VAXNEUVANCE immunogenicity

Immunogenicity is the capacity of a vaccine to elicit a measurable immune response.¹ Clinical trials of VAXNEUVANCE assessed immune response, based on OPA against S pneumoniae serotypes, as a surrogate measure of protection against invasive pneumococcal disease.

In a clinical trial of pneumococcal vaccine-naive adults 50 years of age and older

VAXNEUVANCE delivered robust immunogenicity against key disease causing serotypes when administered as a single vaccine

VAXNEUVANCE elicited strong immune responses to all serotypes in the vaccine and was noninferior vs PCV13 for the 13 shared serotypes.

**VAXNEUVANCE includes 15 S pneumoniae serotypes**

Graphic Showing the 15 S. Pneumoniae Serotypes Included in VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) — Serotypes 22F and 33F are included in VAXNEUVANCE but not in PCV13.

Study design

Study 1 assessed serotype specific OPA responses for each of the 15 serotypes contained in VAXNEUVANCE at 30 days postvaccination in a double-blind, active comparator-controlled study that enrolled pneumococcal vaccine naïve participants 50 years of age and older. Participants were randomized to receive either VAXNEUVANCE (N=604) or PCV13 (N=601) at sites in the United States, Canada, Spain, Taiwan, and Japan. The mean age of participants was 66 years and 57.3% were female. The racial distribution was as follows: 67.7% were White, 25.1% were Asian, 6.1% were Black or African American, and 22.0% were of Hispanic or Latino ethnicity.

Immune responses were assessed based on OPA GMTs.

GMT, geometric mean titer; OPA, opsonophagocytic activity; PCV13, 13-valent pneumococcal conjugate vaccine.

VAXNEUVANCE demonstrated a superior immune response vs PCV13 for serotype 3, the leading cause of adult IPD in the United States²

Comparative OPA GMTs for Serotype 3 GMT Ratio: 1.62 (95% CI: 1.40-1.87)

Chart Showing the Immunogenicity of VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) Against Serotype 3 Compared to PCV13

VAXNEUVANCE elicited 62% higher immunogenicity vs PCV13 against serotype 3

The clinical significance of this finding has not been demonstrated.

VAXNEUVANCE also demonstrated a superior immune response to serotypes 22F and 33F.

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

Regimen schedule

<strong>Regimen schedule</strong>

CI, confidence interval; GMT, geometric mean titer; IPD, invasive pneumococcal disease; OPA, opsonophagocytic activity; PCV13, 13-valent pneumococcal conjugate vaccine; S pneumoniae, Streptococcus pneumoniae.

References

WHO. Guidelines on clinical evaluation of vaccines: Regulatory expectations. 2017. Accessed October 18, 2022. who.int/publications/m/item/WHO-TRS-1004-web-annex-9
ACIP. Introduction of the pneumococcal work group. Updated October 28, 2020. Accessed March 3, 2023. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-10/pneumo-01-Poehling-Kobayashi-508.pdf

Indications

Indication for VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine)

VAXNEUVANCE 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.

Indication for PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent)

PNEUMOVAX 23 is a vaccine indicated for active immunization for the prevention of pneumococcal disease caused by the 23 serotypes contained in the vaccine (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F).

PNEUMOVAX 23 is approved for use in persons 50 years of age or older and persons aged ≥2 years who are at increased risk for pneumococcal disease.

PNEUMOVAX 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine.

Select Safety Information for VAXNEUVANCE

Do not administer VAXNEUVANCE 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.

The most commonly reported solicited adverse reactions in individuals 18 through 49 years of age were: injection-site pain (75.8%), fatigue (34.3%), myalgia (28.8%), headache (26.5%), injection-site swelling (21.7%), injection-site erythema (15.1%), and arthralgia (12.7%).

The most commonly reported solicited adverse reactions in individuals 50 years of age and older were: injection-site pain (66.8%), myalgia (26.9%), fatigue (21.5%), headache (18.9%), injection-site swelling (15.4%), injection-site erythema (10.9%), and arthralgia (7.7%).

Vaccination with VAXNEUVANCE may not protect all vaccine recipients.

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

Select Safety Information for PNEUMOVAX 23

Do not administer PNEUMOVAX 23 to individuals with a history of a hypersensitivity reaction to any component of the vaccine.

Defer vaccination with PNEUMOVAX 23 in persons with moderate or severe acute illness.

Use caution and appropriate care in administering PNEUMOVAX 23 to individuals with severely compromised cardiovascular and/or pulmonary function in whom a systemic reaction would pose a significant risk.

Available human data from clinical trials of PNEUMOVAX 23 in pregnancy have not established the presence or absence of a vaccine-associated risk.

Since elderly individuals may not tolerate medical interventions as well as younger individuals, a higher frequency and/or a greater severity of reactions in some older individuals cannot be ruled out.

Persons who are immunocompromised, including persons receiving immunosuppressive therapy, may have a diminished immune response to PNEUMOVAX 23.

PNEUMOVAX 23 may not be effective in preventing pneumococcal meningitis in patients who have chronic cerebrospinal fluid (CSF) leakage resulting from congenital lesions, skull fractures, or neurosurgical procedures.

The most common adverse reactions, reported in >10% of subjects vaccinated with PNEUMOVAX 23 for the first time in a clinical trial, were: injection-site pain/soreness/tenderness, injection-site swelling/induration, headache, injection-site erythema, asthenia and fatigue, and myalgia.

For subjects aged 65 years or older in a clinical study, systemic adverse reactions which were determined by the investigator to be vaccine-related were higher following revaccination than following initial vaccination.

Vaccination with PNEUMOVAX 23 may not offer 100% protection from pneumococcal infection.

Before administering PNEUMOVAX 23, please read the accompanying Prescribing Information. The Patient Information also is available.