Prevenar 13 Special Precautions

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.
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: Infants and children aged 6 weeks to 5 years: 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.
The use of pneumococcal conjugate vaccine does not replace the use of PPSV23 in children ≥24 months of age with sickle cell disease, asplenia, HIV infection, chronic illness, or who are otherwise immunocompromised. Data on sequential vaccination with Prevenar 13 followed by PPSV23 vaccine are not available; data on sequential vaccination with pneumococcal 7-valent conjugate vaccine followed by PPSV23 are limited.
As with all injectable pediatric vaccines, the potential risk of apnea should be considered when administering the primary immunisation series to premature infants. The need for monitoring for at least 48 hours after vaccination should be considered for very premature infants (born ≤30 weeks of gestation) who remain hospitalized at the time of the recommended administration.
As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
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).
Use in Elderly: Prevenar 13 has been shown to be safe and immunogenic in the geriatric population (see Pharmacology: Pharmacodynamics under Actions).
Of the 48,806 adults 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, 30,793 (63.1%) were 65-74 years of age, and 14,498 (29.7%) were 75 years of age and over. No clinically significant differences in safety or immunogenicity were observed between 65-74-year-old individuals and greater than 75-year-old individuals.