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 Streptococcus 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.
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 Streptococcus 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 will not protect against disease caused by Streptococcus 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. Do not inject intravenously, intradermally, or subcutaneously.
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, young 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 1†||Dose 2†||Dose 3†||Dose 4‡|
|Age at Dose||2 months||4 months||6 months||12-15 months|
|* Dose 1 may be given as early as 6 weeks of age.
† The recommended dosing interval is 4 to 8 weeks.
‡ The fourth dose should be administered at approximately 12-15 months of age, and at least 2 months after the third dose.
Vaccination Schedule for Unvaccinated Children ≥ 7 Months of Age
For children who are beyond the age of the routine infant schedule and have not received Prevnar® or Prevnar 13, the following catch-up schedule applies:
Table 2: Vaccination Schedule for Unvaccinated
Children ≥ 7 Months of Age
|Age at First Dose||Total Number of 0.5 mL Doses|
|7-11 months of age||3*|
|12-23 months of age||2†|
|24 months through 5 years of age (prior to the 6th birthday)||1|
|* The first 2 doses at least 4 weeks apart; third dose
after the one-year birthday, separated from the second dose by at least 2
† 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 to 15 months). In children 24 months through 5 years of age, the catch-up schedule may result in lower antibody concentrations 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 who have received one or more doses of Prevnar may complete the immunization series with Prevnar 13. 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 to 15 months).
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.
Store refrigerated at +2°C to +8°C (36°F to 46°F).
The tip cap and rubber plunger of the prefilled syringe do not contain latex.
Do not freeze. Discard if the vaccine has been frozen.
Manufactured by: Wyeth Pharmaceuticals Inc, A subsidiary of Pfizer Inc, Philadelphia, PA 19101. Revised: 08/2012
Last reviewed on RxList: 1/14/2013
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
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