PREVNAR 20™

Product Information

• Name: PREVNAR 20™
• Type: Pneumococcal 20-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
• Form: Suspension for Intramuscular Injection
• Manufacturer: Pfizer Canada ULC

Indications and Clinical Use

• Adults (18 years and older): Active immunization for the prevention of pneumonia and invasive pneumococcal disease (including sepsis, meningitis, bacteremic pneumonia, pleural empyema, and bacteremia) caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F.
• Pediatric Use: Safety and immunogenicity not established for individuals younger than 18 years.
• Geriatric Use: Studied in individuals 65 years and older.

Contraindications

• Severe allergic reaction to any component of the vaccine, including diphtheria toxoid.

Warnings and Precautions

• General: Postpone vaccination in individuals with acute severe febrile illness. Minor infections are not a reason to delay.
• Immune Response: Reduced immune response in immunocompromised individuals.
• Pregnant and Breastfeeding Women: Safety not established.
• Pediatrics: Safety and immunogenicity not established.
• Geriatrics: Shown to be safe and immunogenic.

Adverse Reactions

• Very Common (>10%): Pain/tenderness at injection site, muscle pain, fatigue, headache, joint pain.
• Common (1-10%): Redness, swelling at injection site, fever ≥38°C.
• Uncommon (0.1-1%): Diarrhea, nausea, vomiting, rash, itching, swollen glands, chills.
• Rare: Severe allergic reactions, including anaphylaxis.

Drug Interactions

• No data available on concomitant use with other vaccines. If administered with another injectable vaccine, use different syringes and injection sites.

Dosage and Administration

• Dose: Single 0.5 mL dose intramuscularly.
• Administration: Preferably in the deltoid muscle. Do not mix with other vaccines/products in the same syringe.

Storage and Stability

• Store refrigerated at 2°C to 8°C. Do not freeze. Protect from light. Administer as soon as possible after removal from refrigeration.

Clinical Trials and Efficacy

• Study Design: Three Phase 3 clinical trials (Study 1006, Study 1007, and Study 1008) conducted in the US and Sweden.
• Participants: Included healthy adults and those with stable underlying conditions.
• Immunogenicity: Measured by opsonophagocytic activity (OPA) assay before and one month after vaccination. PREVNAR 20 demonstrated non-inferiority to PREVNAR 13 for 13 shared serotypes and superior immune responses for the additional seven serotypes.
• Safety: Similar tolerability and safety profile to PREVNAR 13, with most adverse events being mild to moderate.