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Children 6 Weeks Through 5 Years Of Age
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 Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
- active immunization for the prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. No otitis media efficacy data are available for serotypes 1, 3, 5, 6A, 7F, and 19A.
Children 6 Years Through 17 Years Of Age
In children 6 years through 17 years of age (prior to the 18th birthday), Prevnar 13 is indicated for:
- active immunization for the prevention of invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Adults 50 Years Of Age And Older
In adults 50 years of age and older, Prevnar 13 is indicated for:
- active immunization for the prevention of pneumonia and invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. This indication is based on immune responses elicited by Prevnar 13. There have been no controlled trials in adults demonstrating a decrease in invasive pneumococcal disease or pneumococcal pneumonia after vaccination with Prevnar 13.
Limitations Of Prevnar 13 Use And Effectiveness
- Prevnar 13 does not protect against disease caused by S. pneumoniae serotypes that are not in the vaccine.
- The effectiveness of Prevnar 13 administered less than 5 years after Pneumovax® 23 (23 valent pneumococcal vaccine polyvalent, PPSV23) is not known [see Clinical Studies].
DOSAGE AND ADMINISTRATION
Preparation For Administration
Since this product is a suspension containing an adjuvant, shake vigorously immediately prior to use to obtain a homogenous, white suspension in the vaccine container. Do not use the vaccine, if it cannot be resuspended. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration [see DESCRIPTION]. This product should not be used if particulate matter or discoloration is found.
Do not mix Prevnar 13 with other vaccines/products in the same syringe.
For intramuscular injection only.
Each 0.5 mL dose is to be injected intramuscularly using a sterile needle attached to the supplied prefilled syringe. The preferred sites for injection are the anterolateral aspect of the thigh in infants and the deltoid muscle of the upper arm in toddlers, children and adults. The vaccine should not be injected in the gluteal area or areas where there may be a major nerve trunk and/or blood vessel.
Vaccination Schedule For Infants And Toddlers
Prevnar 13 is to be administered as a four-dose series at 2, 4, 6, and 12-15 months of age.
Table 1: Vaccination Schedule for Infants and Toddlers
|Dose||Dose 1a,b||Dose 2b||Dose 3b||Dose 4c|
|Age at Dose||2 months||4 months||6 months||12-15 months|
|a Dose 1 may be given as early as 6 weeks of
b The recommended dosing interval is 4 to 8 weeks.
c The fourth dose should be administered at approximately 12-15 months of age, and at least 2 the third dose.
Vaccination Schedule For Unvaccinated Children 7 Months Through 5 Years Of Age
For children 7 months through 5 years of age who have not received Prevnar® or Prevnar 13, the catch-up schedule in Table 2 applies:
Table 2: Vaccination Schedule for Unvaccinated
Children 7 Months of Age Through 5 Years of Age
|Age at First Dose||Total Number of 0.5 mL Doses|
|7-11 months of age||3a|
|12-23 months of age||2b|
|24 months through 5 years of age (prior to the 6th birthday)||1|
|aThe first 2 doses at least 4 weeks apart;
third dose after the one-year birthday, separated from the second dose by at
least 2 months.
b Two doses at least 2 months apart
The immune responses induced by this catch-up schedule may result in lower antibody concentrations for some serotypes, compared to antibody concentrations following 4 doses of Prevnar 13 (given at 2, 4, 6, and 12-15 months). In children 24 months through 5 years of age, lower antibody concentrations were observed for some serotypes, compared to antibody concentrations following 3 doses of Prevnar 13 (given at 2, 4, and 6 months).
Vaccination Schedule For Children Previously Vaccinated With Prevnar Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
Children 15 months through 5 years of age who are considered completely immunized with Prevnar may receive one dose of Prevnar 13 to elicit immune responses to the six additional serotypes. This catch-up (supplemental) dose of Prevnar 13 should be administered with an interval of at least 8 weeks after the final dose of Prevnar. The immune responses induced by this Prevnar 13 schedule may result in lower antibody concentrations for the 6 additional serotypes (types 1, 3, 5, 6A, 7F, and 19A), compared to antibody concentrations following 4 doses of Prevnar 13 (given at 2, 4, 6, and 12-15 months).
Vaccination Schedule For Children 6 Years Through 17 Years Of Age
In children 6 years through 17 years of age, Prevnar 13 is administered as single dose. If Prevnar was previously administered, then at least 8 weeks should elapse before receiving Prevnar 13.
Vaccination Schedule For Adults 50 Years Of Age And Older
Prevnar 13 is administered as a single dose.
Dosage Forms And Strengths
Prevnar 13 is a suspension for intramuscular injection available in 0.5 mL single-dose prefilled syringes.
Storage And Handling
Prefilled Syringe, 1 Dose (10 per package) – NDC 0005-1971-02.
Prefilled Syringe, 1 Dose (1 per package) – NDC 0005-1971-04 (Pfizer Helpful Answers Program).
Prefilled Syringe, 1 Dose (1 per package) – NDC 0005-1971-05.
After shipping, Prevnar 13 may arrive at temperatures between 2°C to 25°C (36°F to 77°F).
Upon receipt, store refrigerated at 2°C to 8°C (36°F to 46°F).
Do not freeze. Discard if the vaccine has been frozen.
The tip cap and rubber plunger of the prefilled syringe are not made with natural rubber latex.
Manufactured by: Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA 19101. Revised: Jan 2014
Last reviewed on RxList: 9/19/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Prevnar 13 Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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