Prevenar 13 Warnings

Prevenar 13 must not be administered intravascularly.
As with all injectable vaccines, appropriate medical treatment and supervision must always be readily available in case of a rare anaphylactic event following the administration of the vaccine (see Adverse Reactions).
The administration of Prevenar 13 should be postponed in subjects suffering from acute severe febrile illness.
As with any intramuscular injection, Prevenar 13 should be given with caution to infants, children or adults with thrombocytopenia or any coagulation disorder, or to those receiving anticoagulant therapy, but may be given subcutaneously if the potential benefit clearly outweighs the risks (see Pharmacology: Pharmacodynamics under Actions).
Prevenar 13 will only protect against S. pneumoniae serotypes included in the vaccine, and will not protect against other microorganisms that cause invasive disease, pneumonia, or otitis media. As with any vaccine, Prevenar 13 may not protect all individuals receiving the vaccine from pneumococcal disease.
Individuals with impaired immune responsiveness, whether due to the use of immuno-suppressive therapy, a genetic defect, human immunodeficiency virus (HIV) infection, or other causes, may have reduced antibody response to active immunisation.
Safety and immunogenicity data on Prevenar 13 are not available for individuals in immunocompromised groups (e.g., individuals with malignancy or nephrotic syndrome) and vaccination should be considered on an individual basis.
Use in Children: Infants and children aged 6 weeks to 5 years: In clinical studies, Prevenar 13 elicited an immune response to all thirteen serotypes included in the vaccine. The immune response for serotype 3 following the booster dose was not increased above the levels seen after the infant vaccination series; the clinical relevance of this observation regarding the induction of serotype 3 immune memory is unknown (see Pharmacology: Pharmacodynamics under Actions).
The proportions of functional antibody responders (opsonophagocytic activity (OPA) titres ≥1:8) to serotypes 1, 3 and 5 were high. However, the OPA geometric mean titres were lower than those against each of the remaining additional vaccine serotypes; the clinical relevance of this observation for protective efficacy is unknown (see Pharmacology: Pharmacodynamics under Actions).
Limited data have demonstrated that pneumococcal 7-valent conjugate vaccine (3-dose primary series) induces an acceptable immune response in infants with sickle cell disease with a safety profile similar to that observed in non-high-risk groups (see Pharmacology: Pharmacodynamics under Actions).
Children younger than 2 years old should receive the appropriate-for-age Prevenar 13 vaccination series (see Dosage & Administration). The use of pneumococcal conjugate vaccine does not replace the use of PPSV23 in children ≥2 years of age with conditions (such as sickle cell disease, asplenia, HIV infection, chronic illness, or those who are immunocompromised) placing them at higher risk for invasive disease due to S. pneumoniae. Whenever recommended, children at risk who are ≥24 months of age and already primed with Prevenar 13 should receive PPSV23. The interval between the 13-valent pneumococcal conjugate vaccine (Prevenar 13) and the 23-valent pneumococcal polysaccharide vaccine should not be less than 8 weeks. There are no data available to indicate whether the administration of PPSV23 to unprimed children or to children primed with Prevenar 13 might result in hyporesponsiveness to further doses of Prevenar 13.
The potential risk of apnoea and the need for respiratory monitoring for 48-72 hours should be considered when administering the primary immunisation series to very premature infants (born ≤30 weeks of gestation), and particularly for those with a previous history of respiratory immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
For vaccine serotypes, protection against otitis media is expected to be 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 (see Pharmacology: Pharmacodynamics under Actions).
When Prevenar 13 is administered concomitantly with Infanrix hexa (DTPa-HBV-IPV/Hib), the rates of febrile reactions are similar to those seen with concomitant administration of pneumococcal 7-valent conjugate vaccine and Infanrix hexa (see Adverse Reactions).
Antipyretic treatment should be initiated according to local treatment guidelines for children with seizure disorders or with a prior history of febrile seizures and for all children receiving Prevenar 13 simultaneously with vaccines containing whole cell pertussis.