The regimen schedule aligns with the adult 2022 CDC recommendations¹

Administer VAXNEUVANCE followed at least one year later by PNEUMOVAX 23¹

VAXNEUVANCE + PNEUMOVAX 23

≥ 1 Year Later¹

The CDC recommends this schedule as an option for adults who have not previously received a PCV or whose previous vaccination history is unknown, and are¹

Aged ≥65 years
Aged 19-64 years with certain underlying medical conditions or other risk factors^a

Alternatively, the CDC recommends a dose of 20-valent pneumococcal conjugate vaccine for these patients.¹

^aThese include certain chronic medical conditions (eg, diabetes, chronic heart disease, chronic lung disease, or chronic liver disease); certain immunocompromising conditions (eg, HIV); or behavioral risk factors (eg, smoking or alcoholism).

Studies: VAXNEUVANCE in series with PNEUMOVAX 23

Study 3 was a double-blind, active comparator-controlled, descriptive study of pneumococcal vaccine-naïve adults 50 years of age and older. Patients were randomized to receive either VAXNEUVANCE (n=327) or PCV13 (N=325), followed by PNEUMOVAX 23 one year later. Immune responses were assessed by OPA GMTs at 30 days following vaccination with PNEUMOVAX 23, and were numerically similar between the two vaccination groups for the 15 serotypes in VAXNEUVANCE.

Study 4 was a double-blind, descriptive study of adults 18 through 49 years of age. It included individuals with increased risk of developing pneumococcal disease who were randomized to receive VAXNEUVANCE (N=1135) or PCV13 (N=380), followed by PNEUMOVAX 23 six months later. Among those who received VAXNEUVANCE, 620 participants had one risk factor and 228 participants had two or more risk factors for pneumococcal disease. Immune response was assessed by OPA GMTs at 30 days following vaccination. VAXNEUVANCE elicited immune responses to all 15 serotypes in the vaccine. Following vaccination with PNEUMOVAX 23, immune responses for the 15 serotypes in VAXNEUVANCE were numerically similar among subjects who had received VAXNEUVANCE or PCV13 for the first vaccination.

This included people with stable underlying medical conditions (eg, diabetes mellitus, renal disorders, chronic heart disease, chronic liver disease, chronic lung disease, including asthma) and/or behavioral risk factors (eg, smoking, increased alcohol use) that increased their risk of developing pneumococcal disease.

Study 7 was a double-blind, descriptive study, in which the safety and immunogenicity of VAXNEUVANCE were evaluated in pneumococcal vaccine-naïve adults ≥18 years of age living with HIV, 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. Immune response was assessed by OPA GMTs at 30 days following vaccination. Immune responses were higher after administration of VAXNEUVANCE compared to pre-vaccination for the 15 serotypes included in VAXNEUVANCE. After sequential administration with PNEUMOVAX 23 two months later, immune responses were numerically similar between the two vaccination groups for all 15 serotypes included in VAXNEUVANCE.

GMT, geometric mean titer; HIV, human immunodeficiency virus; OPA, opsonophagocytic activity; PCV13, 13-valent pneumococcal conjugate vaccine; RNA, ribonucleic acid.

Additional interval considerations

A minimum interval of 8 weeks can be considered for adults with an immunocompromising condition, cochlear implant, or cerebrospinal fluid leak to minimize the risk for IPD caused by serotypes unique to PNEUMOVAX 23 in these vulnerable groups.¹

Altered immunocompetence may result in a reduced immune response to VAXNEUVANCE and/or PNEUMOVAX 23.

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

Neither VAXNEUVANCE nor PNEUMOVAX 23 has been studied in patients with cerebrospinal fluid leak or cochlear implants.

Stocking information

<strong>Stocking information</strong>

CDC, Centers for Disease Control and Prevention; HIV, human immunodeficiency virus; PCV, pneumococcal conjugate vaccine.

Reference

Centers for Disease Control and Prevention (CDC). Use of 15-valent pneumococcal conjugate vaccine and 20-valent pneumococcal conjugate vaccine among US adults: updated recommendations of the Advisory Committee on Immunization Practices — United States, 2022. MMWR. 2022;71:109–117.

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.