Prevnar 13: Pneumococcal 13-valent Conjugate Vaccine
   
About the Importance of an Additional Dose of Prevnar 13
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Vaccination Schedule for Prevnar 13

Getting Started

Children 2 months old may be ready to get started on Prevnar 13. In fact, the schedule for unvaccinated infants can begin as early as 6 weeks.

Following through

Doctors at the Centers for Disease Control recommend that children receive 4 doses of Prevnar 13 by the time they are 15 months old. See the complete schedule for infants and toddlers below.

Vaccination Schedule for Infants and Toddlers

Vaccine Schedule for Unvaccinated Children ≥7 Months of Age

The immune responses provided by this catch-up schedule might not increase the number of antibodies ("infection-fighting cells") for some strains, as much as if your child had received the full 4 doses of
Prevnar 13 (given at 2, 4, 6, and 12 to 15 months). In children 24 months through 5 years of age, the catch-up schedule might not increase the number of antibodies for some strains, as much as if your child had received 3 doses of Prevnar 13 (given at 2, 4, and 6 months). It's not known how medically important these differences are.

Making the transition

Children who have received one or more doses of Prevnar® (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) may complete the 4-dose immunization series with Prevnar 13.

PREVNAR 13 may e introduced at any point during the recommended pneumococcal vaccination schedule

The immune responses provided by this Prevnar 13 schedule might not increase the number of antibodies ("infection-fighting cells") for the 6 additional strains (types 1, 3, 5, 6A, 7F, and 19A), as much as if your child had received the full 4 doses of Prevnar 13 (routinely given at 2, 4, 6, and 12 to 15 months). It's not known how medically important this difference is.

Following up

Children 15 months to 5 years of age who have already received 4 doses of Prevnar® may receive protection against the 6 additional strains covered by Prevnar 13 with one additional dose.

The immune responses provided by this dose of Prevnar 13 might not increase the number of antibodies ("infection-fighting cells") for the 6 additional strains (types 1, 3, 5, 6A, 7F, and 19A), as much as if your child had received the full 4 doses of Prevnar 13 (routinely given at 2, 4, 6, and 12 to 15 months). It's not known how medically important this difference is.

Talk to your child's doctor about the risks, benefits and if Prevnar 13 is right for your child.

Learn more: What can happen if my child is not vaccinated?



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

INDICATION FOR PREVNAR®

Prevnar® is indicated for active immunization of infants and toddlers against serious invasive disease caused by Streptococcus pneumoniae, including bacteremia (bloodstream infection) and meningitis (infection of the membranes surrounding the brain and spinal cord) caused by the seven serotypes in the vaccine. The seven serotypes (strains) of S. pneumoniae included in the vaccine (4, 6B, 9V, 14, 18C, 19F, and 23F) were the strains that most commonly caused these serious diseases in children prior to the introduction of the vaccine. The routine schedule is 2, 4, 6, and 12 to 15 months of age.

Prevnar® is also indicated for immunization of infants and toddlers against otitis media (ear infections) caused by the seven serotypes in the vaccine. Protection against ear infections is expected to be less than that for invasive disease.

As with any vaccine, Prevnar® may not protect all individuals receiving the vaccine from serious invasive disease caused by S. pneumoniae. This vaccine should not be used for treatment of active infection.

IMPORTANT SAFETY INFORMATION FOR PREVNAR®

In clinical studies, the most frequently reported adverse events included injection site reactions, fever (≥38°C/100.4°F), irritability, drowsiness, restless sleep, decreased appetite, vomiting, diarrhea, and rash.

Risks are associated with all vaccines, including Prevnar®. Hypersensitivity to any vaccine component, including diphtheria toxoid, is a contraindication to its use. Prevnar® does not protect 100% of children vaccinated. Immunization with Prevnar® does not substitute for routine diphtheria immunization.

Please see Prescribing Information for PREVNAR® Adobe Reader

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The above Prescribing Information is available in PDF (portable document format).
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The Importance of an Additional Dose  |  Important Safety Information  |  Prescribing Information  |  For US Healthcare Professionals

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