Safety profile

Prevnar 13® showed a comparable adverse event profile to Prevnar® (PCV7)1*
  • A total of 4729 infants and toddlers received at least 1 dose of Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) in 13 clinical trials1
  • A total of 1907 subjects received at least 1 dose of Prevnar 13® and 701 subjects received 1 dose of PCV7 in the 3 US studies1
    • A similar proportion of Prevnar 13® and PCV7 recipients reported solicited local and systemic adverse reactions as well as unsolicited adverse events, among US study subjects
    • The most commonly reported adverse reactions (20%) in US clinical trials were redness, swelling, and tenderness at the injection site; fever; decreased appetite; irritability; increased sleep; and decreased sleep
  • As shown in clinical trials, Prevnar 13® can be administered concomitantly with routine pediatric vaccines1
    • Responses to diphtheria toxoid; tetanus toxoid; pertussis; polio types 1, 2, and 3; hepatitis B; PRP-T; PRP-OMP; measles; and varicella antigens in Prevnar 13® recipients were similar to those in PCV7 recipients. Based on limited data, responses to mumps and rubella antigens in Prevnar 13® recipients were similar to those in PCV7 recipients
    • In children and adolescents, data are insufficient to assess the concomitant administration of Prevnar 13® with human papillomavirus (HPV) vaccine; meningococcal conjugate vaccine (MCV4); and tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine, adsorbed (Tdap)
    • When Prevnar 13® is administered at the same time as another injectable vaccine(s), the vaccines should always be administered with different syringes and given at different injection sites

*Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein).

CDC=Centers for Disease Control and Prevention.

Reference:

  1. Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) Prescribing Information, Wyeth Pharmaceuticals LLC, 2019.

Reference:

  1. Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) Prescribing Information, Wyeth Pharmaceuticals LLC, 2019.