Prevnar® 13

Product Information

• Name: Prevnar® 13
• Type: Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
• Form: Suspension for intramuscular injection
• Manufacturer: Pfizer Canada ULC

Indications and Clinical Use

• 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.
• Common: Vomiting, diarrhea, rash, and urticaria.
• Uncommon: Seizures (including febrile seizures), hypotonic-hyporesponsive episode, hypersensitivity reactions, and lymphadenopathy.
• 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.