Pneumococcal 13-valent saccharide conjugated vaccine adsorbed
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Vaccine containing polysaccharide from 13 types of pneumococcus, conjugated to the CRM197 carrier protein and adsorbed on aluminium phosphate
Drugs List
Therapeutic Indications
Uses
Vaccination against pneumococcal diseases
Active immunisation against invasive disease (including bacteraemia, sepsis, meningitis, bacteraemic pneumonia and acute otitis media) caused by Streptococcus pneumoniae serotypes according to the brand product.
Vaccination should be based on official recommendations and the variability of serotype epidemiology in different geographical areas. The impact of invasive disease at different age groups should be considered.
Individuals at an increased risk from pneumococcal infection:
Patients aged 65 years and over
Asplenia or splenic dysfunction (including homozygous sickle cell disease and coeliac disease which could lead to splenic dysfunction)
Chronic respiratory disease (including chronic obstructive pulmonary disease, chronic bronchitis, emphysema, bronchiectasis, cystic fibrosis, interstitial lung fibrosis, pneumoconiosis and bronchopulmonary dysplasia, children with respiratory conditions caused by aspiration, or neurological disease (e.g. cerebral palsy) with risk of aspiration, asthma that requires the use of oral steroids at a dose sufficient to act as a significant immunosuppressant)
Chronic heart disease (including those requiring medication/follow up for ischaemic heart disease, congenital heart disease, hypertension with cardiac complications, and chronic heart failure)
Chronic renal disease (including nephrotic syndrome, chronic renal failure, and renal transplantation)
Chronic hepatic disease (including cirrhosis, biliary atresia, and chronic hepatitis)
Diabetes (requiring insulin or oral hypoglycaemic drugs)
Immunosuppression (due to disease or treatment. Including asplenia or splenic dysfunction, HIV infection at all stages, patients undergoing immunosuppressive chemotherapy. Individuals on or likely to be on systemic steroids for more than one month at a dose equivalent to prednisolone at 20mg or more per day (any age), or for children under 20kg, a dose of 1mg or more per kg per day)
Individuals with cochlear implants (immunisation should not delay cochlear implantation)
Individuals with cerebrospinal fluid leaks (includes leakage following trauma or major skull surgery)
Children under 5 years with a history of invasive pneumococcal disease
Individuals at occupational risk (e.g. welding)
For comprehensive information or advice on this product or the immunisation programme in the UK, the following website should be accessed.
https://www.gov.uk/government/organisations/public-health-england/series/immunisation-against-infectious-disease-the-green-book
Dosage
Adults
One single dose of 0.5ml.
The need for revaccination with a subsequent dose has not been established.
Children
Primary immunisation series
Infants aged 6 weeks to 6 months
Three doses, each of 0.5ml, the first dose usually given at 2 months of age with an interval of at least one month between doses. The first dose may be given as early as 6 weeks of age. A fourth (booster) dose is recommended between 11 and 15 months of age.
Alternatively, when pneumococcal vaccine is given as part of a routine infant immunisation programme, a two-dose schedule may be considered. The first dose may be given from the age of 2 months with a second dose at least 2 months later and a third (booster) dose at 11 to 15 months of age.
Infants born less than 37 weeks gestation
Three doses, each of 0.5ml, the first dose usually given at 2 months of age with an interval of at least one month between doses. The first dose may be given as early as 6 weeks of age. A fourth (booster) dose is recommended between 11 and 15 months of age.
Previously unvaccinated older infants and children
Children aged 2 years to 17 years
One single dose of 0.5ml.
Children aged 12 months to 23 months
Two doses, each of 0.5ml, with an interval of at least 2 months between doses.
Children aged 7 months to 12 months
Two doses, each of 0.5ml, with an interval of at least one month between doses. A third dose is recommended in the second year of life.
Patients who are immunocompromised or have asplenia/splenic dysfunction
Children aged 1 to 4 years
Two doses, each of 0.5ml, with an interval of at least 2 months between doses.
Pneumococcal 13-valent vaccination schedule for infants and children previously immunised with pneumococcal 7-valent vaccine
Infants and children who have begun immunisation with pneumococcal 7-valent vaccine may switch to pneumococcal 13-valent vaccine at any point in the schedule.
Children aged 12 to 59 months who are considered completely immunised with pneumococcal 7-valent vaccine should receive one dose of 0.5ml of pneumococcal 13-valent vaccine to elicit immune responses to the 6 additional serotypes. This dose of pneumococcal 13-valent vaccine should be administered at least 8 weeks after the final dose of pneumococcal 7-valent vaccine.
Children aged 5 to 17 years of age may receive a single dose of the pneumococcal 13-valent vaccine if they have been previously vaccinated with one or more doses of the pneumococcal 7-valent vaccine. This dose of pneumococcal 13-valent vaccine should be administered at least 8 weeks after the final dose of pneumococcal 7-valent vaccine.
Additional Dosage Information
It is recommended that subjects who receive a first dose of the 13-valent vaccine complete the full vaccination course with the same valent vaccine.
Pneumococcal vaccine should be administered preferably four to six weeks before an elective splenectomy, cochlear implant surgery or the initiation of chemotherapy or other immunosuppressive treatment. Where it is not possible, it can be administered up to two weeks before treatment. If it is not possible to vaccinate beforehand, splenectomy, cochlear implant surgery or the initiation of chemotherapy or other immunosuppressive treatment should not be delayed.
If it is not practical to vaccinate at least 2 weeks before splenectomy or chemotherapy, the vaccine should be given at least 2 weeks after the splenectomy. There may be a reduced immune response in patients after they have completed chemotherapy/radiotherapy. The vaccine should not be administered for at least 3 months following completion of such therapy. Immunisation of these patients should not be delayed if this is likely to result in a failure to vaccinate.
Individuals who have underlying conditions predisposing them to invasive pneumococcal disease (such as sickle cell disease or HIV infection) including those previously vaccinated with one or more doses of 23-valent pneumococcal polysaccharide vaccine may receive at least one dose of the 13-valent pneumococcal polysaccharide vaccine.
In individuals with an haematopoietic stem cell transplant (HSCT), the recommended immunisation series consists of four doses of the 13-valent pneumococcal polysaccharide vaccine, each of 0.5ml. The primary series consists of three doses, with the first dose given at 3 to 6 months after HSCT and with an interval of at least 1 month between doses. A fourth (booster) dose is recommended 6 months after the third dose.
Severely immunocompromised children diagnosed from 5 years onwards and adults should be given one single dose of the pneumococcal 13-valent vaccine, followed by one single dose of the pneumococcal 23-valent vaccine at least 2 months later (irrespective of their routine childhood vaccinations). Immunocompromised patients who have already received pneumococcal 23-valent vaccine should be offered pneumococcal 13-valent vaccine with an interval of at least 6 months following the dose of the pneumococcal 23-valent vaccine to reduce the risk of pneumococcal serotype-specific hypo-responsiveness.
For leukaemia patients, pneumococcal 13-valent vaccine should be given from 6 months after completion of chemotherapy. For bone marrow transplant patients, pneumococcal 13-valent vaccine should be offered 9 to 12 months following transplantation.
Administration
The vaccine should be given by intramuscular injection preferably in the anterolateral aspect of the thigh in infants or the deltoid muscle in children and adults.
The vaccine may be given subcutaneously to patients with thrombocytopenia or coagulation disorder if the potential benefit outweighs the risks.
Contraindications
Children under 6 weeks
Severe febrile conditions
Precautions and Warnings
Immunosuppression
Breastfeeding
Coagulopathy
History of seizures
Immunodeficiency syndromes
Pregnancy
Thrombocytopenia
Postpone immunisation if there is active or suspected infection
Prophylactic antipyretic recommended if history of seizure
Advise ability to drive/operate machinery may be affected by side effects
Impaired response possible in immunocompromised patients
Not a substitute for use of pneumococcal 23-valent polysaccharide vaccine
Prophylactic antipyretic recommended if history of febrile reactions
Prophylactic antipyretic recommended with simultaneous whole cell pertussis
Vaccine may not be effective in 100% of patients
Do not mix with other vaccines in the same syringe
Inject other vaccines at different sites
Leave 8 weeks before immunisation with the 23-valent polysaccharide vaccine
Resuscitation facilities must be immediately available
Risk of apnoea in premature infants - monitor respiration for 72 hours
Increased rate of local reactions when over 1 year of age
Follow national immunisation guidelines
Limited data have demonstrated that pneumococcal conjugate vaccine induces an acceptable immune response in infants with sickle cell disease, HIV infection, or with an haematopoietic stem cell transplant. Safety and immunogenicity data are not yet available for patients in other specific immunocompromised groups (e.g. malignancy or nephrotic syndrome) and so vaccination should be determined on an individual basis.
The vaccine may not protect all individuals from pneumococcal disease. For vaccine serotypes, protection against otitis media is expected to be substantially lower than protection against invasive disease. As otitis media is caused by many organisms other than pneumococcal serotypes represented in the vaccine, protection against all otitis media is expected to be low.
The use of prophylactic antipyretic medicinal products is recommended for children with seizure disorders or with a prior history of febrile seizures.
Pregnancy and Lactation
Pregnancy
Use pneumococcal vaccine with caution in pregnancy.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Lactation
Use pneumococcal vaccine with caution in breastfeeding.
It is not known whether pneumococcal vaccine is excreted in human milk.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Side Effects
Anaphylactic reaction
Anaphylactoid reaction
Angioedema
Apnoea
Arthralgia
Bronchospasm
Chills
Convulsions
Decreased appetite
Dermatitis
Diarrhoea
Dyspnoea
Erythema at injection site
Erythema multiforme
Facial oedema
Fatigue
Fever
Flushing
Headache
Hypersensitivity reactions
Hypotonic hyporesponsive episode
Induration (injection site)
Injection site reactions
Irritability
Local pain (injection site)
Lymphadenopathy
Myalgia
Nausea
Pruritus
Rash
Shock
Sleep disturbances
Somnolence
Swelling (injection site)
Tenderness (injection site)
Urticaria
Vomiting
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org )
Further Information
Last Full Review Date: January 2015
Reference Sources
Immunisation Against Infectious Disease. The Green Book.
Available at: https://www.gov.uk/government/organisations/public-health-england/series/immunisation-against-infectious-disease-the-green-book
Last accessed: 09 January 2015.
Summary of Product Characteristics: Prevenar 13 suspension for injection. Pfizer Limited. Revised October 2015.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 25 August 2017
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