Adult

PREVNAR 13 safety information

IMPORTANT SAFETY INFORMATION

  • Severe allergic reaction (eg, anaphylaxis) to any component of Prevnar 13® or any diphtheria toxoid–containing vaccine is a contraindication
  • Immunocompromised individuals or individuals with impaired immune responsiveness due to the use of immunosuppressive therapy may have reduced antibody response
  • In adults, antibody responses to Prevnar 13® were diminished when given with inactivated influenza vaccine, trivalent (IIV3)
  • In adults, the most commonly reported solicited adverse reactions were pain, redness, and swelling at the injection site, limitation of arm movement, fatigue, headache, muscle pain, joint pain, decreased appetite, vomiting, fever, chills, and rash

INDICATIONS

  • Prevnar 13® is a vaccine indicated for active immunization for the prevention of disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F
  • In adults 50 years and older for pneumococcal pneumonia and invasive disease. Indication is based on immune responses
  • In children 6 weeks through 17 years for invasive disease caused by the 13 serotypes, and for children 6 weeks through 5 years of age for otitis media caused by 7 of the 13 serotypes only (4, 6B, 9V, 14, 18C, 19F, and 23F)

Limitations of Use and Effectiveness

  • Prevnar 13® will only help protect against S pneumoniae serotypes in the vaccine
  • Effectiveness when administered <5 years after pneumococcal polysaccharide vaccine is not known

You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit www.vaers.hhs.gov or call 1-800-822-7967.

Please see full Prescribing Information for Prevnar 13®.

ACIP=Advisory Committee on Immunization Practices; CDC=Centers for Disease Control and Prevention.

References:

  • Centers for Disease Control and Prevention. Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine among adults aged ≥65 years: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2014;63(37):822-825.
  • Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) Prescribing Information, Wyeth Pharmaceuticals, Inc, 2015.