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Risk and reporting for Prevenar 13

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.

Administration of Prevenar 13® (Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)) should be postponed in subjects suffering from acute, severe febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination.

Prevenar 13 is contraindicated in patients with hypersensitivity to the active substances, to any of the excipients or to diphtheria toxoid.

Additional prescribing considerations:

  • Prevenar 13 will not protect against Streptococcus pneumoniae serotypes not included in the vaccine or other micro-organisms
  • Prevenar 13 may not protect all individuals receiving the vaccine from pneumococcal disease
  • Prevenar 13 should be administered intra-muscularly
  • Different injectable vaccines should always be given at different injection sites.

Other Risks

This vaccine should not be given to infants or children with thrombocytopaenia or any coagulation disorder that would contraindicate intramuscular injection, unless the potential benefit clearly outweighs the risk of administration.

The potential risk of apnoea and the need for respiratory monitoring (48-72 hours) should be considered when administering the primary immunisation series to very premature infants (born =28 weeks gestation) and particularly for those with a previous history of respiratory immaturity.

Adverse Events

The most commonly reported adverse events reported in Prevenar 13 clinical studies were injection site reactions, fever, irritability, decreased appetite, and increased and/or decreased sleep.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Pfizer Medical Information on 01304 616161 or emailed to [email protected]

Further information on adverse event reporting can be found by clicking here. Summary of Product Characteristics can be found on electronic Medicines Compendium (eMC).