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About Prevnar 13About Prevnar 13Mechanism of ActionSerotype coverageIncidence of IPD and Colonization dataExperienceImmunogenicityDosingDosingDosingEfficacy and Safety ProfileEfficacy and Safety ProfileEfficacy profileSafety profileGuidelinesGuidelinesGuidelinesResourcesResourcesMaterialsVideos
Product MonographImportant Safety Information 
Safety ProfileDemonstrated safety profile

The safety of Prevnar 13 was assessed across 13 controlled clinical trials in 4,729 healthy infants up to 16 months who received at least 1 dose.1

Adverse reactions

The most common adverse reactions (≥10%) include decreased appetite, irritability, drowsiness/increased sleep; restless sleep/decreased sleep, fever, vaccination-site erythema, induration/swelling, vaccination-site pain/tenderness.1 

Serious Adverse Events (SAEs)

In 13 controlled clinical trials for Prevnar and Prevnar 13:1 

  • 11 of 7,489 subjects (0.1%) were reported for SAEs
  • 3 cases of febrile convulsions and 4 cases of fever
  • 1 case each of crying, bronchitis, infantile spasms, nephroblastoma
TitlePrevnar 13 can be given at the same time as the following other childhood vaccines at different vaccination sites: Diphtheria, Tetanus, Acellular pertussis, Haemophilus influenza type b, Inactivated poliomyelitis, Hepatitis B, Meningococcal serogroup C, Measles, Mumps, Rubella
and Varicella.

Potential for higher incidence of fever (≥38.0°C to ≤39.0°C), convulsions (with or without fever), and hypotonic-hyporesponsive episode (HHE) with concomitant Infanrix hexa® use in infants. Reference:Prevnar® 13 Product Monograph. Pfizer Canada ULC. 2022. Efficacy and safety profile
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