Consumer medicine information

Pneumovax 23

Pneumococcal 23 valent polysaccharide vaccine

BRAND INFORMATION

Brand name

Pneumovax 23

Active ingredient

Pneumococcal 23 valent polysaccharide vaccine

Schedule

SUMMARY CMI

PNEUMOVAX^® 23

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about getting this vaccine, speak to your doctor, nurse or pharmacist.

1. Why am I or my child being given PNEUMOVAX 23?

PNEUMOVAX 23 contains a mixture of inactive parts from 23 of the most common types of pneumococcal bacteria. PNEUMOVAX 23 is a vaccine given to help prevent infections caused by certain types of germs or bacteria called pneumococcus (pronounced new-mo-kock-us).

For more information, see Section 1. Why am I or my child being given PNEUMOVAX 23? in the full CMI.

2. What should I know before I or my child are given PNEUMOVAX 23?

Do not get PNEUMOVAX 23 if you or your child have ever had an allergic reaction to PNEUMOVAX 23 or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you or your child have any other medical conditions, take any other medicines or vaccines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I or my child are given PNEUMOVAX 23? in the full CMI.

3. What if I or my child are taking other medicines or vaccines?

Some medicines or vaccines may interfere with PNEUMOVAX 23 and affect how it works. Tell your doctor, nurse or pharmacist if you or your child are taking, have recently taken or might take any other vaccines or medicines, including medicines obtained without a prescription.

For more information, see Section 3. What if I or my child are taking other medicines or vaccines? in the full CMI.

4. How is PNEUMOVAX 23 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.

More instructions can be found in Section 4. How is PNEUMOVAX 23 given? in the full CMI.

5. What should I know after I or my child are given PNEUMOVAX 23?

Things you should do	Remind any doctor, nurse or pharmacist you visit that you or your child have been given PNEUMOVAX 23.
Looking after your vaccine	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 in the refrigerator, do not freeze.

For more information, see Section 5. What should I know after I or my child are given PNEUMOVAX 23? in the full CMI.

6. Are there any side effects?

Common side effects are: soreness, redness, warmth, swelling or hard lump where you had the injection, fever, chills, headache, unusual tiredness or weakness, generally feeling unwell, nausea, vomiting.

Other side effects include: extensive swelling of the vaccinated limb, 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.

Serious side effects can include signs of allergy such as skin rash, itching, pinkish, itchy swellings on the skin, also called hives, 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.

For more information, including what to do if you or your child have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

PNEUMOVAX^® 23

Active ingredient(s): Pneumococcal Vaccine Polyvalent; Pneumococcal purified capsular polysaccharides

Consumer Medicine Information (CMI)

This leaflet provides important information about using PNEUMOVAX 23. You should also speak to your doctor, nurse or pharmacist if you would like further information or if you have any concerns or questions about using PNEUMOVAX 23.

Where to find information in this leaflet:

1. Why am I or my child being given PNEUMOVAX 23?
2. What should I know before I or my child are given PNEUMOVAX 23?
3. What if I or my child are taking other medicines or vaccines?
4. How is PNEUMOVAX 23 given?
5. What should I know after I or my child are given PNEUMOVAX 23?
6. Are there any side effects?
7. Product details

1. Why am I or my child being given PNEUMOVAX 23?

PNEUMOVAX 23 contains a mixture of inactive parts from 23 of the most common types of pneumococcal bacteria.

PNEUMOVAX 23 is a vaccine given 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 works by causing your body to produce its own protection against pneumococcal infection. It does this by making disease-fighting substances called antibodies to fight 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.

The chance of a severe reaction from PNEUMOVAX 23 is very small, but the risks from not being vaccinated may be very serious.

As with all vaccines, PNEUMOVAX 23 may not fully protect all those who get it.

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 disease
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 of age.

In addition, PNEUMOVAX 23 is recommended 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.

2. What should I know before I or my child are given PNEUMOVAX 23?

Warnings

You or your child should not get PNEUMOVAX 23 if:

you or your child are allergic to PNEUMOVAX 23, or any of the ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can get this vaccine.
the expiry date on the pack has passed
If the vaccine is given after the expiry date has passed, it may not work.
your child is under 2 years of age
The safety and effectiveness of PNEUMOVAX 23 in children below the age of 2 years have not been established.

If you are not sure whether you or your child should be given PNEUMOVAX 23, talk to your doctor.

Check with your doctor if you or your child:

are pregnant or intend to become pregnant
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
- blood problems
have an infection or a high temperature
Your doctor may decide to delay you or your child's injection of PNEUMOVAX 23.
are currently being treated or have recently been treated with radiotherapy or chemotherapy
Your doctor may decide to delay you or your child's injection of PNEUMOVAX 23.
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 or your child need another injection of PNEUMOVAX 23.
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.

After being given PNEUMOVAX 23, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if 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.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

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. What if I or my child are taking other medicines or vaccines?

Tell your doctor, nurse or pharmacist if you or your child are taking any other medicines or vaccines, including any medicines, vitamins or supplements 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.

Getting PNEUMOVAX 23 with other vaccines

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.

Check with your doctor, nurse or pharmacist if you are not sure about what medicines, vaccines, vitamins or supplements you or your child are taking and if these affect PNEUMOVAX 23.

4. How is PNEUMOVAX 23 given?

How much is given

Your doctor will decide on the dose of PNEUMOVAX 23 that you or your child will be given.

The usual dose of PNEUMOVAX 23 is 0.5 mL. The dose of the vaccine is the same for everyone.

Usually only one injection is needed to help protect against pneumococcal disease. However, if you or your child are at increased risk of serious pneumococcal infection, you may need to have a second injection. Your doctor will decide if and when you or your child need a second injection of PNEUMOVAX 23.

How is PNEUMOVAX 23 given

PNEUMOVAX 23 is given as an injection by a doctor or trained nurse, either into a muscle, such as you or your child's upper arm or mid-thigh, or under the skin. The vaccine should not be injected directly into veins (intravenously).

5. What should I know after I or my child are given PNEUMOVAX 23?

Things you should do

Remind any doctor, nurse or pharmacist you visit that you or your child have been given PNEUMOVAX 23.

Looking after your vaccine

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.

Getting rid of any unwanted medicine

It is unlikely that you will be asked to dispose PNEUMOVAX 23. However, if you no longer need this vaccine or it is out of date, take it to any pharmacy for safe disposal.

Do not get this vaccine after the expiry date.

6. Are there any side effects?

All medicines, including vaccines, can have side effects. If you or your child do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor, nurse or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects	What to do
soreness, redness, warmth, swelling or hard lump where you had the injection. These may be more common and intense after a second injection than after the first injection. fever chills headache unusual tiredness or weakness generally feeling unwell nausea, vomiting These are usually mild side effects of PNEUMOVAX 23. They usually improve or disappear within a few days.	Speak to your doctor if you or your child have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects

What to do

extensive swelling of the vaccinated limb
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 or your child may need urgent medical attention. These side effects are rare.

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Allergic Reaction

Allergic Reaction

What to do

As with all vaccines given by injection, there is a very small risk of a serious allergic reaction or other serious conditions.

skin rash, itching
pinkish, itchy swellings on the skin, also called hives
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 or your child have them, you or your child may have had a serious allergic reaction or other serious reaction to PNEUMOVAX 23. You or your child may need urgent medical attention or hospitalisation.

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these allergic reactions.

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, nurse or pharmacist if you notice anything else that may be making you or your child feel unwell.

Do not be alarmed by this list of possible side effects. You or your child may not experience any of them.

Reporting side effects

After you have received medical advice for any side effects you or your child experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this vaccine.

7. Product details

This medicine is only available with a doctor's prescription.

What PNEUMOVAX 23 contains

Active ingredient (main ingredient)	Inactive parts from 23 of the most common types of pneumococcal bacteria.
Other ingredients (inactive ingredients)	phenol sodium chloride 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.

Do not get this vaccine if you or your child are allergic to any of these ingredients.

What PNEUMOVAX 23 looks like

PNEUMOVAX 23 comes in glass vials or pre-filled syringes.

Vials - AUST R 10507

Pre-filled syringes - AUST R 222235

Who distributes PNEUMOVAX 23

Seqirus (Australia) Pty Ltd
63 Poplar Road
PARKVILLE VIC 3052

This leaflet was prepared in 28 August 2023.

S-WPPI-V110-1-022016

Published by MIMS October 2023

BRAND INFORMATION

Brand name

Pneumovax 23

Active ingredient

Pneumococcal 23 valent polysaccharide vaccine

Schedule

1 Name of Medicine

Pneumococcal purified capsular polysaccharides.

2 Qualitative and Quantitative Composition

Pneumovax 23 (pneumococcal vaccine, polyvalent) is a sterile, liquid vaccine for intramuscular or subcutaneous injection. It consists of a mixture of purified capsular polysaccharides from the 23 most prevalent or invasive pneumococcal types of Streptococcus pneumoniae, including the six serotypes that most frequently cause invasive drug-resistant pneumococcal infections among children and adults in the United States (see Table 1). The 23-valent vaccine accounts for at least 90% of pneumococcal blood isolates and approximately 85% of all pneumococcal isolates from sites which are generally sterile as determined by ongoing surveillance of U.S. data.
Pneumovax 23 is manufactured according to methods developed by MSD Research Laboratories. Each 0.5 mL dose of vaccine contains 25 microgram of each polysaccharide type dissolved in isotonic saline solution containing 0.25% phenol as preservative.
The manufacture of this product includes exposure to bovine derived material. 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.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Pneumovax 23 (pneumococcal vaccine, polyvalent) is a sterile, liquid vaccine for intramuscular or subcutaneous injection.
Pneumovax 23 is a clear, colourless solution for injection.

4 Clinical Particulars

4.1 Therapeutic Indications

Pneumovax 23 is indicated for immunisation of individuals in the following situations:
All individuals over the age of 65 years;
Individuals with asplenia, either functional or anatomical, including sickle cell disease, in persons more than 2 years of age; where possible the vaccine should be given at least 14 days before splenectomy;
Immunocompromised patients at increased risk of pneumococcal disease (e.g. patients with HIV infection before the development of AIDS, nephrotic syndrome, multiple myeloma, lymphoma, Hodgkin's disease and organ transplantation);
Aboriginal and Torres Strait Islander people over 50 years of age;
Immunocompetent persons at increased risk of complications from pneumococcal disease because of chronic illness (e.g. chronic cardiac, renal or pulmonary disease, diabetes mellitus, alcoholism and cirrhosis);
Patients with cerebrospinal fluid leaks.
In Australia, the National Health and Medical Research Council (NHMRC) currently recommends the vaccination of tobacco smokers with the 23-valent polysaccharide pneumococcal vaccine.
Pneumovax 23 is indicated for immunisation only against pneumococcal disease caused by those pneumococcal types included in the vaccine. Effectiveness of the vaccine in the prevention of pneumococcal pneumonia and pneumococcal bacteraemia has been demonstrated.
Pneumovax 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine.

4.2 Dose and Method of Administration

Timing of vaccination.

Pneumococcal vaccine should be given at least two weeks before elective splenectomy, if possible. For planning cancer chemotherapy or other immunosuppressive therapy (e.g. for patients with Hodgkin's disease or those who undergo organ or bone marrow transplantation), the interval between vaccination and initiation of immunosuppressive therapy should be at least two weeks. Vaccination during chemotherapy or radiation therapy should be avoided. Pneumococcal vaccine may be given several months following completion of chemotherapy or radiation therapy for neoplastic disease. In Hodgkin's disease, immune response to vaccination may be suboptimal for two years or longer after intensive chemotherapy (with or without radiation). For some patients, during the two years following the completion of chemotherapy or other immunosuppressive therapy (with or without radiation), significant improvement in antibody response has been observed, particularly as the interval between the end of treatment and pneumococcal vaccination increased.
Persons with asymptomatic or symptomatic HIV infection should be vaccinated as soon as possible after their diagnosis is confirmed.

Revaccination.

Revaccination of immunocompetent persons previously vaccinated with 23-valent polysaccharide vaccine is not routinely recommended.
However, revaccination is recommended for persons ≥ 2 years of age who are at highest risk of serious pneumococcal infection and those likely to have a rapid decline in pneumococcal antibody levels, provided that at least five years have passed since receipt of a first dose of pneumococcal vaccine.
The highest risk group includes persons with functional or anatomic asplenia (e.g. sickle cell disease or splenectomy), HIV infection, leukaemia, lymphoma, Hodgkin's disease, multiple myeloma, generalised malignancy, chronic renal failure, nephrotic syndrome or other conditions associated with immunosuppression (e.g. organ or bone marrow transplantation), and those receiving immunosuppressive chemotherapy (including long-term systemic corticosteroids) (see Section 4.1 Therapeutic Indications).
For children ≤ 10 years of age at revaccination and at highest risk of severe pneumococcal infection (e.g. children with functional or anatomic asplenia, including sickle cell disease or splenectomy or conditions associated with rapid antibody decline after initial vaccination including nephrotic syndrome, renal failure or renal transplantation), it is recommended that revaccination may be considered three years after the previous dose.
If prior vaccination status is unknown for patients in the high risk group, patients should be given pneumococcal vaccine.
In Australia, recommendations for revaccination are available in the Australian Immunisation Handbook.

Method of administration.

Do not inject intravenously. Intradermal administration should be avoided.
Administer a single 0.5 mL dose of Pneumovax 23 subcutaneously or intramuscularly (preferably in the deltoid muscle or lateral mid-thigh), with appropriate precautions to avoid intravascular administration.
Pneumovax 23 vials and pre-filled syringes are for use in a single individual on one occasion only.
The vaccine is used directly as supplied. No dilution or reconstitution is necessary. Phenol 0.25% is added as preservative.

Single dose vial.

For syringe use only: withdraw 0.5 mL from the vial using a sterile needle and syringe free of preservatives, antiseptics and detergents.

Prefilled syringe.

The prefilled syringe is for single use only. Inject the entire contents of the syringe.
It is important to use a separate sterile syringe and needle for each individual patient to prevent transmission of infectious agents from one person to another.

4.3 Contraindications

Hypersensitivity to any component of the vaccine.

4.4 Special Warnings and Precautions for Use

Immunocompromised patients.

Effectiveness of Pneumovax 23 in immunocompromised patients is not proven, but the high risk for disease and the potential benefits and safety of the vaccine justify vaccination.
For planning cancer chemotherapy or other immunosuppressive therapy (e.g. for patients with Hodgkin's disease or those who undergo organ or bone marrow transplantation), the timing of the vaccination is critical (see Section 4.2 Dose and Method of Administration).
If the vaccine is used in persons receiving intensive immunosuppressive therapy, (e.g. in patients with Hodgkin's disease), the expected serum antibody response may not be obtained and potential impairment of future immune responses to pneumococcal antigens may occur.
Treatments with proven efficacy, such as penicillin prophylaxis, should be continued despite vaccination or revaccination with Pneumovax 23.

General.

Intradermal administration may cause severe local reactions.
Pneumovax 23 may not be effective in preventing meningitis in patients who have chronic cerebrospinal fluid leakage resulting from congenital lesions, skull fractures or neurosurgical procedures.
Caution and appropriate care should be exercised in administering Pneumovax 23 to individuals with severely compromised cardiac and/or pulmonary function in whom a systemic reaction would pose a significant risk.
Any febrile respiratory illness or other active infection is reason for delaying use of Pneumovax 23, except when, in the opinion of the physician, withholding the agent entails even greater risk.
As with any vaccine, vaccination with Pneumovax 23 may not result in complete protection in all recipients.

Use in renal impairment.

See Section 4.2 Dose and Method of Administration, Revaccination.

Use in the elderly.

Persons 65 years of age or older were enrolled in several clinical studies of Pneumovax 23 that were conducted pre- and post-licensure. In the largest of these studies, the safety of Pneumovax 23 in adults 65 years of age and older (n = 629) was compared to the safety of Pneumovax 23 in adults 50 to 64 years of age (n = 379). The data did not suggest an increased rate of adverse reactions among subjects ≥ 65 years of age compared to those 50 to 64 years of age. However, since elderly individuals may not tolerate medical interventions as well as younger individuals, a higher frequency and/or a greater severity of reactions in some older individuals cannot be ruled out.

Paediatric use.

Pneumovax 23 is not recommended for use in children less than 2 years of age. Safety and effectiveness in children below the age of 2 years have not been established. Children in this age group respond poorly to the capsular types contained in this vaccine.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

In Australia, the National Health and Medical Research Council (NHMRC) advises that influenza vaccine can be administered concurrently with pneumococcal polysaccharide vaccine.
Pneumovax 23 and Zostavax should not be given concurrently because concomitant use in a clinical trial resulted in reduced immunogenicity of Zostavax. In this trial, the immunogenicity of Pneumovax 23 was not affected by Zostavax. Consider administration of the two vaccines separated by at least 4 weeks.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B2)
Animal reproduction studies have not been conducted with Pneumovax 23. It is also not known whether Pneumovax 23 can cause foetal harm when administered to pregnant women or can affect reproduction capacity. Pneumovax 23 should be given to pregnant women only if clearly needed.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Pneumovax 23 is administered to a nursing woman.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Clinical trial experience.

A clinical trial was undertaken to evaluate immunogenicity and safety of revaccination at 3-5 years following primary vaccination. Enrolled were 1008 subjects ≥ 50 years of age. The results were analysed separately for subjects ≥ 65 years of age (primary analysis), and 50-64 years (secondary analysis).
In this study, the overall injection site adverse experience rate was higher after revaccination than after primary vaccination. For subjects ≥ 65 years of age, the rate was 52.9% following primary vaccination and 79.3% after revaccination. For subjects 50-64 years of age, the rates were similar (72.8% and 79.6%, respectively). The injection site reactions occurred within the 3 days monitoring period and typically resolved by day 5.
The study also analysed a composite endpoint including one or more of the following:
moderate pain, severe pain and/or large induration at the injection site. In both age groups, revaccination resulted in a higher reported rate of the composite endpoint than following primary vaccination. Among subjects ≥ 65 years of age, the composite endpoint was reported by 10.4% of subjects following primary vaccination and 30.6% following revaccination. For subjects 50-64 years of age, the endpoint was reported by 18.9% after primary vaccination and 35.5% after revaccination.
The rate of overall systemic adverse experiences was similar after primary vaccination and revaccination, regardless of age. For subjects ≥ 65 years of age, the rates were 32.1% and 39.1%, respectively. For subjects 50-64 years of age, the rates were 48.8% and 47.4%, respectively. A generally small increase in post-vaccination analgesic use was observed in the four study groups (range from < 1% to 13%) and returned to baseline by day 5.
The most common adverse experiences reported in clinical trials were fever (≤ 38.8°C/102°F), injection site reactions including soreness, erythema, warmth, swelling and local induration.

Post-marketing experience.

Cellulitis-like reactions have been reported in post-marketing experience. These cellulitis-like reactions were reported with primary vaccination or revaccination at a median onset time of 1 day after vaccine administration. Local reactions may be accompanied by systemic signs and symptoms including fever, leukocytosis and an increase in the laboratory value for serum C-reactive protein.

Tabulated summary of adverse events.

Table 2 summarizes the frequencies of the adverse events that were reported with Pneumovax 23 in clinical trials and/or post-marketing surveillance, using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from available data).

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

No specific information is available on the treatment of overdose.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

Epidemiology.

Invasive pneumococcal disease (e.g. bacteraemia or meningitis) and pneumonia cause high morbidity and mortality in spite of effective antimicrobial control by antibiotics. Vaccination offers an effective means of further reducing the morbidity and mortality of this disease.

Risk factors.

In addition to the very young and persons 65 years of age or older, patients with certain chronic conditions and disease states are at increased risk of developing pneumococcal infection and severe pneumococcal illness. Examples of such patients include individuals with asplenia, immunocompromised patients, cirrhotic patients, immunocompetent patients with chronic cardiac, renal or pulmonary disease, and patients with cerebrospinal fluid leaks.
A case-control study has shown an increased risk of pneumococcal infection among cigarette smokers, suggesting that smoking is an important risk factor for invasive pneumococcal disease among immunocompetent adults.

5.1 Pharmacodynamic Properties

Mechanism of action.

It has been established that the purified pneumococcal capsular polysaccharides induce antibody production and that such antibody is effective in preventing pneumococcal disease.

Clinical trials.

Efficacy.

The protective efficacy of pneumococcal vaccines containing 6 and 12 capsular polysaccharides was investigated in two controlled studies of young, healthy gold miners in South Africa, in whom there is a high attack rate for pneumococcal pneumonia and bacteraemia. Capsular type-specific attack rates for pneumococcal pneumonia were observed for the period from 2 weeks through about 1 year after vaccination. Protective efficacy was 76% and 92%, respectively, in the two studies for the capsular types represented.
In similar studies carried out by Dr. R. Austrian and associates using similar pneumococcal vaccines prepared for the National Institute of Allergy and Infectious Diseases, the reduction in pneumonias caused by the capsular types contained in the vaccines was 79%. Reduction in type-specific pneumococcal bacteraemia was 82%.
A prospective study in France found pneumococcal vaccine to be 77% effective in reducing the incidence of pneumonia among nursing home residents.
In the United States, two postlicensure randomised controlled trials, in the elderly or patients with chronic medical conditions who received a multivalent polysaccharide vaccine, did not support the efficacy of the vaccine for nonbacteraemic pneumonia. However, these studies may have lacked sufficient statistical power to detect a difference in the incidence of laboratory confirmed, nonbacteraemic pneumococcal pneumonia between the vaccinated and nonvaccinated study groups.
A meta-analysis of nine randomised controlled trials of pneumococcal vaccine concluded that pneumococcal vaccine is efficacious in reducing the frequency of nonbacteraemic pneumococcal pneumonia among adults in low risk groups but not in high-risk groups. These studies may have been limited because of the lack of specific and sensitive diagnostic tests for nonbacteraemic pneumococcal pneumonia. The pneumococcal polysaccharide vaccine is not effective for the prevention of acute otitis media and common upper respiratory diseases (e.g. sinusitis) in children.
More recently, multiple, case-control studies have shown pneumococcal vaccine is effective in the prevention of serious pneumococcal disease, with point estimates of efficacy ranging from 56% to 81% in immunocompetent persons.
Only one case-control study did not document effectiveness against bacteraemic disease, possibly due to study limitations including small sample size and incomplete ascertainment of vaccination status in patients. In addition, case-patients and persons who served as controls may not have been comparable regarding the severity of their underlying medical conditions, potentially creating a biased underestimate of vaccine effectiveness.
A serotype prevalence study, based on the Centers for Disease Control pneumococcal surveillance system, demonstrated 57% overall protective effectiveness against invasive infections caused by serotypes included in the vaccine in persons ≥ 6 years of age, 65-84% effectiveness among specific patient groups (e.g. persons with diabetes mellitus, coronary vascular disease, congestive heart failure, chronic pulmonary disease and anatomic asplenia) and 75% effectiveness in immunocompetent persons aged ≥ 65 years of age. Vaccine effectiveness could not be confirmed for certain groups of immunocompromised patients; however, the study could not recruit sufficient numbers of unvaccinated patients from each disease group.
In an earlier study, vaccinated children and young adults aged 2 to 25 years who had sickle cell disease, congenital asplenia, or undergone a splenectomy experienced significantly less bacteraemic pneumococcal disease than patients who were not vaccinated.

Duration of immunity.

Following pneumococcal vaccination, serotype-specific antibody levels decline after 5-10 years. A more rapid decline in antibody levels may occur in some groups (e.g. children). Limited published data suggest that antibody levels may decline more rapidly in the elderly > 60 years of age. These findings indicate that revaccination may be needed to provide continued protection (see Section 4.2 Dose and Method of Administration).

Immunogenicity of Pneumovax 23.

It has been established that the purified pneumococcal capsular polysaccharides induce antibody production and that such antibody is effective in preventing pneumococcal disease. Clinical studies have demonstrated the immunogenicity of each of the 23 capsular types when tested in polyvalent vaccines. Studies with 12-valent, 14-valent and 23-valent pneumococcal vaccines in children two years of age and older and in adults of all ages showed immunogenic responses.
Protective capsular type-specific antibody levels generally develop by the third week following vaccination. Bacterial capsular polysaccharides induce antibodies primarily by T-cell-independent mechanisms. Therefore, antibody response to most pneumococcal capsular types is generally poor or inconsistent in children aged < 2 years whose immune systems are immature.

Immunogenicity following concomitant administration with zoster virus vaccine.

In a double-blind, controlled clinical trial, 473 adults, 60 years of age or older, were randomized to receive Zostavax and Pneumovax 23 concomitantly (N = 237), or Pneumovax 23 alone followed 4 weeks later by Zostavax alone (N = 236). At four weeks postvaccination, the VZV antibody levels following concomitant use were significantly lower than the VZV antibody levels following nonconcomitant administration (GMTs of 338 vs. 484 gpELISA units/mL, respectively; GMT ratio = 0.70 (95% CI: [0.61, 0.80])). VZV antibody levels 4 weeks postvaccination were increased 1.9-fold (95% CI: [1.7, 2.1]; meeting the pre-specified acceptance criterion) in the concomitant group vs. 3.1-fold (95% CI: [2.8, 3.5]) in the nonconcomitant group. The GMTs for Pneumovax 23 antigens were comparable between the two groups. Concomitant use of Zostavax and Pneumovax 23 demonstrated a safety profile that was generally similar to that of the two vaccines administered nonconcomitantly.

5.2 Pharmacokinetic Properties

Absorption.

Not applicable.

Distribution.

Not applicable.

Metabolism.

Not applicable.

Excretion.

Not applicable.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sodium chloride, phenol, water for injection.

6.2 Incompatibilities

Please see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions for further information.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store unopened and opened vials and pre-filled syringes at 2°C to 8°C. All vaccine must be discarded after the expiration date.

6.5 Nature and Contents of Container

Pneumovax 23 (pneumococcal vaccine, polyvalent) is supplied as follows:
Carton of single-dose injection vial of vaccine (25 microgram/0.5 mL), in packs of 1* or 10*;
Carton of single-dose injection pre-filled syringe of vaccine (25 microgram/0.5 mL) in packs of 1 or 10.
* Currently not supplied.
Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

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Pneumovax 23

Pneumococcal 23 valent polysaccharide vaccine

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