Prevnar 13: Pneumococcal 13-valent Conjugate Vaccine
   

*Compared to Prevnar®
About the Importance of an Additional Dose of Prevnar 13®
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What Can Happen If My Child Is Not Vaccinated?

Infection with pneumococcal bacteria can cause serious illness and death.
Prior to the introduction of Prevnar® (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), invasive pneumococcal disease (IPD) caused about 200 deaths each year among children under 5 years old. It's also the leading cause of bacterial meningitis in the United States. Bacterial meningitis can cause serious problems in children such as deafness and brain damage.

REMEMBER: even children who have been fully vaccinated with 4 doses of Prevnar® may not be covered against the most common strains seen today.

One way to help prevent IPD is vaccination. Prevnar® was the first conjugate vaccine developed for infants and young children to help protect against 7 of the most common strains of pneumococcal bacteria prior to the introduction of the vaccine.

Since its introduction in 2000, Prevnar® has routinely been given to infants and young children and the number of cases of IPD has decreased significantly.

However, additional strains of pneumococcal bacteria not covered by Prevnar® continue to cause invasive disease in young children. That's why Prevnar 13® is important.

What can you do?
Pfizer has developed the vaccine Prevnar 13®, which helps provide protection against the 7 strains in Prevnar® plus 6 additional strains. Thanks to Prevnar 13®, you and your doctor can now provide your child with broader
coverage* against IPD.

The immune response from this schedule might be lower for the 6 additional strains (types 1, 3, 5, 6A, 7F, and 19A) than if your child had received the full 4 doses of Prevnar 13®. It's not known how medically important this difference is.

Learn more: Broader Coverage* for Children Already Vaccinated With
4 Doses of Prevnar®

INDICATION FOR PREVNAR 13®

  • Prevnar 13® is a vaccine approved for use in children 6 weeks through 5 years of age (prior to the 6th birthday).
  • Prevnar 13® is indicated for active immunization for the prevention of invasive disease caused by 13 strains of Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F).
  • Prevnar 13® is also indicated for the prevention of otitis media (ear infection) caused by 7 strains of Streptococcus pneumoniae (4, 6B, 9V, 14, 18C, 19F, and 23F). No efficacy data for ear infections are available for strains 1, 3, 5, 6A, 7F, and 19A.

IMPORTANT SAFETY INFORMATION FOR PREVNAR 13®

  • Prevnar 13® should not be given to anyone with a severe allergic reaction to any component of Prevnar 13®, Prevnar® or any diphtheria toxoid–containing vaccine.
  • Prevnar 13® may not protect all individuals receiving the vaccine.
  • Protection against ear infections is expected to be less than that for invasive disease.
  • Children with weakened immune systems may have a reduced immune response to Prevnar 13®.
  • A temporary pause of breathing following vaccination has been observed in some infants born prematurely.
  • The most commonly reported serious adverse events include bronchiolitis (an infection of the lungs) (0.9%, 1.1%), gastroenteritis (inflammation of the stomach and small intestine) (0.9%, 0.9%), and pneumonia (0.9%, 0.5%) for Prevnar 13® and Prevnar®, respectively.
  • The most common side effects are redness, swelling and tenderness at the injection site, fever, decreased appetite, irritability, increased sleep, and decreased sleep. Any side effects associated with the vaccination should be reported to your child's health care provider.
  • Ask your child's health care provider about the risks, benefits and if Prevnar 13® is right for your child.

Please see Prescribing Information for Prevnar 13® Adobe Reader

*Compared to Prevnar®

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The above Prescribing Information is available in PDF (portable document format).
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PREVNAR® and Prevnar 13® are registered trademarks of Wyeth LLC.
Wyeth Manufactured by Wyeth Pharmaceuticals Inc.   Marketed by Pfizer Inc.
262249-01   © 2010 Pfizer Inc.   All rights reserved.   August 2010
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