Pneumococcal Vaccine Polyvalent
Pneumococcal purified capsular polysaccharides
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about PNEUMOVAX 23 (pronounced new-mo-vax).
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines and vaccines have risks and benefits. Your doctor has weighed the risks
of you being given PNEUMOVAX 23 against the benefits they expect it will have for
If you have any concerns about being given this vaccine, ask your doctor or pharmacist.
Keep this leaflet.
You may need to read it again.
What PNEUMOVAX 23 is used for
PNEUMOVAX 23 is a vaccine used to help prevent infections caused by certain types
of germs or bacteria called pneumococcus (pronounced new-mo-kock-us). PNEUMOVAX 23
helps protect against the most common types of pneumococcal bacteria.
PNEUMOVAX 23 is not recommended for use in
children below 2 years of age.
It can be given to children 2 years of age and older, teenagers and adults who:
have no spleen or a spleen that does not function properly, including sickle cell
have a decreased immune system and are at increased risk of pneumococcal infection,
for example, people with organ transplants, HIV or certain cancers
have long-term diseases and are at increased risk of pneumococcal infection
have leakage of fluid from around the brain and spinal cord
It can also be given to Aboriginal and Torres Strait Islander people over 50 years
In addition, PNEUMOVAX 23 is recommended as a routine vaccination for people aged
65 years and older.
Pneumococcal infection is an important cause of death worldwide. Protection against
pneumococcal infection is important because the germs or bacteria can cause serious
diseases such as:
meningitis, an infection of the brain and/or spinal cord
pneumonia, an infection of the lungs
a severe infection of the middle ear
a severe infection in the blood.
Groups of people who are at increased risk of pneumococcal disease include those who
have poor immune systems, such as people with organ transplants, certain cancers and
HIV/AIDS. Other people who are at risk of pneumococcal disease include those with
no spleen, those with long-term problems of the heart, lung, kidney or liver, diabetes
mellitus, alcoholics and people aged 65 years and older, and those who smoke. In Australia,
the vaccine is currently recommended by the National Health and Medical Research Council
(NHMRC) for tobacco smokers.
Infection from pneumococcal bacteria usually occurs when you come into contact with
an infected person. The infection may be spread when an infected person coughs or
sneezes near another person. Apart from certain diseases, other situations that may
increase the risk of infection include:
being around groups of other children (e.g. Daycare)
living in the same household as someone who is infected.
How it works
PNEUMOVAX 23 works by causing your body to produce its own protection against pneumococcal
infection. It does this by making disease-fighting substances called antibodies to
the bacteria. The vaccine itself cannot cause the infection. If a vaccinated person
comes into contact with live bacteria, the body is usually ready and produces antibodies
to destroy it.
However, as with all vaccines, 100% protection against pneumococcal disease cannot
The chance of a severe reaction from PNEUMOVAX 23 is very small, but the risks from
not being vaccinated may be very serious.
PNEUMOVAX 23 only protects against infections caused by the most common types of pneumococcal
bacteria, not against the less common types of pneumococcal bacteria or other germs.
Before you are given PNEUMOVAX 23
When you or your child must not be given it
Do not have PNEUMOVAX 23 if:
you have an allergy to PNEUMOVAX 23 or any of the ingredients listed at the end of
the expiry date on the pack has passed
If the vaccine is used after the expiry date has passed, it may not work.
If you are not sure whether you or your child should be given PNEUMOVAX 23, talk to
Do not give PNEUMOVAX 23 to children under 2 years of age.
The safety and effectiveness of PNEUMOVAX 23 in children below the age of 2 years
have not been established.
Before you or your child are given it
Tell your doctor if:
1. you are pregnant or intend to become pregnant
It is not known whether the vaccine is harmful to an unborn baby when given to a pregnant
woman. Your doctor will give you PNEUMOVAX 23 only if it is clearly needed.
2. you are breast-feeding
It is not known whether PNEUMOVAX 23 passes into breast milk. Your doctor will discuss
the possible risks and benefits of you being given PNEUMOVAX 23 while breast-feeding.
3. you have any medical conditions, especially the following:
heart or lung problems
idiopathic thrombocytopenic purpura (ITP), a disease which causes unusual bleeding
or bruising under the skin
4. you have an infection or a high temperature
Your doctor may decide to delay your injection of PNEUMOVAX 23.
5. you are currently being treated or have recently been treated with radiotherapy or
Your doctor may decide to delay your injection of PNEUMOVAX 23.
6. you have been vaccinated with a pneumococcal vaccine before
Routine revaccination of people with normal immune systems previously vaccinated with
PNEUMOVAX 23 is not recommended.
However, revaccination is recommended for people at highest risk of serious pneumococcal
infection, at different times. Your doctor will decide if and when you need another
injection of PNEUMOVAX 23.
7. you have any allergies to any other medicines or vaccines, or any other substances,
such as foods, preservatives or dyes.
If you have not told your doctor about any of the above, tell them before you or your
child are given an injection of PNEUMOVAX 23.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you buy
without a prescription from your pharmacy, supermarket or health food shop.
PNEUMOVAX 23 may not work as well as it should if you or your child are taking or
receiving medicines that decrease the immune system, such as corticosteroids (e.g.
prednisone), cyclosporin, or chemotherapy.
PNEUMOVAX 23 should not be given at the same time as ZOSTAVAX®. For more information about these vaccines, talk to your doctor or health care provider,
because it may be better to get these vaccines at least 4 weeks apart.
Your doctor will advise you if you are taking or receiving any of these or other medicines
that decrease the immune system. Your doctor will decide whether or not to give the
How PNEUMOVAX 23 is given
How much is given
Your doctor will decide on the dose of PNEUMOVAX 23 that you or your child will be
The usual dose of PNEUMOVAX 23 is 0.5 mL. The dose of the vaccine is the same for
Usually only one injection is needed to help protect against pneumococcal disease.
However, if you are at increased risk of serious pneumococcal infection, you may need
to have a second injection. Your doctor will decide if and when you need a second
injection of PNEUMOVAX 23.
How it is given
PNEUMOVAX 23 is given as an injection by a doctor or trained nurse, either into a
muscle, such as your upper arm or mid-thigh, or under the skin. The vaccine should
not be injected directly into veins (intravenously).
Tell your doctor or pharmacist as soon as possible if you do not feel well during
or after having had an injection of PNEUMOVAX 23.
PNEUMOVAX 23 helps protect most people from pneumococcal infections, but it may have
unwanted side effects in a few people. All medicines and vaccines can have side effects.
Sometimes they are serious, most of the time they are not. You may need medical treatment
if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you or your child has any of the following and if they are troublesome
soreness, redness, warmth, swelling or hard lump where you had the injection. These
may be more common and intense after a second shot than after the first shot.
unusual tiredness or weakness
generally feeling unwell
These are usually mild side effects of PNEUMOVAX 23. They usually improve or disappear
within a few days.
Tell your doctor immediately if you or your child notice any of the following:
aching muscles, muscle tenderness or weakness, not caused by exercise
decreased ability to move limb
painful or swollen joints
tingling or numbness of the hands or feet
swollen and painful lymph glands
unusual bleeding or bruising
convulsions or fits due to fever
These may be serious side effects. You may need urgent medical attention. These
side effects are rare.
Allergic Reaction or Other Serious Conditions:
As with all vaccines given by injection, there is a very small risk of a serious allergic
reaction or other serious conditions.
Tell your doctor immediately or go to accident and emergency at your nearest hospital
if you or your child notice any of the following:
skin rash, itching
pinkish, itchy swellings on the skin, also called hives or nettle rash
swelling of the face, lips, mouth, tongue or throat which may cause difficulty in
swallowing or breathing
swelling of other parts of the body
shortness of breath, wheezing or trouble breathing
These are serious side effects. If you have them, you may have had a serious allergic
reaction or other serious reaction to PNEUMOVAX 23. You may need urgent medical attention
or hospitalisation. Most of these side effects occur within the first few hours of
vaccination but some may occur later.
Other side effects not listed above may also occur in some patients. Tell your doctor
if you notice any other effects.
Do not be alarmed by this list of possible side effects. You may not experience any
PNEUMOVAX 23 is usually stored in the doctor's surgery or clinic, or at the pharmacy.
However if you need to store PNEUMOVAX 23:
Keep it where children cannot reach it.
Keep it in the refrigerator, but not in the door compartment.
Do not put PNEUMOVAX 23 in the freezer, as freezing destroys the vaccine.
Keep the injection in the original pack until it is time for it to be given.
What it looks like
PNEUMOVAX 23 comes in glass vials or pre-filled syringes.
The active ingredient of PNEUMOVAX 23 is a mixture of inactive parts from 23 of the
most common types of pneumococcal bacteria. Each 0.5 mL of vaccine contains 25 micrograms
of each polysaccharide type.
water for injection
PNEUMOVAX 23 is made without any human blood or blood products.
The manufacture of this product includes exposure to bovine derived materials. No
evidence exists that any case of vCJD (considered to be the human form of bovine spongiform
encephalopathy) has resulted from the administration of any vaccine product.
PNEUMOVAX 23 is supplied in Australia by:
Seqirus (Australia) Pty Ltd.,
63 Poplar Road
PARKVILLE VIC 3052
This leaflet was prepared in 13 February 2020
Australian Register Numbers:
PNEUMOVAX 23 vials -
AUST R 10507
PNEUMOVAX 23 pre-filled syringes - AUST R 222235