Prevenar 13 Special Precautions

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.
This vaccine should not be given to individuals with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection or to those receiving anticoagulant therapy, unless the potential benefit clearly outweighs the risk of administration.
Prevenar 13 will only protect against Streptococcus 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.
In clinical studies, Prevenar 13 elicited an immune response to all 13 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).
Individuals with impaired immune responsiveness, whether due to the use of immunosuppressive therapy, a genetic defect, HIV infection, or other causes, may have reduced antibody response to active immunization.
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). Safety and immunogenicity data are not yet available for individuals in other specific high-risk groups for invasive pneumococcal disease (e.g., individuals with malignancy, hematopoietic stem, nephrotic syndrome). Vaccination in high-risk groups should be considered on an individual basis. Specific data are not yet available for Prevenar 13.
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 23-valent pneumococcal polysaccharide vaccines (PPSV23) in children ≥24 months of age with conditions (such as asthma, diabetes mellitus, sickle cell disease, asplenia, HIV infection, chronic illness, or those who are immunocompromised) placing them at higher risk for invasive disease due to Streptococcus pneumoniae. Whenever recommended, children at risk who are ≥24 months of age and already primed with Prevenar 13 should receive 23-valent pneumococcal polysaccharide vaccine. 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 23-valent pneumococcal polysaccharide vaccine 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 h - 72 h should be considered when administering the primary immunization series to very premature infants (born ≤28 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).
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.
When Prevenar 13 is administered concomitantly with Infanrix hexa (DTaP 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).
Additional Information in Special Populations: Individuals who may be at higher risk of pneumococcal infection (i.e., individuals with HIV infection) who are previously vaccinated with 23-valent pneumococcal polysaccharide vaccine (PPSV23) may receive 2 doses of Prevenar 13 with interval of 6 months between doses. Individuals who are naïve may receive 2 doses of Prevenar 13 with interval of 1 month between doses.
Adults with HIV infection had similar frequencies of adverse reactions as adults 50 years of age and older, except that fever and vomiting were very common and nausea was common.
Effects on Ability to Drive and Use Machines: Prevenar 13 has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under Adverse Reactions may temporarily affect the ability to drive or use machines.
Use in Children: Safety and effectiveness of Prevenar 13 in children below the age of 6 weeks have not been established. Prevenar 13 is not approved for use in children in these age groups.
Use in Elderly: Prevenar 13 has been shown to be safe and immunogenic in the geriatric population.
Of the 48,806 adults enrolled in the 7 studies (6115A1-004, 6115A1-3005, 6115A1-3010, 6115A1-3000, 6115A1-3001, 6115A1-3008, 6115A1-3006) of the clinical development program who received Prevenar 13 alone, 63.1% were 65 to 74 years of age, while 29.7% were 75 years of age and over. No clinically significant differences in safety or immunogenicity were observed between 65 to 74 year old individuals and greater than 75 year old individuals.