Pneumovax-23

Drug overview for PNEUMOVAX-23 (pneumococcal 23-valent polysaccharide vaccine):

Generic name: pneumococcal 23-valent polysaccharide vaccine (NEU-mo-KOK-al paa-lee-SA-kr-ide)
Drug class: Pneumococcal Vaccines
Therapeutic class: Biologicals

Pneumococcal vaccine is an inactivated (polysaccharide) vaccine that is commercially available in the US as 2 different vaccine types: pneumococcal conjugate vaccine (pneumococcal 15-valent conjugate vaccine, pneumococcal 20-valent conjugate vaccine, and pneumococcal 21-valent vaccine) and pneumococcal vaccine polyvalent (pneumococcal 23-valent vaccine; PPSV23; Pneumovax(R) 23). All of the vaccines contain capsular antigens extracted from Streptococcus pneumoniae and are used to stimulate active immunity to pneumococcal infection.

No enhanced Uses information available for this drug.

DRUG IMAGES

PNEUMOVAX 23 SYRINGE

The following indications for PNEUMOVAX-23 (pneumococcal 23-valent polysaccharide vaccine) have been approved by the FDA:

Indications:
Streptococcus pneumoniae vaccination

Professional Synonyms:
Active immunization against Streptococcus pneumoniae
Active immunization to prevent Streptococcus pneumoniae infection
Vaccination to prevent Streptococcus pneumoniae infection
Vaccination to prevent Streptococcus pneumoniae

The following dosing information is available for PNEUMOVAX-23 (pneumococcal 23-valent polysaccharide vaccine):

Dosing
Administration
PNEUMOVAX 23
Generic

The dosage schedule (i.e., number of doses) and specific pneumococcal vaccine administered vary depending on age, immunization status, and presence of medical conditions that increase the risk of pneumococcal disease. The age-appropriate recommendations for the specific preparation used should be followed. (See ACIP Recommendations for Pneumococcal Vaccination under Uses.)

Medically stable preterm infants (i.e., gestational age less than 37 weeks), regardless of birthweight, should be vaccinated at the usual chronologic age using the usual dosage and dosage schedules.

Interruptions resulting in an interval between doses longer than recommended should not interfere with the final immunity achieved; there is no need to administer additional doses or start the vaccination series over.

Each IM dose of PCV13 (Prevnar 13(R)) in infants and children 6 weeks of age or older, adolescents, and adults consists of the entire contents (0.5 mL) of the commercially available single-dose prefilled syringe.

Each IM dose of PCV15 (Vaxneuvance(R)) in infants and children 6 weeks of age or older, adolescents, and adults consists of the entire contents (0.5 mL) of the commercially available single-dose prefilled syringe.

Each IM dose of PCV20 (Prevnar 20(R)) in infants and children >=6 weeks of age, adolescents, and adults consists of the entire contents (0.5 mL) of the commercially available single-dose prefilled syringe.

Each IM dose of PCV21 (Capvaxive(R)) in adults consists of the entire contents (0.5 mL) of the commercially available single-dose prefilled syringe.

Each IM or subcutaneous dose of PPSV23 (Pneumovax(R) 23) in children 2 years of age or older, adolescents, and adults consists of the entire contents (0.5 mL) of the commercially available single-dose prefilled syringe or 0.5 mL from a single-dose vial.

Pneumococcal 13-valent conjugate vaccine (PCV13; Prevnar 13(R)), pneumococcal 15-valent conjugate vaccine (PCV15; Vaxneuvance(R)), pneumococcal 20-valent conjugate vaccine (PCV20; Prevnar 20(R)), and pneumococcal 21-valent conjugate vaccine (PCV-21; Capvaxive(R)) are administered only by intramuscular (IM) injection. Pneumococcal vaccine, polyvalent (pneumococcal 23-valent vaccine; PPSV23; Pneumovax(R) 23) is administered only by IM or subcutaneous injection. PCV13 (Prevnar 13(R)), PCV15 (Vaxneuvance(R)), PCV20 (Prevnar 20(R)), PCV-21 (Capvaxive(R)), and PPSV23 (Pneumovax(R) 23) should not be diluted or mixed with any other vaccine or solution.

PCV13 (Prevnar 13(R)) or PCV15 (Vaxneuvance(R)) should not be administered concomitantly with PPSV23 (Pneumovax(R) 23). When these vaccines are indicated, PPSV23 (Pneumovax(R) 23) should be administered sequentially after the recommended age-appropriate regimen of PCV13 (Prevnar 13(R)) or PCV15 (Vaxneuvance(R)), if possible. However, PCV13 (Prevnar 13(R)), PCV15 (Vaxneuvance(R)), PCV20 (Prevnar 20(R)), PCV21 (Capvaxive(R)), or PPSV23 (Pneumovax(R) 23) may be given simultaneously with other age-appropriate vaccines during the same healthcare visit.

When multiple vaccines are administered during a single healthcare visit, each parenteral vaccine should be given with a different syringe and at different injection sites, and injection sites should be separated by at least 1 inch (if anatomically feasible) to allow appropriate attribution of any local adverse effects that may occur. PCV13 (Prevnar 13(R)) should be stored at 2-8degreesC; after shipping, the vaccine may arrive at temperatures ranging from 2-25degreesC. PCV13 (Prevnar 13(R)) should not be frozen.

Since the vaccine contains an aluminum adjuvant, exposure to freezing temperatures causes irreversible loss of vaccine potency. PCV15 (Vaxneuvance(R)) should be stored at 2-8degreesC and should not be frozen. PCV20 (Prevnar 20(R)) should be stored at 2-8degreesC; after shipping, the vaccine may arrive at temperatures ranging from 2-25degreesC.

PCV20 (Prevnar 20(R)) should not be frozen. Store syringes horizontally in the refrigerator to minimize the resuspension time. PCV21 (Capvaxive(R)) should be stored at 2-8degreesC and should not be frozen.

Protect from light. PPSV23 (Pneumovax(R) 23) should be stored at 2-8degreesC.

Dosing information for PNEUMOVAX 23
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
PNEUMOVAX 23 SYRINGE	Maintenance	Adults inject 0.5 milliliter by intramuscular route once

No generic dosing information available.

The following drug interaction information is available for PNEUMOVAX-23 (pneumococcal 23-valent polysaccharide vaccine):

Contraindicated
Severe
Moderate

There are 0 contraindications.

There are 1 severe interactions. These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.

Drug Interaction	Drug Names
Non-Live or Non-Replicating Vaccines/Teplizumab SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Teplizumab may cause lymphopenia and alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a non-live vaccine within the 2 weeks prior to, during, or for 6 weeks following teplizumab therapy may result in decreased effectiveness of the vaccine.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating teplizumab therapy. The manufacturer of teplizumab states that non-live vaccines (e.g., inactivated or mRNA vaccines) are not recommended within the 2 weeks prior to, during, or for 6 weeks after stopping teplizumab therapy.(1) The immune response to non-live vaccines should be monitored in patients who receive teplizumab within these time frames. The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) For COVID-19 vaccines, the CDC advises planning for vaccination at least 2 weeks before starting or resuming immunosuppressive therapy. Patients should be offered and given a COVID-19 vaccine even if the use and timing of immunosuppressive agents cannot be adjusted. The CDC states that an age-appropriate mRNA COVID-19 vaccine is preferred over the Janssen COVID-19 vaccine for the primary and booster doses for immunocompromised patients. All immunocompromised patients over 5 years of age should receive at least 1 booster dose if eligible. See the CDC's Interim Clinical Considerations for Use of COVID-19 Vaccines for age- and product-specific recommendations.(3) DISCUSSION: Vaccinations may be less effective if administered within 2 weeks before, during, and for 6 weeks following teplizumab therapy.(1)	TZIELD

Drug Interaction

Drug Names

Non-Live or Non-Replicating Vaccines/Teplizumab

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Teplizumab may cause lymphopenia and alter the immune system's response to vaccines.(1)

CLINICAL EFFECTS: Administration of a non-live vaccine within the 2 weeks prior to, during, or for 6 weeks following teplizumab therapy may result in decreased effectiveness of the vaccine.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating teplizumab therapy. The manufacturer of teplizumab states that non-live vaccines (e.g., inactivated or mRNA vaccines) are not recommended within the 2 weeks prior to, during, or for 6 weeks after stopping teplizumab therapy.(1) The immune response to non-live vaccines should be monitored in patients who receive teplizumab within these time frames.

The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) For COVID-19 vaccines, the CDC advises planning for vaccination at least 2 weeks before starting or resuming immunosuppressive therapy.

Patients should be offered and given a COVID-19 vaccine even if the use and timing of immunosuppressive agents cannot be adjusted. The CDC states that an age-appropriate mRNA COVID-19 vaccine is preferred over the Janssen COVID-19 vaccine for the primary and booster doses for immunocompromised patients. All immunocompromised patients over 5 years of age should receive at least 1 booster dose if eligible. See the CDC's Interim Clinical Considerations for Use of COVID-19 Vaccines for age- and product-specific recommendations.(3)

DISCUSSION: Vaccinations may be less effective if administered within 2 weeks before, during, and for 6 weeks following teplizumab therapy.(1)

TZIELD

There are 9 moderate interactions. The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.

Drug Interaction	Drug Names
Zoster Vaccine Live/Pneumococcal Vaccine SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Concurrent administration of pneumococcal and zoster vaccines may decrease the immune response to the zoster vaccine. The mechanism is not clear.(1,2) CLINICAL EFFECTS: Concurrent administration of pneumococcal vaccine may decrease antibody titers and possibly the effectiveness of the zoster vaccine.(1,2) The safety profile of the vaccines is unaffected.(3) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The CDC states that to avoid potential barriers to vaccination posed by separation of vaccine administration, zoster and pneumovax vaccines may be administered during the same visit.(3,4) A large observational study did not find an increased risk for herpes zoster in patients who received pneumococcal and zoster vaccines on the same day compared with patients who received pneumococcal vaccine 30 to 265 days prior to zoster vaccine administration.(5) The US manufacturer of zoster vaccine states providers should consider separating administration of pneumococcal and zoster vaccines by 4 weeks.(1) DISCUSSION: In a manufacturer sponsored double-blind controlled trial, 473 adults who received concurrent administration of zoster and Pneumovax(r) had significantly lower varicella zoster virus antibody titers compared with individuals who had vaccine administration separated by 4 weeks. Based upon this trial result the manufacturer recommends consideration of a 4 week separation between zoster and pneumococcal vaccine administration.(1-2) A retrospective cohort study compared the incidence of herpes zoster in 7,187 patients who received pneumococcal and zoster vaccines on the same day with 7,179 patients who received pneumococcal vaccine 30 - 365 days prior to zoster vaccination. Patients were followed for up to 3.5 years. The estimated incidence of herpes zoster in the concomitant vaccination cohort was 4.54 per 1000 person-years, and in the nonconcomitant cohort was 4.51 per 1000 person-years. The hazard ratio for concomitant vaccination compared with noncomitant vaccination was 1.19 (95% CI, 0.81 - 1.74), not statistically significant.(5)	VARIVAX VACCINE
Non-Live or Non-Replicating Vaccines/Fingolimod SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Fingolimod is an immunosuppressant and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a vaccine during and for 2 months following fingolimod therapy may result in decreased effectiveness of the vaccine.(1,2) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating fingolimod therapy. The immune response to non-live vaccines should be monitored in patients receiving fingolimod or who have received fingolimod in the previous two months. Vaccinations given during and for 2 months after stopping fingolimod therapy may need to be repeated.(1,2) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(3) DISCUSSION: Vaccinations may be less effective during and for 2 months following fingolimod therapy(1) however they are considered safe to administer.(2)	FINGOLIMOD, GILENYA, TASCENSO ODT
Non-Live or Non-Replicating Vaccines/Siponimod SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Siponimod is an immunosuppressant and may alter the immune system's response to vaccines.(2) CLINICAL EFFECTS: Administration of a vaccine during and for up to 1 month after discontinuation of siponimod therapy may result in decreased effectiveness of the vaccine. Siponimod treatment should be paused 1 week prior and for 4 weeks after vaccination.(2) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating siponimod therapy. The immune response to non-live vaccines should be monitored in patients receiving siponimod or who have received siponimod in the previous week. Vaccinations given during and for up to 1 month after discontinuation of siponimod therapy may need to be repeated.(2) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(3) DISCUSSION: Vaccinations may be less effective if administered during and for up to 1 month after siponimod treatment(2) however they are considered safe to administer.(1)	MAYZENT
Non-Live or Non-Replicating Vaccines/Satralizumab SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Satralizumab is an immunosuppressant and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a vaccine during satralizumab therapy may result in decreased effectiveness of the vaccine. If possible, non-live vaccines should be administered at least two weeks prior to initiation of satralizumab.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines two weeks prior to initiating satralizumab therapy. The immune response to non-live vaccines should be monitored in patients receiving satralizumab. Vaccinations given during satralizumab therapy may need to be repeated.(1) Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) DISCUSSION: Vaccinations may be less effective if administered during satralizumab treatment.(1)	ENSPRYNG
Non-Live or Non-Replicating Vaccines/Ublituximab SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Ublituximab is an immunosuppressant and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a non-live vaccine within 2 weeks before or during ublituximab therapy may result in decreased effectiveness of the vaccine. If possible, non-live vaccines should be administered at least two weeks prior to initiating ublituximab therapy.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer non-live vaccines at least two weeks prior to initiating ublituximab therapy. The immune response to non-live vaccines should be monitored in patients receiving ublituximab. Vaccinations given during ublituximab therapy may need to be repeated.(1) Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) DISCUSSION: Vaccinations may be less effective if administered within 2 weeks before or during ublituximab treatment.(1)	BRIUMVI
Systemic Corticosteroids; Corticotropin/Non-Live or Non-Replicating Vaccines SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Corticosteroids and corticotropin suppress the immune system and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Vaccines administered during or within 2 weeks prior to therapy with corticosteroids or corticotropin may result in decreased effectiveness of the vaccine.(1) PREDISPOSING FACTORS: Patients receiving immunosuppressive doses of corticosteroids or corticotropin for equal to or greater than 14 consecutive days.(1) PATIENT MANAGEMENT: The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed, including those who are receiving or have received high-dose, systemic steroids for greater than or equal to 14 consecutive days. When initiating immunosuppressives doses of corticosteroids, wait 2 weeks after a non-live vaccines is administered. However, if patients require therapy for chronic inflammatory conditions, do not delay therapy due to past vaccines.(1) The immune response to non-live vaccines should be monitored in patients receiving corticosteroids. Vaccinations given during corticosteroid therapy may need to be repeated.(1) Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(1) DISCUSSION: Vaccinations given during and within 2 weeks prior to corticosteroid therapy may be less effective. However they are considered safe to administer.(1) Many clinicians consider a dose equivalent to either 2 mg/kg of body weight or a total of 20 mg/day of prednisone as sufficiently immunosuppressive to raise safety concerns about live-virus vaccines.(1) Immunization procedures may be undertaken in patients receiving corticosteroids when the therapy is short term (less than 2 weeks); low to moderate dose; long-term, alternate-day treatment with short-acting preparations; maintenance physiologic doses (replacement therapy); or administered topically (skin or eyes), by aerosol, or by intra-articular, bursal, or tendon injection.(1)	ACTHAR, ACTHAR SELFJECT, ADRENOCORTICOTROPHIC HORMONE, ALDOSTERONE, ALKINDI SPRINKLE, ANUCORT-HC, ANUSOL-HC, BECLOMETHASONE DIPROPIONATE, BETA 1, BETALOAN SUIK, BETAMETHASONE ACETATE MICRO, BETAMETHASONE ACETATE-SOD PHOS, BETAMETHASONE DIPROPIONATE, BETAMETHASONE SOD PHOS-ACETATE, BETAMETHASONE SOD PHOS-WATER, BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE VALERATE, BSP 0820, BUDESONIDE, BUDESONIDE DR, BUDESONIDE EC, BUDESONIDE ER, BUDESONIDE MICRONIZED, BUPIVACAINE-DEXAMETH-EPINEPHRN, CELESTONE, CLOBETASOL PROPIONATE MICRO, CORTEF, CORTENEMA, CORTICOTROPHIN, CORTIFOAM, CORTISONE ACETATE, CORTROPHIN, DEFLAZACORT, DEPO-MEDROL, DESONIDE MICRONIZED, DESOXIMETASONE, DESOXYCORTICOSTERONE ACETATE, DEXABLISS, DEXAMETHASONE, DEXAMETHASONE ACETATE, DEXAMETHASONE ACETATE MICRO, DEXAMETHASONE INTENSOL, DEXAMETHASONE ISONICOTINATE, DEXAMETHASONE MICRONIZED, DEXAMETHASONE SOD PHOS-WATER, DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE-0.9% NACL, DMT SUIK, DOUBLEDEX, EMFLAZA, EOHILIA, FLUDROCORTISONE ACETATE, FLUNISOLIDE, FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE MICRO, FLUOCINONIDE MICRONIZED, FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE MICRO, HEMADY, HEMMOREX-HC, HEXATRIONE, HYDROCORTISONE, HYDROCORTISONE ACETATE, HYDROCORTISONE SOD SUCCINATE, KENALOG-10, KENALOG-40, KENALOG-80, LIDOCIDEX-I, MAS CARE-PAK, MEDROL, MEDROLOAN II SUIK, MEDROLOAN SUIK, METHYLPREDNISOLONE, METHYLPREDNISOLONE AC MICRO, METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE SODIUM SUCC, MILLIPRED, MILLIPRED DP, MOMETASONE FUROATE, ORAPRED ODT, ORTIKOS, PEDIAPRED, PREDNISOLONE, PREDNISOLONE ACETATE MICRONIZE, PREDNISOLONE MICRONIZED, PREDNISOLONE SODIUM PHOS ODT, PREDNISOLONE SODIUM PHOSPHATE, PREDNISONE, PREDNISONE INTENSOL, PREDNISONE MICRONIZED, PRO-C-DURE 5, PRO-C-DURE 6, PROCTOCORT, RAYOS, SOLU-CORTEF, SOLU-MEDROL, TAPERDEX, TARPEYO, TRIAMCINOLONE, TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE DIACETATE, TRIAMCINOLONE DIACETATE MICRO, TRILOAN II SUIK, TRILOAN SUIK, UCERIS, VERIPRED 20, ZCORT
Non-Live or Non-Replicating Vaccines/Etrasimod SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Etrasimod is an immunosuppressant and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a vaccine during and for up to 5 weeks after discontinuation of etrasimod therapy may result in decreased effectiveness of the vaccine. Etrasimod treatment should be paused 5 weeks prior and for 4 weeks after vaccination.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating etrasimod therapy. The immune response to non-live vaccines should be monitored in patients receiving etrasimod or who have received etrasimod in the previous 5 weeks. Vaccinations given during and for up to 5 weeks after discontinuation of etrasimod therapy may need to be repeated.(1) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) DISCUSSION: Vaccinations may be less effective if administered during and for up to 5 weeks after etrasimod treatment.(1) However they are considered safe to administer.	VELSIPITY
Non-Live or Non-Replicating Vaccines/Ozanimod SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Ozanimod is an immunosuppressant and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a vaccine during and for up to 3 months after discontinuation of ozanimod therapy may result in decreased effectiveness of the vaccine. Ozanimod treatment should be paused 3 months prior and for 1 month after vaccination.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating ozanimod therapy. The immune response to non-live vaccines should be monitored in patients receiving ozanimod or who have received ozanimod in the previous 3 months. Vaccinations given during and for up to 3 months after discontinuation of ozanimod therapy may need to be repeated.(1) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) DISCUSSION: Vaccinations may be less effective if administered during and for up to 3 months after ozanimod treatment.(1) However they are considered safe to administer.	ZEPOSIA
Non-Live or Non-Replicating Vaccines/Ponesimod SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Ponesimod is an immunosuppressant and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a vaccine during and for up to 2 weeks after discontinuation of ponesimod therapy may result in decreased effectiveness of the vaccine. Ponesimod treatment should be paused 1-2 weeks prior and for 4 weeks after vaccination.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating ponesimod therapy. The immune response to non-live vaccines should be monitored in patients receiving ponesimod or who have received ponesimod in the previous 2 weeks. Vaccinations given during and for up to 2 weeks after discontinuation of ponesimod therapy may need to be repeated.(1) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) DISCUSSION: Vaccinations may be less effective if administered during and for up to 2 weeks after ponesimod treatment.(1) However they are considered safe to administer.	PONVORY

Severe List
High fever >101 degrees fahrenheit

The following adverse reaction information is available for PNEUMOVAX-23 (pneumococcal 23-valent polysaccharide vaccine):

Overview
Severe
Less Severe

Adverse reaction overview.

Local Effects with Pneumococcal 13-valent Conjugate Vaccine (PCV13; Prevnar 13(R)): The most common adverse effects reported with PCV13 (Prevnar 13(R)) are local reactions at the injection site, including pain/tenderness, redness, and swelling. In infants who received a 4-dose immunization series of PCV13 (Prevnar 13(R)) at 2, 4, 6, and 12-15 months of age in 3 US safety studies, tenderness at the injection site was reported in 59-65% of infants after each of the first 3 vaccine doses and in 58% after the fourth dose; tenderness interfered with limb movement in 8-10% and 7% of these infants, respectively. Redness was reported in 24-37% of infants after the first 3 vaccine doses and in 42% after the fourth dose.

Swelling at the injection site was reported in 20-27% of infants after the first 3 vaccine doses and in 32% after the fourth dose. When a dose of PCV13 (Prevnar 13(R)) was administered to adults 50-64 years of age who were previously unvaccinated (had not received PPSV23 (Pneumovax(R) 23)), local reactions at the injection site, including pain (69-89%), redness (12-20%), and swelling (10-22%), were commonly reported and limitation of arm movement was reported in 24-41%. When a dose of PCV13 (Prevnar 13(R)) was administered to previously vaccinated adults 68 years of age or older (had received PPSV23 (Pneumovax(R) 23) at least 3-5 years prior to study enrollment), pain, redness, swelling, and limitation of arm movement were reported in 51-52%, 11-14%, 10-13%, and 11-16%, respectively.

Dermatitis, urticaria, and pruritus at the injection site were reported during postmarketing experience with PCV13 (Prevnar 13(R)). Systemic Effects with Pneumococcal 13-valent Conjugate Vaccine (PCV13; Prevnar 13(R)): In infants who received a 4-dose immunization series of PCV13 (Prevnar 13(R)) at 2, 4, 6, and 12-15 months of age in 3 US safety studies, fever (38degreesC or greater) occurred in 24-37% of infants after each of the first 3 doses; fever was reported in 32% after the fourth dose. Irritability was reported in 80-86%, increased sleep in 58-72%, and decreased sleep in 43-47% of infants after each of the first 3 doses; after the fourth dose, these effects were reported in 80, 49, and 45%, respectively.

Decreased appetite was reported in 48% of infants after each of the first 3 doses of PCV13 (Prevnar 13(R)) and in 51% after the fourth dose. Diarrhea, vomiting, and rash have been reported in greater than 1% of infants and children receiving PCV13 (Prevnar 13(R)) in clinical studies. Adverse reactions occurring in less than 1% of infants and children receiving the vaccine included crying, hypersensitivity reaction (e.g., facial edema, dyspnea, bronchospasm), seizures (e.g., febrile seizures), and urticaria or urticaria-like rash.

When a dose of PCV13 (Prevnar 13(R)) was administered to adults 50-64 years of age who were previously unvaccinated (had not received PPSV23 (Pneumovax(R) 23)), fatigue occurred in 51-63%, headache in 50-66%, chills in 20-24%, muscle pain in 22-62%, joint pain in 14-32%, rash in 9-17%, decreased appetite in 15-25%, vomiting in 3-7%, and fever in 2-4%. When a dose of PCV13 (Prevnar 13(R)) was administered to previously vaccinated adults 68 years of age and older (had received PPSV23 (Pneumovax(R) 23) at least 3-5 years prior to study enrollment), fatigue occurred in 34%, headache in 24-26%, chills in 8%, muscle pain in 12-37%, joint pain in 10-13%, rash in 7-8%, decreased appetite in 10-11%, vomiting in 1-2%, and fever in 1%. Lymphadenopathy in the region of the injection site, cyanosis, pallor, hypotonia, anaphylactic/anaphylactoid reactions (including shock), angioedema, erythema multiforme, and apnea were reported during postmarketing experience with PCV13 (Prevnar 13(R)).

Local Effects with PCV15 (Vaxneuvance(R)): The most commonly reported local adverse reactions reported in infants receiving a 4-dose series at 2, 4, 6, and 12 through 15 months of age were injection-site pain (25.9-40.3%), injection-site induration (13.2-15.4%), injection-site erythema (13.7-21.4%), and injection-site swelling (11.3-13.4%). Reported local adverse reactions in children and adolescents 2 through 17 years of age vaccinated with a single dose were injection-site pain (54.8%), injection-site swelling (20.9%), injection-site erythema (19.2%), and injection-site induration (6.8%). The most commonly reported adverse reactions in adults 18-49 years of age were injection-site pain (75.8%), injection-site swelling (21.7%), and injection-site erythema (15.1%).

The most commonly reported adverse reactions in adults >=50 years of age were injection-site pain (66.8%), injection-site swelling (15.4%), and injection-site erythema (10.9%). Systemic Effects with PCV15 (Vaxneuvance(R)): The most commonly reported systemic adverse reactions reported in infants receiving a 4-dose series at 2, 4, 6, and 12 through 15 months of age were irritability (57.3-63.4%), somnolence (24.2-47.5%), fever >=38.0degreesC (13.3-20.4%), and decreased appetite (14.1-19.0%).

Reported systemic reactions in children and adolescents 2 through 17 years of age vaccinated with a single dose were myalgia (23.7%), fatigue (15.8%), and headache (11.9%). The most commonly reported systemic reactions in adults 18-49 years of age were fatigue (34.3%), myalgia (28.8%), headache (26.5%), and arthralgia (12.7%). The most commonly reported systemic reactions in adults >=50 years of age were myalgia (26.9%), fatigue (21.5%), headache (18.9%), and arthralgia (7.7%).

Local Effects with PCV20 (Prevnar 20(R)): The most commonly reported local adverse reactions reported in infants receiving a 4-dose series at 2, 4, 6, and 12 through 15 months of age were pain at the injection site (>30%) and injection site redness (>20%) and swelling (>10%). Reported local reactions in children and adolescents 15 months through 17 years of age vaccinated with a single dose were pain at the injection site (>50%) and injection site redness and swelling (>10%). In adults 18-59 years of age, the most commonly reported local adverse reactions were pain at the injection site (>70%) and injection site swelling (10%).

In adults >=60 years of age, the most commonly reported local adverse reaction was pain at the injection site (>50%). Systemic Effects with PCV20 (Prevnar 20(R)): The most commonly reported systemic adverse reactions reported in infants receiving a 4-dose series at 2, 4, 6, and 12 through 15 months of age were irritability (>60%), drowsiness (>30%), decreased appetite (>20%), and fever (>10%). Reported systemic reactions in children and adolescents 15 months through 17 years of age vaccinated with a single dose were irritability (>60% in individuals <2 years of age), drowsiness (>40% in individuals less than 2 years of age), fatigue and muscle pain (>20% in individuals 2 years of age and older), decreased appetite (>20% in individuals less than 2 years of age), headache (>10% in individuals 5 years of age and older), and fever (>10% in individuals less than 2 years of age).

In adults 18-59 years of age, the most commonly reported systemic reactions were muscle pain (>50%), fatigue (>40%), headache (>30%), and arthralgia(>10%). In adults >=60 years of age, the most commonly reported systemic reactions were muscle pain and fatigue (>30%), headache (>20%), and arthralgia (>10%). Local Effects with PCV21 (Capvaxive(R)): In adults 18-49 years of age, the most commonly reported local adverse reactions were pain at the injection site (73.1%), injection site erythema (13.8%), and injection site swelling (13.3%).

In adults >=50 years of age, the most commonly reported local adverse reaction was pain at the injection site (41.2%). Systemic Effects with PCV21 (Capvaxive(R)): In adults 18-49 years of age, the most commonly reported systemic adverse reactions were fatigue (36.0%), headache (27.5%), and myalgia (16.4%). In adults >=50 years of age, the most commonly reported systemic reactions were fatigue (19.7%) and headache (11.0%).

Local Effects with Pneumococcal 23-valent Vaccine (PPSV23; Pneumovax(R) 23): The most common adverse effects reported after initial vaccination with PPSV23 (Pneumovax(R) 23) are local reactions at the injection site, including pain/soreness/tenderness (60%), swelling/induration (20%), and erythema (16%). Following revaccination with PPSV23 (Pneumovax(R) 23) approximately 3-5 years after the initial vaccine dose, the most common local adverse effects were pain/soreness/tenderness (77%), swelling (40%), and erythema (35%). Injection site reactions generally resolved within 5 days after vaccination.

Data from one study in adults indicate that the incidence of adverse effects at the injection site in those 50-64 years of age is similar following initial vaccination (73%) and revaccination (80%). However, the incidence of injection site reactions is higher following revaccination than following initial vaccination in those >=65 years of age. There have been postmarketing reports of cellulitis or cellulitis-like reactions, warmth at the injection site, decreased limb mobility, and peripheral edema in the injected extremity following administration of PPSV23 (Pneumovax(R) 23).

Systemic Effects with Pneumococcal 23-valent Vaccine (PPSV23; Pneumovax(R) 23): The most common systemic adverse effects reported after initial vaccination with PPSV23 (Pneumovax(R) 23) are headache (18%), asthenia/fatigue (13%), and myalgia (12%). Following revaccination with PPSV23 (Pneumovax(R) 23) approximately 3-5 years after the initial vaccine dose, the most common systemic adverse effects were headache (18%), asthenia/fatigue (18%), and myalgia (17%). Rash, urticaria, and erythema multiforme have been reported following vaccination with PPSV23 (Pneumovax(R) 23).

Anaphylactoid reactions, serum sickness, and angioedema also have been reported. Other systemic reactions reported following vaccination with PPSV23 (Pneumovax(R) 23) during clinical studies or postmarketing experience include fever, chills, arthralgia, arthritis, malaise, diarrhea, dyspepsia, nausea, and vomiting. In addition, there have been postmarketing reports of lymphadenitis, lymphadenopathy, thrombocytopenia (in patients with stabilized idiopathic thrombocytopenic purpura), hemolytic anemia (in patients who have had other hematologic disorders), and leukocytosis.

There also have been postmarketing reports of adverse nervous system effects, including paresthesia, radiculoneuropathy, Guillain-Barre syndrome, and febrile seizures. Data from one study in adults indicate that the incidence of systemic adverse effects in those 50-64 years of age is similar following initial vaccination (36%) and revaccination (38%). However, the incidence of systemic reactions is higher following revaccination than following initial vaccination in those >=65 years of age.

There are 9 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Anaphylaxis Angioedema Dermal necrosis Erythema multiforme Febrile convulsions Guillain-barre syndrome High fever >101 degrees fahrenheit Serum sickness Urticaria

There are 23 less severe adverse reactions.

More Frequent	Less Frequent
Erythema Fatigue General weakness Headache disorder Induration of skin Injection site erythema Injection site pain Injection site sequelae Myalgia	None.

Rare/Very Rare
Arthralgia Arthritis Chills Extensive limb swelling after injection Fever Leukocytosis Lymphadenopathy Malaise Nausea Pain Paresthesia Peripheral edema Skin rash Vomiting

The following precautions are available for PNEUMOVAX-23 (pneumococcal 23-valent polysaccharide vaccine):

Pediatric
Pregnant
Lactation
Geriatric

Safety and efficacy of PCV13 (Prevnar 13(R)) have not been established in infants younger than 6 weeks of age. The manufacturer of PCV13 (Prevnar 13(R)) states that the immune response to the vaccine in preterm infants has not been adequately studied to date. Although the vaccination schedule differed from the US recommended schedule, there is some evidence from a study in preterm infants (gestational age less than 37 weeks) that immunoglobulin G (IgG) antibody responses to some of the pneumococcal vaccine serotypes were lower after the third and fourth vaccine dose compared with responses in term infants (gestational age 37 weeks or greater).

The manufacturer of PCV15 (Vaxneuvance(R)) states that the immune responses and safety profile in preterm infants receiving a 4-dose series were similar to those observed in term infants in clinical studies. However, the effectiveness of PCV15 (Vaxneuvance(R)) in premature infants has not been established. Safety of PCV20 (Prevnar 20(R)) has been established in individuals 6 weeks through 17 years of age.

The effectiveness of PCV20 for the prevention of invasive disease caused by S.pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F has been established in individuals 6 weeks through 17 years of age. The effectiveness of PCV20 for the prevention of otitis media caused by serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F also has been established in individuals 6 weeks through 5 years of age.

However, the effectiveness of PCV20 for the prevention of pneumonia has not been established in individuals younger than 18 years of age. The safety and effectiveness of Prevnar 20 have not been established in individuals younger than 6 weeks of age. Safety and efficacy of PCV21 (Capvaxive(R)) have not been established in individuals younger than 18 years of age.

Safety and efficacy of PPSV23 (Pneumovax(R) 23) have not been established in children younger than 2 years of age. Such children may not have a satisfactory antibody response to PPSV23 (Pneumovax(R) 23).

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Data are insufficient to date regarding use of pneumococcal vaccines in pregnant females to inform vaccine-associated risks during pregnancy. ACIP states that the safety of PPSV23 during the first trimester of pregnancy has not been evaluated, although no adverse consequences have been reported among newborns whose mothers were inadvertently vaccinated during pregnancy. Animal developmental and reproduction studies in female rabbits using PCV13 (Prevnar 13(R)) at doses 20 times the human dose based on body weight did not reveal evidence of fetal harm or impaired female fertility.

There are no adequate and well-controlled studies using PCV13 (Prevnar 13(R)) in pregnant females. Animal reproduction studies have not been conducted with PPSV23 (Pneumovax(R) 23). It is not known whether PPSV23 (Pneumovax(R) 23) can cause fetal harm when administered to a pregnant females or can affect reproductive capacity.

PPSV23 (Pneumovax(R)) should be administered during pregnancy only when clearly needed. ACIP, AAP, and other experts state that PPSV23 (Pneumovax(R) 23) may be used when indicated in pregnant females at increased risk for pneumococcal disease. ACIP has not addressed pregnancy recommendations for PCV15, PCV20, or PCV21 at this time. AAP states that pneumococcal vaccination generally should be deferred during pregnancy, but the risk of severe pneumococcal disease in a pregnant female who has not received PPSV23 (Pneumovax(R) 23) within the previous 5 years and has an underlying medical condition that increases the risk of invasive pneumococcal disease should prompt immunization with PPSV23 (Pneumovax(R) 23).

It is not known if antigens contained in PCV13 (Prevnar 13(R)), PCV15 (Vaxneuvance(R)), PCV20 (Prevnar 20(R)), PCV21 (Capvaxive(R)), or PPSV23 (Pneumovax(R) 23) are distributed into milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for vaccination and any potential adverse effects on the breastfed child from the vaccine or from the underlying maternal condition (the susceptibility to disease prevented by the vaccine). ACIP states that, because inactivated vaccines do not multiply within the body, they should not pose any unusual problems for lactating women or their infants.

Antibody responses to PCV13 (Prevnar 13(R)) in adults 65 years of age or older are lower compared with antibody responses in adults 50 through 59 years of age. There are no overall differences in safety outcomes in adults 65 years of age or older compared with adults 50 through 59 years of age. Several clinical studies evaluating PPSV23 (Pneumovax(R) 23) included individuals 65 years of age or older.

In one study, the rate of vaccine-related systemic adverse effects was similar following primary vaccination and revaccination in adults 50-64 years of age, but was higher following revaccination than primary vaccination in those 65 years of age or older. The possibility that some older adults may exhibit a higher frequency and/or greater severity of adverse reactions to the vaccine cannot be ruled out. Clinical studies of PCV15 (Vaxneuvance(R)) included individuals who were 65 years and older, and individuals who were 75 years and older.

No clinically meaningful differences in the safety profile or immune responses were observed in the groups of older individuals (65-74 years and >=75 years of age) when compared to younger individuals. In safety studies of PCV20 (Prevnar 20(R)) in adults, 26.7% were 65 years of age and older and 1.7%

were 80 years of age and older. Prevnar 20(R) recipients 70-79 years of age and >=80 years of age had lower antibody responses for all pneumococcal serotypes compared to Prevnar 20(R) recipients 18-49, 50-59, and 60-64 years of age. In safety studies of PCV21 (Capvaxive(R)) in adults, 32.6%

were 65 years of age and older and 7.4% were 75 years of age and older. PCV 21 (Capvaxive(R)) recipients >=65 years of age had lower opsonophagocytic activity (OPA) responses for all pneumococcal serotypes compared to PCV21 recipients <65 years of age.

Streptococcus pneumoniae vaccination
Z23	Encounter for immunization