VAXNEUVANCE®

Product Information

• Name: VAXNEUVANCE®
• Type: Pneumococcal 15-valent Conjugate Vaccine (CRM197 Protein), adsorbed
• Form: Suspension for injection
• Manufacturer: Merck Canada Inc.

Indications and Clinical Use

• Indication: Active immunization of adults 18 years of age and older for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F.
• Pediatric Use: Safety and effectiveness not established for individuals under 18 years.
• Geriatric Use: Studied in individuals 65 years and older.

Contraindications

• Severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or any diphtheria toxoid-containing vaccine.

Warnings and Precautions

• General: Vaccination may not protect all vaccine recipients. Postpone in cases of acute severe febrile illness.
• Immune Response: Reduced immune response in individuals with immunosuppressive conditions or treatments.
• Pregnant Women: Insufficient data; use only if clearly needed.
• Breastfeeding: Unknown if excreted in human milk.

Adverse Reactions

• Common: Pain, erythema, and swelling at injection site; fatigue, headache, arthralgia, and myalgia.
• Less Common: Injection-site pruritis.
• Serious: Rare severe reactions include anaphylaxis.

Drug Interactions

• Other Vaccines: Can be administered with inactivated influenza vaccine. No data on concomitant administration with other vaccines.
• Immunosuppressive Therapies: May reduce the immune responses to VAXNEUVANCE®.

Dosage and Administration

• Dose: 0.5 mL intramuscularly.
• Administration: Do not inject intravascularly. Preferred injection site is the deltoid muscle. Do not dilute or mix with other vaccines.

Storage and Stability

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

Clinical Trials and Efficacy

• Study Demographics: Trials included healthy and immunocompetent adults, including those with stable underlying medical conditions.
• Immunogenicity: Assessed by serotype-specific opsonophagocytic activity (OPA) and immunoglobulin G (IgG) responses. Demonstrated noninferiority to Prevnar 13® for shared serotypes and superiority for unique serotypes (22F and 33F).

Key Takeaway

VAXNEUVANCE® is a pneumococcal 15-valent conjugate vaccine indicated for adults to prevent invasive pneumococcal diseases. It is effective and generally well-tolerated, with most adverse reactions being mild to moderate. Proper administration and adherence to storage guidelines are essential for optimal vaccine efficacy and safety.