Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pneumovax 23 solution for injection in pre-filled syringe
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Pneumococcal vaccine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
PNEUMOVAX 23 is a pneumococcal vaccine. Vaccines are used to protect you or your child against infectious diseases. Your doctor has recommended that you or your child (two years of age and older) have the vaccine to help protect against severe infections caused by bacteria that are called pneumococci. Pneumococci can cause infections of the lungs (especially pneumonia) and of the coverings over the brain and spinal cord (meningitis) and in the blood (bacteraemia or septicaemia). The vaccine will only be able to protect you or your child against pneumococcal infections that are due to the types of these bacteria that are included in the vaccine. However, the 23 pneumococcal types in the vaccine include those that cause almost all (about nine out of ten) infections caused by pneumococci. When the vaccine is given to you or your child, the body's natural defences make antibodies that help to protect against pneumococcal infections. Pneumococcal infections occur throughout the world and can occur in anyone at any age, but are most likely in: • elderly people. • people who have lost their spleen or whose spleen is not working. • people who have low resistance to infections due to longstanding illnesses or infections (such as heart disease, lung disease, diabetes mellitus, kidney disease, liver disease or HIV infection). • people who have low resistance to infections due to treatment that they have had for some illnesses (such as cancer). Pneumococcal infections of the coverings of the brain and spinal cord (meningitis) sometimes occur after injuring and cracking the skull and very rarely after certain medical operations. The vaccine may not be able to prevent all of these infections.
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Also, pneumococcal infections can occur in the sinuses, ears, and in other parts of the body. The vaccine is not thought likely to protect you or your child against these more minor kinds of infections. 2.
What you need to know before you or your child use PNEUMOVAX 23
PNEUMOVAX 23 is for use only in persons who are at least two years old. This is because younger children do not reliably respond to the vaccine. To make sure that the vaccine is suitable for you or your child, it is important to tell your doctor or nurse if any of the points below apply to you or your child. If there is anything you do not understand, or if you are not sure, ask your doctor or nurse to explain. As with other vaccines, PNEUMOVAX 23 may not fully protect all those who get it. Do not use PNEUMOVAX 23 if you or your child are allergic (hypersensitive) to PNEUMOVAX 23 or any of the ingredients that are listed in section 6. Warnings and precautions Talk to your doctor, pharmacist or nurse before vaccination if: • you or your child has an infection with a high temperature, as vaccination may need to be delayed until you or your child has recovered. You should also tell your doctor before vaccination if: • you or your child has a low resistance to infections because of a course of treatment (such as drugs or radiation treatment for cancer). • you or your child has a longstanding illness or an infection that may have lowered resistance to pneumococcal infections. In these cases vaccination may need to be delayed and even then it may not protect you as well as it protects healthy people. Individuals aged 65 years and older may not tolerate medical interventions as well as younger individuals. Therefore a higher number and/or greater severity of reactions in some older individuals cannot be ruled out. Other medicines and PNEUMOVAX 23 Tell your doctor or pharmacist if you or your child are using, have recently used or might use any other medicines. PNEUMOVAX 23 can be given at the same time as influenza vaccine as long as different injection sites are used. Most people are able to respond to both vaccines at the same time so that they can be protected against both infections. For information about the administration of PNEUMOVAX 23 and ZOSTAVAX at the same time, talk to your doctor or health care provider. If you or your child are already taking antibiotics to prevent pneumococcal infection, these should not be stopped after vaccination. Also, even after having the vaccine, it is still important that you see a doctor and get antibiotic treatment quickly if you think that you or your child may have any type of infection and you or your child have been told that you have a high risk of getting a pneumococcal infection (for example, if you have no spleen or it is not working properly). Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby or to breast-feed, ask your doctor or pharmacist for advice before taking this vaccine.
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Driving and using machines There is no information to suggest that the vaccine will affect your ability to drive or use machines. PNEUMOVAX 23 contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially sodium-free. 3.
How to take it
PNEUMOVAX 23
The vaccination should be given by a doctor or nurse who has been trained in the use of vaccines. The vaccine should be given in a surgery or clinic because there is equipment to deal with any uncommon severe allergic reaction to the injection. Always use this vaccine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The vaccine is given as an injection into a muscle or deep under the skin. Your doctor or nurse will avoid giving you or your child the injection either into the skin or into a blood vessel. The vaccine is sometimes given before (usually at least two weeks before) the planned date for taking out your spleen or for starting special treatments for cancer. If you or your child have already started or have finished special treatments, the vaccine may be delayed for about three months. When the vaccine is given to people who are HIV positive, it is usually given as soon as the test result is known. You or your child will receive one dose of the vaccine. A second dose of the vaccine is not usually given until at least three years after the first dose. Healthy people do not usually need to have a second dose. However, for persons at increased risk of serious pneumococcal infection (such as those who have no spleen or a spleen that does not work properly), further doses of the vaccine may be recommended, usually between 3 and 5 years after the first dose. A repeat dose is not usually recommended within 3 years of the first dose due to a higher risk of side effects. Your doctor or nurse will be able to decide if and when you or your child need a further dose of the vaccine. If you use more PNEUMOVAX 23 than you should There have been no reports of overdose with the vaccine. Overdose is very unlikely because the vaccine is provided in single dose, pre-filled syringe and is given by a doctor or nurse. 4.
Possible side effects
Like all vaccines and medicines, PNEUMOVAX 23 can cause side effects, although not everybody gets them. Allergic Reactions You must seek urgent medical help if you or your child experience any of the symptoms, listed below, or other serious symptoms after vaccination: • difficulty in breathing, blue discolouration of the tongue or lips, • low blood pressure (causing dizziness) and collapse, • fever, generally feeling unwell with pains or even inflammation and swelling in the joints and muscle pain, • swelling of the face, lips, tongue and/or throat and neck, • swelling of the hands, feet or ankles, • hives (inflamed wheals on the skin) and rashes. Page 3 of 5
If serious allergic reactions occur, they often do so very soon after the injection, while still in the clinic. Side Effects The most common reactions (may affect more than 1 in 10 people) reported are soreness, pain, redness, warmth, swelling and hardening at the injection site, and fever. These reactions tend to be more common after the second dose of the vaccine than after the first dose. Other side effects include: Rare (may affect up to 1 in 1,000 people): • extensive swelling of the vaccinated limb. Not known (frequency cannot be estimated from the available data): • decreased mobility of the injected limb, • feeling tired, • feeling generally unwell, • uncontrollable shivering, • feeling sick or being sick, • enlarged and/or inflamed glands, • pain, inflammation and swelling of the joints and muscle pains, • a drop in the number of certain types of particles in the blood called platelets in people who already have low numbers of these due to another illness called ITP that causes a higher risk of bleeding and bruising, • headache, altered skin sensation or pins and needles, decreased limb mobility, numbness and weakness of the legs and arms (including an illness called Guillain-Barré syndrome), • an increase in the value of a blood test that is a measure of inflammation in the body (C-reactive protein (CRP)), • patients who have had blood disorders may develop destruction of red blood cells leading to an inadequate number of red blood cells (haemolytic anaemia), • an increase in the number of certain types of white blood cells, • a fit (convulsion) associated with a high temperature, • death of skin tissue in the injection site (injection site necrosis). Reporting of side effects If you or your child get any side effects, talk to your doctor, pharmacist or nurse. This includes any
Possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5.
How to store it
PNEUMOVAX 23
Keep this vaccine out of the sight and reach of children. Do not use this vaccine after the expiry date which is stated on the box after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2C – 8C). Do not freeze. Your doctor or nurse will check that the liquid is clear and colourless and that there are no large particles in it before giving you or your child the vaccine. Do not throw away any vaccines via wastewater or house hold waste. Ask your pharmacist how to throw away vaccines you no longer need. These measures will help protect the environment.
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6.
Contents of the pack and other information
What PNEUMOVAX 23 contains 0.5 millilitre dose contains the following: •
•
Active ingredients – 25 micrograms (a very small amount) of each of 23 types of polysaccharide from bacteria known as pneumococci. The 23 types of pneumococcal polysaccharide in the vaccine are types 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F and 33F. Other ingredients – phenol, sodium chloride and water for injections.
The vaccine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially 'sodium-free'. What PNEUMOVAX 23 looks like and contents of the pack It is provided as a solution for injection in pre-filled syringe (0.5 mL). It is available in pack containing 1 or 10 pre-filled syringes without needle. It is available in pack containing 1 or 10 pre-filled syringes with 1 separate needle. It is available in pack containing 1 or 10 pre-filled syringes with 2 separate needles. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Merck Sharp & Dohme (UK) Limited 120 Moorgate London EC2M 6UR UK Manufacturer: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands. This leaflet was last revised in May 2026. © 2026 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved. IAIN/002
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Frequently asked questions about Pneumovax 23 solution for injection in pre-filled syringe
How do I take Pneumovax 23 solution for injection in pre-filled syringe?
Pneumovax 23 solution for injection in pre-filled syringe comes as injection. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Pneumovax 23 solution for injection in pre-filled syringe?
The active substance in Pneumovax 23 solution for injection in pre-filled syringe is pneumococcal vaccine.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Pneumovax 23 solution for injection in pre-filled syringe, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Pneumovax 23 solution for injection in pre-filled syringe without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: pneumococcal vaccine
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Pneumococcal polysaccharide vaccine is recommended for active immunisation against pneumococcal disease in children aged from 2 years, adolescents and adults.
See section 5.1 for information on protection against specific pneumococcal serotypes.
4.2. Posology and method of administration
The immunisation schedules for Pneumococcal polysaccharide vaccine should be based on official recommendations.
Posology
Primary vaccination:
Adults and children of 2 years of age or older- one single dose of 0.5 millilitre by intramuscular or subcutaneous injection. Pneumococcal polysaccharide vaccine is not recommended for use in children below 2 years of age as the safety and efficacy of the vaccine have not been established and the antibody response may be poor.
Special dosing:
It is recommended that pneumococcal vaccine should preferably be given at least two weeks before elective splenectomy or the initiation of chemotherapy or other immunosuppressive treatment. Vaccination during chemotherapy or radiation therapy should be avoided.
Following completion of chemotherapy and/or radiation therapy for neoplastic disease, immune responses to vaccination may remain diminished. The vaccine should not be administered any sooner than three months after completion of such therapy. A longer delay may be appropriate for patients who have received intensive or prolonged treatment (see section 4.4).
Persons with asymptomatic or symptomatic HIV infection should be vaccinated as soon as possible after their diagnosis is confirmed.
Revaccination:
One single dose of 0.5 millilitre by intramuscular or subcutaneous injection.
The specific timing of, and need for, revaccination should be determined on the basis of available official recommendations.
See section 5.1 for information on immune responses following revaccination.
Revaccination at an interval of less than three years is not recommended because of an increased risk of adverse reactions. The rates of local and, in persons aged ≥65 years, some systemic reactions have been shown to be higher after revaccination than after primary vaccination when three to five years have elapsed between doses. See section 4.8.
There are very limited clinical data regarding administration of more than two doses of Pneumococcal polysaccharide vaccine.
Adults
Healthy adults should not be revaccinated routinely.
Revaccination may be considered for persons at increased risk of serious pneumococcal infection who were given pneumococcal vaccine more than five years earlier or for those known to have a rapid decline in pneumococcal antibody levels. For selected populations (e.g., asplenics) who are known to be at high risk of fatal pneumococcal infections, revaccination at three years may be considered.
Children
Healthy children should not be revaccinated routinely.
Children of 10 years of age and over
May be considered for revaccination according to the adult recommendation (see above).
Children between the ages of 2 and 10 years
Should only be considered for revaccination after 3 years if they are at high risk of pneumococcal infection (e.g., those with nephrotic syndrome, asplenia or sickle cell disease).
Method of administration
A dose of 0.5 mL from a single-dose of Pneumococcal polysaccharide vaccine is to be injected intramuscularly (IM) or subcutaneously (SC).
4.3. Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Delay the use of the vaccine in any significant febrile illness, other active infection or when a systemic reaction would pose a significant risk except when this delay may involve even greater risk.
Pneumococcal polysaccharide vaccine should never be injected intravascularly, and precautions should be taken to make sure the needle does not enter a blood vessel. Also, the vaccine should not be injected intradermally, as injection by that route is associated with increased local reactions.
If the vaccine is administered to patients who are immunosuppressed due to either an underlying condition or medical treatment (e.g., immunosuppressive therapy such as cancer chemotherapy or radiation therapy), the expected serum antibody response may not be obtained after a first or second dose. Accordingly, such patients may not be as well protected against pneumococcal disease as immunocompetent individuals.
As with any vaccine, vaccination with Pneumococcal polysaccharide vaccine may not result in complete protection in all recipients.
For patients receiving immunosuppressive therapy, the time to recovery of the immune response varies with the illness and the therapy. Significant improvement in antibody response has been observed for some patients during the two years following the completion of chemotherapy or other immunosuppressive therapy (with or without radiation), particularly as the interval between the end of treatment and pneumococcal vaccination increased (see section 4.2).
As with any vaccine, adequate treatment provisions including epinephrine (adrenaline) should be available for immediate use should an acute anaphylactic reaction occur.
Required prophylactic antibiotic therapy against pneumococcal infection should not be stopped after pneumococcal vaccination.
Patients at especially increased risk of serious pneumococcal infection (e.g., asplenics and those who have received immunosuppressive therapy for any reason), should be advised regarding the possible need for early antimicrobial treatment in the event of severe, sudden febrile illness.
Pneumococcal vaccine may not be effective in preventing infection resulting from basilar skull fracture or from external communication with cerebrospinal fluid.
A clinical study of primary vaccination and revaccination was conducted in 629 adults ≥65 years of age and 379 adults 50 to 64 years of age. The data obtained suggested that the rates of injection site and systemic adverse reactions among subjects ≥65 years of age were not higher than the rates amongst subjects 50 to 64 years of age. It should be noted that, in general, 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 (see section 4.2).
Sodium
This medicinal product contains less than 1 mmol (23 mg) sodium per dosage unit and is considered to be essentially sodium-free.
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
4.5. Interaction with other medicinal products and other forms of interaction
Pneumococcal vaccine can be administered simultaneously with influenza vaccine as long as different needles and injection sites are used.
The concomitant use of PNEUMOVAX 23 and ZOSTAVAX resulted in reduced immunogenicity of ZOSTAVAX in a small clinical trial (see section 5.1). However, data collected in a large observational study did not indicate increased risk for developing herpes zoster after concomitant administration of the two vaccines.
4.6. Fertility, pregnancy and lactation
Pregnancy
Animal studies are insufficient with respect to effects on reproductive toxicity (see section 5.3). The vaccine should not be used during pregnancy unless clearly necessary (the potential benefit must justify any potential risk to the foetus).
Breast-feeding
It is unknown whether this vaccine is excreted in human milk. Caution should be exercised when it is administered to a nursing mother.
Fertility
The vaccine has not been evaluated in fertility studies.
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
4.8. Undesirable effects
a. Summary of the safety profile
A clinical study of primary vaccination and revaccination was conducted in 379 adults 50 to 64 years of age and 629 adults ≥65 years of age. The rate of overall injection site adverse reactions in the older revaccination group was comparable to the rate observed in the younger revaccination recipients. Injection site reactions occurred within 3 days of vaccination and typically resolved by day 5. The rate of systemic and vaccine related systemic reactions in the older revaccination group was comparable to the rate observed in the younger revaccination recipients. The most common systemic adverse events overall were as follows: asthenia/fatigue, myalgia and headache. Symptomatic treatment resulted in complete recovery in most cases.
b. Tabulated list of adverse reactions
The table below summarises the frequencies of the adverse reactions that were reported with Pneumococcal polysaccharide vaccine 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).
Adverse reactions
Frequency
Blood and the lymphatic system disorders
Haemolytic anaemia*
Leukocytosis
Lymphadenitis
Lymphadenopathy
Thrombocytopenia**
Not known
Immune system disorders
Anaphylactoid reactions
Angioneurotic oedema
Serum sickness
Not known
Nervous system disorders
Febrile convulsions
Guillain-Barré Syndrome
Headache
Paraesthesia
Radiculoneuropathy
Not known
Gastrointestinal disorders
Nausea
Vomiting
Not known
Skin and subcutaneous tissue disorders
Rash
Urticaria
Not known
Musculoskeletal and connective tissue disorders
Arthralgia
Arthritis
Myalgia
Not known
General disorders and administration site conditions
Fever (≤38.8°C)
Injection site reactions:
• erythema
• induration
• pain
• soreness
• swelling
• warmth
Very common
Extensive swelling of the vaccinated limb†
Rare
Asthenia
Chills
Fever
Injected limb mobility decreased
Injection site necrosis
Malaise
Peripheral oedema††
Not known
Investigations
C-reactive protein increased
Not known
* in patients who have had other haematologic disorders
** in patients with stabilised idiopathic thrombocytopenic purpura
† with short onset time from vaccine administration; defined by clinical review of cases reporting the preferred terms of extensive swelling of the vaccinated limb, injection site cellulitis and cellulitis, all of which described cellulitis-like reactions.
†† in the injected extremity
c. Paediatric population
A clinical study was conducted to evaluate the safety and immunogenicity of Pneumococcal polysaccharide vaccine in 102 individuals, including 25 subjects 2 to 17 years of age, 27 subjects 18 to 49 years of age, and 50 subjects 50 years of age and older. The type and severity of injection-site and systemic adverse reactions reported among children 2 to 17 years of age were comparable to those reported among adults 18 years of age and older. However, the proportions of subjects reporting injection-site and systemic adverse reactions were higher among subjects 2 to 17 years of age than those 18 years of age and older.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation 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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Not applicable.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Not the same combination. This medicine contains Pneumococcal vaccine. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
- BCG VACCINE prescription partial — not the same combinationVACCIN BCG · injection / infusion
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Not the same combination. This medicine contains Pneumococcal vaccine. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
- Prevenar 13 partial — not the same combinationVaccinum pneumococcale saccharidicum coniugatum adsorbatum (13-valentum). Szczepionka przeciw pneumokokom sacharydowa, skoniugowana, adsorbowana (13-walentna) · injection / infusion
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Pneumovax 23 solution for injection in pre-filled syringe. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.