Safety and Side Effects of PREVENAR 13 (Pneumococcal Conjugate) Vaccine
PREVENAR 13 (PCV13) is generally safe with a well-established safety profile similar to its predecessor PCV7, with most adverse events being mild to moderate and transient.
Common Side Effects
PCV13 has been extensively studied in clinical trials involving thousands of children. The most commonly reported side effects include:
- Injection-site reactions (48.8% of recipients): pain/tenderness, erythema (redness), and induration/swelling 1
- Systemic reactions:
Less common but still reported side effects (occurring in >1% of recipients) include:
Severe Side Effects
Severe adverse events are rare with PCV13. Post-marketing surveillance has identified certain rare adverse events, although a causal relationship to vaccination has not been established:
- Hypotonic-hyporesponsive episode 1
- Apnea 1
- Anaphylactic/anaphylactoid reactions including shock 1
- Angioneurotic edema 1
- Erythema multiforme 1
- Injection-site dermatitis, pruritus, and urticaria 1
- Lymphadenopathy localized to the injection site 1
Safety in Special Populations
A comprehensive post-licensure surveillance study conducted through the Vaccine Safety Datalink Project evaluated 599,229 doses of PCV13 and found:
- No increased risk for febrile seizures, urticaria, angioneurotic edema, asthma, thrombocytopenia, or anaphylaxis compared to PCV7 2
- A possible signal for Kawasaki disease (relative risk 1.94,95% CI: 0.79-4.86) was noted but not statistically significant 2
Contraindications and Precautions
PCV13 is contraindicated in:
- Persons with known severe allergic reaction (e.g., anaphylaxis) to any component of PCV13 or PCV7 1
- Persons with severe allergic reaction to any diphtheria toxoid-containing vaccine 1
Administration Considerations
- PCV13 is administered intramuscularly as a 0.5-mL dose 1
- Available in latex-free, single-dose, prefilled syringes 1
- Can be administered concurrently with other routine childhood vaccines if given in separate syringes at separate injection sites 1
- Concurrent administration with PPSV23 is not recommended as safety and efficacy have not been studied 1
Long-term Safety Data
Long-term safety data from multiple studies and post-marketing surveillance confirm that PCV13 has a safety profile comparable to that of PCV7, which has been in use since 2000 3, 4. The vaccine has been demonstrated to be safe and well-tolerated across multiple settings in both industrialized and developing countries 1.
Clinical Implications
Healthcare providers should:
- Inform patients/parents about potential side effects, emphasizing that most are mild and transient
- Monitor for 15-30 minutes after vaccination for any immediate reactions
- Report any serious adverse events to appropriate vaccine safety monitoring systems
- Consider the overall benefit of protection against invasive pneumococcal disease, which significantly outweighs the risks of vaccination 1