Dosing & Uses
Dosage Forms & Strengths
injection, IM suspension
- 0.5mL single-dose prefilled syringe
Streptococcus pneumoniae Immunization
Pneumococcal vaccine 20-valent (PCV20) is indicated 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
<18 years: Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (2)
- elivaldogene autotemcel
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. .
- teplizumab
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.
Monitor Closely (4)
- satralizumab
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. .
- tralokinumab
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.
- ublituximab
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.
- voclosporin
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.
Minor (0)
Adverse Effects
>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
Warnings
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
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 & Lactation
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 vaccine
Pregnancy 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.Pharmacology
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
Administration
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
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