Infants and Children (6 weeks to 5 years): Prevention of invasive pneumococcal disease (IPD) and acute otitis media caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.
Children (6 to 17 years): Prevention of IPD caused by the same serotypes.
Adults (18 years and older): Prevention of pneumonia and IPD caused by the same serotypes.
Contraindications
Hypersensitivity to any component of the vaccine, including diphtheria toxoid.
Warnings and Precautions
General: Immunocompromised individuals may have a reduced antibody response. Not all individuals may be protected against pneumococcal disease.
Specific Populations:
Pregnant Women: Use only if clearly needed.
Nursing Women: Safety during lactation has not been established.
Infants and Children: The use of pneumococcal conjugate vaccine does not replace the use of 23-valent pneumococcal polysaccharide vaccine (PPSV23) in certain high-risk children ≥24 months.
Geriatrics: Data available on the safety and immunogenicity of Prevnar 13 in the geriatric population.
Adverse Reactions
Very Common: Irritability, decreased appetite, fever, drowsiness, sleep disturbances, pain, redness, and swelling at the injection site.
Rare: Anaphylactic/anaphylactoid reactions, angioedema, erythema multiforme, vaccination-site dermatitis, and pruritus.
Drug Interactions
Can be administered concomitantly with various vaccines (e.g., diphtheria, tetanus, pertussis, Hib, IPV, hepatitis B, meningococcal, MMR, and varicella vaccines) at different sites.
Prophylactic use of antipyretics may reduce the immune response to Prevnar 13 after the infant series.
Dosage and Administration
Infants and Children (6 weeks to 5 years): 3 doses at 2-month intervals starting at 2 months, followed by a booster dose at 12-15 months (3+1 schedule). Alternatively, a 2-dose primary series with a booster dose at 11-12 months (2+1 schedule).
Children (6 to 17 years): Single dose. If previously vaccinated with Prevnar (7-valent), administer at least 8 weeks apart.
Adults (18 years and older): Single dose. If sequential administration with PPSV23 is considered, Prevnar 13 should be given first.
Storage and Stability
Store at 2°C to 8°C. Do not freeze. Protect from light. Stable at temperatures up to 25°C for 4 days.
