Pediatric Formulary

Pneumococcus vaccine

Generic name

Pneumococcus vaccine

Brand name

ATC Code

J07AL02

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Dosages

Side effects in children

Warnings & precautions in children

Contra-indications in children

Interactions

Renal impairment

References

Pharmacokinetics in children

No information

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

NATIONAL VACCINATION PROGRAMME pneumococci
Intramuscular 6 weeks up to 9 weeks First vaccination 0.5 ml/dose, once only. 4 months Second vaccination 0.5 ml/dose, once only. 11 months Third vaccination 0.5 ml/dose, once only. Start vaccination programm at age < 6 months <according to national vaccination schedule>

Immunization against pneumococci: Non-standard schedules (not the National Vaccination Programme)
Intramuscular 0 years up to 18 years ^{[2] [4] [5] [8]} Synflorix: Premature infants born between 27-36 weeks duration of pregnancy: 4 doses, of which the first is at the age of 2 months. The first 3 doses are given with 1 month between each dose and the fourth is given at least 6 months after the third dose. 6 weeks-6 months: Regimen of 4 doses, of which the first three are given with 1 month between each dose and the fourth is given at least 6 months after the third , preferably at an age of 12-15 months. Regimen of 3 doses, of which the first 2 are given with 2 months between each dose; the third is given at least 6 months after the second dose. Previously unvaccinated infants and older children: 7 months to 11 months: 3 doses, of which the first 2 are given with at least 1 month between each dose and the third is given in the second year of life, at least 2 months after the second dose. 12 months-5 years: 2 doses with at least 2 months in between doses. Prevenar 13: Premature infants (< 37 weeks): 4 doses, of which the first is given at the age of 6-8 weeks, the next 2 are given with 1 month between each dose and the fourth is given at least 6 months after the third dose, preferably at an age of 11-15 months. 6 weeks to 6 months: Regimen of 4 doses: of which the first three are given with 1 month between each dose and the fourth is given at least 6 months after the third , preferably at an age of 11-15 months. Regimen of 3 doses: of which the first 2 doses are given with 2 months between each dose; the third dose is recommended at 11-15 months. Previously unvaccinated infants and older children: 7 months to 11 months: 3 doses, of which the first 2 are given with at least 1 month between each dose and the third is given in the second year of life. 12-23 months: 2 doses with at least 2 months in between doses. 2-17 years: 1 dose. Vaxneuvance Standard vaccination schedule Premature infants (< 37 weeks at birth): primary series of three doses followed by a booster dose. First dose at 6 weeks of age, with 4-8 weeks interval between primary doses. 4th dose (booster dose) at left age 11-16 months and at least 2 months after the 3rd dose. 6 weeks to 2 years: 4-dose schedule: primary series of three doses followed by a booster dose. First dose at 6 weeks of age, with 4-8 weeks interval between primary doses. 4th dose (booster dose) at 11-16 months of age and at least 2 months after the 3rd dose. 3 dose schedule: primary series of 2 doses followed by a booster dose. First dose at 6 weeks of age and 2nd dose 8 weeks later. 3rd dose (booster dose) at 11-16 months of age. Schedule for previously unvaccinated children: 7 months-12 months: 2 doses at 4-week intervals. A third booster dose after 12 months of age and at least 2 months after the last dose 12 months-2 years: 2 doses at 2-month intervals 2 - 18 years: (unvaccinated or incompletely vaccinated children) 1 dose (at least 2 months after a previous dose of pneumococcal conjugate vaccine Infants and children who have begun immunization with another pneumococcal conjugate vaccine may switch to Vaxneuvance at any time within the schedule Pneumovax 23: (at-risk groups) > 2 years: 1 dose. Revaccination should be considered if the last vaccination took place more than 5 years ago and in children aged < 10 years with nephrotic syndrome, asplenia or sickle cell anaemia who were vaccinated 3-5 years ago. 6 weeks up to 18 years Prevenar 13: Premature infants (< 37 weeks): 4 doses, of which the first is given at the age of 6-8 weeks, the next 2 are given with 1 month between each dose and the fourth is given at least 6 months after the third dose, preferably at an age of 11-15 months. 6 weeks to 6 months: Regimen of 4 doses: of which the first three are given with 1 month between each dose and the fourth is given at least 6 months after the third , preferably at an age of 11-15 months. Regimen of 3 doses: of which the first 2 doses are given with 2 months between each dose; the third dose is recommended at 11-15 months. Previously unvaccinated infants and older children: 7 months to 11 months: 3 doses, of which the first 2 are given with at least 1 month between each dose and the third is given in the second year of life. 12 to 23 months: 2 doses with at least 2 months in between doses. 2 to 17 years: 1 dose. Prevenar 20 6 weeks to 7 months: 3 doses, with the first 3 doses given at least 1 month apart and the 4th (booster) dose at 11–15 months of age 7 to 12 months: 3 doses, with the first 2 doses given at least 4 weeks apart. A third dose is recommended in the second year of life. 12 to 24 months: 2 doses with an interval of at least 8 weeks. If previously vaccinated with Prevenar 13, wait at least 8 weeks before administering Prevenar 20. 2 to 18 years: 1 dose. If previously vaccinated with Prevenar 13, wait at least 8 weeks before administering Prevenar 20. Vaxneuvance Standard vaccination schedule Premature infants (< 37 weeks at birth): primary series of three doses followed by a booster dose. First dose at 6 weeks of age, with 4-8 weeks interval between primary doses. 4th dose (booster dose) at left age 11-16 months and at least 2 months after the 3rd dose. 6 weeks to 2 years: 4-dose schedule: primary series of three doses followed by a booster dose. First dose at 6 weeks of age, with 4-8 weeks interval between primary doses. 4th dose (booster dose) at 11-16 months of age and at least 2 months after the 3rd dose. 3 dose schedule: primary series of 2 doses followed by a booster dose. First dose at 6 weeks of age and 2nd dose 8 weeks later. 3rd dose (booster dose) at 11-16 months of age. Schedule for previously unvaccinated children: 7 months to 12 months: 2 doses at 4-week intervals. A third booster dose after 12 months of age and at least 2 months after the last dose 12 months to 2 years: 2 doses at 2-month intervals 2 to 18 years: (unvaccinated or incompletely vaccinated children) 1 dose (at least 2 months after a previous dose of pneumococcal conjugate vaccine Infants and children who have begun immunization with another pneumococcal conjugate vaccine may switch to Vaxneuvance at any time within the schedule Pneumovax 23: (at-risk groups) > 2 years: 1 dose. Revaccination should be considered if the last vaccination took place more than 5 years ago and in children aged < 10 years with nephrotic syndrome, asplenia or sickle cell anaemia who were vaccinated 3-5 years ago.

Immunization against pneumococci: Non-standard schedules (not the National Vaccination Programme)

Intramuscular
- 0 years up to 18 years
  ^{[2]
  
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  - Synflorix:
    Premature infants born between 27-36 weeks duration of pregnancy: 4 doses, of which the first is at the age of 2 months. The first 3 doses are given with 1 month between each dose and the fourth is given at least 6 months after the third dose.
    6 weeks-6 months:
    Regimen of 4 doses, of which the first three are given with 1 month between each dose and the fourth is given at least 6 months after the third , preferably at an age of 12-15 months.
    Regimen of 3 doses, of which the first 2 are given with 2 months between each dose; the third is given at least 6 months after the second dose.
    Previously unvaccinated infants and older children:
    7 months to 11 months: 3 doses, of which the first 2 are given with at least 1 month between each dose and the third is given in the second year of life, at least 2 months after the second dose.
    12 months-5 years: 2 doses with at least 2 months in between doses.
    
    Prevenar 13:
    Premature infants (< 37 weeks): 4 doses, of which the first is given at the age of 6-8 weeks, the next 2 are given with 1 month between each dose and the fourth is given at least 6 months after the third dose, preferably at an age of 11-15 months.
    6 weeks to 6 months:
    Regimen of 4 doses: of which the first three are given with 1 month between each dose and the fourth is given at least 6 months after the third , preferably at an age of 11-15 months.
    Regimen of 3 doses: of which the first 2 doses are given with 2 months between each dose; the third dose is recommended at 11-15 months.
    Previously unvaccinated infants and older children:
    7 months to 11 months: 3 doses, of which the first 2 are given with at least 1 month between each dose and the third is given in the second year of life.
    12-23 months: 2 doses with at least 2 months in between doses.
    2-17 years: 1 dose.
    
    Vaxneuvance
    Standard vaccination schedule
    Premature infants (< 37 weeks at birth): primary series of three doses followed by a booster dose. First dose at 6 weeks of age, with 4-8 weeks interval between primary doses. 4th dose (booster dose) at left age 11-16 months and at least 2 months after the 3rd dose.
    6 weeks to 2 years:
    4-dose schedule: primary series of three doses followed by a booster dose. First dose at 6 weeks of age, with 4-8 weeks interval between primary doses. 4th dose (booster dose) at 11-16 months of age and at least 2 months after the 3rd dose.
    3 dose schedule: primary series of 2 doses followed by a booster dose. First dose at 6 weeks of age and 2nd dose 8 weeks later. 3rd dose (booster dose) at 11-16 months of age.
    Schedule for previously unvaccinated children:
    7 months-12 months: 2 doses at 4-week intervals. A third booster dose after 12 months of age and at least 2 months after the last dose
    12 months-2 years: 2 doses at 2-month intervals
    2 - 18 years: (unvaccinated or incompletely vaccinated children) 1 dose (at least 2 months after a previous dose of pneumococcal conjugate vaccine
    
    Infants and children who have begun immunization with another pneumococcal conjugate vaccine may switch to Vaxneuvance at any time within the schedule
    
    Pneumovax 23: (at-risk groups)
    > 2 years: 1 dose.
    Revaccination should be considered if the last vaccination took place more than 5 years ago and in children aged < 10 years with nephrotic syndrome, asplenia or sickle cell anaemia who were vaccinated 3-5 years ago.
- 6 weeks up to 18 years
  - Prevenar 13:
    Premature infants (< 37 weeks): 4 doses, of which the first is given at the age of 6-8 weeks, the next 2 are given with 1 month between each dose and the fourth is given at least 6 months after the third dose, preferably at an age of 11-15 months.
    6 weeks to 6 months:
    Regimen of 4 doses: of which the first three are given with 1 month between each dose and the fourth is given at least 6 months after the third , preferably at an age of 11-15 months.
    Regimen of 3 doses: of which the first 2 doses are given with 2 months between each dose; the third dose is recommended at 11-15 months.
    Previously unvaccinated infants and older children:
    7 months to 11 months: 3 doses, of which the first 2 are given with at least 1 month between each dose and the third is given in the second year of life.
    12 to 23 months: 2 doses with at least 2 months in between doses.
    2 to 17 years: 1 dose.
    
    Prevenar 20
    6 weeks to 7 months: 3 doses, with the first 3 doses given at least 1 month apart and the 4th (booster) dose at 11–15 months of age
    7 to 12 months: 3 doses, with the first 2 doses given at least 4 weeks apart. A third dose is recommended in the second year of life.
    12 to 24 months: 2 doses with an interval of at least 8 weeks. If previously vaccinated with Prevenar 13, wait at least 8 weeks before administering Prevenar 20.
    2 to 18 years: 1 dose. If previously vaccinated with Prevenar 13, wait at least 8 weeks before administering Prevenar 20.
    
    Vaxneuvance
    Standard vaccination schedule
    Premature infants (< 37 weeks at birth): primary series of three doses followed by a booster dose. First dose at 6 weeks of age, with 4-8 weeks interval between primary doses. 4th dose (booster dose) at left age 11-16 months and at least 2 months after the 3rd dose.
    6 weeks to 2 years:
    4-dose schedule: primary series of three doses followed by a booster dose. First dose at 6 weeks of age, with 4-8 weeks interval between primary doses. 4th dose (booster dose) at 11-16 months of age and at least 2 months after the 3rd dose.
    3 dose schedule: primary series of 2 doses followed by a booster dose. First dose at 6 weeks of age and 2nd dose 8 weeks later. 3rd dose (booster dose) at 11-16 months of age.
    Schedule for previously unvaccinated children:
    7 months to 12 months: 2 doses at 4-week intervals. A third booster dose after 12 months of age and at least 2 months after the last dose
    12 months to 2 years: 2 doses at 2-month intervals
    2 to 18 years: (unvaccinated or incompletely vaccinated children) 1 dose (at least 2 months after a previous dose of pneumococcal conjugate vaccine
    
    Infants and children who have begun immunization with another pneumococcal conjugate vaccine may switch to Vaxneuvance at any time within the schedule
    
    Pneumovax 23: (at-risk groups)
    > 2 years: 1 dose.
    Revaccination should be considered if the last vaccination took place more than 5 years ago and in children aged < 10 years with nephrotic syndrome, asplenia or sickle cell anaemia who were vaccinated 3-5 years ago.

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Prevenar 13
≤ 5 years:
Very common (> 10%): decreased appetite, fever, irritability, drowsiness, poor sleep, injection site reactions (such as swelling, induration, erythema, pain, tenderness).

Common (1-10%): vomiting, diarrhea, rash, fever> 39 ° C, vaccination site movement restriction.

Uncommon (0.1-1%): (febrile) seizures, urticaria, (abnormal) crying,

Rare (0.01-0.1%): hypersensitivity reactions (such as facial edema, dyspnoea, bronchospasm), hypotonic-hyporesponsive episode.

Further reported: anaphylaxis, angioedema, lymphadenopathy, apnea in very preterm infants (≤28 weeks gestation), erythema multiforme, itching and injection site rash, flushing.

6–17 years:
Very common (> 10%): decreased appetite, irritability, injection site reactions (such as swelling, induration, erythema, pain, tenderness, limited movement), somnolence, poor sleep.

Common (1-10%): headache, vomiting, diarrhea, rash, urticaria, fever.

Children with sickle cell disease, HIV, or a haematopoietic stem cell transplant have similar side effects, except headache, vomiting, diarrhea, fever, fatigue, arthralgia and myalgia are very common.

Prevenar 20:
6 weeks to 5 years
Very common (> 10%): reactions at the injection site (redness, swelling, pain, tenderness). Reduced appetite. Irritability. Drowsiness/sleeping a lot, restlessness or sleeping little. Fever.

Common (1-10%): reactions at the injection site (pain or tenderness leading to limited movement of the limb). Fever >38.9 °C. Diarrhoea, vomiting. Skin rash

Uncommon (0.1-1%): crying. Seizure (including febrile convulsions). Urticaria.

Rare (0.01-0.1%): hypersensitivity reaction (such as facial oedema, dyspnoea, bronchospasm). Hypersensitivity at the vaccination site. Hypotonic-hyporesponsive episode.

The following have been reported: lymphadenopathy in the vaccination site region, anaphylactic reaction (including shock), angioedema, erythema multiforme, dermatitis, urticaria and itching at the vaccination site.

5–18 years
Very common (> 10%): reactions at the injection site (redness, swelling, induration, pain, tenderness). Decreased appetite. Irritability. Feeling drowsy/sleeping a lot, restless or sleeping little. Headache. Muscle pain. Fatigue. Erythema, induration or swelling at the vaccination site.

Common (1–10%): reactions at the injection site (pain or tenderness leading to limited movement of the limb). Diarrhoea, vomiting. Skin rash. Joint pain. Uncommon (0.1–1%): fever. Urticaria.

Vaxneuvance:
6 weeks - 2 years
Very common (> 10%): decreased appetite. Irritability. Drowsiness. Pyrexia (38°-39°C). Pain, swelling, induration and erythema at the injection site.

Common (1-10%): urticaria. Skin rash. Redness. Vomiting. Pyrexia (≥ 40°C). Haematoma at the injection site.

Uncommon (0.1-1%): urticaria at the injection site.

2-18 years
Very common (> 10%): pain, swelling and erythema at the injection site. Fatigue. Headache. Muscle pain.

Common (1-10%): decreased appetite. Irritability. Drowsiness. Urticaria. Nausea. Pyrexia (≥ 38°C). Induration, haematoma at the injection site.

Sometimes (0.1-1%): vomiting.

Reported: skin rash (2 cases in sickle cell disease and HIV population).

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications in children

acute serious illness with fever;
hypersensitivity to diphtheria toxoid.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Prevenar 13:
Protection against otitis media is substantially lower than against invasive diseases.

Safety and immunogenicity data are available for HIV infected infants (asymptomatic or with mild symptoms according to the WHO classification), HIV negative infants born to HIV positive mothers, children with sickle cell disease and children with spleen dysfunction. These are not available for other specific immunocompromised groups. Risks and benefits of vaccination should be assessed on a case-by-case basis for children of these groups. .

The vaccine does not replace the 23-valent pneumococcal polysaccharide vaccine in children over two years of age with conditions that are more prone to invasive diseases by Streptococcus pneumoniae such as sickle cell anemia, asplenia, HIV infection, chronic diseases, or other immune-compromising conditions; if applicable, maintain an interval of at least eight weeks between the administration of Synflorix (10-valent vaccine) and the 23-valent vaccine.

It is recommended that prophylactic antipyretic medications be administered when co-administered with whole pertussis cell vaccines and in a history of epileptic or febrile seizures; however, there is some evidence that prophylactic administration of paracetamol could reduce the immune response to Synflorix; the clinical relevance is unknown.

When administering the primary immunization series to very preterm infants (born ≤ 28 weeks of gestation), consider respiratory monitoring for 48–72 hours due to the potential risk of apnea, especially in children with a history of insufficient lung maturation; however, since the benefit of vaccination is great in this group of children, do not withhold or delay vaccination.

Prevenar 20:

Postpone vaccination in the event of acute serious illness accompanied by fever. Vaccination does not need to be postponed in the event of a mild infection.

Consider vaccination on an individual basis in immunocompromised individuals; no safety and immunogenicity data are available. In cases of reduced immune response, whether due to the use of immunosuppressants, a genetic abnormality, HIV infection or other causes, a reduced antibody response is possible. The clinical relevance of this is unknown.

Safety and immunogenicity data are available for a limited number of people with HIV infection, sickle cell disease (SCD) or haematopoietic stem cell transplantation (HSCT) with Prevenar 13 (a vaccine with 13 polysaccharide conjugates that are also included in the 20-valent vaccine). For the 20-valent vaccine, lower mean titres were observed for most serotypes than with the 13-valent vaccine. However, the clinical relevance for immunocompromised people is unknown.

Consider respiratory monitoring for 48–72 hours when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) due to the potential risk of apnoea, especially in infants with a history of lung immaturity; However, given the significant benefit of vaccination in this group of children, vaccination should not be withheld or delayed.
No data are available on sequential vaccination with other pneumococcal vaccines or a booster dose. If the use of a 23-valent pneumococcal polysaccharide vaccine (Pneumovax 23) is considered appropriate, the manufacturer recommends that the 20-valent vaccine be given first, based on clinical experience with the 13-valent vaccine.

Vaxneuvance
Postpone vaccination in case of acute high fever or acute infection; this is not necessary in case of a mild infection or slight fever.

A weakened immune system due to treatment with immunosuppressive drugs, a genetic abnormality, HIV infection, or other causes may result in a reduced antibody response.

Exercise caution when using anticoagulants, thrombocytopenia, or blood clotting disorders due to the risk of hematoma formation.

Consider respiratory monitoring for 48–72 hours when administering the primary immunization series to very premature infants (born ≤ 28 weeks of gestation) due to the potential risk of apnea, especially in infants with a history of lung immaturity; However, given the significant benefit of vaccination in this group of children, vaccination should not be withheld or delayed.

Data on safety and immunogenicity are available in people with HIV, people with sickle cell disease, or people who have received a hematopoietic stem cell transplant (HSCT). These are not available in people in other specific immunocompromised groups. Vaccination should then be assessed on a case-by-case basis.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

BACTERIAL VACCINES

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Cholera vaccines
	Cholera vaccin Related Medicines Menu">	J07AE01

Haemophilus influenzae B vaccines
	Haemophilus influenzae B vaccine (HiB) Related Medicines Menu">	J07AG01

Meningococcal vaccines
	Meningococcen B vaccin Related Medicines Menu">	J07AH09
	Meningococcen C vaccin Related Medicines Menu">	J07AH07
	Meningococcus A, C, W135, Y vaccin Related Medicines Menu">	J07AH08
	Meningokokken impf Related Medicines Menu">	J07AH

Pertussis vaccines
	Difterie-Tetanus-Kinkhoest (DTP) vaccin Related Medicines Menu">	J07AJ52

Tuberculosis vaccines
	BCG vaccine Related Medicines Menu">	J07AN01

Typhoid vaccines
	Typhoid vaccine Related Medicines Menu">	J07AP03
	Typhoid vaccine (oral) Related Medicines Menu">	J07AP01

References

Nederlands Vaccin Instituut, Vaccinatieschema (geraadpleegd 28 okt 2009)., www.nvi-vaccins.nl, http://www.nvi-vaccin.nl/?id=564
GlaxoSmithKline Biologicals S.A., SmPC Synflorix (EU/1/09/508//001-010)Rev 31, 30-11-2018, www.geneesmiddeleninformatiebank.nl
RIVM, Rijksvaccinatieprogramma 2011-Richtlijn 2011, www.rivm.nl
Pfizer Limited, SPC Prevenar 13 (EU/1/09/590/001-006) Rev 40, 08-01-2021, www.ema.europa.eu
Merck Sharp & Dohme B.V., SPC Pneumovax 23 (RVG 25853) 09-07-2019, www.geneesmiddeleninformatiebank.nl
RIVM, Rijksvaccinatieprogramma pneumokokken, www.rivm.nl, 27 november 2013, http://www.rivm.nl/Documenten_en_publicaties/Algemeen_Actueel/Nieuwsberichten/2013/Babys_krijgen_één_prik_minder_tegen_pneumokokken
RIVM, Richtlijn voor preventie van infecties bij mensen met (functionele) hypo-en asplenie., Feb 2012
Merck Sharp & Dohme B.V., SmPC Vaxneuvance (EU/1/21/1591) Rev 5, 22-09-2023, www.ema.europa.eu
Pfizer Europe MA EEIG, SmPC Prevenar 20 ( EU/1/21/1612) Rev. 11; 24-04-2025, www.ema.europa.eu

Pneumococcus vaccine

Pneumococcus vaccine

Pneumococcus vaccine

Pharmacokinetics in children

dose recommendation of formulary compared to licensed use (on-label versus off-label)

Available formulations

Dosages

Renal impaiment in children > 3 months

Side effects in children

Contra-indications in children

Warnings & precautions in children

Interactions

BACTERIAL VACCINES

References

Changes

Therapeutic Drug Monitoring

Overdose