NATIONAL IMMUNIZATION PROGRAM

MANUAL OF OPERATIONS

BOOKLET 3

CHAPTER 4
The Vaccines
Cover Photo from the National Vaccine Storage,
Research Institute for Tropical Medicine
Chapter 4
THE VACCINES
CHAPTER 4
The Vaccines

A. Rationale
Chapter 4 details the essential information on the immunization or vaccination process,
the various types of vaccines, their availability and which the DOH is recommending
for the VPDs described in the previous chapter. This section further describes how
immunization works and the basic principles relative to the timing and spacing, storage,
handling and administering vaccines. The information will also help you in giving
appropriate advice and counsel to parents and clients as well as in educating other
stakeholders in your community or catchment area.

B. Objectives
After reading Chapter 4, it is expected that we will be able to:

1. describe the immunization or vaccination process and classify the various types of
vaccines generating immunity;
2. enumerate the key principles in handling and administering vaccines; and
3. specify the key features of each vaccine product recommended by the NIP.

C. Scope and Coverage

The chapter defines immunization and immunity; lists the types or categories of vaccines;
and describes the basic principles related to:

• Efficacy and safety and adverse effects

• Proper storage and transportation
• The age of administration
• The number and size of doses
• Administration site and route of giving vaccine

The Chapter also provides a summary table of the vaccines used in the NIP for easy
reference.

Chapter 4 | The Vaccines 79

D. What is Immunization?
D.1 Disease Control, Elimination and Eradication

1. Immunization is the process

where a person is made
immune or resistant to an
infectious disease, typically
by the administration of a

Photo by: cglightNing

vaccine. Vaccines stimulate
the body’s own immune
system to protect the person
against subsequent infection
or disease.
Antibodies attacking viruses

2. Immunity refers to protection from disease through the formation of antibodies.

There are two basic mechanisms for acquiring immunity:
2.1. Passive Immunity: Acquired through the administration of products derived
from human or animals providing short-term protection, usually a few weeks
or months. The three ways of gaining passive immunity are either from blood
products, through administration of immune globulins or vertical transmission
from mother to newborn.
2.2. Active Immunity: Formed by stimulating the immune system to produce cellular
and antibody immunity. Ways of producing active immunity include:
• Exposure to an infection or disease, although infection does not lead to
immunity in all cases.
• Vaccination to produce immune responses similarly evoked by natural
infection without the development of the disease and its complications. The
immune response to vaccination is influenced by the:
› nature and dosage of administered antigen
› route of administration
› adjuvants
› maternal antibodies
› age
› nutritional status, co-existing diseases
› other host factors

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3. Types of Vaccines
3.1. Live Attenuated Vaccines are derived from wild viruses or bacteria which are
modified or weakened in laboratories. Immunity is elicited by replication of the
attenuated organism in the vaccinated person. The immune response to a live
attenuated vaccine is identical to that induced by natural infection.
• However, immuno-deficient or immuno-compromised individuals may
only receive such vaccine with caution as this may cause serious adverse
reactions as a result of uncontrolled replications
• Currently available live attenuated vaccines are those for TB (BCG), Oral
Polio, measles, mumps, rubella, and JE.
3.2. Inactivated Vaccines are produced by growing the bacteria or virus in culture
media which are then subjected to heat or chemical agents. In fractional or sub-
unit form of these vaccines, organisms are treated to be able to derive those
components needed to produce the vaccines. Both the inactivated or sub-unit
preparations must contain sufficient antigenic mass to stimulate the desired
response since it is incapable of replicating inside the host.

Forms of inactivated vaccines include:

• Whole viruses (e.g. influenza, IPV, rabies)
• Whole bacteria (e.g. pertussis, typhoid, cholera )
• Subunit or fractional vaccines (e.g. influenza, hepB, etc.)
• Pure polysaccharides and conjugates (e.g. Hib, PPV, PCV, etc.)
• Toxoids: diphtheria, tetanus.

• Inactivated vaccines may not elicit the range of immunologic response provided by the
live-attenuated agents.
• Maintenance of long-lasting immunity with inactivated viral or bacterial vaccines often
requires periodic booster doses.
• Unlike live attenuated vaccines, inactivated vaccines cannot replicate in or be
excreted by the recipient as infectious agent and thus cannot adversely affect
immunosuppressed hosts or their contacts.

Chapter 4 | The Vaccines 81

E. Basic Principles in Immunization
E.1 Timing and Spacing of Vaccines

Timing and spacing in administering vaccines are the two most important considerations
in ensuring optimal results:

1. Multiple vaccines can be administered at the recommended schedule and time using
different injection sites. Consider the following: (i) the chance of clients coming back
for additional dose to prevent drop-outs; and, (ii) the capacity of the client to receive
multiple doses.

2. Two to three inactivated injectable vaccines can be given in the same visit. Example:
PENTA, PCV and IPV can be given at the same immunization schedule at different
injection sites.
2.1. Simultaneous administration of 2 live vaccines can be given in same visit.
Example: Oral Polio and MMR

2.2. Two live parenteral vaccines can be given together, with the 2nd dose of the
same vaccines usually administered after 4 weeks. Example: MMR and JE can be
given together.
2.3. Longer interval between doses does not reduce the effectiveness of the vaccine.
It is not necessary to restart the series of any vaccine due to extended interval
between doses. Example: When the child does not come back for the 2nd dose
of PENTA at 10 weeks but rather after the child is already 5 months, we can still
continue with the 2nd dose and advise parents to come after a month for the
3rd dose.
2.4. Vaccine doses should not be administered at less than the recommended
minimum intervals or earlier than the indicated minimum age.

E.2 Administration of Vaccines

Appropriate method of vaccination is a critical component of the NIP. As a vaccine

provider, you must observe utmost professional care to ensure the optimal immune
response of the recipient.

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1. Client Preparation and Care
• IMPORTANT: Always screen clients for possible contra-indications every time you
administer a vaccine.
• Explain to the client how the vaccines work, including safety and risk. Establish
an atmosphere in which clients and their parents can freely evaluate information,
discuss vaccine concerns and make informed decisions regarding the vaccination.
• Make the vaccination least stressful to the client and their parents or guardians.
This can be done through:
› A positive attitude through your facial expression, body language and comments.
› A soft and calm tone of voice.
› Eye contact even with small children.
› Explaining why vaccines are needed.
› An honest explanation of what to expect. Never say that injection won’t hurt.

2. Infection Control
• Wash your hands thoroughly before and after each new client contact.
• It is not necessary to wear gloves when administering vaccines unless you have
open lesions or are likely to come in contact with potentially infected body fluids.
• Properly dispose of used needles and syringes to prevent needle stick injury and reuse.

E.3 Site and Route Administration

The route recommended for administration of a particular vaccine is primarily based on

clinical trials, practical experience and theoretical considerations. This is usually
indicated in the packaging and in the manufacturer’s product information of each
vaccine. There are five acceptable routes used in the administration of vaccines.
Intranasal administration of vaccine is not common and thus not explained in this
manual.

Non-compliance to recommended route of administration may reduce vaccine efficacy or

may result in exaggerated local adverse reaction.

Chapter 4 | The Vaccines 83

1. Oral Route (Per Oral - PO)
1.1. Commonly oral polio, rota and oral cholera
vaccines are the licensed-vaccines
administered by the oral route.
1.2. Oral vaccines should be administered first
before giving injectable vaccines or performing
other procedures that might cause discomfort
especially in children.
• Administer the liquid agent slowly down one
side of the inside of the cheek toward the
back of the infant’s mouth.
• Take extra care not to trigger the gag-reflex
while administering the oral vaccine.
• Do NOT administer or spray the vaccine
directly into the throat.

2. Subcutaneous Route (SC)

2.1. Injections are administered into the fatty tissue
underneath the dermis and above the muscle
tissue.
2.2. Recommended sites are the upper outer triceps
of the arm.

3. Intramuscular Route (IM)

3.1. Vaccines are administered into the muscle tissue below the dermis and the
subcutaneous tissue.
3.2. Mostly inactivated vaccines are administered by intramuscular route.
3.3. Many inactivated vaccines contain adjuvants that enhance immune response to
the antigen administered.
3.4. The anterolateral thigh (vastus lateralis muscle, lower left photo) and upper arm
(deltoid muscle, lower right photo) are the two routinely recommended sites for
intramuscular route of administration.

3.5. There is less chance of hitting nerves or blood vessels through this route.
3.6. Administration through this site depends on the individual’s age and degree of
muscle development.

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4. Intradermal Route (ID)
4.1. The vaccine is administered in between the
layers of the skin until a wheal appears.
4.2. This is the route of choice for only a very limited
number of vaccines such as Bacille Calmette
Guerin (BCG) against tuberculosis and post
exposure rabies vaccination.
4.3. For intradermal injection, insert a small thin
needle (25 or 27 gauge) and 3/8 to 3/4 inch
(1-2 cm) underneath the skin to introduce the
vaccine. The bevel should be facing upward.

E.4 Administering multiple vaccines at the same time

If you are giving more than one vaccine:

1. Do NOT use the same syringe for more than one vaccine.
2. As much as possible, do NOT inject the same arm or leg more than once. However,
if it is necessary to administer at least 2 vaccines on the same site, ensure that the
injection sites are at least 2 finger breadths apart (e.g. PCV, IPV).
3. Do NOT give more than one dose of the same vaccine in one session.
4. Give doses of the same vaccine at the correct intervals.
5. Wait at least 4 weeks between subsequent doses of OPV, DPT-HepB-Hib (PENTA),
and PCV.

E.5 Contraindications to Immunization

1. Contraindications and Precautions

While vaccines benefit most individuals, there are rare situations where vaccination is
not recommended. Contraindications and precautions identify situations when vaccines
should not be given.
Contraindications are conditions in the recipient that greatly increase the chance of a
serious adverse reaction.
Precautions are conditions in the recipient that may increase the chance of an adverse
reaction or may impair the ability of the vaccine to produce immunity. Study and
remember the appropriate restrictions for each vaccine.
Most contraindications and precautions are temporary, so the vaccine may still be given
once the condition passes. Since contraindications and precautions vary by vaccine,
health workers should screen recipients carefully.

Chapter 4 | The Vaccines 85

Use every opportunity to immunize eligible infants and adults, unless the person has
a health condition that does not permit vaccination. Sometimes there are reasons
why a specific vaccine should NEVER be administered (also called an absolute
contraindication) and there are times when you should delay giving the vaccine for a
short period of time (also called a temporary contraindication). Review and remember
the correct reasons for withholding immunization.

2. The following are reasons why specific vaccines should NEVER be administered and
reasons why vaccines may be DELAYED for a short time.
• Reason for NEVER administering a specific vaccine (Absolute contraindications):
An infant or person who has a history of anaphylaxis or a severe hypersensitivity
reaction during previous immunization is an absolute contraindication to
subsequent doses of a vaccine. Persons with a known allergy to a vaccine
component should NOT be vaccinated.
• Reasons for DELAYING administering a specific vaccine (Temporary
contraindications).
› If a mother/parent strongly objects to immunization of a sick infant. Ask the
mother to come back when the infant is well.
› If a child is suffering from some chronic condition and is under medication. ,
Consultation with the primary physician could result in postponed immunization
until after the medication or treatment is completed.

3. Report to supervisors IMMEDIATELY if a reaction does occur upon vaccination. There

are precautionary measures for particular vaccines which are explained on the
following pages.

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F. Vaccines Available in the Philippines
and Recommended by DOH for Use
Against VPDs
The following table summarizes the vaccines available in the Philippines recommended by
the DOH for VPDs:

Some of the vaccines are currently in process of nationwide expansion and some are
about to be introduced.

TABLE 3.
Vaccines Used in the NIP

Usual No. of
Type of Formulation doses in primary Common Damaged
Vaccine Disease
Vaccine (1st column) series and route vial sizes* by freezing?
of administration
BCG Tuberculosis Bacillus Freeze-dried 1 dose - 20 dose No, but
Calmette - intradermal diluent
Guérin (BCG): should not
live attenuated be frozen
mycobacterium
bovis
Hepa B Hepatitis B Liquid Monovalent 1 dose - 1 dose Yes
Vaccine intramuscular 10 dose
OPV Polio (Oral Live attenuated Liquid 2 drops per dose 10 dose No
Polio Vaccine) OPV contains 3 doses - oral 20 dose
2 types of polio
virus
IPV (Inactivated Inactivated, Liquid 1 dose - 1 dose Yes
Polio Vaccine) whole-cell IPV intramuscular 10 dose
contains 3 types
of polio virus.
PENTA Diphtheria, Inactivated: Liquid 3 doses - 1 dose Yes
DPT-HepB, Tetanus, conjugate lyophilized intramuscular 2 dose
Hib Pertussis, polysaccharide 10 dose
Hepatitis B, vaccine
Haemophilus
influenzae
type b (Hib)
diseases
PCV Pneumonia Inactivated Liquid 3 doses - 1 dose Yes
conjugated intramuscular 10 dose
PPV Pneumonia Inactivated Liquid 1 dose - 1 dose Yes
polysaccharide intramuscular
MMR Measles Live attenuated Freeze-dried 1 dose - 1 dose No but
– Mumps- Monovalent, subcutaneous 10 dose diluent
Rubella measles- should not
rubella (MR), be frozen
and measles-
mumps-
rubella (MMR)

Chapter 4 | The Vaccines 87

Usual No. of
Type of Formulation doses in primary Common Damaged
Vaccine Disease
Vaccine (1st column) series and route vial sizes* by freezing?
of administration
MR Measles - Live attenuated Freeze-dried 1 dose - 1 dose No but
Rubella Monovalent, subcutaneous 10 dose diluent
measles- should not
rubella (MR), be frozen
and measles-
mumps-
rubella (MMR)
Rotavirus Rotavirus Live attenuated Liquid oral 2 doses – oral 1 dose No
Vaccine suspension
JE Vaccine Japanese Live attenuated Lyophilized 1 dose - 1 dose No but
Encephalitis powder subcutaneous diluent
should not
be frozen
Td Vaccine Tetanus Inactivated: Liquid SBI [2 doses] – 10 dose Yes
Diphtheria toxoid Multivalent Intramuscular
form: Td WCBA [2 dose
vaccine in 1st pregnancy
and 1 dose in
each subsequent
pregnancy for
5 total doses] –
Intramuscular
HPV vaccine Human Recombinant Liquid 2 doses - 1 dose Yes
Papilloma intramuscular
Virus
Influenza Influenza Inactivated Liquid 1 dose - 1 dose Yes
Vaccine intramuscular 10 dose

F.1 Tuberculosis Vaccine - BCG

What is BCG vaccine?

BCG vaccine protects infants against tuberculosis. The letters B, C, G
stand for Bacillus Calmette-Guérin. Bacillus describes the shape of a
bacterium while Calmette and Guérin are the names of the people who
developed the vaccine.

What are the forms and presentations of BCG?

BCG vaccine comes in powder form. BCG vaccine is freeze-dried, so
it must be reconstituted with a diluent before use. It is essential that
only the diluent made by the same manufacturer as the vaccine be
used. BCG vaccine should be kept at +2°C to +8°C after reconstitution.
Like other reconstituted vaccines, BCG has a short life span and, once
reconstituted, must be discarded after six hours or at the end of the immunization session,
whichever comes first.

How safe is BCG vaccine and what are its potential adverse effects?
BCG is a safe vaccine with rare adverse events. Most children do have a reaction at the
site of injection. Normally, when BCG vaccine is injected, a small raised lump appears at
the injection site. This usually disappears within 30 minutes. After about two weeks, a

88 National Immunization Program Manual of Operations

red sore forms about the size of the end of an unsharpened pencil. The sore remains for
another two weeks and then heals. A small scar, about 5 mm across remains. Health
workers look for this to determine whether a child has been vaccinated. However, the
absence of a scar does not mean that the BCG vaccination did not work.

• When given properly, BCG vaccine has no side effects other than that described above.
• Sometimes the glands in a child’s armpit or near the elbow swell after injection with
BCG vaccine, or he/she may develop an abscess. Swollen glands or abscesses occur
because an unsterile needle or syringe was used, too much vaccine was injected, or
most commonly, the vaccine was injected incorrectly under the skin instead of on its
top layer.
• Generalized infection due to BCG vaccination occurs at a rate of 5 per million doses of
vaccine given.

How effective is BCG?

Vaccination of uninfected children can provide protection for more than 90%, but the
protective effect varies.

Administration Summary

Type of Vaccine Live bacterial

Number of Doses 1 dose

Schedule Given preferrably 90 minutes after birth. Areas with high TB

infection incidence should routinely immunize infants with a single
dose of BCG at birth. If not given at birth, BCG may be given at
the infant’s first contact with the health system before turning one
year old. BCG immunization of infants born of mothers positive for
TB should be delayed and should be given after one month after
negative PPD Test.

Booster None

Contraindications Known HIV infection and other immune deficiency.

PRECAUTION FOR HIV:

If the Mother is HIV positive, the new born must be tested for HIV.
However if the HIV test is not available, BCG vaccine is NOT given.
• If the Baby is positive with HIV infection, BCG vaccine is NOT
given.
• If the Baby is negative for HIV infection, BCG vaccine is given.

PRECAUTION FOR TB:

If the new born baby is exposed to smear positive tuberculosis
clients (mother or other first degree relative), it is recommended
that the infant be treated with Isoniazid for 6 months before
administering BCG vaccine.

Chapter 4 | The Vaccines 89

Adverse Local abscess, regional lymphadenitis; rarely, distant spread to
Reactions osteomyelitis, disseminated disease

Correct intradermal administration is essential. A special syringe

Special and needle is used to administer BCG vaccine. Health workers must
Precautions keep in mind that BCG is the most difficult vaccine to administer
because of the tiny arms of the newborn and the vaccine must
be injected intradermally (at the topmost layer of the skin). They
need extensive and continuing practice to master this skill. A short
narrow needle (15 mm, 26 gauge) is needed for this injection.

Dosage 0.05ml

Injection Site Outer upper arm or shoulder just below the deltoid. Health workers
MUST administer BCG in the same place on every child so that their
colleagues know where to look for the BCG scar.

Injection Type It is injected intradermally

Storage Store between +2°C to +8°C (vaccine maybe frozen for long-term
storage but not the diluent)

F.2 Hepatitis B (HepB) Vaccine

What is HepB vaccine?

Hepatitis B vaccine protects against Hepatitis B infection. The vaccine
contains only one antigen (monovalent). Only monovalent HepB
vaccine should be used as a birth dose (within 24 hours). It is available
in combination and should not be used at birth, but may be used in
subsequent doses. If HepB vaccine is left standing for a long time, the
vaccine may separate from the liquid. In this state, the vaccine looks
like fine sand at the bottom of the vial. Shake the vial to mix the vaccine
and liquid before using the vaccine. HepB vaccine should NEVER be
frozen. The “shake test” will determine if the vaccine has been damaged
by freezing. If the vaccine fails the shake test you must discard it.

What are the forms and presentation of Hep B vaccine?

HepB vaccine is a cloudy liquid provided in single or multi-dose vials or in prefilled auto-
disable (AD) injection devices. Hepatitis B vaccines are available in single-dose and multi-
dose glass vials. Multi-dose vials contain 2, 6, 10, or 20 doses.

How effective is Hep B vaccine?

Hep B is one of the safest and most effective of vaccines. Studies show that it is 95%
effective in preventing chronic infection. For infants exposed through the mother at birth,
monovalent Hep B vaccine is 90% effective in preventing transmission if the first dose
is administered within 24 hours and the series completed at the recommended intervals
using the combination vaccines.

90 National Immunization Program Manual of Operations

How safe is HepB vaccine and what are its potential adverse effects?
Mild, temporary local reactions are common after an injection of Hep B vaccine. It is highly
unusual to see an anaphylactic reaction. Reactions and complications due to the vaccine are
rare. Allergic reactions, such as rash, difficulty in breathing, and choking, occur about once
every 600,000 doses. No fatal allergic reaction has been reported. Mild reactions include:

• Soreness. About 15% of adults and 5% of children experience tenderness, redness, or

mild swelling at the injection site.
• Fever. About 1% to 6% of those who receive the vaccine develop a mild fever that
lasts one or two days after injection of the vaccine.

Administration Summary

Type of Vaccine Recombinant DNA

Number of Doses 1 dose

Schedule Give within 24 hours, ideally 90 minutes after birth. If Hep B vaccine
is not given within 24 hours after birth, it can still be given within
seven days.

Booster Booster doses are not recommended. Hep B vaccinations is also

not usually recommended for health workers because it is likely that
they have been exposed to the virus during childhood, and are less
likely to be carriers if they become infected as adults.

Contraindications There are no contraindications, except if a very rare anaphylactic

reaction to a previous dose has occurred. In this case, Hep B should
not be given again.

Adverse Local soreness and redness, rarely anaphylactic reaction

Reactions

Special Birth dose must be given if there is a risk of perinatal transmission

Precautions

Dosage 0.5ml

Injection Site For infants, Hep B vaccine is injected usually into the outer part
of the mid-thigh. For children and adults, it is injected in the outer
upper arm. If more than one vaccine is injected at the same time,
different sites should be used for each injection.

Injection Type Intramuscular

Storage Store between +2°C to +8°C.

Chapter 4 | The Vaccines 91

F.3 Polio Vaccine

What is polio vaccine?

Polio vaccine protects against the poliovirus. Two
types of polio vaccines are used throughout the world
to provide immunity to poliovirus. One uses inactivated
(dead) poliovirus and the other uses attenuated
(weakened) poliovirus. The vaccines became available
in 1955 and 1962, respectively. Interruption of person-
to-person transmission of the virus by vaccination led
to global polio eradication. The two vaccines have
eliminated polio from most countries in the world,
and reduced worldwide incidence from an estimated
350,000 cases in 1988 to just 37 cases in 2016.

What are the forms and presentations of polio vaccine?

1. Oral Polio Vaccine (OPV)
• Contains live, attenuated (weakened) virus
• Administered by drops
• Inexpensive
• Easy to administer
• Provides mucosal/gut immunity
• Protects close contacts who are unvaccinated

2. Inactivated Polio Vaccine (IPV)

• Contains killed virus
• Administered by injection
• Highly effective
• Used commonly in developed countries
• More expensive than OPV
• Requires trained health workers
• Provides immunity through blood
• Carries no risk of vaccine-associated polio paralysis (VAPP) or vaccine-derived
poliovirus (VDPV)

How effective is the polio vaccine?

• In more than 95% of recipients, three doses of OPV produce immunity for all of the
poliovirus types in the vaccine.
• IPV is also highly effective in preventing paralytic disease caused by all three types of
poliovirus but induces very low levels of immunity in the intestine. As a result, when a
person immunized with IPV is infected with wild poliovirus, the virus can still multiply
inside the intestines and be shed in the feces, risking continued circulation.

92 National Immunization Program Manual of Operations

How safe is Polio Vaccine and what are its potential adverse effects?
Both OPV and IPV are extremely safe. With OPV, vaccine-associated paralytic polio
(VAPP) can occur in approximately 1 in 2.7 million doses. VAPP usually occurs with the
first dose of OPV, and this small risk declines further with subsequent doses. On rare
occasions, over time, in areas of low vaccination coverage, the live attenuated (weakened)
viruses contained in OPV can begin to circulate and regain the ability to cause paralytic
cases. This is known as vaccine-derived poliovirus.

IPV is one of the safest vaccines in routine use. No serious adverse events have been
linked to it. Mild events include injection site redness in less than 1% of those vaccinated,
swelling in 3%–11% and soreness in 14%–29%.

Administration Summary

Type of Vaccine Live,attenuated virus, oral (OPV), inactivated virus, injectable (IPV)

Number of Doses Three to four doses

Schedule 6, 10, 14 weeks

(OPV+IPV) Three OPV doses initiated from six weeks of age with minimum
interval of four weeks; an IPV dose should be given from 14 weeks
of age (with OPV dose).

(Sequential IPV- 1–2 doses of IPV starting from two months of age, followed by
OPV) at least two doses of OPV; an interval of 4–8 weeks is required
between all doses

(IPV only) Three doses beginning at two months of age, with an interval of
4–8 weeks between doses

Special Postpone vaccination if the child has moderate to severe illness

Precautions (with temperature ≥39 °C)

Booster activities Supplementary doses given during polio eradication

Contraindications Known hypersensitivity (allergy) or anaphylaxis to a previous dose

Adverse OPV – Rare vaccine-associated paralytic polio (VAPP)

Reactions IPV – No known serious reactions; mild injection site reactions do
occur

Dosage OPV: two (2) drops into the mouth; IPV: 0.5 ml

Injection site For IPV left upper thigh (outer part); OPV is given orally through
mouth

Injection type For IPV - intramuscular

Storage OPV must be kept frozen from -15°C to -25°C. Do not freeze IPV. It
should be stored from +2°C to +8°C.

Chapter 4 | The Vaccines 93

TABLE 4 Minimum Interval
OPV and IPV Age Dose
Between Doses
Immunization Schedule
Six (6) weeks Four (4) weeks OPV1
for Children under
One Year of Age 10 weeks Four (4) weeks OPV2
14 weeks Four (4) weeks OPV3 and IPV

F.4 DPT-HepB+Hib Combination Vaccine (PENTA)

What is DPT-HepB+Hib vaccine (PENTA)?

DPT-HepB+Hib vaccine is called a pentavalent vaccine because it protects
against five diseases: diphtheria, tetanus, and pertussis, hepatitis B, and
Haemophilus influenzae type b. The vaccine may come in single or multi-
dose vials. Do not useDPT-HepB+Hib as a birth dose.

What are the forms and presentation of Pentavalent vaccine?

Pentavalent vaccine is available in liquid suspension for injection which
may be available in one (1) -, two (2)- and 10-dose vials.

How effective is Pentavalent vaccine?

Pentavalent vaccine is highly effective against five different diseases.
However as Pentavalent contains vaccine aginst five different diseases some of the
components need booster doses.

How safe is DPT-HepB+Hib vaccine and what are its potential adverse effects?
The number of cases of serious reactions to the DPT-HepB+Hib vaccine is similar to those
of the other vaccines that contain DPT. If a serious reaction does occur, health workers
should report the problem to supervisors immediately. Children who have a severe reaction
should NOT receive additional doses of the vaccine. Mild reactions to the vaccine include:
(i) soreness, redness, or swelling at the injection site, which resolves within one to three
days; and (ii) fever.

Administration Summary

Type of Vaccine Pentavalent vaccine

Number of Doses Three doses. PENTAVALENT vaccine is given as 3 dose infancy

schedule however some vaccines such as Diphtheria and Tetanus
need booster doses.

Schedule Given at 6, 10, 14 weeks of age

pentavalent1 starting at six weeks (minimum) with pentavalent2 and
pentavalent3 at intervals of four weeks (minimum) after each dose.

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Booster For Tetanus vaccine:
Total childhood schedule of five (5) doses (3 in infancy), another (Td)
in early childhood (1–6 years), and another (Td) during adolescence
(12–15 years) is required. A further dose in adulthood is likely to
provide lifelong protection.

For Diphtheria vaccine:

Total childhood schedule of 6 doses is recently recommended by
WHO. Three (3) doses in infancy, 4th dose at two years old and two
other doses with Td vaccine at school age.

Contraindications Anaphylaxis or hypersensitivity (allergy) after a previous dose

Adverse Mild local and systemic reactions are common

Reactions

Special Do not use as a birth dose

Precautions

Dosage 0.5 ml

Injection Site Right Outer Upper Thigh

Injection Type Intramuscular

Storage Store between +2°C to +8°C. Never freeze the vaccine.

F.5 Pneumococcal vaccine

What is Pneumococcal vaccine?

A pneumococcal vaccine is a vaccine against Streptococcus
pneumoniae. Types include: pneumococcal conjugate vaccine and
pneumococcal polysaccharide vaccine.

What are the forms and presentations of Pneumococcal vaccine?

• Pneumococcal Conjugate Vaccine (PCV13) – contains serotypes 1,
3, 4V, 5, 6A, 6B, 7, 9F, 14, 18, 18C, 19A, 19F and 23F.
• Pneumococcal Polysaccharide Vaccine (PPV) – contains serotypes
1, 2 , 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C,
19A, 19F, 20, 22F, 23F and 33F.

How effective is Pneumococcal vaccine?

Each pneumococcal vaccine protects against disease caused by the pneumococcal
serotypes that it contains; it is unlikely to protect against serotypes that it does not
contain. It does not protect against other bacteria that cause the same types of infections
(pneumonia, meningitis, etc.) as pneumococcus. The usage of these vaccines resulted in a
huge reduction in invasive pneumococcal disease.

Chapter 4 | The Vaccines 95

How safe is Pneumococcal vaccine and what are its potential adverse effects?
Pneumococcal conjugate vaccine is safe and well tolerated in all target groups. No severe
adverse events have been proven with use of these vaccines to date. Mild events include
soreness at the injection site in about 10% of those vaccinated; fever has been reported in
less than 1%.

Administration Summary

Type of Vaccine Pneumococcal Polysaccharide and Pneumococcal Conjugate

Number of Doses PCV - three doses for infants.

PPV - one dose for adults.

Schedule PCV - 6, 10 and 14 weeks of age for infants.

PPV - At 60 and 65 years old for adults.

Contraindications Anaphylaxis or hypersensitivity (allergy) after a previous dose

Adverse Severe: none known

Reactions Mild: injection site reactions and fever

Special Postpone vaccination if the child has moderate to severe illness

Precautions (with temperature ≥39 °C)

Dosage 0.5 ml

Injection Site Anterolateral (outer) part of the left thigh (vastus lateralis) for
infants, upper arm (deltoid) for adults

Injection Type Intramuscular

Storage Store between +2°C to +8°C

TABLE 5. Pneumococcal Conjugate Pneumococcal

PCV and PPV Type of Vaccine
(PCV) Polysaccharide (PPV)
Immunization
Target Population Infants under one year Seior Citizes: 60 and 65
of age years old
No. of Doses Three (3) doses One (1) dose
Schedule At 6, 10, and 14 weeks At age 60 and 65 years old
Dosage 0.5 mL 0.5 mL

96 National Immunization Program Manual of Operations

F.6 Measles-Rubella (MR) and Measles-Mumps-Rubella (MMR)
Combination Vaccines

What are the MR and MMR vaccines?

In the Philippines, the NIP uses combination vaccines for measles, rubella
(MR) and for measles, mumps, and rubella (MMR). MR and MMR vaccines
are provided in powder form with diluents and must be reconstituted before
they can be used. It is essential that only the diluent supplied with the
vaccine be used. MR and MMR vaccines should be kept at +2ºC– +8°C after
reconstitution. Any remaining reconstituted vaccine must be discarded after
six hours or at the end of the immunization session, whichever comes first.

What are the forms and presentations of Measles and Rubella

containing vaccine?
Measles and Rubella containing vaccines are available as freeze dried
vaccine to be mixed with the diluent. Formerly these vaccines used to be single
antigen vaccines which contained only Measles or Rubella vaccine, however it is highly
recommended to use vaccines that contain both Measles and Rubella with other antigen
as per the need and availability such as Measles Rubella (MR), Measles Mumps Rubella
(MMR) or Measles Mumps Rubella Varicella (MMRV).

How effective are the MMR and MR Vaccines?

Measles, Rubella and Mumps containing vaccines when given in required doses are highly
effective. The usage of Measles and Rubella containing vaccine has decreased rates of the
disease significantly in many countries in Asia and Africa.

How safe are MR and MMR vaccines and what are their potential adverse effects?
Both MR and MMR vaccines are very safe to use and may cause some rare adverse events
as described below:
• Mild events are more common and include local injection site pain and tenderness,
(5%–15%), fever and rash (in about 5%), which can occur five to 12 days after
vaccination. Serious events are rare and include anaphylaxis in 1–3.5 per one
million doses administered; severe allergic reaction in one per 100 000 doses; and,
thrombocytopenia (decreased platelet count) in one per 30,000 doses.
• Rubella-containing vaccine may cause a temporary form of arthritis one to three
weeks after vaccination in up to one in four post pubertal females (who have already
reached sexual maturity).
• Mumps containing vaccine may cause parotid swelling (in 1%–2%).

Chapter 4 | The Vaccines 97

Administration Summary

Type of Vaccine Live attenuated viral

Number of Doses Two (2) doses

Schedule Childhood Dose of MMR: 9 months and 12 months

Booster In Philippines, booster dose are given at school age children at

grade 1 and grade 7.

Contraindications For Measles Containing Vaccine(MCV)

• Known allergy to vaccine components (including neomycin and
gelatin)
• Pregnancy
• Severe congenital or acquired immune disorders, including
advanced HIV infection/AIDS

Adverse Mild: fever, rash 5–12 days following administration

Reactions Serious: Thrombocytopenia (decreased platelets), anaphylaxis,
encephalitis.

Joint pain when rubella containing vaccine (RCV) is given to adult

women; parotitis with mumps component.

Special None
Precautions

Dosage 0.5ml

Injection Site Upper arm

Injection Type Subcutaneous

Storage Store between +2°C to +8°C.

TABLE 6. Measles Mumps and

MMR and MR Type of Vaccine Measles Rubella (MR)
Rubella (MMR)
Immunization
Target Population Infants under 15 months School age children
of age
No. of Doses Two (2) doses Two (2) doses
Schedule 9 months and 12 months Grade1(5-6years old) and
Grade7 (11-12 years old)
Dosage 0.5 mL 0.5 mL

98 National Immunization Program Manual of Operations

F.7 Rotavirus Vaccine

What is Rotavirus vaccine?

A rotavirus vaccine protects children from rotaviruses, the
leading cause of severe diarrhea among infants and young
children. It contains genetically engineered live attenuated
human rotavirus strains or hybrid human-bovine reassortment
rotavirus strains.

What are the forms and presentations of Rotavirus

vaccine?
• Rotarix™
Rotarix is a monovalent, human, live attenuated rotavirus
vaccine containing one rotavirus strain of G1P[8]
specificity. ROTARIX is indicated for the prevention of
rotavirus gastroenteritis caused by G1 and non-G1 types
(G3, G4, and G9) when administered as a 2-dose series
in infants and children.
• RotaTeq™
RotaTeq is a live, oral pentavalent vaccine containing five rotavirus strains produced
by reassortment.

What is the efficacy of Rotavirus vaccine?

Safety and efficacy trials in Africa and Asia found that the vaccines dramatically reduced
severe disease among infants in developing countries, where majority of rotavirus-related
deaths occur. The incidence and severity of rotavirus infections has dropped in countries
that introduced the rotavirus vaccine. The vaccines may also prevent illness in non-
vaccinated children by limiting exposure through the number of circulating infections.

How safe is Rotavirus vaccine and what are its potential adverse effects?
The available rotavirus vaccines are safe and well tolerated.

Mild adverse reactions include irritability, runny nose, ear infection, vomiting and diarrhea
(in 5% or more of children vaccinated).

There is a low risk of intussusception or inversion of one portion of the intestine within
another portion (about one to two per 100,000 infants vaccinated). Rotavirus vaccines are
generally not recommended for infants with a history of intussusception.

Chapter 4 | The Vaccines 99

Administration Summary

Type of Vaccine Live attenuated virus, oral

Number of Doses Two (2) doses (Rotarix™); three (3) doses (Rotateq™)

Schedule Six (6) and 10 weeks of age

Contraindications • Severe allergic reaction to previous dose

• Severe immunodeficiency (but not HIV infection)
• History of uncorrected congenital malformation of gastro-
intestinal (GI) tract.
Adverse • Mild: irritability, runny nose, ear infection, diarrhoea, vomiting
Reactions • Severe: intussusception

Special • Should be postponed for acute gastroenteritis and/or fever with

Precautions moderate to severe illness
• Not routinely recommended if with a history of intussusception
or intestinal malformations that possibly predispose to
intussusception

Dosage 1 ml

Storage Store between +2°C to +8°C

F.8 Japanese encephalitis (JE) vaccine

What is JE vaccine?
Japanese Enchephalitis vaccine protects people against viral enchepahilits
caused by Japanese Enchephaltis virus (JEV). JEV is the leading cause of
viral encephalitis in Asia.

What are forms and presentations of JE vaccine?

Four vaccines for preventing JE are currently available. Inactivated Vero
cell derived vaccine, live attenuated vaccine, live recombinant vaccine and
inactivated mouse brain derived vaccine.

The most commonly used one is live attenuated powered vaccine mixed
with a diluent provided in a separate vial by the manufacturer. Before it can
be used, JE vaccine must be reconstituted. The reconstituted vaccine must be discarded
after six hours or at the end of the immunization session, whichever comes first.

How effective is JE vaccine?

JE vaccines are highly effective in preventing JEV infection. Several related studies
demonstrate that vaccination is the best possible way to reduce the disease burden. Data
on the population impact of vaccination programs show significant reduction in JE cases.

100 National Immunization Program Manual of Operations

How safe is JE vaccine and what are its potential side effects?
JE vaccines are safe. High fever (in 5%–7% of those vaccinated); injection site reactions
(redness, swelling: in less than 1% with some types of vaccine); and, low-grade fever,
irritability, nausea and dizziness (rare) are the usual side effects.

Administration Summary

Type of Vaccine Live attenuated virus vaccine

Number of Doses One (1)

Schedule Single dose administered at less than eight (8) months of age

Booster The WHO states that the need for a booster in endemic settings has
not been clearly established. However most of the countries have
adopted the one (1) dose schedule.

Contraindications • Known allergy to the vaccine or any of its components

• Pregnancy
• Any condition that results in a decreased or abnormal immune
system response, including due to any infection (such as HIV),
medication and/or congenital problems (since birth)
• Acute diseases, severe chronic diseases, and chronic diseases
with acute symptoms and/or fever
• Encephalopathy (brain disease), uncontrolled epilepsy (seizures)
or other diseases of the nervous system

Adverse High fever (in 5%–7% of those vaccinated); injection site reactions
Reactions (redness, swelling: in less than 1% with some types of vaccine); low-
grade fever, irritability, nausea and dizziness (rare)

Special • Medical history: caution needed for family or individual history of

Precautions seizures or other chronic diseases, allergies and for women who
are lactating
• Postpone vaccination for at least three (3) months if the person
has been given immunoglobulin

Dosage 0.5ml

Injection Site Upper arm

Injection Type Subcutaneous

Storage Store between +2°C to +8°C

Chapter 4 | The Vaccines 101

F.9 Tetanus Diptheria (Td) Vaccine

What is Td vaccine?
Td is the tetanus diphtheria toxoid vaccine. It is suitable for children older
than five years old and adults, including pregnant women. Td has the
added advantage of protecting against diphtheria and tetanus.

What are the forms and presentation of Td vaccine?

The vaccine can come in either as dT or DT. The capital or small letter D
signifies the amount of diphtheria toxoid in vaccine either high or low.

How effective is the Td vaccine?

A three-dose course of Td provides protection against maternal and
neonatal tetanus for at least five years. Five doses will protect women
throughout their childbearing years. When given to women of childbearing age, vaccines
that contain Td not only protect women against tetanus, but also prevent neonatal tetanus
in their newborn infants and act as booster for diphtheria. When Td vaccine is given to a
woman who is or who becomes pregnant, the antibodies that form in her body are passed
to her fetus. These antibodies protect the baby against tetanus and diphtheria during birth
and for a few months afterwards.

How safe is Td vaccine and what are its potential side effects?
• Mild reactions to Td vaccines include:
› Soreness. About one in ten people who receive the vaccines have mild pain,
redness, warmth, and swelling at the injection site for about one to three days after
the injection. This mild reaction is likely to be more common after later doses than
earlier ones, and may affect between 50% and 85% of people who receive booster
doses.
› Fever. About one in ten people may develop a mild fever after receiving the vaccines.
• Severe reactions, such as seizures, neurological complications, and anaphylaxis
following Td vaccination are very rare.

Administration Summary

Type of Vaccine Toxoid

Number of Doses • Tetanus vaccine is given as five (5)-dose schedule. Three (3)
doses in infancy as Pentavalent and two (2) doses in school age
children as Td.
• Children (Grade 1 and Grade 7) who had received three primary
doses in the form of PENTA should receive at least two doses of Td
• Pregnant women who had received three childhood DPT/PENTA
doses should receive three doses of Td.
• Pregnant women with no previous DPT/PENTA immunization or
unreliable immunization information should receive 5 Td.

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Schedule After receiving primary doses during infancy (three doses in the
form of PENTA), Td should be given to children 5-7 years old (Grade
1) and 12-15 years old (Grade 7). For pregnant women, Td vaccine
should be given as early as possible upon onset of pregnancy.

For the prevention of tetanus in women through their childbearing

years and in newborns, women should receive five doses of tetanus
toxoid. The table below shows the schedule by dose and the length
of protection provided. Td can be used instead of TT to protect
against both tetanus and diphtheria.

Contraindications There are no contraindications to tetanus toxoid. It is safe to give at

any time, even in the first trimester of pregnancy. However, PENTA,
DT, and Td should not be given to individuals who have suffered a
severe reaction to a previous dose.

Adverse • Severe: rare anaphylaxis, brachial neuritis (inflammation of the

Reactions nerves that control the shoulder, arm and hand)
• Mild: injection site reactions and fever

Dosage 0.5 ml

Injection Site Td is injected into the upper outer part of the arm

Injection Type Intramuscular

Storage Store between +2°C to +8°C. Never freeze.

When vaccines containing tetanus toxoid are left standing for a long time, the vaccine
separates from the liquid and looks like fine sand at the bottom of the vial. Shake the vial
to mix the vaccine and liquid again before giving the vaccine. Td vaccine should never be
frozen. The “shake test” will determine if the vaccine has been damaged by freezing. If the
vaccine fails the shake test you must discard it.

TABLE 7. Expected Duration of

Tetanus diphtheria Dose When To Give
Protection for Woman
Immunization Schedule
Td 1 As early as possible in pregnancy, or May be very limited duration
at first contact when a girl reaches protection
childbearing age
Td 2 At least four weeks after Td1 One to three years
Td 3 At least six months after Td2 or in Five years
next pregnancy
Td 4 At least one year after Td3 or in 10 years
next pregnancy
Td 5 At least one year after Td4 or in All childbearing years
next pregnancy

Chapter 4 | The Vaccines 103

F.10 Human Papilloma Virus (HPV) vaccine

What is HPV vaccine?

HPV vaccine is primarily used for prevention of cervical cancer for
women. Other benefits are prevention of ano-genital warts, vulvular,
vaginal and anal cancer and penile intraepithelial neoplasia (pre-
cancerous disease of the outer skin layer of the penis).

What are the forms and presentations of HPV vaccine?

There are three available HPV vaccines:

Bivalent HPV vaccine

1.
• contains types 16 and 18 L1 major capsid protein, self-
assembled as intact, non-infectious virus-like particles (VLP’s)
• manufactured in insect cells, Baculovirus.
• adjuvanted with ASO4 (Aluminum Hydroxide) plus monophosphoryl lipid A derived
from Salmonella minnesota.

2. Quadrivalent HPV vaccine

• Contains types 6, 11, 16, 18 L1 major capsid protein, self-assembled as intact,
non-infectious virus-like particles (VLP’s)
• manufactured in yeast, Saccharomyces cereviseae
• adjuvanted with propriety amorphous aluminium hydroxyphosphate sulphate.

Nonavalent HPV vaccine

3.
• contains types 6,11,16,18,31,33,45,52 and 58 purified viral L1 protein
• manufactured in yeast, Saccharomyces cereviseae
• adjuvanted with propriety amorphous aluminium hydroxyphosphate sulphate.

What is the efficacy of HPV vaccine?

• Studies of the quadrivalent vaccine were conducted in young women and men (16
through 26 years of age). Among persons not previously exposed to a targeted HPV
type, the vaccine was nearly 100% effective in preventing cervical precancers, vulvar
and vaginal precancers, and genital warts in women, as well as 90% effective in
preventing genital warts and 75% effective in preventing anal precancers in men.
• Study of the bivalent vaccine among young women aged 15 through 25 years who
were not previously exposed to a targeted HPV type showed 93% vaccine efficacy in
preventing cervical precancers due to HPV 16 or 18. In all studies of the bivalent HPV
vaccine, more than 99% of females developed an HPV 16 and 18 antibody response
a month after completing the three-dose series.
• While promising, HPV vaccines do not replace other prevention strategies, such as
regular cervical cancer screening using the Pap Smear test.

104 National Immunization Program Manual of Operations

How safe is HPV vaccine and what are its potential side effects?
Potential side-effects and adverse events to the vaccine include:
• Local reactions: 84% experience mostly burning pain and swelling at the
injection site.
• Fever: 10% of vaccine recipients
• Vasovagal syncope can occur among adolescents and adults after receiving the
vaccine. If this happens:
› Clients should be observed for 15 minutes after receiving the vaccine.
› Recipients should always be seated during vaccine administration.

Administration Summary

Type of Vaccine Recombinant

Number of Doses Two (2) doses

Schedule Routinely given to females nine to 10 years old. Given in two (2)
doses six months apart

Contraindications Persons with history of immediate hypersensitivity to yeast or to

any vaccine component

Adverse • Mild: injection site reactions; fever, dizziness, nausea

Reactions • Severe: rare anaphylaxis

Special • Postpone vaccination for pregnancy

Precautions • Adolescents should be seated during injections and for
15 minutes afterwards since they sometimes faint

Dosage 0.5 ml

Injection Site Upper arm (deltoid)

Injection Type Intramuscular

Storage Store between +2°C to +8°C. Protect from light.

Chapter 4 | The Vaccines 105

F.11 Seasonal Influenza Vaccine

What is Influenza vaccine?

Most seasonal influenza vaccines are trivalent, containing
two strains of influenza A and one strain of influenza B,
chosen based on known circulating strains. The influenza
vaccine, also known as flu shot, is an annual vaccination
using a vaccine that is specific for a given year to protect
against the highly variable influenza virus.

What are the forms and presentations of Influenza vaccine?

There are two different types of flu vaccines, trivalent and quadrivalent.
Trivalent vaccines protect against two influenza A viruses (an H1N1 and an H3N2) and an
influenza B virus.

Quadrivalent vaccines protect against two influenza A viruses and two influenza B viruses.

How effective is the Influenza vaccine?

Seasonal influenza vaccines are usually effective if given during the right time according
to the circulating strain in a particular setting. Vaccine effectiveness is dependent upon
the extent of the match between the virus strains used to prepare the vaccine and those
viruses in actual circulation.

Research has shown that when there is a good match between the virus strains chosen for
the vaccine and those in circulation, the vaccine prevents influenza illness in approximately
70-90% of healthy adults.

How safe is Influenza vaccine and what are its potential side effects?
While there are side effects to the vaccine, they are usually minor. The safety is high. Side
effects include runny nose and sore throat, which can last for up to several days. The flu
vaccine in rare circumstances may cause an allergic reaction which needs immediate
medical attention.

Common side effects are mild and temporary when compared to the burden of
hospitalization and deaths during annual epidemics.

Administration Summary

Type of Vaccine Inactivated influenza virus

Number of Doses Usually one dose to be given annually

Schedule Adults 60 years of age or older should get vaccine as it becomes

available in the health center near you ideally before flu season.

Contraindications Known hypersensitivity (allergy) or anaphylaxis to a previous dose

or to a vaccine component such as egg protein

106 National Immunization Program Manual of Operations

Adverse • Mild: injection site reactions and fever
Reactions • Severe: rare anaphylaxis, Guillain-Barré syndrome, oculo-
respiratory syndrome

Special May postpone vaccination in case of moderate to severe illness

Precautions (with temperature ≥39 °C)

Dosage 0.5 ml

Injection Site Upper arm (deltoid)

Injection Type Intramuscular

Storage Store between +2°C - +8°

Chapter 4 | The Vaccines 107

G. Summary of Route of Administration,
Injection Sites and Schedule
TABLE 8.
Summary of Vaccines by Route of Administration, Injection Site and Schedule

Route of
No. Vaccine Injection Site Schedule
Administration
1 BCG Intradermal Upper right arm At birth
2 HepB Intramuscular Outer mid-thigh At birth
3 OPV Oral Mouth 6-10-14 weeks
4 IPV Intramuscular Outer left upper thigh 14 weeks
5 PENTA Intramuscular Outer right upper thigh 6-10-14 weeks
6 PCV Intramuscular Outer left upper thigh 6-10-14 weeks
7 PPV Intramuscular Upper right arm Adults 60 and 65 years old
8 Rotavirus Oral Mouth 6-10 weeks
Vaccine
9 MMR Subcutaneous Upper right arm 9 months and 12 months
10 MR Subcutaneous Upper right arm Grade 1 and 7
11 Td Intramuscular Outer, left upper arm Grade 1 and 7 for children
For child-bearing woman:
Td1: As early as possible
in pregnancy
Td2: 4 weeks after Td1
Td3: 6 months after Td2
Td4: 1 year after Td3
Td5: 1 year after Td4
12 JE Subcutaneous Upper arm 9 months
13 HPV Intramuscular Outer, upper arm Female: 9 – 10 years old
14 Influenza Intramuscular Outer, upper arm 60 years old and above,
Vaccine annually
Intradermal = into the skin; Intramuscular = into a muscle; subcutaneous = under the skin

108 National Immunization Program Manual of Operations