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  • CLASSES

    Pneumococcal Vaccines

    DEA CLASS

    Rx

    DESCRIPTION

    Protects against serious pneumococcal infection
    Contain capsular polysaccharides from S. pneumoniae; 4 polyvalent vaccines available, 13-valent conjugated vaccine (Prevnar 13), 15-valent conjugated vaccine (Vaxneuvance), 20-valent conjugated vaccine (Prevnar 20), and non-conjugated 23-valent vaccine (Pneumovax 23)
    Only Prevnar 13 is immunogenic in children younger than 2 years of age

    COMMON BRAND NAMES

    Pneumovax 23, Prevnar 13

    HOW SUPPLIED

    Pneumovax 23 Intramuscular Inj Sol
    Pneumovax 23 Subcutaneous Inj Sol
    Prevnar 13 Intramuscular Inj Susp

    DOSAGE & INDICATIONS

    For pneumococcal prophylaxis.
    For routine prophylaxis of infants and children as part of the primary childhood immunization schedule.
    Intramuscular dosage (Prevnar 13 only)
    Children 24 to 71 months of age at first dose

    0.5 mL IM for 1 dose prior to the sixth birthday. The FDA-approved product labeling recommends a single dose for patients 15 to 71 months of age whereas the ACIP recommends a single dose for all children 24 to 59 months of age and for all children 60 to 71 months of age with underlying medical conditions.[39165] [53026]

    Children 12 to 23 months of age at first dose

    0.5 mL IM for 2 doses administered at least 2 months apart.

    Infants 7 to 11 months of age at first dose

    0.5 mL IM for 3 doses. Give the first 2 doses 4 to 8 weeks apart. The third dose should ideally be given at 12 to 15 months; it must be separated from the second dose by 2 months or more and given after the first birthday.

    Infants 6 weeks to 6 months of age at first dose

    0.5 mL IM for a total of 4 doses. Give the first 3 doses at intervals of 4 to 8 weeks, ideally at 2, 4, and 6 months of age; the first dose can be given as young as 6 weeks. The fourth dose is given as a booster between 12 to 15 months of age and at least 8 weeks after the third dose.

    For routine prophylaxis of healthy adults, adolescents, and children 6 years and older.
    Intramuscular or Subcutaneous dosage (Pneumovax 23 only)
    Adults 50 to 64 years

    0.5 mL IM or subcutaneously once.

    Intramuscular dosage (Prevnar 13 only)
    Adults 18 to 64 years

    0.5 mL IM once.

    Children and Adolescents 6 to 17 years

    0.5 mL IM once.

    Intramuscular dosage (Prevnar 20 only)
    Adults 18 to 64 years

    0.5 mL IM once.

    Intramuscular dosage (Vaxneuvance only)
    Adults 18 to 64 years

    0.5 mL IM once.

    For routine prophylaxis of healthy geriatric patients.
    NOTE: The Advisory Committee on Immunization Practices (ACIP) recommends shared clinical decision-making regarding administration of PCV13 in patients 65 years of age and older who are at increased risk (e.g., patients residing in long-term care facilities, in areas with low childhood PCV13 uptake, or when traveling to areas with no pediatric PCV13 program). Routine vaccination with a single dose of PPSV23 is recommended for all patients.[53026] [64773]
    Intramuscular dosage (Prevnar 13)
    Geriatric patients

    0.5 mL IM once then 1 dose of PPSV23 at least 1 year after PCV13.

    Intramuscular or Subcutaneous dosage (Pneumovax 23)
    Geriatric patients

    0.5 mL IM or subcutaneously once. Administer at least 1 year after PCV13 if PCV13 was previously given.

    Intramuscular dosage (Prevnar 20 only)
    Geriatric patients

    0.5 mL IM once.

    Intramuscular dosage (Vaxneuvance only)
    Geriatric patients

    0.5 mL IM once.

    For invasive pneumococcal prophylaxis in high-risk patients (e.g. chronic heart disease, chronic lung disease [e.g., asthma treated with high-dose oral corticosteroids], diabetes mellitus).
    Intramuscular dosage (Prevnar 13)
    Geriatric patients

    0.5 mL IM once then 1 dose of PPSV23 at least 1 year after PCV13 and at least 5 years after a previous dose of PPSV23 if administered prior to age 65. The Advisory Committee on Immunization Practices (ACIP) recommends shared clinical decision-making regarding administration of PCV13 in patients 65 years of age and older who are at increased risk (e.g. patients residing in long-term care facilities, in areas with low childhood PCV13 uptake, or when traveling to areas with no pediatric PCV13 program). Routine vaccination with a single dose of PPSV23 is recommended for all patients.

    Children 2 to 5 years of age

    If 3 doses of PCV13 were received previously, give one 0.5 mL dose IM at least 8 weeks after the last PCV13 dose. If less than 3 doses of PCV13 were received previously, give 2 doses at least 8 weeks apart. Children who have received a dose of PPSV23 should also receive the recommended PCV13 doses. If not previously received, a dose of PPSV23 is needed at least 8 weeks after the last PCV13 dose.

    Intramuscular or Subcutaneous dosage (Pneumovax 23)
    Geriatric patients

    0.5 mL IM or subcutaneously once. Administer at least 1 year after PCV13 if PCV13 was previously given and at least 5 years after a previous dose of PPSV23 if administered prior to age 65.

    Adults 19 to 64 years who are PPSV23-naive

    0.5 mL IM or subcutaneously once.

    Adults 18 years who are PPSV23-naive

    0.5 mL IM or subcutaneously once at least 8 weeks after the last dose of PCV13.

    Children and Adolescents 2 to 17 years who are PPSV23-naive

    0.5 mL IM or subcutaneously once at least 8 weeks after the last dose of PCV13.

    For invasive pneumococcal prophylaxis in high-risk patients (e.g. cerebrospinal fluid leak, cochlear implant).
    Intramuscular dosage (Prevnar 13)
    Adults 19 years and older

    0.5 mL of PCV13 IM once, followed at least 8 weeks later by a dose of PPSV23. Geriatric patients who received original PPSV23 vaccination before age 65, should receive another PPSV23 dose at or after age 65 years if at least 5 years have elapsed since the previous dose.

    Adults 18 years who are PCV13-naive and PPSV23-naive

    0.5 mL of PCV13 IM once, followed at least 8 weeks later by a dose of PPSV23.

    Adults 18 years old who are PCV13-naive, but received previous vaccination with PPSV23

    0.5 mL of PCV13 IM once at least 8 weeks after the last PPSV23 dose.

    Children and Adolescents 6 to 17 years who are PCV13-naive and PPSV23-naive

    0.5 mL of PCV13 IM once, followed at least 8 weeks later by a dose of PPSV23.

    Children and Adolescents 6 to 17 years who are PCV13-naive, but received previous vaccination with PPSV23


    0.5 mL of PCV13 IM once at least 8 weeks after the last PPSV23 dose.

    Children 2 to 5 years

    If 3 doses of PCV13 were received previously, give one 0.5 mL dose IM at least 8 weeks after the last PCV13 dose. If less than 3 doses of PCV13 were received previously, give 2 doses at least 8 weeks apart and at least 8 weeks after the last PCV13 dose. Children who have received a dose of PPSV23 should also receive the recommended PCV13 doses. If not previously received, a dose of PPSV23 is needed at least 8 weeks after the last PCV13 dose.

    Intramuscular or Subcutaneous dosage (Pneumovax 23)
    Adults 19 years and older

    0.5 mL IM or subcutaneously once at least 8 weeks after the last dose of PCV13. Geriatric patients who received original PPSV23 vaccination before age 65, should receive another PPSV23 dose at or after age 65 years if at least 5 years have elapsed since the previous dose.

    Adults 18 years who are PPSV23-naive

    0.5 mL IM or subcutaneously once at least 8 weeks after the last dose of PCV13.

    Children and Adolescents 2 to 17 years who are PPSV23-naive

    0.5 mL IM or subcutaneously once at least 8 weeks after the last dose of PCV13.

    For invasive pneumococcal prophylaxis in high-risk patients (e.g. sickle cell disease and other hemoglobinopathies, anatomic or functional asplenia, congenital or acquired immunodeficiency, HIV infection, chronic renal failure, nephrotic syndrome, malignant neoplasms, leukemias, lymphomas, Hodgkin disease, solid organ transplantation, multiple myeloma, iatrogenic immunosuppression from drug or radiation therapy).
    Intramuscular dosage (Prevnar 13)
    Adults 19 years and older

    0.5 mL of PCV13 IM once, followed at least 8 weeks later by PPSV23. A second PPSV23 vaccination is recommended 5 years after the first dose. Geriatric patients who received original PPSV23 vaccination before age 65, should receive another PPSV23 dose at or after age 65 years if at least 5 years have elapsed since the previous dose.

    Adults 18 years who are PCV13-naive and PPSV23-naive

    0.5 mL of PCV13 IM once, followed at least 8 weeks later by a dose of PPSV23. A second PPSV23 vaccination is recommended 5 years after the first dose of PPSV23 (Max: 2 doses of PPSV23 before age 65 years).

    55134

    Adults 18 years who received previous vaccination with PPSV23

    0.5 mL of PCV13 IM once at least 8 weeks after the last PPSV23 dose. A second PPSV23 vaccination is recommended 5 years after the first dose of PPSV23 and at least 8 weeks after a dose of PCV13 (Max: 2 doses of PPSV23 before age 65 years).

    Children and Adolescents 6 to 17 years who are PCV13-naive and PPSV23-naive

    0.5 mL of PCV13 IM once, followed at least 8 weeks later by a dose of PPSV23. A second PPSV23 vaccination is recommended 5 years after the first dose of PPSV23 (Max: 2 doses of PPSV23 before age 65 years).

    Children and Adolescents 6 to 17 years who received previous vaccination with PPSV23


    0.5 mL of PCV13 IM once at least 8 weeks after the last PPSV23 dose. A second PPSV23 vaccination is recommended 5 years after the first dose of PPSV23 and at least 8 weeks after a dose of PCV13 (Max: 2 doses of PPSV23 before age 65 years).

    Children 2 to 5 years


    If 3 doses of PCV13 were received previously, give one 0.5 mL dose IM at least 8 weeks after the last PCV13 dose. If less than 3 doses of PCV13 were received previously, give 2 doses at least 8 weeks apart. Children who have received a dose of PPSV23 should also receive the recommended PCV13 doses. If not previously received, 2 doses of PPSV23 are needed; first PPSV23 dose at least 8 weeks after the last PCV13 dose and second PPSV23 dose 5 years later.

    Intramuscular or Subcutaneous dosage (Pneumovax 23)
    Adults 19 years and older

    0.5 mL IM or subcutaneously once at least 8 weeks after the last dose of PCV13. A second PPSV23 vaccination is recommended 5 years after the first dose of PPSV23. Geriatric patients who received original vaccination before age 65, should receive another PPSV23 dose at or after age 65 years if at least 5 years have elapsed since the previous dose. For adults with HIV and CD4 counts less than 200 cells/mm3, the PPSV23 can be offered; however, it may be beneficial to wait until the CD4 count increases to more than 200 cells/mm3.

    Adults 18 years who are PPSV23-naive

    0.5 mL IM or subcutaneously once at least 8 weeks after the last dose of PCV13. A second PPSV23 vaccination is recommended 5 years after the first dose of PPSV23 (Max: 2 doses of PPSV23 before age 65 years). For adults with HIV and CD4 counts less than 200 cells/mm3, the PPSV23 can be offered; however, it may be beneficial to wait until the CD4 count increases to more than 200 cells/mm3.

    Children and Adolescents 2 to 17 years who are PPSV23-naive

    0.5 mL IM or subcutaneously once at least 8 weeks after the last dose of PCV13. A second PPSV23 vaccination is recommended 5 years after the first dose of PPSV23 (Max: 2 doses of PPSV23 before age 65 years). For adolescents with HIV and CD4 counts less than 200 cells/mm3, the PPSV23 can be offered; however, it may be beneficial to wait until the CD4 count increases to more than 200 cells/mm3.

    For invasive pneumococcal prophylaxis in high-risk patients (e.g. chronic liver disease or alcoholism).
    Intramuscular dosage (Prevnar 13)
    Geriatric patients

    0.5 mL IM once then 1 dose of PPSV23 at least 1 year after PCV13 and at least 5 years after a previous dose of PPSV23 if administered prior to age 65. The Advisory Committee on Immunization Practices (ACIP) recommends shared clinical decision-making regarding administration of PCV13 in patients 65 years of age and older who are at increased risk (e.g. patients residing in long-term care facilities, in areas with low childhood PCV13 uptake, or when traveling to areas with no pediatric PCV13 program). Routine vaccination with a single dose of PPSV23 is recommended for all patients.

    Intramuscular or Subcutaneous dosage (Pneumovax 23)
    Geriatric patients


    0.5 mL IM or subcutaneously once. Administer at least 1 year after PCV13 if PCV13 was previously given and at least 5 years after a previous dose of PPSV23 if administered prior to age 65.

    Adults 19 to 64 years who are PPSV23-naive

    0.5 mL IM or subcutaneously once.

    Adults 18 years who are PPSV23-naive

    0.5 mL IM or subcutaneously once at least 8 weeks after the last dose of PCV13.

    Children and Adolescents 6 to 17 years who are PPSV23-naive

    0.5 mL IM or subcutaneously once at least 8 weeks after PCV13 administration.

    For invasive pneumococcal prophylaxis in high-risk patients (e.g. cigarette smoking).
    Intramuscular dosage (Prevnar 13)
    Geriatric patients who are PCV13-naive


    0.5 mL IM once then 1 dose of PPSV23 at least 1 year after PCV13 and at least 5 years after a previous dose of PPSV23 if administered prior to age 65. The Advisory Committee on Immunization Practices (ACIP) recommends shared clinical decision-making regarding administration of PCV13 in patients 65 years of age and older who are at increased risk (e.g. patients residing in long-term care facilities, in areas with low childhood PCV13 uptake, or when traveling to areas with no pediatric PCV13 program). Routine vaccination with a single dose of PPSV23 is recommended for all patients.

    Intramuscular or Subcutaneous dosage (Pneumovax 23)
    Geriatric patients

    0.5 mL IM or subcutaneously once. Administer at least 1 year after PCV13 if PCV13 was previously given and at least 5 years after a previous dose of PPSV23.

    Adults 19 to 64 years who are PPSV23-naive


    0.5 mL IM or subcutaneously once.

    For otitis media prophylaxis in infants and children younger than 6 years.
    Intramuscular dosage (Prevnar 13 only)
    Children 24 to 71 months of age at first dose

    0.5 mL IM for 1 dose prior to the sixth birthday. The manufacturer recommends a single dose for patients 15 to 71 months of age whereas the ACIP recommends a single dose for all children 14 to 59 months of age and for all children 60 to 71 months of age with underlying medical conditions.

    Children 12 to 23 months of age at first dose

    0.5 mL IM for 2 doses administered at least 2 months apart.

    Infants 7 to 11 months of age at first dose

    0.5 mL IM for 3 doses. Give the first 2 doses 4 to 8 weeks apart. The third dose should ideally be given at 12 to 15 months; it must be separated from the second dose by 2 months or more and given after the first birthday.

    Infants 6 weeks to 6 months of age at first dose


    0.5 mL IM for a total of 4 doses. Give the first 3 doses at intervals of 4 to 8 weeks, ideally at 2, 4, and 6 months of age; the first dose can be given as young as 6 weeks. The fourth dose is given as a booster between 12 to 15 months of age and at least 8 weeks after the third dose.

    MAXIMUM DOSAGE

    Adults

    0.5 mL/dose IM or subcutaneous for Pneumovax 23; 0.5 mL/dose IM for Prevnar 13, Prevnar 20, and Vaxneuvance.

    Geriatric

    0.5 mL/dose IM or subcutaneous for Pneumovax 23; 0.5 mL/dose IM for Prevnar 13, Prevnar 20, and Vaxneuvance.

    Adolescents

    0.5 mL/dose IM or subcutaneous for Pneumovax 23; 0.5 mL/dose IM for Prevnar 13; safety and efficacy have not been established for Prevnar 20 and Vaxneuvance.

    Children

    2 to 12 years: 0.5 mL/dose IM or subcutaneous for Pneumovax 23; 0.5 mL/dose IM for Prevnar 13; safety and efficacy have not been established for Prevnar 20 and Vaxneuvance.
    1 year: 0.5 mL/dose IM for Prevnar 13; safety and efficacy have not been established for Pneumovax 23, Prevnar 20, and Vaxneuvance.

    Infants

    6 weeks and older: 0.5 mL/dose IM for Prevnar 13; safety and efficacy have not been established for Pneumovax 23, Prevnar 20, and Vaxneuvance.
    Younger than 6 weeks: Do not use.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

    Renal Impairment

    Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

    ADMINISTRATION

    Health care professionals administering vaccines should take appropriate precautions to prevent allergic reactions in vaccine recipients.
    Inform the patient, parent, guardian, or responsible adult of the benefits and risks of the vaccine. Provide the Vaccine Information Statements from the manufacturer to the recipient or guardian before each immunization. The action is required by the National Childhood Vaccine Injury Act of 1986.
    Per U.S. federal law, record the manufacturer and lot number of the vaccine; date of administration; and the name, address, and title of the person who administered the vaccine in the recipient's permanent medical record.

    Injectable Administration

    Visually inspect parenteral products for particulate matter and discoloration prior to administration.
    Prevnar 13: Administer by intramuscular (IM) injection only.
    Prevnar 20: Administer by intramuscular (IM) injection only.
    Pneumovax 23: May give intramuscularly (IM) or subcutaneously.
    Vaxneuvance: Administer by intramuscular (IM) injection only.
     
    Prevnar 13 preparation:
    No dilution or reconstitution is necessary. Aseptic technique must be observed. Use a separate syringe and needle for each patient.
    Shake the vial well immediately before use to re-suspend the vaccine into a homogenous suspension. Do not use the vaccine if it cannot be re-suspended.
    Do not mix with any other vaccine in the same syringe.
     
    Prevnar 20 preparation:
    Shake the pre-filled syringe horizontally to re-suspend the vaccine into a homogenous white suspension. Do not use the vaccine if it cannot be re-suspended. Do not use if large particulate matter or discoloration is found.
    Do not mix with any other vaccine in the same syringe.
     
    Pneumovax 23 preparation:
    No dilution or reconstitution is necessary. Aseptic technique must be observed. Use a separate syringe and needle for each patient.
    The vaccine is a clear and colorless solution. Do not use if discolored or contains a precipitate.
     
    Vaxneuvance preparation:
    Shake the pre-filled syringe horizontally to re-suspend the vaccine into an opalescent suspension. Do not use the vaccine if it cannot be re-suspended. Do not use if particulate matter or discoloration is found.
    Do not mix with any other vaccine in the same syringe.

    Intramuscular Administration

    Pneumovax 23 or Prevnar 13:
    Adults: Inject IM into the deltoid muscle or into the anterolateral thigh muscle.
    Toddlers and young children: Inject IM into the deltoid muscle of the upper arm. Do not inject in the gluteal area or other areas where there may be a major nerve trunk and/or blood vessel.
    Infants: Inject IM into the anterolateral thigh muscle. Do not inject in the gluteal area or other areas where there may be a major nerve trunk and/or blood vessel.
     
    Prevnar 20 or Vaxneuvance:
    Adults: Inject IM into the deltoid muscle or into the anterolateral thigh muscle.

    Subcutaneous Administration

    Pneumovax 23 only:
    Inject subcutaneously into the outer aspect of the upper arm. Care should be taken to avoid intradermal injection.

    STORAGE

    Pneumovax 23:
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Store between 36 to 46 degrees F
    Prevnar:
    - Protect from freezing
    - Refrigerate (between 36 and 46 degrees F)
    Prevnar 13 :
    - Discard if product has been frozen
    - Do not freeze
    - Refrigerate (between 36 and 46 degrees F)

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    Pneumococcal vaccines are contraindicated in patients who have had a previous hypersensitivity reaction to the vaccine to be administered or to any components of the vaccine. Prevnar 13, Prevnar 20, and Vaxneuvance are contraindicated in patients who have had a hypersensitivity reaction to any diphtheria toxoid-containing vaccine. As with any biologic product, the prescriber or health care professional should have procedures in place to manage allergic reactions. The health care professional should have immediate availability of epinephrine (1 mg/mL) injection and other agents used in the treatment of severe anaphylaxis in the event of a serious allergic reaction to the pneumococcal vaccines.

    Intravenous administration

    Do not give the pneumococcal vaccines via intravenous administration. Prior to administration, health care personnel should inform the patient, parent, guardian, or responsible adult of the vaccine's benefits and risks. This should include the provision of the vaccine information statement from the manufacturer. The responsible adult should report any adverse reaction after vaccine administration to the health care provider. The US Department of Health and Human Services has established a Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine. This includes, but is not limited to, the reporting of events required by the National Childhood Vaccine Injury Act of 1986. The toll-free number for VAERS is (800) 822-7967.

    Fever

    Pneumococcal vaccine can cause fever, so it should not be given to patients with fever of unknown etiology. During the 2010-2011 influenza season, there were increased reports of febrile seizures in children 6 months to 4 years of age receiving the inactivated influenza vaccine and the conjugated pneumococcal vaccine (Prevnar 13) concomitantly. At this time the CDC is not recommending any changes to the childhood immunization schedule, and based on the benefits of timely vaccination against these diseases, they are also not recommending that the vaccines be separated into multiple healthcare visits. The CDC found that febrile seizures were rare in this group with approximately one additional seizure occurring for every 2000—3000 children vaccinated. Febrile seizures occurred most commonly in children 12—23 months of age who received both vaccines at the same healthcare visit.

    Idiopathic thrombocytopenic purpura (ITP)

    Use pneumococcal vaccine with caution in patients with immune thrombocytopenic purpura (ITP) because pneumococcal vaccination has been associated with relapse of this condition in previously stabilized patients.

    Cardiac disease, pulmonary disease

    Use pneumococcal vaccine cautiously in patients with severe cardiac disease or pulmonary disease because anaphylactoid reactions may not be well tolerated in these individuals.

    Chemotherapy, Hodgkin's disease, immunosuppression, organ transplant, radiation therapy

    Pneumococcal vaccine should be given at least 2 weeks before elective splenectomy, organ transplant, immunosuppressive therapy, or chemotherapy. Patients with severe immunosuppression can have a suboptimal antibody response to vaccination. The formerly-available 12 valent pneumococcal vaccine was less immunogenic in patients with Hodgkin lymphoma who had received intensive chemo- or radio-therapy. Furthermore, the 12 valent vaccine has been shown to decrease preexisting antibody concentrations to other strains of pneumococcus. Because of this, the 23 valent pneumococcal vaccine is not indicated in Hodgkin lymphoma patients who have received intensive chemotherapy and/or radiation therapy. In patients (age 2 to 71 years) who received an allogeneic hematopoietic stem cell transplant 3 to 6 months prior to a series of PCV13 vaccines, sera was obtained approximately one month after each vaccination. Immune responses (IgG GMCs) were numerically higher after the first dose compared with baseline and were, similarly, numerically higher after each subsequent dose compared to the previous dose.

    Acquired immunodeficiency syndrome (AIDS), human immunodeficiency virus (HIV) infection

    Compared to healthy individuals, patients with human immunodeficiency virus (HIV) infection generally have lower vaccine-induced antibody concentrations, which are proportional to the severity of infection (i.e., CD4 counts) and are lowest in those with acquired immunodeficiency syndrome (AIDS). The 13-valent pneumococcal conjugate vaccine (PCV13) may be administered to all persons with HIV, regardless of CD4 counts. In those who receive the PCV13 when the CD4 count is less than 200 cells/mm3, some experts may choose to defer the 23-valent pneumococcal polysaccharide vaccine (PPV23) until CD4 counts are above 200 cells/mm3 in order to optimize vaccine efficacy. Vaccination is increasingly pertinent with the rising incidence of drug-resistant S. pneumoniae infections. Pneumococcal vaccine can be administered to pregnant patients. In studies evaluating antibody response to the pneumococcal conjugate vaccine (PCV13) in children and adults with HIV infection, antipneumococcal opsonophagocytic activity (OPA) geometric mean antibody titers (GMTs) for all vaccine serotypes were higher than pre-vaccination concentrations after the first dose, and were generally comparable after subsequent doses.

    Children, infants

    The efficacy of pneumococcal 23-valent vaccine (Pneumovax 23) is reduced in children younger than 5 years, and it is not recommended in infants and children younger than 2 years of age. The conjugated pneumococcal vaccine (Prevnar 13) is safe and effective for routine pneumococcal prophylaxis in healthy infants older than 6 weeks of age and children younger than 18 years of age. However, safety and efficacy data are limited regarding use of Prevnar 13 in immunocompromised pediatric patients. Immunocompromised patients may display reduced antibody response to the Prevnar 13; therefore, Prevnar 13 does not replace vaccination with Pneumovax 23 in children 2 years of age and older with sickle cell disease, asplenia, chronic illnesses, or other immune-compromising conditions. In addition, apnea has occurred in some premature infants after intramuscular injections; therefore, carefully consider the possible risks and benefits prior to intramuscular vaccine administration in premature infants. During the 2010-2011 influenza season, there were increased reports of febrile seizures in children 6 months to 4 years of age receiving the inactivated influenza vaccine and the conjugated pneumococcal vaccine (Prevnar 13) concomitantly. At this time, the CDC is not recommending any changes to the childhood immunization schedule, and based on the benefits of timely vaccination against these diseases, separating the vaccines into multiple healthcare visits also is not being recommended. The CDC found that febrile seizures were rare in this group with approximately 1 additional seizure occurring for every 2,000 to 3,000 children vaccinated. Febrile seizures occurred most commonly in children 12 to 23 months of age who received both vaccines at the same healthcare visit.

    Neonates, premature neonates

    Apnea has occurred in some premature neonates and infants after intramuscular injections. The risks and benefits of intramuscular injections, including vaccination with the pneumococcal vaccine, must be considered on an individual patient basis. In addition, health care providers are advised that immunogenicity may be lower in premature neonates. In one study, premature neonates (< 37 weeks gestational age; n = 100) receiving Prevnar 13 on a non-United States 4 dose schedule displayed lower serotype-specific IgG antibody responses after the 3rd and 4th doses when compared to term neonates (>= 37 weeks gestational age; n = 100). Safety and efficacy have not been established for Prevnar 13 in infants < 6 weeks of age; Pneumovax 23 is not recommended for use in infants.

    Pregnancy

    Available data on pneumococcal vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. No adequate and well controlled studies have been conducted in pregnant women. In rabbits, a dose approximately 20 times the human dose, given prior to mating and during gestation, did not impair female fertility and no fetal malformations were noted. According to the Advisory Committee on Immunization Practices (ACIP), administration of inactivated vaccines to pregnant women has not resulted in adverse effects in the fetus. The ACIP recommends vaccination during pregnancy when the likelihood of disease exposure is high, potential infection would cause harm to mother or fetus, and when the vaccine is unlikely to cause harm. The FDA-approved product labeling recommends administration of the vaccine only if clearly needed.

    Breast-feeding

    Data are limited regarding use of the pneumococcal vaccine during breast-feeding and its' excretion in human breast milk is unknown. The manufacturer recommends caution when administering to nursing mothers; however according to the Advisory Committee on Immunization Practices (ACIP), inactivated vaccines pose no risk for mothers or their infants. Additionally, breast-feeding does not adversely affect immunization; limited data suggest breast-feeding may enhance the immune response to certain vaccine antigens. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.

    Anticoagulant therapy, coagulopathy, hemophilia, thrombocytopenia, vitamin K deficiency

    The pneumococcal vaccine, polyvalent is indicated for intramuscular administration. Therefore, the vaccine should be given cautiously to persons receiving anticoagulant therapy. Also, patients with thrombocytopenia, coagulopathy (e.g., hemophilia), other bleeding disorders, or vitamin K deficiency should be monitored closely for bleeding at the IM injection site. Steps to avoid hematoma formation are recommended.

    ADVERSE REACTIONS

    Severe

    seizures / Delayed / 0-1.0
    bronchospasm / Rapid / 0-1.0
    skin necrosis / Early / Incidence not known
    hemolytic anemia / Delayed / Incidence not known
    aplastic anemia / Delayed / Incidence not known
    Guillain-Barre syndrome / Delayed / Incidence not known
    serum sickness / Delayed / Incidence not known
    erythema multiforme / Delayed / Incidence not known
    anaphylactic shock / Rapid / Incidence not known
    angioedema / Rapid / Incidence not known
    anaphylactoid reactions / Rapid / Incidence not known

    Moderate

    erythema / Early / 10.8-70.0
    dyspnea / Early / 0-1.0
    lymphadenopathy / Delayed / Incidence not known
    thrombocytopenia / Delayed / Incidence not known
    Arthus reaction / Early / Incidence not known
    hypotonia / Delayed / Incidence not known

    Mild

    irritability / Delayed / 14.3-85.6
    headache / Early / 15.9-81.4
    fatigue / Early / 13.2-80.5
    drowsiness / Early / 2.6-71.5
    myalgia / Early / 11.9-61.8
    anorexia / Delayed / 10.4-56.7
    insomnia / Early / 6.8-47.7
    chills / Rapid / 2.7-38.1
    fever / Early / 0.3-36.5
    arthralgia / Delayed / 7.7-31.5
    infection / Delayed / 0.5-2.6
    nausea / Early / 1.8-1.8
    pruritus / Rapid / 0.2-1.6
    ecchymosis / Delayed / 1.1-1.1
    dyspepsia / Early / 1.1-1.1
    pharyngitis / Delayed / 0.4-1.1
    urticaria / Rapid / 0-1.0
    back pain / Delayed / 0.9-0.9
    rash / Early / 1.0
    vomiting / Early / 0.9
    diarrhea / Early / 0.7
    malaise / Early / Incidence not known
    injection site reaction / Rapid / Incidence not known
    petechiae / Delayed / Incidence not known
    purpura / Delayed / Incidence not known
    leukocytosis / Delayed / Incidence not known
    paresthesias / Delayed / Incidence not known
    pallor / Early / Incidence not known
    dizziness / Early / Incidence not known
    syncope / Early / Incidence not known

    DRUG INTERACTIONS

    Acetaminophen: (Moderate) Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Aspirin, ASA; Caffeine: (Moderate) Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen. (Moderate) Concomitant administration of antipyretics, such as aspirin, ASA, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Caffeine: (Moderate) Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Caffeine; Dihydrocodeine: (Moderate) Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Caffeine; Magnesium Salicylate; Phenyltoloxamine: (Moderate) Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Caffeine; Phenyltoloxamine; Salicylamide: (Moderate) Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Chlorpheniramine: (Moderate) Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Chlorpheniramine; Dextromethorphan: (Moderate) Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Chlorpheniramine; Dextromethorphan; Phenylephrine: (Moderate) Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Chlorpheniramine; Dextromethorphan; Pseudoephedrine: (Moderate) Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Chlorpheniramine; Phenylephrine : (Moderate) Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Chlorpheniramine; Phenylephrine; Phenyltoloxamine: (Moderate) Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Codeine: (Moderate) Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Dextromethorphan: (Moderate) Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Dextromethorphan; Doxylamine: (Moderate) Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Dextromethorphan; Guaifenesin; Phenylephrine: (Moderate) Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Dextromethorphan; Guaifenesin; Pseudoephedrine: (Moderate) Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Dextromethorphan; Phenylephrine: (Moderate) Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Dextromethorphan; Pseudoephedrine: (Moderate) Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Dichloralphenazone; Isometheptene: (Moderate) Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Diphenhydramine: (Moderate) Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Guaifenesin; Phenylephrine: (Moderate) Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Hydrocodone: (Moderate) Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Oxycodone: (Moderate) Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Pamabrom; Pyrilamine: (Moderate) Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Pentazocine: (Moderate) Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Propoxyphene: (Moderate) Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Pseudoephedrine: (Moderate) Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Amlodipine; Celecoxib: (Moderate) Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Aspirin, ASA: (Moderate) Concomitant administration of antipyretics, such as aspirin, ASA, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Aspirin, ASA; Butalbital; Caffeine: (Moderate) Concomitant administration of antipyretics, such as aspirin, ASA, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Aspirin, ASA; Butalbital; Caffeine; Codeine: (Moderate) Concomitant administration of antipyretics, such as aspirin, ASA, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Aspirin, ASA; Caffeine: (Moderate) Concomitant administration of antipyretics, such as aspirin, ASA, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Aspirin, ASA; Caffeine; Dihydrocodeine: (Moderate) Concomitant administration of antipyretics, such as aspirin, ASA, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Aspirin, ASA; Caffeine; Orphenadrine: (Moderate) Concomitant administration of antipyretics, such as aspirin, ASA, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Aspirin, ASA; Carisoprodol: (Moderate) Concomitant administration of antipyretics, such as aspirin, ASA, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Aspirin, ASA; Carisoprodol; Codeine: (Moderate) Concomitant administration of antipyretics, such as aspirin, ASA, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Aspirin, ASA; Citric Acid; Sodium Bicarbonate: (Moderate) Concomitant administration of antipyretics, such as aspirin, ASA, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Aspirin, ASA; Dipyridamole: (Moderate) Concomitant administration of antipyretics, such as aspirin, ASA, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Aspirin, ASA; Omeprazole: (Moderate) Concomitant administration of antipyretics, such as aspirin, ASA, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Aspirin, ASA; Oxycodone: (Moderate) Concomitant administration of antipyretics, such as aspirin, ASA, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Aspirin, ASA; Pravastatin: (Moderate) Concomitant administration of antipyretics, such as aspirin, ASA, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Benzhydrocodone; Acetaminophen: (Moderate) Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Bupivacaine; Meloxicam: (Moderate) Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Butalbital; Acetaminophen: (Moderate) Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Butalbital; Acetaminophen; Caffeine: (Moderate) Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Butalbital; Acetaminophen; Caffeine; Codeine: (Moderate) Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Celecoxib: (Moderate) Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Chlorpheniramine; Ibuprofen; Pseudoephedrine: (Moderate) Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Diclofenac: (Moderate) Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Diclofenac; Misoprostol: (Moderate) Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Diflunisal: (Moderate) Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Diphenhydramine; Ibuprofen: (Moderate) Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Diphenhydramine; Naproxen: (Moderate) Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Etodolac: (Moderate) Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Famotidine; Ibuprofen: (Moderate) Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Fenoprofen: (Moderate) Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Flurbiprofen: (Moderate) Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Hydrocodone; Ibuprofen: (Moderate) Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Ibuprofen: (Moderate) Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Ibuprofen; Oxycodone: (Moderate) Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Ibuprofen; Pseudoephedrine: (Moderate) Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Indomethacin: (Moderate) Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Ketoprofen: (Moderate) Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Ketorolac: (Moderate) Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Lansoprazole; Naproxen: (Moderate) Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Meclofenamate Sodium: (Moderate) Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Mefenamic Acid: (Moderate) Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Meloxicam: (Moderate) Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Nabumetone: (Moderate) Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Naproxen: (Moderate) Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Naproxen; Esomeprazole: (Moderate) Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Naproxen; Pseudoephedrine: (Moderate) Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Nonsteroidal antiinflammatory drugs: (Moderate) Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Ocrelizumab: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
    Ofatumumab: (Major) Administer all needed non-live vaccines according to immunization guidelines at least 2 weeks before initiation of ofatumumab. Ofatumumab may interfere with the effectiveness of inactivated vaccines due to its actions, which cause B-cell depletion.
    Oxaprozin: (Moderate) Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Piroxicam: (Moderate) Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Rofecoxib: (Moderate) Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Satralizumab: (Major) Administer all non-live vaccines according to immunization guidelines at least 2 weeks before initiation of satralizumab.
    Siponimod: (Moderate) Administer all non-live vaccines at least 4 weeks before siponimod initiation, whenever possible. Vaccines may be less effective if given during siponimod treatment and for 1 month after discontinuation of siponimod treatment.
    Sulindac: (Moderate) Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Sumatriptan; Naproxen: (Moderate) Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Tolmetin: (Moderate) Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Tramadol; Acetaminophen: (Moderate) Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Valdecoxib: (Moderate) Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.

    PREGNANCY AND LACTATION

    Pregnancy

    Available data on pneumococcal vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. No adequate and well controlled studies have been conducted in pregnant women. In rabbits, a dose approximately 20 times the human dose, given prior to mating and during gestation, did not impair female fertility and no fetal malformations were noted. According to the Advisory Committee on Immunization Practices (ACIP), administration of inactivated vaccines to pregnant women has not resulted in adverse effects in the fetus. The ACIP recommends vaccination during pregnancy when the likelihood of disease exposure is high, potential infection would cause harm to mother or fetus, and when the vaccine is unlikely to cause harm. The FDA-approved product labeling recommends administration of the vaccine only if clearly needed.

    Data are limited regarding use of the pneumococcal vaccine during breast-feeding and its' excretion in human breast milk is unknown. The manufacturer recommends caution when administering to nursing mothers; however according to the Advisory Committee on Immunization Practices (ACIP), inactivated vaccines pose no risk for mothers or their infants. Additionally, breast-feeding does not adversely affect immunization; limited data suggest breast-feeding may enhance the immune response to certain vaccine antigens. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.

    MECHANISM OF ACTION

    The high virulence of the pneumococcal organism is largely due to its polysaccharide capsule, which inhibits phagocytosis by white blood cells. There are at least 90 known pneumococcal capsular types. The preponderance of pneumococcal disease, however, is caused by only a minority of these 90 types. Surveillance data revealed that 56% of all deaths due to pneumococcal pneumonia at a New York medical center from 1952 to 1962 were caused by only 6 different capsular types and that 78% of all pneumococcal pneumonias were caused by 12 capsular types. A similar pattern has been demonstrated throughout the world.
     
    Non-conjugate pneumococcal vaccine, polyvalent: Non-conjugated polyvalent pneumococcal vaccines (Pneumovax 23) contain the capsular polysaccharides from the 23 most virulent and common strains of pneumococcus. The vaccines include the 6 most-commonly virulent serotypes: 6B, 9V, 14, 19A, 19F, and 23F. These 23 antigens represent roughly 90% of the reported types associated with clinical infection. Studies in humans have demonstrated the immunogenicity of each of the 23 antigens when tested in polyvalent vaccines; although, some of the serotypes are reported to be poor immunogens. Non-conjugated polysaccharide vaccines stimulate a T-cell independent immune response. Vaccine exposure stimulates the immune system to produce pneumococcal capsule-specific antibodies that make the organism more vulnerable to phagocytosis and other host-defenses. The antibody produced by these vaccines is primarily IgM, which affects vaccine efficacy. They do not induce T-cell dependent responses associated with immunologic memory. After revaccination, antibody titers increase, but an anamnestic response does not occur. Clinical trials suggest a protective efficacy of 60% to 90%.
     
    Conjugated pneumococcal vaccine: Prevnar 13 is a 13-valent conjugate vaccine that contains 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Serotype 1 has been reported to be the most common cause of pneumococcal empyema (24% to 50% of cases), and serotype 19A is reported to be the most common cause of invasive pneumococcal disease since the introduction of Prevnar into the childhood immunization series. Vaxneuvance is a 15-valent conjugate vaccine that contains 15 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F). Prevnar 20 is a 20-valent conjugate vaccine that contains 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F).
     
    The polysaccharides of the pneumococcal serotypes are bound to a non-toxic diphtheria protein known as CRM197. By coupling the polysaccharides to this carrier protein, a T-cell dependent immune response is generated. The conjugated polysaccharide (antigen) can then be presented by major histocompatibility complex molecules, which signals the activation of T-helper cells. The T-helper cells are then able to stimulate B-cells to mature into antibody-secreting plasma or memory cells. The exposure to the vaccine produces pneumococcal capsule-specific antibodies that make the organism more vulnerable to phagocytosis and other host-defenses.

    PHARMACOKINETICS

    The immunologic response and duration of immunity conferred by pneumococcal vaccine, polyvalent is dependent upon the serotypes present in the vaccine and whether the polysaccharides are coupled/conjugated to various carrier proteins.
     
    Pneumovax 23: Pneumococcal 23-polyvalent vaccine is administered via subcutaneous or intramuscular injection. Immunity after injection occurs in 2 to 3 weeks. Antibodies against the vaccine serotypes develop in more than 80% of vaccinated healthy adults; older adults and patients with chronic illness or immunodeficiency may not respond well. Serotype-specific antibodies decline after 5 to 10 years; however, the rate of decline varies depending on the patient population. In healthy adults, increased antibody concentrations exist for at least 5 years. Data from 1 epidemiologic study suggest vaccination may provide protection for at least 9 years after the initial dose in adults; however, the correlation between serology and clinical protection is not firm. There is some evidence that revaccination can raise antibody concentrations and can ensure life-long immunity without significantly increasing the risk of adverse reactions. Revaccination is recommended for certain patients, such as those with immunosuppression.
    Prevnar 13: Pneumococcal 13-valent conjugate vaccine is administered via intramuscular injection only. Patients who received Pneumovax 23 within 1 year prior to Prevnar 13 receipt experienced diminished immune responses to Prevnar 13 compared to Pneumovax 23 naive individuals.
    Vaxneuvance: Pneumococcal 15-valent conjugate vaccine is administered via intramuscular injection only. Immune response to Vaxneuvance was similar to that seen after Prevnar 13 administration in clinical studies, including patients administered Pneumovax 23 six months to 1 year after Vaxneuvance or Prevnar 13.
    Prevnar 20: Pneumococcal 20-valent conjugate vaccine is administered via intramuscular injection only. Patients who received Pneumovax 23 within 1 to 5 years prior to Prevnar 20 receipt experienced diminished immune responses to Prevnar 20 compared to patients who received Prevnar 13 at least 6 months prior and compared to patients who received Prevnar 13 followed by Pneumovax 23, with the last dose of Pneumovax 23 given at least 1 year prior to Prevnar 20.