Key safety and tolerability data for VAXNEUVANCE
Most commonly reported adverse reactions
Most commonly reported solicited adverse reactions in children vaccinated with a 4-dose series at 2, 4, 6, and 12 through 15 months of age, provided as a range across the series
| Adverse reactions | Range across series |
|---|---|
| Irritability | 57.3% – 63.4% |
| Somnolence | 24.2% – 47.5% |
| Injection-site pain | 25.9% – 40.3% |
| Fever ≥38.0°C | 13.3% – 20.4% |
| Decreased appetite | 14.1% – 19.0% |
| Injection-site induration | 13.2% – 15.4% |
| Injection-site erythema | 13.7% – 21.4% |
| Injection-site swelling | 11.3% – 13.4% |
Most commonly reported solicited adverse reactions in children and adolescents 2 through 17 years of age vaccinated with a single dose
| Adverse reactions | Single dose |
|---|---|
| Injection-site pain | 54.8% |
| Myalgia | 23.7% |
| Injection-site swelling | 20.9% |
| Injection-site erythema | 19.2% |
| Fatigue | 15.8% |
| Headache | 11.9% |
| Injection-site induration | 6.8% |
Comparable safety profile to PCV13
The safety profile of VAXNEUVANCE was comparable to that of PCV13 in clinical trials of both healthy children and those at increased risk for IPD.a
The safety profile of a series initiated with PCV13 and completed with VAXNEUVANCE was similar to the safety profile following a complete 4-dose regimen of either vaccine.
aPediatric populations with risk conditions were preterm infants, children living with HIV or SCD (immunocompromising diseases), or children who had received an allo-HSCT (an immunocompromising condition): preterm infants, <37 weeks gestation at birth; children living with HIV, 6–17 years of age; children living with SCD, 5–17 years of age; and recipients of allo-HSCT, 3–17 years of age.1
Allo-HSCT, allogeneic hematopoietic stem cell transplant; HIV, human immunodeficiency virus; IPD, invasive pneumococcal disease; PCV13, 13-valent pneumococcal conjugate vaccine; SCD, sickle cell disease.
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Reference
- Gierke R, Wodi P, Kobayashi M. Epidemiology and Prevention of Vaccine-Preventable Diseases (Pink Book). 14th edition. Chapter 17: Pneumococcal disease. Centers for Disease Control and Prevention. Last reviewed May 1, 2024. Accessed August 1, 2024. https://www.cdc.gov/pinkbook/hcp/table-of-contents/chapter-17-pneumococcal-disease.html?CDC_AAref_Val=https://www.cdc.gov/vaccines/pubs/pinkbook/pneumo.html