General Information

Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) is a 15-valent pneumococcal conjugate vaccine.

Vaxneuvance is specifically indicated for active immunization 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 in patients 6 weeks of age and older.  

Vaxneuvance is supplied as a suspension for intramuscular injection. Administer a single 0.5 mL dose.

Mechanism of Action

Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) confers protection against invasive disease mainly by opsonophagocytic killing of S. pneumoniae. Vaxneuvance induces opsonophagocytic activity against the serotypes contained in the vaccine.

Side Effects

Adverse effects associated with the use of Vaxneuvance in individuals 18 through 49 years of age may include, but are not limited to, the following:

• injection-site pain
• fatigue
• myalgia
• headache
• injection-site swelling
• injection-site erythema
• arthralgia

Adverse effects associated with the use of Vaxneuvance  in individuals 50 years of age and older may include, but are not limited to, the following:

• injection-site pain
• myalgia
• fatigue
• headache
• injection-site swelling
• injection-site erythema
• arthralgia

Clinical Trial Results

Vaxneuvance was approved based on data from seven randomized, double-blind clinical studies designed to evaluate its safety, tolerability, and immunogenicity in 7,438 individuals from a variety of adult populations and clinical circumstances, 5,630 of whom received Vaxneuvance. 

Healthy adults 50 years of age and older: V114-019/PNEU-AGE 

• The pivotal Phase 3 active comparator-controlled study assessed serotype-specific OPA responses for each of the 15 serotypes contained in Vaxneuvance at 30 days post-vaccination in pneumococcal vaccine naïve participants randomized to receive either Vaxneuvance (n=604) or PCV13 (n=601). The study demonstrated that Vaxneuvance was non-inferior to PCV13 for the 13 shared serotypes and induces statistically significantly greater OPA GMTs compared to PCV13 for shared serotype 3 and for the two unique serotypes (22F, 33F).

Adults 18-49 years of age with no history of pneumococcal vaccination, including individuals at increased risk of developing pneumococcal disease: V114-017/PNEU-DAY

• A Phase 3 descriptive study included individuals with stable underlying medical conditions (e.g., diabetes mellitus, renal disorders, chronic heart disease, chronic liver disease, chronic lung disease including asthma) and/or behavioral risk factors (e.g., smoking, increased alcohol use) that increased their risk of developing pneumococcal disease. Participants were randomized to receive Vaxneuvance (n=1,135) or PCV13 (n=380), followed by Pneumovax 23 (pneumococcal vaccine polyvalent) six months later. Vaxneuvance elicited immune responses to all 15 serotypes as assessed by OPA GMTs at 30 days following vaccination. Additionally, following vaccination with Pneumovax 23, the OPA GMTs for the 15 serotypes in Vaxneuvance were numerically similar among subjects who had received Vaxneuvance or PCV13 for the first vaccination.

Adults living with HIV: V114-018/PNEU- WAY

• A Phase 3 descriptive study assessed the use of Vaxneuvance in pneumococcal vaccine naïve HIV-infected adults 18 years of age and older with CD4+ T cell count ≥50 cells per microliter and plasma HIV RNA value <50,000 copies/mL. Participants were randomized to receive Vaxneuvance (n=152) or PCV13 (n=150), followed by Pneumovax 23 two months later. OPA GMTs were higher after administration of Vaxneuvance, compared to pre-vaccination, for the 15 serotypes contained in Vaxneuvance. After sequential administration with Pneumovax 23, OPA GMTs were numerically similar between the two vaccination groups for all 15 serotypes contained in Vaxneuvance.

Co-administration of Vaxneuvance with seasonal quadrivalent influenza vaccine (QIV): V114-021/PNEU-FLU

• A Phase 3 trial evaluated adults 50 years of age and older who were randomized to receive Vaxneuvance concomitantly with a seasonal inactivated QIV (Fluarix Quadrivalent) (n=600) or non-concomitantly 30 days after QIV (n=600). The non-inferiority criteria for the comparisons of GMTs were met for the 15 pneumococcal serotypes in Vaxneuvance and for the 4 influenza vaccine strains tested. Vaxneuvance can be administered concomitantly with seasonal inactivated influenza vaccine.

Use of Vaxneuvance as part of a sequential regimen with Pneumovax 23: V114-016/PNEU-PATH

• A Phase 3 active comparator-controlled descriptive study in pneumococcal vaccine-naïve adults 50 years of age or older assessed the use of Vaxneuvance (n=327) or PCV13 (n=325), followed by Pneumovax 23 one year later. Following vaccination with Pneumovax 23, OPA GMTs were numerically similar between the two vaccination groups for the 15 serotypes in Vaxneuvance.