For intramuscular use only.
The dose is 0.5 mL given intramuscularly, with care to avoid injection into or near nerves and blood vessels. The preferred sites are the anterolateral aspect of the thigh in infants or the deltoid muscle of the upper arm in older children and adults. The vaccine should not be injected in the gluteal area. Do not administer Prevnar 13 intravascularly.
The vaccine should not be injected intradermally, subcutaneously or intravenously, since the safety and immunogenicity of these routes have not been evaluated.
Parenteral products should be inspected visually for particulate matter or discoloration prior to use.
The vaccine is not to be mixed with other vaccines/products in the same syringe.
Data on the interchangeability of Prevnar 13 with other pneumococcal conjugate vaccines containing a protein carrier different from CRM197 are not available.
1. Infants and Children Aged 6 Weeks to 5 Years (Prior to the 6th Birthday)
It is recommended that infants who receive a first dose of Prevnar 13 complete the vaccination course with Prevnar 13.
For infants, the recommended immunization series of Prevnar 13 consists of 3 doses of 0.5 mL each, at approximately 2-month intervals, followed by a fourth dose (booster) of 0.5 mL at 12-15 months of age (3+1 schedule). The customary age for the first dose is 2 months of age, but it can be given as young as 6 weeks of age. The recommended dosing interval is 4-8 weeks. The fourth dose should be administered at approximately 12-15 months of age, and at least 2 months after the third dose.
Dose 1 a
Dose 2 b
Dose 3 b
Dose 4 c
Age at Dose
a. Dose 1 may be given as early as 6 weeks of age.
b. The recommended dosing interval is 4-8 weeks.
c. The fourth dose should be administered at approximately 12-15 months of age, and at least 2 months after the third dose.
Prevnar 13 Schedule for Preterm Infants (< 37 Weeks Gestation):
Preterm infants in stable condition should be immunized with Prevnar 13 at the same chronological age and according to the same schedule as full-term infants (see Table 9, WARNINGS AND PRECAUTIONS – Infants and Children Aged 6 Weeks to 5 Years, and PART II, CLINICAL TRIALS – Preterm Infants).
Previously Unvaccinated Infants and Children 7 Months to 5 Years of Age:
For children who are beyond the age of the routine infant schedule, the following Prevnar 13 schedule applies:
Age at First Dose
Total Number of 0.5 mL Doses
7-11 months of age
12-23 months of age
≥24 months to 5 years of age
a. 2 doses at least 4 weeks apart; third dose after the 1-year birthday, separated from the second dose by at least 2 months.
b. 2 doses at least 2 months apart.
If Prevnar 13 is given as part of a routine infant immunization program, a 3-dose (2+1) schedule may be considered. The first dose may be given from the age of 2 months, with a second dose 2 months later, and a third (booster) dose is recommended between 11-12 months of age. Lower immunogenicity responses for serotypes 6B and 23F were observed when Prevnar 13 is given as a 2-dose (e.g., at 2 and 4 months of age, or at 3 and 5 months of age) schedule in infants up to 6 months of age. After the booster dose, all vaccine serotypes had immune responses consistent with adequate priming with a 2-dose primary series (See PART II, CLINICAL TRIALS section).
Infants and Children Previously Vaccinated with Prevnar (7-valent) (Streptococcus pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F):
Prevnar 13 contains the same 7 serotypes contained in Prevnar (7-valent) and is manufactured based on the same conjugate technology using the CRM197 carrier protein. A booster dose of Prevnar 13 in children (n = 100) previously vaccinated with 3 doses of Prevnar (7-valent) elicited anti-capsular antibody levels (GMCs) to each of the seven common serotypes that were comparable to those elicited by 4 doses of Prevnar (7-valent) (see Table 15 of PART II, CLINICAL TRIALS section).
Children who have completed the infant series with Prevnar (7-valent) can receive a single dose of Prevnar 13 in the second year of life. A single dose of Prevnar 13 in children >1 year of age elicits immune responses to the 6 additional serotypes that are comparable to those elicited by a 3-dose infant series of Prevnar 13, but are generally lower than those elicited by a 3 infant doses + 1 toddler dose schedule of Prevnar 13.
2. Children and Adolescents 6 to 17 Years of Age (Prior to the 18th Birthday)
Children 6 years to 17 years of age may receive a single dose of Prevnar 13. If Prevnar (7-valent) was previously administered, then at least 8 weeks should elapse before receiving Prevnar 13.
3. Adults 18 Years and Older
Prevnar 13 is to be administered as a single dose of 0.5 mL to adults 18 years and older including those previously vaccinated with a pneumococcal polysaccharide vaccine.
Regardless of prior pneumococcal vaccination status, if sequential administration of Prevnar 13 and pneumococcal polysaccharide vaccine is considered, Prevnar 13 should be given first.
The need for re-vaccination with a subsequent dose of Prevnar 13 has not been established.
4. Special Populations
(Also see WARNINGS AND PRECAUTIONS – General, and PART II, CLINICAL TRIALS – Immune Responses in Special Populations)
Individuals who may be at higher risk of pneumococcal infection (e.g., individuals with sickle cell disease or HIV infection), including those previously vaccinated with 1 or more doses of 23-valent pneumococcal polysaccharide vaccine (PPSV23), may receive 1 dose of Prevnar 13.
In individuals aged ≥ 2 years with a hematopoietic stem cell transplant (HSCT), the recommended immunization series consists of 4 doses of Prevnar 13, each of 0.5 mL. The primary series consists of 3 doses, with the first dose given 3 to 6 months after HSCT and with an interval of at least 1 month between doses. A booster dose is recommended 6 months after the third dose.
Based on the National Advisory Committee on Immunization (NACI) recommendations, if sequential administration of Prevnar 13 and pneumococcal polysaccharide vaccine is considered, it is recommended that Prevnar 13 be given first.11