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VAXNEUVANCE delivers superior immune responses at 7 months for 3 key disease-causing serotypes1,a

VAXNEUVANCE delivers robust immune responses postdose 3 and postdose 4a

Superior immune responses for critical disease-causing Serotypes 3, 22F, and 33F1,b,c

Image Showing Immune Responses to Serotypes 3, 22F, 33F (Secondary Endpoint) Versus PCV13 and Immune Response to Serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F (Primary Endpoint) Versus PCV13.

Comparable immune responses for 12 shared serotypes2

VAXNEUVANCE was studied vs PCV13.

Randomized controlled trials assessing the clinical efficacy of VAXNEUVANCE compared to PCV13 have not been conducted.


No randomized controlled clinical trials have been conducted between PCV20 and VAXNEUVANCE in pediatric patients.3

Postdose 3 lgG response rates for Serotype 3b

Serotype 3 Postdose 3 - VAXNEUVANCE: 93.1%; PCV13: 74% Serotype 3 Postdose 3 - VAXNEUVANCE: 93.1%; PCV13: 74%

Postdose 3: For IgG GMC ratios postdose 3, VAXNEUVANCE recipients had 70% higher immunogenicity compared to PCV13 for shared Serotype 3c

Postdose 4: For IgG GMC ratios postdose 4, VAXNEUVANCE recipients had 43% higher immunogenicity compared to PCV13 for shared Serotype 3d

GMC ratios postdose 3a
Primary endpoint: VAXNEUVANCE delivered comparable immune responses for 12 of the 13 shared serotypes found in PCV13. Shared Serotype 6A was just below the noninferiority criteria by a small margin, with the lower bound of the 2-sided 95% CI for the GMC ratio being 0.48 vs >0.5.4

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Study design

Study 8 was a pivotal, double-blind, active comparator-controlled study in which participants were randomized to receive VAXNEUVANCE (N=860) or PCV13 (N=860) in a 4-dose series. The first 3 doses were administered to infants at 2, 4, and 6 months of age and the fourth dose was administered to children at 12 through 15 months of age. Participants also received other licensed pediatric vaccines concomitantly. Immune responses were measured by IgG response rates, IgG GMCs, and OPA GMTs for all 15 serotypes contained in VAXNEUVANCE.

aMeasurements were taken 30 days postdose specified.
bSecondary endpoint: Postdose 3 IgG response rate percentage point difference vs PCV13 (95% CI): for Serotype 3, 19.1 (14.4, 24.0); for Serotype 22F, 8.1 (5.1, 11.5); for Serotype 33F, -5.1 (-9.5, -0.7).4
cSecondary endpoint: Postdose 3 lgG GMC ratio vs PCV13 (95% CI): for Serotype 3, 1.70 (1.54, 1.86).4

dSecondary endpoint: Postdose 4 IgG GMC ratio vs PCV13 (95% CI): for Serotype 3, 1.43 (1.30, 1.57); for Serotype 22F, 4.77 (4.28, 5.32); for Serotype 33F, 2.68 (2.40, 3.00).4

Choose the robust and early protection of VAXNEUVANCE.

CI, confidence interval; GMC, geometric mean concentration (mcg/mL); GMT, geometric mean titer; IgG, Immunoglobulin G; OPA, opsonophagocytic activity; PCV13, 13-valent pneumococcal conjugate vaccine; PCV20, 20-valent pneumococcal conjugate vaccine.

Learn about special populations

Learn about special populations

View safety & tolerability data

View safety & tolerability data

Stay updated on serotypes

Stay updated on serotypes

Get details on first year of life

Get details on first year of life

References:

  1. Visualization – based on 2018-2022 serotype data for invasive pneumococcal disease cases by age group from Active Bacterial Core surveillance (ABCs). Centers for Disease Control and Prevention. Updated July 22, 2024. Accessed August 27, 2024. https://data.cdc.gov/d/qvzb-qs6p/visualization
  2. Prevnar 13. Prescribing Information. Pfizer; 2019.
  3. Prevnar 20. Prescribing Information. Pfizer; 2023.
  4. Lupinacci R, Rupp R, Wittawatmongkol O, et al. A phase 3, multicenter, randomized, double-blind, active-comparator controlled study to evaluate the safety, tolerability, and immunogenicity of a 4-dose regimen of V114, a 15-valent pneumococcal conjugate vaccine, in healthy infants (PNEU-PED). Vaccine. 2023;41(5):1142-1152. doi:10.1016/j.vaccine.2022.12.054
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Indications and Usage

VAXNEUVANCE® (Pneumococcal 15-valent Conjugate Vaccine) is 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 individuals 6 weeks of age and older.

Select Safety Information

Do not administer VAXNEUVANCE® (Pneumococcal 15-valent Conjugate Vaccine) to individuals with a severe allergic reaction (eg, anaphylaxis) to any component of VAXNEUVANCE or to diphtheria toxoid.

 

Some individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to VAXNEUVANCE.

 

Apnea following intramuscular vaccination has been observed in some infants born prematurely. Vaccination of premature infants should be based on the infant’s medical status and the potential benefits and possible risks.

 

The most commonly reported solicited adverse reactions in children vaccinated at 2, 4, 6, and 12 through 15 months of age, provided as a range across the 4-dose series, were: irritability (57.3% to 63.4%), somnolence (24.2% to 47.5%), injection-site pain (25.9% to 40.3%), fever ≥38.0°C (13.3% to 20.4%), decreased appetite (14.1% to 19.0%), injection-site induration (13.2% to 15.4%), injection-site erythema (13.7% to 21.4%), and injection-site swelling (11.3% to 13.4%).

 

The most commonly reported solicited adverse reactions in children 2 through 17 years of age vaccinated with a single dose were: injection-site pain (54.8%), myalgia (23.7%), injection-site swelling (20.9%), injection-site erythema (19.2%), fatigue (15.8%), headache (11.9%), and injection-site induration (6.8%).

 

The reported solicited adverse reactions in children 7 through 11 months of age who received 3 doses of VAXNEUVANCE were: fever ≥38.0°C (21.9%), irritability (32.8%), injection-site erythema (28.1%), somnolence (21.9%), injection-site swelling (18.8%), injection-site pain (18.8%), injection-site induration (17.2%), decreased appetite (15.6%), and urticaria (1.6%).

 

The reported solicited adverse reactions in children 12 through 23 months of age who received 2 doses of VAXNEUVANCE were: fever ≥38.0°C (11.3%), irritability (35.5%), injection-site pain (33.9%), somnolence (24.2%), decreased appetite (22.6%), injection-site erythema (21.0%), injection-site swelling (14.5%), and injection-site induration (8.1%).

 

Vaccination with VAXNEUVANCE may not protect all vaccine recipients.

 

Before administering VAXNEUVANCE, please read the accompanying Prescribing Information. The Patient Information also is available.

Indications and Usage

VAXNEUVANCE® (Pneumococcal 15-valent Conjugate Vaccine) is 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 individuals 6 weeks of age and older.

VAXNEUVANCE® (Pneumococcal 15-valent Conjugate Vaccine) is indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae

VAXNEUVANCE® (Pneumococcal 15-valent Conjugate Vaccine) is 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 individuals 6 weeks of age and older.

Select Safety Information

Do not administer VAXNEUVANCE® (Pneumococcal 15-valent Conjugate Vaccine) to individuals with a severe allergic reaction (eg, anaphylaxis) to any component of VAXNEUVANCE or to diphtheria toxoid.

 

Some individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to VAXNEUVANCE.

 

Apnea following intramuscular vaccination has been observed in some infants born prematurely. Vaccination of premature infants should be based on the infant’s medical status and the potential benefits and possible risks.

 

The most commonly reported solicited adverse reactions in children vaccinated at 2, 4, 6, and 12 through 15 months of age, provided as a range across the 4-dose series, were: irritability (57.3% to 63.4%), somnolence (24.2% to 47.5%), injection-site pain (25.9% to 40.3%), fever ≥38.0°C (13.3% to 20.4%), decreased appetite (14.1% to 19.0%), injection-site induration (13.2% to 15.4%), injection-site erythema (13.7% to 21.4%), and injection-site swelling (11.3% to 13.4%).

 

The most commonly reported solicited adverse reactions in children 2 through 17 years of age vaccinated with a single dose were: injection-site pain (54.8%), myalgia (23.7%), injection-site swelling (20.9%), injection-site erythema (19.2%), fatigue (15.8%), headache (11.9%), and injection-site induration (6.8%).

 

The reported solicited adverse reactions in children 7 through 11 months of age who received 3 doses of VAXNEUVANCE were: fever ≥38.0°C (21.9%), irritability (32.8%), injection-site erythema (28.1%), somnolence (21.9%), injection-site swelling (18.8%), injection-site pain (18.8%), injection-site induration (17.2%), decreased appetite (15.6%), and urticaria (1.6%).

 

The reported solicited adverse reactions in children 12 through 23 months of age who received 2 doses of VAXNEUVANCE were: fever ≥38.0°C (11.3%), irritability (35.5%), injection-site pain (33.9%), somnolence (24.2%), decreased appetite (22.6%), injection-site erythema (21.0%), injection-site swelling (14.5%), and injection-site induration (8.1%).

 

Vaccination with VAXNEUVANCE may not protect all vaccine recipients.

 

Before administering VAXNEUVANCE, please read the accompanying Prescribing Information. The Patient Information also is available.

Do not administer VAXNEUVANCE® (Pneumococcal 15-valent Conjugate Vaccine) to individuals with a severe allergic reaction (eg, anaphylaxis) to any component of VAXNEUVANCE or

Do not administer VAXNEUVANCE® (Pneumococcal 15-valent Conjugate Vaccine) to individuals with a severe allergic reaction (eg, anaphylaxis) to any component of VAXNEUVANCE or to diphtheria toxoid.

 

Some individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to VAXNEUVANCE.