Pneumococcal polysaccharide conjugate vaccine 13-valent (adsorbed)

Pneumococcal polysaccharide conjugate vaccine 13-valent (adsorbed) is used for: Active immunization for the prevention of pneumococcal disease (including pneumonia & invasive disease) caused by Strep pneumoniae Pneumococcal vaccine 13-valent (PCV13) 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, 9V, 14, 18C, 19A, 19F and 23F Immunocompromised adults aged ≥19 years: ACIP guidelines recommend use for adults with immunocompromising conditions, cerebrospinal fluid leak, or cochlear implant Immunocompetent adults aged ≥65 years: Need for vaccination based on shared decision making between patient and clinician (ie, no longer routinely recommended for all adults aged ≥65 yr)

Injection Cerebrospinal fluid leak or cochlear implant 1 dose PCV13 followed by 1 dose pneumococcal vaccine polyvalent (PPSV23) at least 8 weeks later At age >65 yr, administer another dose PPSV23 at least 5 yr after previous PPSV23 Note: Only 1 dose PPSV23 recommended at age >65 yr Immunocompromised adults aged 19 yr or older 1 dose PCV13 followed by 1 dose PPSV23 at least 8 weeks later, THEN another dose PPSV23 at least 5 yr after previous PPSV23 At age >65 yr, administer 1 dose PPSV23 at least 5 yr after most recent PPSV23 Note: Only 1 dose PPSV23 recommended at age ?65 yr

Injection Streptococcus pneumoniae Immunization Routine vaccination: 4-dose series at ages 2, 4, and 6 months and at age 12-15 months Aged 6 weeks through 17 years: Indicated for active immunization to prevent invasive disease caused by S pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F Aged 6 weeks through 5 years: Also indicated for prevention of otitis media caused by S pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F Dose: 0.5 mL IM Aged 6 weeks through 5 years Routine vaccination: 4-dose series at ages 2, 4, and 6 months and at age 12-15 months May administer 1st dose as early as age 6 weeks Dosing interval between 1st and 2nd doses, and 2nd and 3rd doses is 4-8 weeks Administer 4th dose at approximately age 12-15 months, and at least 2 months after 3rd dose For children aged 14 through 59 months who have received an age-appropriate series of 7-valent PCV (PCV7), administer a single supplemental dose of 13-valent PCV (PCV13) Catch-up vaccination: Administer 1 dose of PCV13 to all healthy children aged 24 through 59 months who are not completely vaccinated for their age Dosage for high risk 2-5 years olds 1. Administer 1 dose of PCV13 if 3 doses of PCV (7- or 13-valent) were received previously 2. Administer 2 doses of PCV at least 8 weeks apart if fewer than 3 doses of PCV13 were received previously 3. Administer 1 supplemental dose of PCV13 if 4 doses of PCV7 or other age-appropriate complete PCV7 series was received previously 4. The minimum interval between doses of PCV is 8 wk 5. For children with no history of PPSV23 vaccination, administer PPSV23 at least 8 wk after the most recent dose of PCV13 0.5 mL (1 dose) IM. Childn 24 mth-17 yr Single dose. If previously vaccinated w/ >1 dose of pneumococcal 7-valent conjugate vaccine, then at least 8 wk should elapse before vaccination. Infant & toddler Vaccination schedule: 1st dose at 2 mth (dose may be given as early as 6 wk); 2nd dose at 4 mth & 3rd dose at 6 mth (dosing interval of 4-8 wk); 4th dose at approx 12-15 mth & at least 2 mth after 3rd dose. As part of routine infant immunization program 3-dose schedule: 1st dose at 2 mth, 2nd dose at 2 mth later & 3rd (booster) dose between 11-15 mth. Patient w/ higher risk of pneumococcal infection (eg, sickle cell disease or HIV infection) May receive at least 1 dose, including those previously vaccinated w/ >1 dose of 23-valent pneumococcal polysaccharide vaccine. Patient w/ hematopoietic stem cell transplant (HSCT) 4-dose (0.5 mL/dose) immunization series: Primary series (3 doses): 1st dose given 3-6 mth after HSCT & w/ interval of at least 1 mth between doses; Booster dose: 6 mth after 3rd dose.

IM Preparation Shake vigorously immediately prior to use to obtain a homogenous, white suspension in the vaccine container Do not use if it cannot be resuspended Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration This product should not be used if particulate matter or discoloration is found IM Administration Adults: IM into the deltoid muscle Pediatrics: IM in anterolateral aspect of thigh for infants, or deltoid muscle of upper arm in toddlers or young children Immunocompetent adults aged 65 yr or older Based on shared clinical decision making If both PCV13 and PPSV23 administered, PCV13 should be administered first PCV13 and PPSV23 should be administered at least 1 year apart Do not administer during the same visit

Documented hypersensitivity to any component or diphtheria toxoid

Do not administer intravascularly; not to be injected in gluteal area. Postpone administration in patients suffering from acute severe febrile illness. Thrombocytopenia or any coagulation disorder, or to those receiving anticoagulant therapy. Individuals in specific immunocompromised groups (eg, malignancy or nephrotic syndrome). Vaccination should be considered on an individual basis. Childn >24 mth w/ sickle cell disease, asplenia, HIV infection, chronic illness, or who are otherwise immunocompromised. Risk of apnea in premature infants; monitor for at least 48 hr after vaccination in very premature infants (gestation ≤30 wk). Concomitant use w/ combined diphtheria-tetanus-acellular pertussis hepatitis B, enhanced inactivated polio vaccine & Haemophilus influenza type B vaccine.

Pregnancy Category: C Lactation: Safety during lactation has not been established. It is not known whether vaccine antigens or antibodies are excreted in human milk.

May reduce immune response w/ paracetamol in infants.

Side effects of Pneumococcal polysaccharide conjugate vaccine 13-valent (adsorbed) : >10% Fever Irritability Altered sleep duration (increased or decreased) Decreased appetite Redness, swelling, and tenderness at injection site

Elicits antibodies in response to antigenic stimulation Capsular polysaccharide vaccine against 13 strains of pneumococci, conjugated to nontoxic diphtheria protein Pneumococcal Conjugate Vaccine, 13-Valent (adsorbed) (Prevenar 13) contains the 7 pneumococcal capsular polysaccharides that are in pneumococcal 7-valent conjugate vaccine (4, 6B, 9V, 14, 18C, 19F, 23F) plus 6 additional polysaccharides (1, 3, 5, 6A, 7F, 19A) all conjugated to CRM197 carrier protein. B cells produce antibodies in response to antigenic stimulation via T-dependent and T-independent mechanisms. The immune response to most antigens is T-dependent and involves the collaboration of CD4+ T cells and B cells, recognizing the antigen in a linked fashion. CD4+ T cells (T-helper cells) provide signals to B-cells directly through cell surface protein interactions, and indirectly through the release of cytokines. These signals result in proliferation and differentiation of the B cells, and production of high-affinity antibodies. CD4+ T cell signaling is a requisite for the generation of long-lived B cells called plasma cells, which continuously produce antibodies of several isotypes (with an IgG component) and memory B cells that rapidly mobilize and secrete antibodies upon re-exposure to the same antigen. Bacterial capsular polysaccharides (PSs), while varied in chemical structure, share the common immunological property of being largely T-independent antigens. In the absence of T-cell help, PS-stimulated B-cells predominantly produce IgM antibodies; there is generally no affinity maturation of the antibodies, and no memory B-cells are generated. As vaccines, PSs are associated with poor or absent immunogenicity in infants less than 24 months of age and failure to induce immunological memory at any age. Conjugation of PSs to a protein carrier overcomes the T-cell-independent nature of PS antigens. Protein carrier-specific T cells provide the signals needed for maturation of the B cell response and generation of B cell memory. Conversion of Streptococcus pneumoniae PSs to a T-cell dependent antigen by covalent coupling to the immunogenic protein carrier CRM197 enhances the antibody response and induces immune memory. This has been demonstrated to elicit booster responses on re-exposure in infants and young children to pneumococcal polysaccharides.