AdultPediatricDosage Forms & Strengths injection, IM suspension 0.5mL single-dose prefilled syringe Streptococcus pneumoniae Immunization Pneumococcal vaccine 20-valent (PCV20) is indicated in adults for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F 0.5 mL IM once Current CDC immunization schedules ACIP pneumococcal vaccine recommendations Pneumococcal vaccine-naïve or vaccination status unknown ≥65 years: 0.5 mL IM once; no need to follow with 23-valent PPSV 19-64 years with certain underlying medical conditions: 0.5 mL IM once; then, repeat when aged ≥65 years PPSV23 previously received: May receive PCV20 ≥1 years after their last PPSV23 dose at discretion of physician PCV13 previously received: Public health benefits of providing PCV20 to adults who have received PCV13 only or both PCV13 and PPSV23 have not been evaluated; these adults should complete the previously recommended PPSV23 series For more information, see full ACIP recommendations at MMWR January 28, 2022 Dosing Considerations Contains all serotypes in Prevnar 13 plus 7 additional serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) Specific medical conditions for aged 19-64 years Alcoholism Chronic heart, liver, or lung disease Cigarette smoking Diabetes mellitus Cochlear implant CSF leak Congenital or acquired asplenia Sickle cell disease or other hemoglobinopathies Chronic renal failure Congenital or acquired immunodeficiencies Generalized malignancy HIV infection Hodgkin disease, leukemia, lymphoma, multiple myeloma Iatrogenic immunosuppression Nephrotic syndrome Solid organ transplant Dosage Forms & Strengths injection, IM suspension 0.5mL single-dose prefilled syringe Streptococcus pneumoniae Immunization Active immunization indications Prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F pediatric patients aged 6 weeks and older Prevention of otitis media caused by y S pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F in children aged 6 weeks through 5 years Dose Aged 6 weeks through 15 months 4-dose series: 0.5 mL IM at 2 months, 4 months, 6 months and 12-15 months (and at least 2 months after 3rd dose) First dose may be given as early as 6 weeks of age Current CDC immunization schedules Catch-up schedule Individuals initiating vaccination at aged 7 months through 17 years 7-11 months: 3 doses; give first 2 doses at least 4 weeks apart; third dose after 1-year birthday, separated from the second dose by at least 2 months 12-23 months: 2 doses; give at least 2 months apart >24 months: 1 dose Catch-up if previously vaccinated with lower valency pneumococcal vaccine Individuals aged 15 months through 17 years previously vaccinated with ≥1 dose of a lower valency pneumococcal conjugate vaccine 1 dose administered at ≥8 weeks after last dose of lower valency pneumococcal vaccine Interaction CheckerEnter a drug name and pneumococcal vaccine 20-valentNo Results No Interactions Found Interactions FoundContraindicatedSerious - Use AlternativeSignificant - Monitor CloselyMinorAll Interactions Sort By: SeverityName Contraindicated (0)Serious - Use Alternative (2)elivaldogene autotemcelelivaldogene autotemcel, pneumococcal vaccine 20-valent. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .teplizumabteplizumab decreases effects of pneumococcal vaccine 20-valent by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.Monitor Closely (5)delandistrogene moxeparvovecdelandistrogene moxeparvovec, pneumococcal vaccine 20-valent. Other (see comment). Use Caution/Monitor. Comment: Consider patient vaccination status before initiating corticosteroid regimen required before delandistrogene moxeparvovec administration. If possible, ensure patients are current with all immunizations according to immunization guidelines. Complete vaccinations at least 4 weeks before starting corticosteroid regimen. High-dose or long-term corticosteroids may decrease immungenicity of vaccines.satralizumabsatralizumab decreases effects of pneumococcal vaccine 20-valent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .tralokinumabtralokinumab will decrease the level or effect of pneumococcal vaccine 20-valent by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.ublituximabublituximab decreases effects of pneumococcal vaccine 20-valent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines at least 4 weeks before initiating ublituximab for live or live-attenuated vaccines and, whenever possible, at least 2 weeks before initiating for non-live vaccines. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion. Do not administer live or live-attenuated vaccines to infants of mothers exposed to ublituximab during pregnancy, before confirming recovery of B-cell counts as measured by CD19+ B cells.voclosporinvoclosporin decreases effects of pneumococcal vaccine 20-valent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment.Minor (0)delandistrogene moxeparvovecMonitor Closely (1)delandistrogene moxeparvovec, pneumococcal vaccine 20-valent. Other (see comment). Use Caution/Monitor. Comment: Consider patient vaccination status before initiating corticosteroid regimen required before delandistrogene moxeparvovec administration. If possible, ensure patients are current with all immunizations according to immunization guidelines. Complete vaccinations at least 4 weeks before starting corticosteroid regimen. High-dose or long-term corticosteroids may decrease immungenicity of vaccines.elivaldogene autotemcelSerious - Use Alternative (1)elivaldogene autotemcel, pneumococcal vaccine 20-valent. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .satralizumabMonitor Closely (1)satralizumab decreases effects of pneumococcal vaccine 20-valent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .teplizumabSerious - Use Alternative (1)teplizumab decreases effects of pneumococcal vaccine 20-valent by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.tralokinumabMonitor Closely (1)tralokinumab will decrease the level or effect of pneumococcal vaccine 20-valent by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.ublituximabMonitor Closely (1)ublituximab decreases effects of pneumococcal vaccine 20-valent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines at least 4 weeks before initiating ublituximab for live or live-attenuated vaccines and, whenever possible, at least 2 weeks before initiating for non-live vaccines. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion. Do not administer live or live-attenuated vaccines to infants of mothers exposed to ublituximab during pregnancy, before confirming recovery of B-cell counts as measured by CD19+ B cells.voclosporinMonitor Closely (1)voclosporin decreases effects of pneumococcal vaccine 20-valent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment. >10% Aged 18-59 years Pain at injection site (>70%) Muscle pain (>50%) Fatigue (>40%) Headache (>30%) Arthralgia (>10%) Injection site swelling (>10%) Aged ≥60 years Pain at injection site (>50%) Muscle pain (>30%) Fatigue (>30%) Headache (>20%) Arthralgia (>10%) Postmarketing Reports Based on experience with 13-valent pneumococcal vaccine Immune system disorders: Anaphylactic/anaphylactoid reaction, including shock Skin and subcutaneous tissue disorders: Angioneurotic edema, erythema multiforme Blood and lymphatic system disorders: Lymphadenopathy localized to injection site region General disorders and administration site conditions: Vaccination-site dermatitis, vaccination-site pruritus, vaccination-site urticaria Contraindications Severe allergic reaction (eg, anaphylaxis) to any component of the vaccine or to diphtheria toxoid Cautions Administer in medically supervised setting with treatments to manage acute allergic reactions Safety and immunogenicity data are not available for individuals in immunocompromised groups; based on experience with pneumococcal vaccines, individuals with altered immunocompetence may have reduced immune responses; consider vaccination on an individual basis Apnea following IM vaccination observed in some infants born prematurely; consider the individual's medical status and potential benefits and/or risks of vaccinating on whether to administer to a premature infant Drug interaction overview Receipt of the 23-valent pneumococcal vaccine 1-5 years prior resulted in diminished immune responses measured by opsonophagocytic activity (OPA) assay Individuals with impaired immune responsiveness owing to immunosuppressive therapy (eg, irradiation, corticosteroids, antimetabolites, alkylating agents, cytotoxic agents) may not respond optimally Pregnancy There are no adequate and well-controlled studies in pregnant females; data are insufficient to assess vaccine-associated risks in pregnancy Animal studies Female rabbits were administered the vaccine IM twice prior to mating (17 days and 4 days prior to mating) and twice during gestation (Gestation Days 10 and 24) with 0.5 mL/rabbit/occasion (a single human dose) No adverse effects on preweaning development observed There were no vaccine-related fetal malformations or variations Lactation Data are not available to assess effects on breastfed infants or on milk production/excretion Consider developmental and health benefits of breastfeeding along with the mother’s clinical need for vaccine and any potential adverse effects on breastfed child from vaccine or from underlying maternal condition; for preventive vaccines, the underlying maternal condition is susceptibility to disease as prevented by vaccinePregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Elicits antibodies in response to antigenic stimulation Protection against pneumococcal disease is conferred mainly by opsonophagocytic killing of S pneumoniae by generated antibodies Incompatibilities Do not mix with other vaccines/products in same syringe IM Preparation Step 1: Hold prefilled syringe horizontally between thumb and forefinger and shake vigorously until vaccine is a homogeneous white suspension; do not use if unable to resuspended Step 2: Visually inspect for large particulate matter and discoloration; do not use if observed; if vaccine is not a homogeneous suspension, repeat steps Step 3: Remove the syringe cap by slowly turning cap counterclockwise while holding the Luer lock adapter; avoid pressing syringe plunger rod while removing syringe cap Step 4: Attach sterile needle for IM administration IM Administration For IM injection only Storage Shipping: May arrive at temperatures between 2-25ºC (36-77ºF) Upon receipt, refrigerate at 2-8ºC (36-46ºF) Store syringes horizontally in refrigerator to minimize resuspension time Do not freeze; discard if frozen Administer as soon as possible after removed from refrigeration Can be administered provided total (cumulative multiple excursions) time out of refrigeration (at temperatures between 8-25ºC) does not exceed 96 hr; cumulative multiple excursions between 0-2ºC are also permitted as long as total time does not exceed 72 hr; these are not, however, recommendations for storage Tip cap and plunger stopper do contain natural rubber latex No images available for this drug. 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