disease.

(2) Recombinant adsorbed bivalent human papillomavirus-like particle vaccine(Cervarix®) and recombinant adsorbed tetravalent human papillomaviruslike particle vaccine (Gardasil®) (inactivated vaccine)
Vaccines to prevent cervical cancer that are available as routine vaccinations inJapan are a bivalent vaccine (Cervarix®) containing antigens of the HPV type 16 and18 viruses, which are most frequently detected from domestic and foreign patients withcervical cancer, and a tetravalent vaccine (Gardasil®) containing antigens of the type 6
and 11 viruses which are causes of condyloma acuminatum and recurrent respiratory
papillomatosis. A 9-valent vaccine (Silgard® 9) has also been approved and included in
the routine vaccines in April 2023. In foreign studies of persons not infected with HPV,
each vaccine has been shown to be highly effective in preventing both infection andprecancerous lesions. Therefore, countries are recommending that the vaccination be
given to young people before their first sexual contact.
Adverse reactions described in domestic package inserts include local reactions suchas pain (83-99%), redness (30-88%) and swelling (25-79%) at the injection site; andsystemic reactions including slight fever (5-6%) and malaise; however, most of these aretransient and disappear (see the following package inserts: Cervarix® [14th ver.] revised in
February 2022; Gardasil® [2nd ver.] revised in August 2021; Silgard® 9 [5th ver.] revisedin October 2022).
The incidence of serious cases (cases deemed to be serious by the reporter) amongsuspected cases of adverse reactions (adverse events) reported by medical institutions was
0.0079% for Cervarix, 0.0063% for Gardasil and 0.0000% for Silgard 9. (The incidence
reported from the start of sales to September 30, 2022. Source: January 2023 documents
2-8, 2-9 and 2-10-1 from the 90th Working Group Meeting on Adverse Events, theSubcommittee on Vaccination and Vaccines of the Health Sciences Council.)
Vaccinated persons still need routine cervical cancer screening because the vaccine
may not always provide sufficient immunization and does not protect against all HPV
types which cause cervical cancer.
a)When using the recombinant adsorbed bivalent human papillomavirus-like particle
vaccine for the prevention of human papillomavirus infection, the standard vaccination
period is from the first to the final day of the year in which the individual turns 13.
The standard schedule is to give 2 injections separated by an interval of 1 month,35

7. Diseases preventable by vaccination and vaccines

followed by another injection after an interval of at least 6 months after the first injection.
If said schedule cannot be followed, 2 injections are given separated by an interval ofat least 1 month, followed by 1 injection after an interval of at least 5 months after the
first injection, and 2.5 months after the second injection.
b)

When using the recombinant adsorbed tetravalent or 9-valent human papillomavirus
virus-like particle vaccine for the prevention of human papillomavirus infection, thestandard vaccination period is from the first day to the last day of the fiscal year inwhich the individual turns 13. The standard schedule is to give 2 injections separated
by an interval of 2 months, followed by another injection after an interval of at least
6 months after the first injection. If said schedule cannot be followed, 2 injections are
given separated by an interval of at least 1 month, followed by 1 injection after aninterval of at least 3 months after the second injection.

c)Since there are no data about the safety, immunogenicity, and efficacy concerninginterchangeability between the recombinant adsorbed bivalent human papillomavirus-likeparticle vaccine and the recombinant adsorbed tetravalent human papillomavirus-likeparticle vaccine, a child is vaccinated using only 1 of the 2 vaccines.

d)Syncope, a vasovagal reaction, sometimes occurs after vaccination against humanpapillomavirus infection. Therefore, to prevent fainting due to syncope, a child who
has been vaccinated should be seated and observed, and the child should be instructed
not to stand if possible, for 30 minutes after injection.

36*Women born between 1997 and 2007 who did not get vaccinatedduring the period of suspension of active recommendation canreceive a catch-up vaccination only for the three years between
2022 and 2024 (Please refer to page 37).

*

20-year-old

19-year-old

18-year-old

17-year-old

16-year-old

15-year-old

14-year-old

13-year-old

12-year-old

11-year-old

10-year-old

9-year-old

8-year-old

7-year-old

6-year-old

5-year-old

4-year-old

3-year-old

2-year-old

1-year-old

9-month-old

3-month-old

Humanpapillomavirus
infection

6-month-old(3) Vaccination schedule7. Diseases preventable by vaccination and vaccines(4) Response concerning routine human papillomavirus vaccination(as of January 2023)
At the June 14, 2013 joint meeting of Working Group Meeting on Adverse Events,
the Subcommittee on Vaccination and Vaccines of the Health Science Council and the
Subcommittee on Drug Safety of the Committee on Drug Safety in the Pharmaceutical
Affairs and Food Sanitation Council, it was set forth that “due to sustained pain whose
relationship with the vaccine cannot be ruled out being observed after vaccination with
the HPV vaccine, the routine vaccination should not be actively recommended until
the frequency of onset of this adverse reaction is further elucidated and appropriate
information can be provided to citizens,” and the decision was made by the Ministry of
Health, Labour and Welfare to suspend active recommendation of the vaccination. After
that, since November 2021, at the same meeting, it has been discussed how to evaluate
the efficacy and safety of HPV vaccines, how to deal with the symptoms that occur after
HPV vaccination, and how to provide information about HPV vaccines. In conclusion, it
was confirmed that there were no particular concerns about safety, and that the efficacy of
vaccination clearly outweighed the risk of adverse reactions. Then, in November 2021, a
notice was issued to end “the suspension of active recommendation.” In December 2021,
a notice was issued stating that vaccination shall be provided temporally beyond the target
age of conventional routine vaccinations (hereinafter referred to as “catch-up vaccinations”)
as a measure for those who missed the opportunity of vaccination due to the suspension ofactive recommendation. The Preventive Vaccination Law Enforcement Ordinance (Cabinet
Order No. 197 of 1948) was revised and came into effect on April 1, 2022.
From the viewpoint of ensuring a fair vaccination opportunity for those who missed thevaccination opportunity due to the suspension of active recommendation, the vaccination
shall be provided beyond the target age of the conventional routine vaccination as follows.

Females born in 1997 to 2007 who were subject to the routine
Target of catch-up vaccination during the period of suspension of active recommendation(Females born in 2006 will be subject from 2023, and females
vaccinations
born in 2007 will be subject from 2024).
Target period

Three years from April 2022 to March 2025

**In response to the Cabinet Order for Partial Revision to the Preventive Vaccination Law Enforcement
Ordinance (Cabinet Order No. 105 of 2022), it came into effect on April 1, 2022.

For more information on the safety and efficacy of the HPV vaccines, please refer tothe brochure on the HPV vaccines posted on the Ministry of Health, Labour and Welfare37

8. What to do if your child experiences an adverse reaction to a vaccination

website (https://www.mhlw.go.jp/bunya/kenkou/kekkaku-kansenshou28/). For details on
how to operate catch-up vaccinations, please check the latest information from the Ministryof Health, Labour and Welfare and your municipality.
Note that the WHO and the Japanese Medical Society have positioned HPV vaccination
as a “vaccine necessary to protect women from cancer.” In Japan, indication to males
was added only in the tetravalent HPV vaccine in December 2020, and males aged 9
has been subject (voluntary vaccination).

8. What to do if your child experiences an adverse
reaction to a vaccination(1) Normally observed reactions
Depending on the type of vaccine, fever, redness, swelling (puffiness), and induration(stiffness), and rashes at the injection site occur fairly often. In many cases, these
symptoms disappear within several days and are not a cause for concern.
(2) Serious adverse reactions
If your child has severe swelling at the vaccination site, or has fever or seizures after
vaccination, consult a doctor. If your child’s symptoms meet the criteria for reporting
adverse reactions after vaccination, the doctor will inform the Pharmaceuticals andMedical Devices Agency (PMDA).
Although adverse reactions depend on the type of vaccine, vaccination extremely rarely(about one in several million people) causes serious adverse reactions, such as encephalitis
and neuropathy. Such cases will be evaluated on the basis of Japan’s basic approach inregard to relief programs, namely that “rigorous medical causation is not imperative andthat relief shall also apply in cases where the possibility of symptoms which appeared after
inoculation having been caused by the vaccination cannot be ruled out.” On this basis, thepatient is considered eligible for compensation for injury to health under the Preventive
Vaccination Law if the Minister of Health, Labour and Welfare gives authorization.
(3) Coincidental reactions
Symptoms that occur soon after vaccination are often thought to have been caused by
vaccination. However, sometimes these symptoms are caused by another infection that
happens to develop simultaneously. This is then called a “coincidental reaction.”38

8. What to do if your child experiences an adverse reaction to a vaccination(4) Aid system for people with impaired health due to vaccinationa) A person who has an adverse reaction due to routine vaccination and whose ability toperform daily activities is impaired due to injury to health can be compensated by thegovernment according to the Preventive Vaccination Law.
b)

The compensation consists of payment of medical expenses, medical benefits, anannuity for disabled children, a disability annuity, lump-sum death benefits, andfuneral expenses, all of which are designated by law according to the severity of
the injury to health. All compensation, except lump-sum death benefits and funeral
expenses, is continually paid until the completion of treatment or improvement in the
injury to health.

c) Compensation is paid to the patient after the relevant injury has been certified to becaused by vaccination by a governmental review committee comprising specialists invaccination, infection medicine, law, and related disciplines, who discuss the causal
relationship of the relevant injury with vaccination, i.e., whether the relevant injury
was caused by vaccination or other factors (infection before or after vaccination, orother causes).
d)

When vaccination is desired after the designated period, vaccination is considered
not to be controlled under the Preventive Vaccination Law (voluntary vaccination).
In the event a child is injured by vaccination in this situation, he/she will receive
compensation according to the Pharmaceuticals and Medical Devices Agency
Law; however, the subject and the amount of compensation differ from those of thePreventive Vaccination Law.

* In the event you need to submit an application for compensation, consult with yourmunicipal office in charge of vaccination.

39

[Reference 1] Novel coronavirus (COVID-19) and its vaccines*T he following topics are partially quoted from the “Vaccination Guidelines 2023
Version” from the Public Foundation of Vaccination Research Center regarding thesituation as of January, 2023, in the COVID-19 vaccination of children.

[Reference 1] Novel coronavirus (COVID-19) and its
vaccines

1 Novel coronavirus (COVID-19)
The global pandemic of novel coronavirus infection (COVID-19) began with an
outbreak of unexplained pneumonia in Wuhan City, Hubei Province, China at the endof December 2019, and it was recognized on January 5, 2020 when the situation wasannounced to the world under the International Health Regulations (IHR) by the WHO.
The WHO received a report from China on January 9, 2020 that the causative virus wasa new coronavirus, and on January 11, information on its entire gene sequence. And
the information was released on January 12. On January 13, an infected person with ahistory of travel to Wuhan City was detected in Thailand as the first case outside China.
The first case in South Korea was reported on January 19, and the first case in the UnitedStates was reported on January 21. Due to the rapid increase in patients and overwhelmed
hospitals, the blockade of Wuhan City was decided on January 23. The rapid increasein cases continued in Northern Italy, South Korea, Iran, Spain and the United States,
especially in New York.
The WHO held an Emergency Committee meeting and declared on January 30 that theoutbreak of infectious diseases caused by COVID-19 was a Public Health Emergency ofInternational Concern (PHEIC), and on March 11 judged this outbreak as a pandemic.
On January 6, 2020, the Tuberculosis and Infectious Diseases Control Division, HealthService Bureau, Ministry of Health, Labour and Welfare notified each prefecture, citywith a health center, special ward hygiene supervision department (bureau) and the Japan
Medical Association of the office communication stating “Alert regarding the outbreakof atypical pneumonia in Wuhan City, Hubei Province, People's Republic of China”
and notified that COVID-19 infection was temporarily added to the target diseases ofvaccination in the notification of December 9, 2020 (HSB Notification No.1209-2).
[Transmission route]
It is considered that the infection route is mainly droplet infection and that infection ina poorly ventilated environment may occur without coughing or sneezing. There is also
the possibility of contact infection from the surface of environments contaminated withdroplets containing the virus.
40[Reference 1] Novel coronavirus (COVID-19) and its vaccines

COVID-19 infection is transmitted primarily by symptomatic individuals, but there is also
a risk of infection from asymptomatic carriers. Airborne precautions are recommended
when performing treatments that generate aerosols in medical institutions.

[Incubation period/infectious period]
The incubation period is considered to be between 1 to 14 days, and symptoms usuallyappear about 5 days after exposure (WHO). COVID-19 is infectious before the onset
and is highly infectious in the early stage of the onset, which is the cause of communityacquired infection.
SARS-CoV-2 is thought to propagate in the respiratory tract, and in severe cases theviral load is high and the excretion period is long. The infectious period is considered tobe from about 2 days before the onset to 7-10 days after the onset. Infectious SARSCoV-2
is rarely detected in blood, urine and stool.
2 Novel coronavirus (COVID-19) vaccines
In Japan, the Pfizer mRNA vaccine was approved for manufacture and sale on February 14,
2021. Provisional vaccination started from February 17, 2021 for medical personnel, etc.,
and from April 12, 2021 for elderly people, etc., based on the Preventive Vaccination Law.
On May 21, 2021, the Takeda/Moderna mRNA vaccine and the AstraZeneca recombinant
chimpanzee adenovirus vector vaccine were approved for manufacture and sale. At thelarge-scale vaccination center, vaccination using the Takeda/Moderna mRNA vaccine
started on May 24, 2021 for the elderly, and workplace vaccinations started on June 21, 2021.
On August 2, a vaccine manufactured by AstraZeneca was introduced for provisional use
on people aged 40 and over in principle, however, vaccination with this vaccine ended at
the end of September 2022.
In June 2021, vaccination of children aged 12 and over with the COVID-19 vaccine
began. On January 21, 2022, the vaccine was approved by pharmaceutical regulatory affairs
for children aged 5 to 11 years, and was positioned as a special provisional vaccination.
Furthermore, from October 2022, vaccinations for children aged 6 months to 4 years also
started. Please refer to the latest information from the Ministry of Health, Labour andWelfare for details.

41

[Reference 2] Diseases preventable by voluntary vaccination and overview of vaccines[Reference 2] Diseases preventable by voluntary
vaccination and overview of vaccines
Voluntary vaccination, which is not subject to the Preventive Vaccination Law, isconducted in consultation between a vaccine recipient (parents/guardians) and a doctor and is
not promoted by the government; however, the vaccines used are approved by the Ministryof Health, Labour and Welfare under the Act on Securing Quality, Efficacy and Safety of
Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene
Therapy Products, and Cosmetics (Act on the Pharmaceuticals and Medical Devices Agency).
Voluntary vaccinations include vaccinations to prevent seasonal influenza (a routine
vaccination for adults from 65 years), mumps, hepatitis A, yellow fever, rabies, tetanus,
meningococcal disease, and herpes zoster (shingles), and also refer to routine vaccinations
when they are given outside the eligible age range or period.
The seasonal influenza and mumps vaccines that many children receive are explained below.
In the unlikely event a child is injured by a vaccination, he/she will receive compensationaccording to the Pharmaceuticals and Medical Devices Agency Law; however, the subject
and the amount of compensation differ from those of the Preventive Vaccination Law(routine vaccination).
* In the event you need to submit the application for compensation, consult with yourmunicipal office in charge of vaccination.

◇ Seasonal inﬂuenza vaccine (inactivated vaccine)
The seasonal influenza vaccination for the elderly is designated as a routine vaccinationby the Preventive Vaccination Law; that for children is considered a voluntary vaccination.

(1) Cause and course
Seasonal influenza is an acute respiratory infection which suddenly develops systemic
symptoms including fever, chill, headache, and muscle pain. The incubation period is
24- 72 hours. Respiratory symptoms (stuffy nose, sore throat, and cough, etc.) often
appear later. Patients without complications recover within 2-7 days. Complications,especially pneumonia and encephalopathy, are severe.
(2) Overview of vaccine
2 lineages of seasonal influenza type A (H1N1 and H3N2) and 2 of type B (Yamagata
and Victoria) are injected into the chorioallantoic membrane of embryonated chicken eggs
and allowed to multiply. After ether treatment to isolate the hemagglutinins on the viralsurface, formalin inactivation is performed to obtain the vaccine. Decisions are made eachyear on which viral strains to include in the seasonal influenza vaccine, on the basis of
epidemiological and virological assessments.
42

[Reference 2] Diseases preventable by voluntary vaccination and overview of vaccines

Reports vary on the effectiveness of the influenza vaccine in infants and young children,with most studies indicating the vaccines provide about 20-60% protection against
influenza. There are also a few studies which suggest vaccination may be effective inpreventing severe disease in infants and young children.
Embryonated chicken eggs are used in the manufacturing process of the seasonal
influenza vaccine; however, the egg components are eliminated in the purification process.
Nevertheless, caution is necessary when vaccinating persons with clear allergies to eggs.
Persons who experience an anaphylactic reaction to chicken eggs and meat are asked toconsult with a specialized facility if they wish to receive the vaccine.
The incidence of serious cases (cases deemed to be serious by the reporter) amongsuspected cases of adverse reactions (adverse events) reported by medical institutions was
0.00007%. (The incidence reported from October 1, 2020 to March 31, 2022. Source:
July 2022 documents 2-22 from the 81th Working Group Meeting on Adverse Events, theSubcommittee on Vaccination and Vaccines of the Health Sciences Council.)◇ Mumps vaccine (live vaccine)(1) Cause and course
Mumps is caused by the mumps virus and is spread by droplet infection. The viruses
proliferate and spread over the body and cause lesions in various internal organs. The
incubation period is 2-3 weeks. The period which an infected person may infect thosearound them is believed to be from several days before onset to 5 days after start ofswelling of the parotid gland, submaxillary gland, or sublingual gland. The primary
symptom is swelling of the parotid gland. The swelling is painful and exhibits indistinct
borders. The submaxillary gland and/or sublingual gland may also develop swelling, andmay also be accompanied by fever. When an older child or adult contracts the disease, thesymptoms are marked and the frequency of complications is greater. The most frequently
encountered complication is aseptic meningitis, at a diagnostic frequency of 1-10%.
Although lower in frequency, other complications include encephalitis and pancreatitis.
Adolescent and older men may also develop the complication of orchitis and women,
oophoritis. Special caution is required for the difficult to treat complication of hearing loss.
(2) Overview of vaccine
This is a live vaccine containing attenuated mumps viruses. The post-inoculation
seroconversion rate is high, at more than 90%, and in domestic outbreak investigation, theeffect of the vaccine is believed to be about 80%. Most people who develop the disease
despite being vaccinated generally experience a milder form of the disease. (Report by
Mumps Vaccine Working Team of the Vaccination Working Group)

43

[Reference 2] Diseases preventable by voluntary vaccination and overview of vaccines

Possible adverse reactions to mumps vaccines available on the market include mild
swelling of the parotid glands in 1% of the individuals who received this vaccine. The
frequency of the adverse reaction of aseptic meningitis is stated to be about 1 in every
1,600-2,300 persons vaccinated (from vaccine package insert); however, although it
has recently been reported that there are differences in frequency depending on the ageof vaccination, it has been reported that the frequency is even lower. Given the 1-10%
incidence of the complication of aseptic meningitis in spontaneous infections; as wellas the risk of hearing loss, the need for extended absence from nursery or elementary
school when infected; and the high incidence in children aged 3-6; it is recommended
that children be vaccinated at the same time as, or as soon as possible after, MR vaccine
phase 1, the first varicella vaccine injection, the Hib vaccine booster, and the pediatricpneumococcus vaccine booster, etc., and at the very latest, no later than 3 years of age,which is the high incidence age. To ensure the preventative effect, the Japan PediatricSociety recommends the second vaccination to be given at the same time as the MR
vaccine phase 2.

44

[Reference 3] Vaccine screening questionnaire

Vaccine Screening Questionnaire for [] (infant/schoolchild)

Form 2

Body temperature before interview

Degrees

Address
Child’s NameM
F

Parent/Guardian’s Name

Born onAge (Birth date

Questionnaire for Vaccination

/
years

AnswerHave you read the document (sent to you previously by the municipal office) explaining thevaccination that will be administered today?
Please answer the following questions about the child.
Did the child have any abnormal findings at delivery?
Birth Weight()g
Did the child have any abnormal findings after birth?
Was any abnormality identified at an infant health check?
Is the child sick today?
If so, describe the nature of the illness. ()

Has the child been ill in the past month?
Disease name ()
Has any family member or friend of the child had measles, rubella, chickenpox or mumps inthe past month?
Disease name ()
Has the child been exposed to anyone with tuberculosis (including family members)?
Has the child been vaccinated in the past month?
Vaccine name ()
Does the child have a congenital anomaly, heart, kidney, liver, central nerve disease, immune
deficiency, or any other diseases for which you have consulted a doctor?
Disease name (
)

Yes

No

Yes
Yes

No
No

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

Where relevant, did the doctor who manages the above disease agree with today's vaccination?

Yes

No

Has the child had a seizure (spasm or fit) in the past?
If so, at what age did it occur? (

Yes

No

If you answered “yes” to the preceding question, did the child have a fever at that time?

Yes

No

Has the child ever had a rash or urticaria (hives or ‘nettle rash’) as a reaction to medications orfood or become ill after eating certain foods or receiving certain medications?

Yes

No

Does the child have a family member or relative with a congenital immunodeficiency?

Yes

No

Has the child had a serious reaction to a vaccine in the past?
Vaccine name (

Yes

No

Has any family member or relative of the child had a serious reaction to a vaccine in the past?

Yes

No

Has the child received a transfusion of blood or blood products or been given a medicine
called gamma globulin in the past 6 months?

Yes

No

Do you have any questions about today’s vaccination?

Yes

No

)

)

/

(d/m/y)months)Doctor’s comment

Doctor’s comment
Based on the above answers and the results of interview, I have decided that the child ( can / should not ) receive a vaccination today.
I have explained to the parent/guardian the information concerning the benefits and side effects of vaccination and the support provided to people
who have had adverse events associated with vaccination.
Signature or Name and Seal of Doctor:
This screening questionnaire is used to improve the safety of vaccination. The child has been interviewed by the doctor, and information
concerning the benefits, objectives, and risks (including serious side effects) of vaccination has been explained to me by the doctor, as has thenature of support provided if adverse events occur. I believe that I understand this information.
I ( do / do not )* give consent for the child to be vaccinated. * Please circle your choice.
I understand the above and agree that this questionnaire can be submitted to the municipal office.
Signature of Parent / Guardian:
Vaccine Name
Vaccine Name
Lot Number[Caution] Confirm that the expiration date of
the vaccine is valid.

DosageInstitution / Doctor Name / Date Administered* (Subcutaneous injection)
mL

Institution:
Doctor Name:
Date Administered://(d/m/y)[Note] Gamma globulin is a blood product that is injected to prevent infections, such as type A hepatitis, and to treat severe infections. Certain vaccines(for example, measles vaccine) are occasionally less effective in people who have received this product in the preceding 3 to 6 months.
* In the case of BCG vaccination, describe, for example, “percutaneous vaccination using a BCG apparatus with multiple needles at a specified volume.”

45

[Reference 3] Vaccine screening questionnaire
Form 8Hepatitis B Vaccine Screening Questionnaire
Body temperature before interview

Degrees

Address
Child’s NameM
F

Parent/Guardian’s Name

Born onAge (Birth date

Questionnaire for Vaccination

/
years

AnswerHave you read the document (sent to you previously by the municipal office) explaining thevaccination that will be administered today?
Please answer the following questions about the child.
Did the child have any abnormal findings at delivery?
Birth Weight()g
Did the child have any abnormal findings after birth?
Was any abnormality identified at an infant health check?

Yes

No

Yes
Yes

No
No

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

Where relevant, did the doctor who manages the above disease agree with today's vaccination?

Yes

No

Has the child had a seizure (spasm or fit) in the past?
If so, at what age did it occur? (

Yes

No

If you answered “yes” to the preceding question, did the child have a fever at that time?

Yes

No

Has the child ever had a rash or urticaria (hives or ‘nettle rash’) as a reaction to medications orfood or become ill after eating certain foods or receiving certain medications?

Yes

No

Has the child a Latex sensitivity?*

Yes

No

Does the child have a family member or relative with a congenital immunodeficiency?

Yes

No

Has the child had a serious reaction to a vaccine in the past?
Vaccine name (

Yes

No

Yes

No

Is the child sick today?
If so, describe the nature of the illness. ()

Has the child been ill in the past month?
Disease name ()
Has any family member or friend of the child had measles, rubella, chickenpox or mumps inthe past month?
Disease name ()
Has the child been vaccinated in the past month?
Vaccine name ()
Does the child have a congenital anomaly, heart, kidney, liver, central nerve disease, immune
deficiency, or any other diseases for which you have consulted a doctor?
Disease name ()))

Has any family member or relative of the child had a serious reaction to a vaccine in the past?
Has the child received a transfusion of blood or blood products or been given a medicine
called gamma globulin in the past 6 months?
Did the child receive the hepatitis B vaccine after birth as part of the mother-to-infanttransmission prevention program?
Do you have any questions about today’s vaccination?

Yes

No

Yes

No

Yes

No

/

(d/m/y)months)Doctor’s comment

Doctor’s comment
Based on the above answers and the results of interview, I have decided that the child ( can / should not ) receive a vaccination today.
I have explained to the parent/guardian the information concerning the benefits and side effects of vaccination and the support provided to people
who have had adverse events associated with vaccination.
Signature or Name and Seal of Doctor:
This screening questionnaire is used to improve the safety of vaccination. The child has been interviewed by the doctor, and information
concerning the benefits, objectives, and risks (including serious side effects) of vaccination has been explained to me by the doctor, as has thenature of support provided if adverse events occur. I believe that I understand this information.
I ( do / do not )* give consent for the child to be vaccinated. * Please circle your choice.
I understand the above and agree that this questionnaire can be submitted to the municipal office.
Signature of Parent / Guardian:
Vaccine Name
Vaccine Name
Lot Number[Caution] Confirm that the expiration date of
the vaccine is valid.

DosageInstitution / Doctor Name / Date Administered* (Subcutaneous injection)
mL

Institution:
Doctor Name:
Date Administered://(d/m/y)(Note) Latex sensitivity is an immediate hypersensitivity to natural rubber products. The condition is suspected when an allergic reaction is observed upon the useof latex gloves. Also seek consultation if there is an allergy to fruits etc. with cross-reactivity to latex (banana, chestnut, kiwifruit, avocado, melon, etc.).

46

[Reference 3] Vaccine screening questionnaireⱥㄒ∧Form 10

Rotavirus Vaccine Screening Questionnaire
Date

Parent/guardian: Please fill out the bolded fields.

//

Pre-examtemperature

Addressdegrees (include decimal)

Phone no.

Child’s name

M / F

–

–

/

Child’s dateof birth

Parent/guardian’s
name(YYYY/MM/DD)

/

(Age:

(YYYY/MM/DD)
weeks

days)

For age in weeks and days, count the day after the date of birth as day 1.

Field for medical
institution to enter(Mark a ;)If this is the first vaccination, have you
confirmed that the child is not older than
14 weeks and 6 days as of today?
Questionnaire

Doctor’scomment

AnswerWhich vaccination will your child receive today?
Please write the date(s) of the vaccination(s) your child has received so far (answer only if this is your child’s 2nd or 3rd
vaccination).
Note: Confirm that at least 27 days have passed since your child’s last rotavirus vaccination.

1st

2nd

3rd

1st

/

/

(YYY/MM/DD)

2nd

/

/

(YYY/MM/DD)

Have you read the document provided by the municipal office explaining the vaccination that will be administered today?

Yes

No

Do you understand the benefits and side effects of the vaccination that will be administered today?

Yes

No

Were you provided with information concerning intussusception, and did you understand that information?

Yes

No

Were there any abnormalities at the time of delivery?

Yes

No

Have there been any abnormalities after birth?

Yes

No

Have any abnormalities been identified in an infant health exam?

Yes

No

Yes

No

Yes

No

Has any family member or friend of the child had measles, rubella, chickenpox, or mumps in the past month?
Name of illness:

Yes

No

Has your child been vaccinated within the past month?
Vaccine:YesNo

Has your child experienced intussusception before? Or does your child have an untreated congenital abnormality of thegastrointestinal tract?

Yes

No

Has your child been diagnosed with immunodeficiency? Or has your child experienced repeated diarrhea, repeated
infections such as pneumonia or middle ear infections, or had difficulty gaining weight?

The following questions concern your child’s growth and development.
Birth weight:g

Is your child experiencing any illness or does your child feel unwell today?
Please describe the symptoms:
Has your child been sick within the last month?
Name of illness:

Date:(YYYY/MM/DD)

Note: If yes, your child cannot receive the rotavirus vaccine.

Yes

No

Does your child have a congenital anomaly; gastrointestinal disorder; heart, kidney, liver, blood, or central nervous
disease; or any other diseases for which you have consulted a doctor? Name of illness:

Yes

No

If you answered yes to the previous question, have you been told by the doctor whom your child is seeing for thatdisease that your child may receive today's vaccination?

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

Note: If yes, your child may not be able to receive the rotavirus vaccine.

Has your child had a seizure (spasm or fit) in the past? If so, at around how many months of age:monthsIf you answered yes to the previous question, did your child have a fever at that time?
Has your child ever had a rash or hives or become ill after eating certain foods or receiving certain medications?
If you answered yes to the previous question, name of medication/food:
To date, has your child ever felt ill after receiving a vaccination?
If you answered yes to the previous question, name of vaccine:
Did the mother take medication which suppresses the immune system while pregnant with the child?

Yes

No

Has a close relative of your child been diagnosed with a congenital immunodeficiency?

Yes

No

Has a close relative of your child ever felt ill after receiving a vaccination?

Yes

No

To date, has your child received a blood transfusion or been injected with gamma globulin?

Yes

No

Do you have any questions about today’s vaccination?

Yes

No

If you answered yes to the previous question, name of medication:

Field for doctor to enter
Based on the above questionnaire and the results of the medical examination, I have decided that the child (can / should not) receive today's vaccination.
I have explained to the parent/guardian the information concerning the benefits and side effects of vaccination (particularly intussusception) and the Relief System for
Injury to Health with Vaccination.
Signature or name and seal of doctor:
Field for parent/guardian to enter
My child has been examined by and I have been provided with information by the doctor. I understand the benefits, objectives, possibility of serious side effects(particularly intussusception), and information concerning the Relief System for Injury to Health with Vaccination, and accordingly I (do / do not)* give consent for mychild to be vaccinated.
Please circle your choice.
I understand that the purpose of the questionnaire is to ensure the safety of vaccinations and I agree that this questionnaire can be submitted to the municipal office.
Signature of parent/guardian:
Vaccine used
Vaccine name:
Lot no.:Warning: Confirm that expiration date of vaccine is valid

DosageOral vaccination
RotaTeq®
2 ml

Rotarix®
1.5 mlPlace of vaccination/doctor's name/date of vaccination
Place of vaccination:
Doctor’s name:Date of vaccination://(YYYY/MM/DD)

47

[Reference 4] Post-vaccination health survey

This table summarizes the incidence of fever and local reactions based on the Ministryof Health, Labour and Welfare 2020 post-vaccination health survey summary report.
It also summarizes the values of the relatively possible typical symptoms of BCG,
seasonal influenza, and, pneumococcus in the elderly. This table includes both single
and simultaneous vaccinations. Since there are many types of vaccines given between
the ages of 0 and 1, they are often given simultaneously. Please refer to the report for thehealth condition after simultaneous vaccination.
2020 Survey on Health Status after Vaccination
Vaccine type*

Number of people
surveyed

All cases offever (%)

37.5°C to
38.4°C (%)

38.5°C or
higher (%)

Local reaction(%)

DPT-IPV phase 1 1st vaccination

1,347

15.4

9.6

5.9

8.8

DPT-IPV phase 1 2nd vaccination

1,124

12.7

8.3

4.4

9.6

DPT-IPV phase 1 3rd vaccination

1,109

3.0

1.9

1.1

5.3

DPT-IPV phase 1 booster

1,019

10.7

5.1

5.6

9.1

DT phase 2

1,965

1.3

0.9

0.4

25.3

MR phase 1

1,996

12.8

5.2

7.6

4.4

MR phase 2

1,293

2.8

1.3

1.5

2.9

Japanese encephalitis phase 1 1st vaccination

1,091

9.9

4.9

4.9

3.8

Japanese encephalitis phase 1 2nd vaccination

797

6.1

2.8

3.4

2.5

Japanese encephalitis phase 1 booster

998

5.6

2.8

2.8

4.2

Japanese encephalitis phase 2

762

2.8

1.6

1.2

4.2

Hib phase 1 1st vaccination

1,226

5.6

4.2

1.4

6.4

Hib phase 1 2nd vaccination

1,013

16.2

9.2

7.0

7.3

Hib phase 1 3rd vaccination

997

14.6

8.6

6.0

9.5

Hib booster

802

15.0

7.7

7.2

8.7

Pediatric pneumococcus phase 1 1st vaccination

1,228

5.5

4.4

1.1

8.0

Pediatric pneumococcus phase 1 2nd vaccination

1,191

17.6

11.9

5.7

12.7

Pediatric pneumococcus phase 1 3rd vaccination

1,125

12.9

8.1

4.8

15.4

952

21.1

9.9

11.2

18.4

Varicella 1st vaccination

1,701

16.3

6.6

9.8

3.4

Varicella 2nd vaccination

1,524

8.1

3.5

4.7

4.3

Hepatitis B 1st vaccination

1,465

4.3

3.2

1.1

4.0

Hepatitis B 2nd vaccination

1,203

16.3

11.1

5.2

8.5

Hepatitis B 3rd vaccination

1,165

5.2

3.0

2.1

4.7

Pediatric pneumococcus booster

Vaccine type*

Number of people
surveyed

All cases offever (%)

37.5°C to
38.4°C (%)

38.5°C or
higher (%)

Diarrhea (%)

Rotavirus phase 1 1st vaccination

1,018

4.9

3.2

1.7

2.9

Rotavirus phase 1 2nd vaccination

649

10.5

7.1

3.4

3.2

Rotavirus phase 1 3rd vaccination

86

9.3

2.3

7.0

1.2

*Includes the incidence of all cases of fever and local reactions during the survey period (28 days).
*Rotavirus vaccine was newly added to the survey target as it was included in the routine vaccines in October 2020.
The table below shows the incidence of “lymphadenopathy” and “local skin moisturization” selected as relatively possible typicalsymptoms of BCG, as well as the “total incidence of all symptoms.” Only the BCG survey period is 4 months.

Vaccine type

BCG

48

Number of people
surveyed

Lymphadenopathy (%)

Local skinmoisturization (%)

Total incidence of all
symptoms (%)

1,784

0.4

0.0

0.4

References (for details, see: https://www.yoboseshu-rc.com/publics/index/7)
1 Vaccination Guidelines

2 “Influenza and Pneumococcal
Disease (Category B Disease)
Vaccination Guidelines”
イ ン フ ル エ ン ザ・肺炎球菌感染症（B類疾病）
予 防 接 種 ガ イド ラ イ ン

March 2023 revised edition (A5 size)
A guidebook on medical and regulatory
information about vaccination for medical staff
in practice to conduct safe and appropriate
vaccination.

3 Vaccination handbook

2022 edition (A4 size)
A handbook for doctors who give vaccinationand municipal staff in charge of vaccination.

2022 edition (A5 size)
An overview of medical and regulatory
information on influenza vaccination androutine vaccination of the elderly forpneumococcal disease.

4 Editions in foreign languages“Vaccination and children’s health”

March 2022 revised edition“Vaccination and childrenʼs health,” a brochurecontaining correct knowledge and information
concerning vaccination for parents and thevaccination screening questionnaire, istranslated in the following languages andavailable from the following site.
Please download them as required.
https://www.yoboseshu-rc.com/publics/index/8/
The entire brochure is available in the following
10 languages: English, Chinese, Korean,
Vietnamese, Spanish, Portuguese, Thai,
Indonesian, Tagalog, and Nepalese
The vaccination questionnaire alone is available
in the following seven languages: Arabic,
Italian, German, French, Mongolian, Russian,and Ukranian.

List of Members of the Review Committee for Vaccination Guidelines
Name

Institution / Job title

Tetsu Isobe

Professor, Keio University Law School○

Kenji Okada

Professor, Fukuoka Nursing College◎

Nobuhiko Okabe

Director of Kawasaki City Institute for Public Health

Satoshi Kamayachi

Executive Board Member of the Japan Medical Association

Hajime Kamiya

Keiko Taya

Chief Researcher of Immunization Program Division, Infectious Disease
Surveillance Center, National Institute of Infectious Diseases

Director, Kanagawa Prefectural Institute of Public HealthOsamu Tokunaga

Deputy Director, Pediatrics, National Hospital Organization Minami Kyoto
Hospital

Kuniko Nakayama

President/Director, Medical corporation MEFA Jinaikai My Family Clinic
Gamagori

Mitsuaki Hosoya

Professor, Department of Pediatrics, Fukushima Medical University

Masago Minami

Managing Director/Researcher, Yomiuri Shimbun Tokyo Headquarters

Mitsuoki Yamamoto

Administrator of the Kokubunji Medical Association
Vaccination Center, Director of Yamamoto Children's Clinic

Shunichiro Yokota

Advisor, Odawara Medical Association
Director of Yokota Children's Clinic

Hiroshi Watanabe

Facility Director, Teikyo University Health Service Center For The Elderly◎ : Chairperson○ : Vice-chairperson(In order of the Japanese syllabary, titles omitted)
As of March 2023

Public Foundation of the Vaccination Research Center
14-1, Nihonbashi Odenmacho, Chuo-ku, Tokyo 103-0011, Japan
Phone: (03) 6206-2113

Fax: (03) 5643-8300

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Unauthorized copying or reproduction strictly prohibited by law.

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