Vaccination andChildren's Health2020 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

4Children who are subject to vaccination and the vaccination schedule.............. 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
Hepatitis B..................................................................................................................... 14
Hib infection.................................................................................................................. 15
Pneumococcal infection in children.............................................................................. 17
Diphtheria, pertussis, tetanus, and polio (acute poliomyelitis)..................................... 20
Tuberculosis................................................................................................................... 24
Measles and rubella....................................................................................................... 26
Varicella (chickenpox)................................................................................................... 28
Japanese encephalitis..................................................................................................... 30
Human papillomavirus infection (protection against cervical cancer).......................... 34

8What to do if your child experiences an adverse reaction to a vaccination........ 37[Reference 1] Diseases preventable by voluntary vaccination and overview of vaccines....39
Seasonal influenza vaccine............................................................................................39
Mumps vaccine..............................................................................................................40
Rotavirus vaccine...........................................................................................................41[Reference 2] Vaccine screening questionnaire.....................................................................43
The 2020 edition is based on revisions as of February 29, 2020.
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(http://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. Children who are subject to vaccination and the vaccination schedule

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. Children who are subject to vaccination and thevaccination schedule
Vaccination includes routine vaccination and voluntary vaccination (see page 40). With
regard to routine vaccination, the Preventive Vaccination Law defines the target diseases,
subjects, and vaccination schedules.
Vaccination is carried out during periods appropriate to each disease.
See page 6 for children who are subject to routine vaccination and recommended
periods (the standard vaccination periods).
With regard to the vaccination against Japanese encephalitis, persons aged lessthan 20 (birth date: April 2, 1995 to April 1, 2007) who did not undergo phase 1 and 2
vaccinations due to the withholding of a positive recommendation to do so in 2005 arenow subject to routine vaccinations for this disease. (See “7 ◆ Japanese encephalitis (4)Special consideration for vaccination” on Page 32)
Since September 2012, the oral polio vaccine used for routine vaccination has been
replaced with an inactivated poliovirus vaccine (IPV). The IPV IMOVAX POLIO®
subcutaneous injection (produced by Sanofi K.K.) has been used since September andthe DPT-IPV quadruple vaccine Quattrovac® (produced by KM Biologics) and Tetrabik®
(produced by the Research Foundation for Microbial Diseases of Osaka University) sinceNovember 2012.
In December 2015, the DPT-IPV quadruple vaccine, Squarekids ® subcutaneous
injection syringe (produced by Daiichi Sankyo Co., Ltd.), was introduced to the market.
(See “7 ◆ Diphtheria, pertussis, tetanus, and polio (acute poliomyelitis)” on page 20)
On October 1, 2014, chickenpox was made a routine vaccination and hepatitis B was
made a routine vaccination on October 1, 2016.
Rotavirus is scheduled to become a routine vaccination from October 1, 2020.
Since January 30, 2013, special measures have been in place for children who wereunable to receive routine vaccinations due to long-term severe illness etc. For more
information, contact your municipal office in charge of vaccination.
35. Let’s make a vaccination plan for your child

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) Fill in a rough target date for vaccination
The routine vaccination is, 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 vaccines are made of attenuated live bacteria and viruses (live bacteria andviruses whose pathogenicity has been weakened). Resistance (immunity) to the disease isestablished similarly to actually being infected by it. The measles-rubella (MR), measles,
rubella, BCG, mumps, varicella (chickenpox), rotavirus, and yellow fever vaccines belong
to this type.
After vaccination, attenuated bacteria 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).
Inactivated vaccines are made by killing the virus or bacteria, extracting thecomponents required to develop resistance (immunity) and eliminating their virulence(pathogenicity). Inactivated vaccines include the hepatitis B vaccine, diphtheria-pertussistetanus inactivated polio vaccine (DPT-IPV), diphtheria-pertussis-tetanus (DPT) vaccine,
diphtheria-tetanus (DT) vaccine, inactivated polio vaccine (IPV), Japanese encephalitis
vaccine, tetanus (T) vaccine, seasonal influenza vaccine, Haemophilus influenzae type b
4

5. Let’s make a vaccination plan for your child(Hib) vaccine, pediatric pneumococcal conjugate vaccine, human papillomavirus (HPV)
vaccine, meningococcal vaccine, hepatitis A vaccine, and rabies vaccine.
In these vaccines, bacteria and viruses do not multiply, and several shots are required toestablish 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 to enhance resistance (immunity) to a sufficient level.
However, the resistance (immunity) diminishes gradually. To keep the resistance(immunity) for a long time, a booster is required at certain intervals, depending on thecharacteristics of the vaccine.

(4) Intervals at which different vaccines are given
Vaccines are classified as live or inactivated vaccines, and the appropriate intervals at
which to give different vaccines must be maintained.
In certain cases, there may be a need to receive more than one kind of vaccine at thesame 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.
Live vaccine
BCG, Measles-rubella (MR), measles, An interval of at least
rubella, varicella (chickenpox)
27 days should be taken.
Mumps, rotavirus, yellow fever

Inactivated vaccine
Live vaccine(An interval of at least 27 days should be taken from the day after receiving a live
vaccine until the day of receiving a different vaccine.)

Inactivated vaccine

Hepatitis B, Hib infection, pediatric pneumococcal
infection (13-valent), DPT-IPV, DPT, DT, polio,
Japanese encephalitis, human papillomavirus infection

An interval of at least
6 days should be taken.

Meningococcal disease, hepatitis A,
rabies, tetanus (T), seasonal influenza

Inactivated vaccine
Live vaccine(An interval of at least 6 days should be taken from the day after receiving aninactivated vaccine until the day of receiving a different vaccine.)55. Let’s make a vaccination plan for your child

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
19-year-old
20-year-old

3-month-old
6-month-old[Note] The starting date for calculating the vaccination interval is the day following the day of vaccination.

Hepatitis B(See page 14)

Hib infection(See page 15)

Pediatric pneumococcal
infection(See page 17)

Phase 1Diphtheria (D) (DPT-IPV•
Pertussis(P)DPT•DT•IPV)
Tetanus (T)Polio (IPV)
Phase 2(See page 20)(DT)

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 the initial vaccination.

BCG/BacilleCalmette-Guérin(See page 24)
Measles (M)Rubella (R)(MR•M•R) (See page 26)
Varicella (chickenpox)(See page 28)

Japanese encephalitis(See page 30)

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.
(Note)

Human papillomavirus
infection(See page 34)
Note: Persons born between April 2, 1995 and April 1, 2007 who were unable to receive the phase 1 and 2 vaccine dueto the suspension of active recommendation in 2005 are able to receive the vaccine as a routine vaccination if under
the age of 20.

6

5. Let’s make a vaccination plan for your childThe
mark indicates the age of children who are subject to routine vaccinations inaccordance with the Preventive Vaccination Law. However, considering the period during
which children are likely to become infected, receiving vaccinations during the terms
marked withis recommended (indicates the standard vaccination periods).
Therefore, please ensure to the extent possible that your child receives his/her vaccinations
during these terms.
The arrow (↓) indicates examples of preferable times for vaccinations.
* About the hepatitis B vaccine
On October 1, 2016, the hepatitis B vaccine was made a routine vaccination.
a) Eligibility: Children born on or after April 1, 2016 up to their first birthday.
b) Exclusions: Children who received the hepatitis B vaccine after birth as part of themother-to-infant transmission prevention program.
c) Method of inoculation: A recombinant adsorbed hepatitis B vaccine is used. The
standard schedule is two injections given between 2 and 9 months of age with aninterval of at least 27 days, and one injection given after an interval of at least 139
days after the first injection.
d) Handling of injections given before October 1, 2016: Hepatitis B vaccinations given
prior to October 1, 2016 (i.e. before the vaccination was made routine) equivalent to
the hepatitis B vaccine of the routine immunization schedule are deemed to beroutine schedule hepatitis B vaccinations. A person who was given such vaccination
is to be deemed to have received the hepatitis B routine vaccination and should
receive subsequent inoculations as indicated below.
* Vaccination intervals
The length of vaccination intervals are established in laws and ordinances. For example,“an interval of one week” means “on the same day of the next week or later.”* If your child happened to:• Have pertussis before DPT-IPV or DPT vaccination, see pages 21-24.
• Have measles or rubella before MR vaccination, see pages 27-28.

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

Example of Vaccination Schedule
Vaccination
Vaccination

child’sof birth:(day)(day)/ (month)/ (year)YourYourchild’s
datedateof birth:/ (month)/ (year)
TargetTargetdatedate

Vaccination
Vaccination
DateDate

From
From
about
about

(d/m/y)(d/m/y)to about
to about(d/m/y)(d/m/y)(d/m/y)(d/m/y)Secondinjection
injection From
From
about
about
Hepatitis
HepatitisB B Second(d/m/y)(d/m/y)to about
to about(d/m/y)(d/m/y)(d/m/y)(d/m/y)

Third
Third
injection
injection

From
From
about
about

(d/m/y)(d/m/y)to about
to about(d/m/y)(d/m/y)(d/m/y)(d/m/y)First administration
First administration From
From
about
about

(d/m/y)(d/m/y)to about
to about(d/m/y)(d/m/y)(d/m/y)(d/m/y)First FirstSecond
Secondadministration
administration
From
From
about
about

(d/m/y)(d/m/y)to about
to about(d/m/y)(d/m/y)(d/m/y)(d/m/y)ThirdThird
administration
administrationFrom
From
about
about

(d/m/y)(d/m/y)to about
to about(d/m/y)(d/m/y)(d/m/y)(d/m/y)Booster
BoosterFirst administration
First administration From
From
about
about

(d/m/y)(d/m/y)to about
to about(d/m/y)(d/m/y)(d/m/y)(d/m/y)FirstFirst
injection
injection

Hib Hib
infection
infection

Note: Note:
The number
The numberof vaccinationsof vaccinations
depends
depends
on ageoninage
monthsin months
at the attime
the time
the initial
the initial
vaccination
vaccination
was initiated.
was initiated.

First administration
First administrationFrom
From
about
about

(d/m/y)(d/m/y)to about
to about(d/m/y)(d/m/y)(d/m/y)(d/m/y)FirstFirst
SecondSecondadministration
administration
From
From
about
about

(d/m/y)(d/m/y)to about
to about(d/m/y)(d/m/y)(d/m/y)(d/m/y)ThirdThird
administration
administrationFrom
From
about
about

(d/m/y)(d/m/y)to about
to about(d/m/y)(d/m/y)(d/m/y)(d/m/y)Booster
BoosterFirst administration
First administration
From
From
about
about

(d/m/y)(d/m/y)to about
to about(d/m/y)(d/m/y)(d/m/y)(d/m/y)Pediatric
Pediatric
pneumococcal
pneumococcal
infection
infection

Note: Note:
The number
The numberof vaccinationsof vaccinations
depends
depends
on ageoninage
monthsin months
at the attime
the time
the initial
the initial
vaccination
vaccination
was initiated.
was initiated.

FirstFirst
administration
administration From
From
about
about

(d/m/y)(d/m/y)to about
to about(d/m/y)(d/m/y)(d/m/y)(d/m/y)DPT-IPV
DPT-IPV
Secondadministration
administrationFrom
From
about
about
DPTDPT/DT/DTSecond
phase
phase
1 1

(d/m/y)(d/m/y)to about
to about(d/m/y)(d/m/y)(d/m/y)(d/m/y)

Third
Third
administration
administration From
From
about
about

(d/m/y)(d/m/y)to about
to about(d/m/y)(d/m/y)(d/m/y)(d/m/y)Note: Note:
If DTIfisDT
usedis forused
theforinitialthe initial
vaccination
vaccinationin phasein phase1,1,
the vaccination
the vaccinationis conducted
is conductedwith 2withshots.
2 shots.

DPT-IPV
DPT-IPV
DPTDPTDT Phase
DT Phase
1 booster
1 boosterFrom
From
about
about

(d/m/y)(d/m/y)to about
to about(d/m/y)(d/m/y)(d/m/y)(d/m/y)DT phase
DT phase
2 2(d/m/y)(d/m/y)to about
to about(d/m/y)(d/m/y)(d/m/y)(d/m/y)

8

From
From
about
about

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

Vaccination

Polio
(IPV)

Target date

Vaccination DateFirst administration

From about(d/m/y) to about(d/m/y)(d/m/y)Second administration

From about(d/m/y) to about(d/m/y)(d/m/y)Third administration

From about(d/m/y) to about(d/m/y)(d/m/y)Fourth administration

From about(d/m/y) to about(d/m/y)(d/m/y)From about(d/m/y) to about(d/m/y)(d/m/y)Phase 1

From about(d/m/y) to about(d/m/y)(d/m/y)Phase 2

From about(d/m/y) to about(d/m/y)(d/m/y)First administration

From about(d/m/y) to about(d/m/y)(d/m/y)Second administration From about(d/m/y) to about(d/m/y)(d/m/y)Firstadministration From about(d/m/y) to about(d/m/y)(d/m/y)Secondadministration From about(d/m/y) to about(d/m/y)(d/m/y)From about(d/m/y) to about(d/m/y)(d/m/y)Phase 2

From about(d/m/y) to about(d/m/y)(d/m/y)First administration

BCG

MR/M/R

Varicella(chickenpox)

Phase 1

Japanese
encephalitis Phase 1 booster

From about(d/m/y) to about(d/m/y)(d/m/y)Humanpapillomavirus Second administration From about
infection(d/m/y) to about(d/m/y)(d/m/y)Third administration(d/m/y) to about(d/m/y)(d/m/y)From about* Fill in a rough target date for vaccinations in accordance with the table on page 6.

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.

106. Before having your child vaccinatedd) The screening questionnaire contains important information for the doctor in
charge of vaccination. Please fill in the form completely and accurately.
e) 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 of andpossible 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) 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.

(3) Children who require careful consideration in receiving a vaccination
Parents/guardians to whom the following may apply should have their child seenby 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.
11

6. Before having your child vaccinateda)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)Children with latex sensitivity.
Latex sensitivity is an immediate hypersensitivity to natural rubber products. The
condition is suspected when an allergic reaction is observed upon the use of latex
gloves. Also seek consultation if your child is allergic to fruits etc. with crossreactivity to latex (banana, chestnut, kiwifruit, avocado, melons, etc.) (source:
Form No. 8, Hepatitis B Vaccine Screening Questionnaire).

g)

As concerns the BCG vaccination, a child who is suspected of being infected withtuberculosis already, such as a child who has been in prolonged contact with afamily member with tuberculosis.

12

6. Before having your child vaccinated(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.

e)

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.

◆ 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 ofhepatitis B-positive (HBs antigen positive) mothers will continue to be covered by healthinsurance, and in the case of accidental exposure to hepatitis B positive blood etc., thecost of the inoculation will continue to be covered by workers’ compensation or healthinsurance.

(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 occurrence ofchronic 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 after14

7. Diseases preventable by vaccination and vaccines

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
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 between April 1, 2013 and June 30, 2019 was 0.7 per 100,000 vaccinations(source: September 2019 documents from the 43rd 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 deep (systemic) infections (also called invasive
infections) such as meningitis, sepsis, and pneumonia. Prior to 2010, the incidence ofmeningitis 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.
15

7. Diseases preventable by vaccination and vaccines(2) Freeze-dried Haemophilus b conjugate vaccine (Hib vaccine) (inactivated vaccine)
Haemophilus influenzae is classified into 7 categories, with type b being the maincause 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.
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 (stiffness) (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 [11th ver.] revised April 2017).
The incidence of severe cases (cases deemed to be serious by the reporter) amongsuspected cases of adverse reactions (adverse events) reported by medical institutions
between its release and June 30, 2019 was 1.5 per 100,000 vaccinations (source:
September 2019 documents from the 43rd Working Group Meeting on Adverse Events,
the Subcommittee 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.
16

7. Diseases preventable by vaccination and vaccinesb) 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 intervalbeing 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
caused by 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 the pneumococcal conjugate vaccine is in wide use, invasive infections suchas pneumococcal meningitis have decreased dramatically.
17

7. Diseases preventable by vaccination and vaccines(2) Adsorbed 13-valent pneumococcal conjugate vaccine(13-valent pneumococcal conjugate vaccine) (inactivated vaccine)
The pediatric pneumococcal conjugate vaccine (13-valent pneumococcal conjugate
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 [third ver.] revised April 2017).
The incidence of severe cases (cases deemed to be serious by the reporter) amongsuspected cases of adverse reactions (adverse events) reported by medical institutions
between October 28, 2013 and June 30, 2019 was 1.9 per 100,000 vaccinations (source:
September 2019 documents from the 43rd 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).
18

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 children197. Diseases preventable by vaccination and vaccines◆ 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 infection
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.
20

7. Diseases preventable by vaccination and vaccines(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. Lockjaw is the first noticeable
symptom; subsequently, generalized tonic seizures occur, and delayed treatment
sometimes results in patient death. Half of all patients are infected through a small skinwound not noticed by themselves or the people around them. As the bacteria are foundin soil, opportunities for infection are constant. If a pregnant mother has immunity, thenewborn is protected from tetanus during delivery.
(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. In
2017, polio was endemic in only two countries, Pakistan and Afghanistan, and the global
eradication of polio had come to seem to no longer be a dream, but the world remains on
guard against polio.
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 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 standard21

7. Diseases preventable by vaccination and vaccinesinterval being 20 to 56 days. The phase 1 booster vaccination is given at least 6months (usually about 1 year to 1 year and 6 months) after the completion of the initial
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 thanthat specified, there are several methods which can be taken, so please consult with yourfamily doctor and the municipal office.
The DPT-IPV vaccine can be used even with children who have already contracted one
or more of 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.
Adverse reactions to DPT-IPV vaccines are mainly local reactions such as redness,swelling (puffiness), and/or induration (stiffness) at the vaccination site, and are seen in
about 18% by the seventh day after injection.
Induration (stiffness) gradually grows smaller, but may remain for several months.
High fevers do not usually occur, but fevers of 37.5°C or higher are observed in 0.5 to 1.8%
of children on the day of vaccination.
The most common adverse reactions of the DT phase 2 vaccination are reactions at thevaccination site. Reactions such as redness, swelling (puffiness), and induration (stiffness)of the vaccination site occur in about 31% of injectees by the seventh day after injection.
Similarly to local reactions after the DPT-IPV vaccine, the redness and swelling resolve
spontaneously within several days, but induration, while growing gradually smaller, may
persist for several months. The incidence of a fever of 37.5°C or higher is under 0.5%(source: The 2013 Survey on Health Status after Vaccination, 1996-2013 Cumulative
Total Report).
The incidence of severe cases (cases deemed to be serious by the reporter) amongsuspected cases of adverse reactions (adverse events) reported by medical institutions22

7. Diseases preventable by vaccination and vaccines

between its release and June 30, 2019 was 1.1 per 100,000 vaccinations for the DPT-IPV
vaccine. The incidence of severe cases (cases deemed to be serious by the reporter) amongsuspected cases of adverse reactions (adverse events) reported by medical institutions
between April 1, 2013 and June 30, 2019 was 1.9 per 100,000 vaccinations for the DPT
vaccine and 0.2 per 100,000 vaccinations for the DT vaccine (source: September 2019
documents from the 43rd 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) was used to eradicate polio in Japan and maintain thisstate; however, the OPV was replaced with an inactivated poliovirus vaccine (IPV) as aroutine 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 inabout one out of one million vaccine recipients. The IPV IMOVAX 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%), swelling (54.1%), fever of 37.5°C or more (33.8%), drowsiness (35.1%), andirritability (41.9%) were observed after the third vaccination. Precautions of shock andanaphylaxis (frequency unknown) and against convulsions as they were observed in 1.4%
are described in the package insert. (See package insert [6th ver.] revised in February 2016)
The incidence of severe cases (cases deemed to be serious by the reporter) amongsuspected cases of adverse reactions (adverse events) reported by medical institutions
between its release and June 30, 2019 was 0.6 per 100,000 vaccinations (source:
September 2019 documents from the 43rd Working Group Meeting on Adverse Events, theSubcommittee on Vaccination and Vaccines of the Health Sciences Council).

23

7. Diseases preventable by vaccination and vaccines

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初回接種はshots are given
at intervalsof 20 daysor more56(usually
20-56 days) as theinitial
20 日以上、標準的には20 日から
日までの間隔をおいて3 回行い、
vaccination,with a booster (once)
given at least 6 months(usually
year to 1 year
追加接種は初回接種終了後
6 月以上、標準的には
12 月から
18 1月までの間隔を
and
6 months)
after the completion of the initial vaccination.
おいて
1 回行います。

DT
phase 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
be given 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 oftimes.

◆ 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 upperarm. The vaccine should not be given elsewhere on the body due to possible adverse
247. Diseases preventable by vaccination and vaccines

reactions, including keloid formation. The vaccination site should be allowed to dry awayfrom 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
between April 1, 2013 and June 30, 2019 was 2.7 per 100,000 vaccinations (source:
September 2019 documents from the 43rd 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
25

7. Diseases preventable by vaccination and vaccines◆ 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 outof 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), and tuberculosis 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,
and the main symptoms are rash, fever, and posterior cervical lymphadenopathy (lymph
nodes swelling in the back of the throat). Conjunctival congestion also occurs. The
complications are joint pain, thrombocytopenic purpura, and encephalitis. About 1 ofevery 3,000 patients get thrombocytopenic purpura, and 1 in 6,000 get 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.
26

7. Diseases preventable by vaccination and vaccines(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.
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 isused.
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.
Major adverse effects of the MR vaccine are fever and rash. In phase 1, a fever
beginning during the observation period (0-28 days after the vaccine) was observedin about 16.6% of the children, with a high fever of 38.5°C or more observed in about
10.6%. In phase 2, a fever beginning during the observation period (0-28 days after thevaccine) was found in about 6.0% of the children, with a high fever of 38.5°C or more
observed in about 3.4%.
Rashes were observed in about 4.3% and 1.0 % in phases 1 and 2, respectively.
Other adverse reactions observed were local reactions including redness, swelling(puffiness), and induration (stiffness) in the injection site, and urticaria, swollen lymph
nodes, joint pain, and febrile seizure (source: The 2013 Survey on Health Status after
Vaccination, 1996-2013 Cumulative Total Report).
The data concerning adverse reactions to the measles and the rubella vaccines showsthat anaphylaxis, thrombocytopenic purpura, encephalitis, and seizure may occur rarely.
27

7. Diseases preventable by vaccination and vaccines

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
between April 1, 2013 and April 30, 2019 was 0.9 per 10,000 vaccinations (source:
August 2019 documents from the 42nd Working Group Meeting on Adverse Events, theSubcommittee 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

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

Measles/Rubella(MR/M/R)
to receive vaccination as soon as possible after the first birthday.
MR1期：お誕生日を過ぎたらできるだけ早期に行います。
(See Notes 1 and 2) MR phase 1: It is recommended

MR phase 2: 1 yearMR2期：小学校就学前の１年間（４月１日から３月31日まで）(from April 1 to March 31) before entering elementary school. It is recommended
to receive vaccination接種期間になったらできるだけ早期に行います。
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.
Note 3: Men born between April 2, 1962 and April 1, 1979 have been added to the list of those eligible forroutine vaccination concerning rubella (phase 5 routine vaccination for rubella).

◆ 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 direct28

7. Diseases preventable by vaccination and vaccines

contact, 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 ahead of therest of the world. About 20% of the individuals who receive this vaccine once experiencevaricella (chickenpox) later, but in a milder form. The vaccine is given twice to ensurethat 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), andinduration (stiffness) are observed in rare cases. High-risk patients (patients who may
be immunosuppressed due 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. (See package insert [21st ver.] revised in November 2018.)
29

7. Diseases preventable by vaccination and vaccines

The incidence of severe cases (cases deemed to be serious by the reporter) amongsuspected cases of adverse reactions (adverse events) reported by medical institutions
between April 1, 2013 and April 30, 2019 was 0.8 per 100,000 vaccinations (source:
August 2019 documents from the 42nd Working Group Meeting on Adverse Events, theSubcommittee 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 multipliedin pigs and other hosts. After an incubation period of 7 to 10 days, it may develop into
acute encephalitis with symptoms such as high fever, headache, vomiting, disturbanceof consciousness, and convulsions. Japanese encephalitis does not spread from person
to person.
One in 100-1,000 people infected with the virus develops encephalitis, etc. Somepeople 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 fromnervous system sequelae 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
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 the30

7. Diseases preventable by vaccination and vaccines

past, 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 2013 Survey on Health Status after Vaccination (the Ministry of Health, Labourand Welfare: MHLW) is a summary of surveys relating to this vaccine (an adverse
reaction survey, in which not all reactions can be determined to be adverse reactions
to the vaccine, but which show changes in symptoms after injection of the vaccine).
According to this Survey, fevers of at least 37.5°C were observed most frequently on the
day after the first injection of the phase 1 vaccine, in 2.4% of vaccine recipients, followedby 1.9% on the day of the injection. Fevers of 38.5°C or higher were seen in 1.0% on
the day following the injection and 0.8% on the day of the injection. The incidence of
local reactions such as swelling of the vaccination site was 1.4% on the day following
the first injection of the phase 1 vaccine, and 0.4% on the second day of the same. Local
reactions such as swelling of the vaccination site were seen most frequently in the phase 2
vaccination, with the peak at 3.8% on the day after injection.
The incidence of severe cases (cases deemed to be serious by the reporter) amongsuspected cases of adverse reactions (adverse events) reported by medical institutions
between November 1, 2012 and June 30, 2019 was 0.7 per 100,000 vaccinations (source:
September 2019 documents from the 43rd 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.

31

7. Diseases preventable by vaccination and vaccines

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

Japanese
encephalitis

6-month-old(3) Vaccination scheduleTwoinjections are given
at intervals of 6 までの間隔をおいて2回行い、days or more (usually 6-28 追加接days) as the initial
初回接種は6日以上、標準的には6日から28日
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).
(Note)

Note: Children born between April 2, 1995 and April 1, 2007 who were unable to receive the phase 1 and 2
vaccine due to the suspension of active recommendation in 2005 are able to receive the vaccine as a routine
vaccination up to the age of 20.

(4) Special consideration for vaccination (to secure opportunities for vaccination
for children who were unable to receive the vaccine due to suspension ofactive 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
and the 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,32

7. Diseases preventable by vaccination and vaccines

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
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.
33

7. Diseases preventable by vaccination and vaccines

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 10,000 women develop cervical cancer in Japan, andan estimated 2,700 die from the disease (source: “Cancer Information Service,” Center for
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 papillomavirus-likeparticle vaccine (Gardasil®) (inactivated vaccine)
Vaccines to prevent cervical cancer that are available in Japan are a bivalent vaccine(Cervarix®) containing antigens to the HPV type 16 and 18 viruses, which are mostfrequently detected from domestic and foreign patients with cervical cancer, and atetravalent vaccine (Gardasil®) containing the type 6 and 11 viruses which are causesof condyloma acuminatum and recurrent respiratory papillomatosis. In foreign studies
of persons not infected with HPV, both vaccines were shown to be highly effective inpreventing both infection and precancerous lesions. Therefore, countries are recommendingthat 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 (32-88%) and swelling (28-79%) 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® [12th ver.] revised in
April 2019; Gardasil® [5th ver.] revised in May 2019).
34

7. Diseases preventable by vaccination and vaccines

The incidence of severe cases (cases deemed to be serious by the reporter) amongsuspected cases of adverse reactions (adverse events) reported by medical institutions
between its release and April 30, 2019 was 7.8 per 100,000 vaccinations for Cervarix®
and 9.7 per 100,000 vaccinations for Gardasil® (source: November 2019 documents fromthe 42nd Working Group Meeting on Adverse Events, the Subcommittee 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,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 byan interval of at 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 human papillomavirus-likeparticle 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
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 an interval 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 papillomaviruslike particle vaccine and the recombinant adsorbed tetravalent human papillomaviruslike particle 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.

35

7. Diseases preventable by vaccination and vaccines

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

Humanpapillomavirus
infection(4) Response concerning routine human papillomavirus vaccination(as of end of December 2019)
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 Ministryof Health, Labour and Welfare to suspend active recommendation of the vaccination.
The safety of the HPV vaccine is being deliberated in the above Council on the basisof a wide range of study data, and the diverse symptoms regarded as having appeared
after injection of the HPV vaccine are believed to be functional somatic symptoms (notassumed to be psychogenic). Although causal links with vaccine injection are not clear,it has become known that there have been a certain number of people not injected with
HPV vaccine who have demonstrated diverse symptoms similar to those reported inpersons who received the vaccine. The national government has designated at least one
medical institution in each of the 47 prefectures to provide diagnosis and treatment for
pain, regardless of the cause. Eligibility evaluations are also being conducted concerning
health injury relief for individual cases. As of the end of December 2019, the suspensionof active recommendation still holds, but it is positioned as a vaccine necessary to protect
women from cancer by the WHO and Japanese medical associations and persons whowish to be inoculated may receive the vaccine as a routine vaccination.
Persons who would like to know more about the safety and efficacy of the HPV
vaccines should also see the brochure on the HPV vaccines which has been publishedon the Ministry of Health, Labour and Welfare website (https://www.mhlw.go.jp/bunya/
kenkou/kekkakukansenshou28/).
36

8. What to do if your child experiences an adverse reaction to a 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 in regard to relief programs, namely that “rigorous medical causation is notimperative and that relief shall also apply in cases where the possibility of symptoms
which appeared after inoculation having been caused by the vaccination cannot be ruledout.” On this basis, the patient is considered eligible for compensation for injury to healthunder 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.”(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.

37

8. What to do if your child experiences an adverse reaction to a vaccinationb) The compensation consists of payment of medical expenses, medical benefits, anannuity for disabled children, a disability annuity, lump-sum death benefits, and funeral
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 tohealth.
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 wascaused by vaccination or other factors (infection before or after vaccination, or othercauses).
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.

38

[Reference 1] Diseases preventable by voluntary vaccination and overview of vaccines[Reference 1] 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
Ministry of 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, rotavirus (a routine vaccinationfrom October 2020), yellow fever, rabies, tetanus, and meningococcal disease, and also
refer to routine vaccinations when they are given outside the eligible age range or period.
The seasonal influenza, mumps, and rotavirus vaccines that many children receive are
explained below.
In the unlikely event a child is injured by a vaccination, 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 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 each
39

[Reference 1] Diseases preventable by voluntary vaccination and overview of vaccines

year on which viral strains to include in the seasonal influenza vaccine, on the basis of
epidemiological and virological assessments.
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 severe cases (cases deemed to be serious by the reporter) amongsuspected cases of adverse reactions (adverse events) reported by medical institutions
between October 1, 2018 and April 30, 2019 was 0.1 per 10,000 vaccinations (source:
August 2019 documents from the 42nd 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)40[Reference 1] 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.

◇ Rotavirus vaccine (live vaccine)(1) Cause and course
Gastroenteritis due to rotavirus manifests as sudden vomiting and frequent waterydiarrhea, with fever present in 30-50% of cases. About 500,000 children aged less than
5 die every year due to rotavirus infection throughout the world, and more than 80% ofthem are in developing countries. Although fatalities are rare in advanced countries, somepatients can require hospitalization due to complications such as dehydration and seizure
associated with vomiting and diarrhea, renal failure, and/or encephalopathy. Rotavirus is
the most common cause of severe acute gastroenteritis requiring hospitalization.

(2) Overview of vaccine
Vaccines consist of a monovalent vaccine containing live attenuated human rotavirus
and a pentavalent vaccine containing 5 bovine-human reassortant rotaviruses. It has beensuggested that both vaccines have an effect in the prevention of infection by rotavirus G1P[8], G2P [4], G3P [8], G4P [8], and G9P [8]. The vaccine cannot prevent gastroenteritis
caused by another virus.
The monovalent vaccine is orally administered twice (1st: 6 weeks after birth or older,
2nd: up to 24 weeks after birth at intervals of at least 4 weeks), and the pentavalentvaccine is orally administered 3 times (1st: 6 weeks after birth or older, 2nd and 3rd: up to
32 weeks after birth at intervals of at least 4 weeks).
It is recommended that the initial vaccination be given no later than 14 weeks and6 days after birth.
41

[Reference 1] Diseases preventable by voluntary vaccination and overview of vaccines

The incidence of rotavirus infection has fallen dramatically in both advanced anddeveloping countries which have introduced the rotavirus vaccine. Not only direct but
also herd immunity effects have been confirmed.
If symptoms of intussusception (exhaustion, pale face, repeated vomiting, repeateddysphoria, bloody stool, flatulence) are observed after vaccination, particularly within one
week after the initial vaccination, promptly consult a doctor.
Infants with untreated congenital abnormality of the gastrointestinal tract (Meckel
diverticulum etc.) which may increase the onset of invagination, infants with a history ofinvagination, and infants with severe combined immunodeficiency disease (SCID) cannot
receive the vaccine.
The rotavirus vaccine will become a routine vaccination from October 2020; as thevaccination age range has been determined based on effectiveness and safety, please haveyour child receive the vaccination at the appropriate age.

42

[Reference 2] 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)?

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

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 (
)

)

)

/

(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.”

43

[Reference 2] 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?
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 (
)

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

Yes

No

Yes

No

Yes

No

)

)

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?

/(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.).

44

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

March 2020 revised edition(A5 size, 132 pages)
A guidebook on medical and regulatory
information about vaccination for
medical staff in practice to conduct safe
and appropriate vaccination.

3 Vaccination handbook

2019 edition (A4 size)
A handbook for doctors who give
vaccination and municipal staff incharge of vaccination.

2 “Influenza and Pneumococcal
Disease (Category B Disease)
Vaccination Guidelines”

2019 edition (A5 size, 44 pages)
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 2019 revised edition“Vaccination and children’s 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.
http://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 six languages: Arabic, Italian,
German, French, Mongolian, and Russian

List of Members of the Review Committee for Vaccination Guidelines
Name
Takashi Inamatsu○◎

Institution / Job title
Adviser of Infection Department and ResearchLaboratory Section, Tokyo Metropolitan Geriatric Hospital

Tatsuo Oya

Former Director, Institute for Children and Persons with Severe Motor andIntellectual Disabilities (Salvia Center), Saiseikai Yokohama City Tobu Hospital

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

Keiko TayaHead of Infectious Disease Surveillance Center Laboratory III,
National Institute of Infectious Diseases

Akira Nishino

Honorary Professor of Niigata University, Lawyer

Mitsuaki Hosoya

Professor, Department of Pediatrics, Fukushima Medical University

Masago Minami

Managing Director, Yomiuri Shimbun Tokyo Headquarters
Chief Officer, Yomiuri Research Institute

Toru Mori

Honorary Director of the Research Institute of Tuberculosis,
Japan Anti-Tuberculosis Association

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

Professor, Pediatrics Department, Teikyo University School of
Medicine University Hospital, Mizonokuchi◎ Chairperson ○ Vice-chairperson(In order of the Japanese syllabary, titles omitted)

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

http://www.yoboseshu-rc.com/(First edition: September 1994)(Revised edition: March 2007)(Revised edition: April 2014)(Reorganized 1st edition, 1st impression: 1995)(Revised edition: March 2008)(Revised edition: April 2015)(Reorganized 1st edition, 4th impression: 1998)(Revised edition: March 2009)(Revised edition: April 2016)(Reorganized 1st edition, 5th impression: 2002)(Revised edition: March 2010)(Revised edition: April 2017)(Revised edition: November 2003)(Revised edition: March 2011)(Revised edition: March 2018)(Reorganized edition: 2005)(Revised edition: March 2012)(Revised edition: March 2019)(Revised edition: March 2006)(Revised edition: April 2013)(Revised edition: March 2020)©Public Foundation of the Vaccination Research Center all rights reserved.
Unauthorized copying or reproduction strictly prohibited by law.

MEMO

MEMO