Pneumococcal polysaccharide conjugate vaccine (21-valent): clinical use

Prescribing considerations

• Confirm age, indication and completion of primary paediatric pneumococcal vaccination where relevant.
• Review previous pneumococcal vaccines and current official recommendations.
• Individualise use in immunocompromised patients because responses may be reduced and specific evidence is unavailable.
• Postpone during acute severe febrile illness or acute infection; minor infection or low-grade fever alone need not delay vaccination.
• Ensure anaphylaxis treatment and supervision are immediately available.

Contraindications and cautions

• Hypersensitivity to the active substances, including diphtheria toxoid, or any excipient.
• Use caution with thrombocytopenia, coagulation disorders or anticoagulant treatment because intramuscular injection can cause bleeding or bruising.

Monitoring

• Record the product name and batch number.
• Take precautions against injury from vasovagal syncope.
• Observe for immediate hypersensitivity and report suspected adverse reactions through the Yellow Card scheme.

Clinical pharmacology

Serotype-specific capsular polysaccharides individually conjugated to CRM197 induce T-cell-dependent B-cell maturation and functional opsonophagocytic antibodies. Pharmacokinetic assessment is not applicable to vaccines.

Formulation and product differences

• Colourless, clear to opalescent solution in a single-use pre-filled syringe.
• Contains polysorbate 20 and is essentially sodium-free.
• Must not be frozen or mixed with other medicinal products; packs may be supplied without needles or with separate needles.