PNEUMOVAX 23
  • PNEUMOVAX 23

  • QTY 0.5 • 25MCG/0.5 • Syringe • Near 77381

PNEUMOCOCCAL VACCINE, POLYVALENT (NEU mo KOK al vak SEEN, pol ee VEY luhnt) is a vaccine to prevent pneumococcus bacteria infection. These bacteria are a major cause of ear infections, Strep throat infections, and serious pneumonia, meningitis, or blood infections worldwide. These vaccines help the body to produce antibodies (protective substances) that help your body defend against these bacteria. This vaccine is recommended for people 2 years of age and older with health problems. It is also recommended for all adults over 50 years old. This vaccine will not treat an infection.

PNEUMOVAX 23 Pediatric Monographs
  • General Administration Information
    For storage information, see the specific product information within the How Supplied section.

    -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. These actions are required by the National Childhood Vaccine Injury Act of 1986.
    -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. These actions are required by the National Childhood Vaccine Injury Act of 1986.

    Route-Specific Administration

    Injectable Administration
    -Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.
    -Do not mix with any other vaccine.
    -When concomitant administration of other vaccines or immunoglobulin is required, they should be given with different syringes and at different injection sites.
    Intramuscular Administration
    -Use vaccine as supplied; reconstitution is not necessary.
    -Shake Prevnar 13 vigorously just prior to administration. With thorough agitation, Prevnar 13 is a homogenous, white suspension. If the vaccine cannot be resuspended, discard it.
    -Pneumovax 23 is a clear solution that does not require shaking prior to administration.
    -For vials, use a sterile syringe and needle to withdraw the vaccine from the vial. For prefilled syringes, attach a sterile needle. -For the majority of infants < 1 year, a 1-inch, 22- to 25-gauge needle is sufficient to penetrate thigh muscle.
    -For children 1-2 years, a needle at least 1 inch long is preferred for administration into the thigh; a 5/8 inch needle is sufficient for administration into the deltoid if the skin is stretched flat and the needle is inserted at a 90 degree angle.
    -For children >= 3 years, the needle size required for deltoid injection ranges from 5/8- to 1-inch.

    -Inject intramuscularly into the anterolateral aspect of the mid-thigh (for infants < 1 year) or the deltoid muscle of the upper arm (usually suitable for older children). Do NOT administer in the gluteal muscle or other areas where there may be a major nerve trunk.

    Subcutaneous Administration
    -Only Pneumovax 23 is approved for subcutaneous administration.
    -Use vaccine as supplied; reconstitution is not necessary. The vaccine is a clear solution.
    -Use a sterile syringe and needle to withdraw solution from the vial. A 5/8-inch, 23- to 25-gauge needle is appropriate.
    -Administer at a 45 degree angle into the subcutaneous tissue. In children and adolescents, inject into the upper-outer triceps area.

    Report all adverse reactions to the Vaccine Adverse Event Reporting System (VAERS), as well as to the manufacturer. The toll-free number for VAERS is 1-800-822-7967. Educate the responsible adult(s) to promptly report any adverse reaction after vaccine administration to a health care provider.

    The most frequent adverse reaction of pneumococcal vaccine, polyvalent administration in infants and children is an injection site reaction, which usually is of minor consequence. During clinical trials of PCV13 (Prevnar 13), patients experienced erythema (24.3% to 70%), swelling (19.6% to 44.5%), warmth, and tenderness (15.1% to 89%) at the injection site. Significant tenderness that interfered with limb movement was reported in up to 43.8% of patients. Skin necrosis at the injection site, itching or hives at the injection site, injection site dermatitis, and peripheral edema in the injected extremity have been observed during postmarketing experience; frequency of these reactions is not established.

    During pre-marketing clinical trials of conjugated pneumococcal vaccine, polyvalent (PCV13 or Prevnar 13), < 1% of infant and children vaccinees experienced seizures (including febrile seizures); vaccinees also received other standard childhood vaccines concomitantly. Febrile convulsions have also been observed during post-marketing experience with PPSV23 (Pneumovax 23). During the first 2 years of licensure of PCV7, and epidemiologic study described 393 reports of seizures (including 94 febrile seizures) that were reported to the Vaccine Adverse Event Reporting System; Of the 393 seizure cases, 57 occurred after receipt of only PCV7. During focused follow-up of the first 98 seizures reported during the surveillance period, 80.6% of seizures occurred in patients with previous seizure history or patients who were febrile. 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 PCV13 concomitantly. 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. No changes to the recommended childhood immunization schedule were recommended.

    Lymphadenitis, lymphadenopathy, hemolytic anemia, and leukocytosis have been reported with post-marketing use of pneumococcal vaccine, polyvalent; however, a causal relationship to the vaccine has not been established. Ecchymosis occurred in 1.1% of adults after pneumococcal vaccination with PPSV23 (Pneumovax 23) in clinical trials. Pneumococcal vaccination has been associated with relapse of idiopathic thrombocytopenic purpura (ITP) in previously stabilized patients. A report of a patient that developed a platelet count less than 150,000 mm3, immune thrombocytopenic purpura, and aplastic anemia 1 week after her first dose of PCV7 (Prevnar) given alone has been received through the Vaccine Adverse Event Reporting System (VAERS). Over the first 2 years after approval of PCV7, 78 reports of possible thrombocytopenia (e.g., petechiae, purpura, or ecchymosis) were received through VAERS. Most patients developed symptoms 1-35 days after immunization. Twelve patients had a documented platelet count < 20,000 mm3, but at least 8 patients had multiple potential causes of the thrombocytopenia (e.g., vaccines, medications, or viral or bacterial infections).

    Paresthesias and acute radiculoneuropathy, such as Guillain-Barre syndrome, have occurred after immunization with pneumococcal vaccine, polyvalent, but such reactions are rare, and a causal relationship cannot be established.

    Myalgia (11.9-61.8%), arthralgia (9.7-31.5%), neck pain (0.7-1.5%), and back pain (0.9%) have been reported in clinical trials of pneumococcal vaccine, polyvalent in the adult population; these reactions may also occur in the pediatric population. Over the first 2 years after approval of PCV7 (Prevnar), 5 reports of serum sickness in patients who only received PCV7 were received through the Vaccine Adverse Event Reporting System. Symptoms occurred within 1 day of vaccination in half of the cases, and with the initial dose in 3 patients. Arthus reaction has occurred and is more likely to occur with repeat vaccination. In addition, 26 reports of arthritis or arthralgia have been received. Although these events have not been specifically reported with PCV13 (Prevnar 13), they should still be considered potential reactions because of the similarity of the PCV13 product to PCV7.

    Development of a rash (unspecified) has occurred after vaccination with pneumococcal vaccine, polyvalent. During pre-marketing trials of PCV13 (Prevnar 13), rash occurred in >= 1% of infants and children and 7.3-16.5% of adults who received the vaccine. Rash has also been reported with post-marketing use of PPSV23 (Pneumovax 23); however, a causal relationship has not been established. Over the first 2 years after approval of PCV7 (Prevnar), 796 reports of a rash were received through the Vaccine Adverse Event Reporting System. Of the 796 cases, 183 patients had only received vaccination with PCV7. Also, there were 39 reports of erythema multiforme of which 9 patients had received vaccination only with PCV7.

    During pre-marketing clinical trials of conjugated pneumococcal vaccine, polyvalent (PCV13 or Prevnar 13), < 1% of vaccinees experienced a hypersensitivity or allergic reaction that included facial edema, dyspnea, and bronchospasm. Urticaria was observed in 1.4-1.9% of patients aged 5-17 years who received the vaccine without other concomitant vaccinations. Anaphylactoid reactions, angioedema, and urticaria have also been reported with post-marketing use of Pneumovax 23; however, a causal relationship has not been established. Of 4154 reports to the Vaccine Adverse Event Reporting System over 2 years during experience with PCV7 (Prevnar), about a third were in regard to allergic reactions (e.g., anaphylactic shock, urticaria, pruritus, facial edema, angioedema, asthma, dyspnea, bronchospasm, anaphylactic or anaphylactoid reactions). Symptoms of anaphylaxis began after 1 dose of PCV7 in 12 patients, and symptoms began 5 minutes to 4 hours after vaccination.

    Anorexia (decreased appetite) occurred in 16.3-44.4% of infants and children who received the conjugated pneumococcal vaccine, polyvalent (PCV13 or Prevnar 13) alone in clinical trials. Vomiting (0.9-6.9% adults; > 1% pediatrics), diarrhea (0.7-1.1% adults; > 1% pediatrics), nausea (1.8% adults), and dyspepsia (1.1% adults) have also been reported to occur in patients receiving the pneumococcal vaccine. Intussusception has been reported in 5 patients that received a dose of PCV7 (Prevnar); one patient developed the adverse event after receipt of only PCV7. Symptoms of intussusception occurred within 2 days of vaccination in 4 patients and within 2 weeks in the other patient. One patient died after months of frequent diarrhea.

    The most frequent neurological adverse reactions in pediatric patients who received conjugated pneumococcal vaccine, polyvalent (PCV13 or Prevnar 13) during clinical trials included increases and decreases in sleep, reported in 2.6-35.3% and 5.7-29.7% of vaccinees who received PCV13 without other concurrent vaccines, respectively. Headache has been reported with PCV13 use in up to 65.9% of adults, and with Pneumovax 23 use in up to 18.1% of adults. During the first 2 years of licensure of PCV7, an epidemiologic study described 144 cases of pallor, syncope, or dizziness that were reported to the Vaccine Adverse Event Reporting System. Eight patients experienced a hypotonic, hyporesponsive episode, hypotonia, or hyporesponsiveness after receipt of a PCV7 dose. As these reports are collected from a population of uncertain size, reaction frequency is unknown. One (0.015%) hypotonic-hyporesponsive episode was reported with Prevnar 13 from infant and toddler clinical studies.

    In clinical trials comparing 2 conjugated pneumococcal vaccines (PCV7 and PCV13), the most commonly reported serious adverse effect was infection. Bronchiolitis, gastroenteritis, and pneumonia were reported in 0.9% of children who received PCV 13. Upper respiratory tract infection and pharyngitis were reported in clinical trials of adults receiving pneumococcal vaccine, polyvalent (PPSV23).

    Apnea following intramuscular administration of vaccines has been observed in some infants born prematurely. Consider the medical status of the infant and risks and benefits of immunization with pneumococcal vaccine, polyvalent in this patient population.

    Fever is a relatively common adverse effect of immunization with pneumococcal vaccine, polyvalent (PCV13) reported in 0.7-19.9% of infants and children during clinical trials. With concomitant administration with other standard childhood vaccines, the incidence increased up to 35.5%. The incidence of fever associated with the primary childhood series is lower with the first dose compared to fevers associated with the second, third, or fourth dose. The majority of fevers experienced are <= 39 degrees C (102.2 degrees F); however, fevers > 40 degrees C (104 degrees F) have been reported in a small number of children (<= 1%). Fever > 102 degrees F has been reported during post-marketing experience with PPSV23 (Pneumovax 23). Pediatric patients aged 6-23 months receiving simultaneous trivalent inactivated influenza vaccine (TIV) and 13-valent pneumococcal vaccine (PCV13) are 2.67 times (CI 1.25-5.66) more likely to have a day 0 to 1 temperature of >= 100.4 degrees F than those receiving PCV13 without TIV. A temperature of 102.2 degrees F is 2.53 times (CI 0.76-8.42) more likely to occur on day 0 to 1 when TIV and PCV13 are administered together vs. PCV13 alone. Chills have been reported with PCV13 use in adult patients. Irritability was noted in 14.3-73.3% of infant and children vaccinees who received PCV13 without other concomitant vaccinations. Counsel patients to report any signs or symptoms of a systemic reaction to their health care provider.

    Fatigue and asthenia have been noted in up to 63.3% and 17.9% of adults who received pneumococcal vaccine, polyvalent during clinical trials (PCV13 or PPSV23). Malaise has been noted during post-marketing observation. Counsel patients to report signs or symptoms of a systemic reaction to their health care provider.

    Prior to administration, inform the parent, guardian, or responsible adult of the benefits and risks of the vaccine, and provide the Vaccine Information Statement, accessible at the Centers for Disease Control and Prevention (CDC) website. These actions are required by the National Childhood Vaccine Injury Act of 1986. If a dose of pneumococcal vaccine, polyvalent has been previously given, question the parent or guardian about previous adverse reactions that may preclude further administration. Report all adverse reactions to the Vaccine Adverse Event Reporting System (VAERS), as well as the manufacturer. The toll-free number for VAERS is 1-800-822-7967. Educate the responsible adult(s) to promptly report any adverse reaction after vaccine administration to a health care provider.

    Pneumococcal vaccine, polyvalent is contraindicated in patients who have had a previous hypersensitivity reaction to the vaccine to be administered or to any components of the vaccine. The pneumococcal conjugate vaccine (PCV13 or Prevnar 13) is contraindicated in patients who have had a hypersensitivity reaction to any diphtheria toxoid-containing vaccine. Before the administration of any dose, precautions should be taken to prevent allergic and other adverse reactions. Specifically, review the patient's immunization history for previous allergic or adverse reactions. Epinephrine and other appropriate medications used to manage anaphylaxis must be readily available.

    The conjugated pneumococcal vaccine, polyvalent (PCV13 or Prevnar 13) is only indicated for intramuscular administration; do not give via intravenous administration, subcutaneous administration, or intradermal administration. PPSV23 (Pneumovax 23) may be administered via intramuscular or subcutaneous routes. Incorrect administration may result in inadequate immunity.

    The decision to administer or to delay vaccination with the pneumococcal vaccine, polyvalent because of current or recent febrile illness depends on the severity of symptoms and on the etiology of the disease. The Advisory Committee on Immunization Practices recommends that vaccinations be delayed during the course of a moderate or severe acute febrile illness and administered after the acute phase of illness has resolved. All vaccines can be given to persons with minor illnesses such as diarrhea, mild upper-respiratory infection with or without low-grade fever, or other low-grade febrile illness.

    Use pneumococcal vaccine, polyvalent with caution in patients with immune thrombocytopenia/idiopathic thrombocytopenic purpura (ITP) because pneumococcal vaccination has been associated with relapse of this condition in previously stabilized patients. Monitor patients for relapse after vaccination.

    Use pneumococcal vaccine, polyvalent cautiously in patients with severe cardiac disease or pulmonary disease because systemic reactions may pose significant risks in these patient populations. In patients at higher risk for pneumococcal infection, including those with chronic heart or lung disease, diabetes mellitus, cochlear implants, or cerebrospinal fluid leaks (due to congential lesions, skull fractures, or neurosurgical procedures), give the pneumococcal vaccine in accordance with current immunization schedules. Pneumococcal meningitis may not be prevented with pneumococcal immunization in patients with cerebrospinal fluid leaks.

    Patients with significant immunosuppression may not have an adequate antibody response to pneumococcal vaccine, polyvalent. Immunosuppressed persons may include those with: absent or deficient splenic function (including sickle cell disease); human immunodeficiency virus (HIV) infection; severe combined immunodeficiency (SCID); hypogammaglobulinemia; agammaglobulinemia; chronic renal failure and nephrotic syndrome; allogeneic stem cell transplant; altered immune states due to generalized neoplastic disease; or an immune system compromised by radiation therapy or drug therapy (e.g., chemotherapy or corticosteroid therapy with greater than physiologic doses). Short-term (< 2 weeks) corticosteroid therapy or intra-articular, bursal, or tendon injections with corticosteroids should not be immunosuppressive. In two studies evaluating antibody response to the pneumococcal conjugate vaccine (PCV13), one in children with sickle cell disease and one in patients 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. 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. In other studies involving children with HIV, antibody response to various formulations of pneumococcal conjugate vaccines (PCV) have been slightly lower but comparable to children who are not infected. Invasive pneumococcal disease has decreased substantially among children with sickle cell disease since the introduction of PCVs; however, risk still remains higher compared to healthy children. Patients with chronic immunodeficiency should receive PCV13 in addition to PPSV23 (23-valent pneumococcal polysaccharide vaccine) according to current immunization schedules. If elective splenectomy or immunosuppressive therapy is planned, complete necessary pneumococcal immunization at least 2 weeks before surgery or therapy initiation.

    Apnea has occurred in some premature neonates and infants after intramuscular injections. The risks and benefits of intramuscular injections, including vaccination with the conjugate pneumococcal vaccine, polyvalent (PCV13 or Prevnar 13), must be considered on an individual patient basis. Additionally, immunogenicity may be lower in premature neonates. In a study of 100 premature neonates (< 37 weeks gestational age) who received 4 doses Prevnar 13 on a non-United States dosing schedule, lower serotype-specific IgG antibody responses were measured after the 3rd and 4th doses compared to responses among term infants (>= 37 weeks gestational age) for some serotypes.

    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.

    Safety and efficacy of the pneumococcal conjugate vaccine 13 (PCV13) have not been established in neonates and infants < 6 weeks of age. Safety and efficacy of the 23-valent pneumococcal polysaccharide vaccine (PPSV23) have not been established in children < 2 years of age.

    Description: Pneumococcal vaccine, polyvalent confers immunity against pneumococcal disease, which may manifest as, but is not limited to, otitis media, pneumonia, bacteremia, or meningitis. The prevention of serious pneumococcal disease has become an increasingly important health issue due to the increased number of Streptococcus pneumoniae isolates that are drug resistant. Pneumococcal vaccines contain highly purified capsular polysaccharides from S. pneumoniae. Both conjugated and non-conjugated vaccines are designed to protect against the most frequent bacterial serotypes associated with pneumococcal infection. PCV13 (pneumococcal conjugate vaccine 13 or Prevnar 13) is a 13-valent vaccine indicated for the prevention of invasive disease or otitis media caused by S. pneumoniae. PCV13 replaced the heptavalent conjugated vaccine (PCV7) in 2010 for use in routine immunization due to broader serotype coverage; the vaccine contains the 7 serotypes that were included in PCV7 and 6 additional serotypes. In the conjugated vaccine, coupling of the capsular polysaccharides to another antigen (nontoxic diphtheria CRM197) in the vaccine induces T-cell dependent immune responses that are immunogenic in patients < 2 years of age whose immune systems are not fully mature. In contrast, non-conjugated PPSV23 (23-valent pneumococcal polysaccharide vaccine or Pneumovax 23) elicits an independent T-cell response and is only used in pediatric patients at high risk of pneumococcal disease. During randomized trials in fully vaccinated infants and children, the efficacy of pneumococcal conjugate vaccines against invasive pneumococcal disease was 97.4%; efficacy against acute otitis media episodes in fully vaccinated infants was 57%. PCVs were associated with a 20% reduction in tympanostomy tube placement. PCV13 (Prevnar 13) is approved for use in infants as young as 6 weeks. PPSV23 (Pneumovax 23) is approved for use in children as young as 2 years.

    General dosing information:
    -PCV13 (pneumococcal conjugate vaccine 13 or Prevnar 13) is a 13-valent vaccine used for routine immunization in infants and children. Non-conjugated PPSV23 (23-valent pneumococcal polysaccharide vaccine or Pneumovax 23) is only used in children 2 years of age and older with a high risk of pneumococcal disease due to certain underlying medical or immunocompromising conditions.
    -PCV 13 (Prevnar) is indicated for immunization for prevention of invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F; the vaccine is also indicated for immunization against serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F for otitis media prevention. No efficacy data for otitis media prevention are available for serotypes 1, 3, 5, 6A, 7F, and 19A.
    -PPSV23 (Pneumovax) is indicated for immunization against S. pneumoniae serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F for prevention of pneumococcal disease.
    -The safety and efficacy of concomitant administration of PCV13 and PPSV23 has not been studied and is therefore not recommended.
    -Interruption of the recommended schedule with a delay between doses should not interfere with the final immunity achieved with the pneumococcal vaccine. There is no need to start a primary series over again, regardless of the time between doses.
    -Premature infants should be immunized according to their chronological age, regardless of birth weight.

    For pneumocoocal prophylaxis:
    -for routine prophylaxis of infants and children as part of the primary childhood immunization schedule:
    Intramuscular dosage (Prevnar 13):
    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.
    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.
    Children 12 to 23 months of age at first dose : 0.5 mL IM for 2 doses administered at least 2 months apart.
    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.
    -for routine prophylaxis of healthy children and adolescents 6 years and older:
    Intramuscular dosage (Prevnar 13):
    Children and Adolescents 6 to 17 years: 0.5 mL IM as a single dose.
    -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):
    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, a dose of PPSV23 is needed at least 8 weeks after the last PCV13 dose.
    Intramuscular or Subcutaneous dosage (Pneumovax 23):
    Children and Adolescents 2 to 17 years who are PPSV23-naive: 0.5 mL IM or subcutaneously as a single dose at least 8 weeks after the last dose of PCV13.
    -for invasive pneumococcal prophylaxis in high-risk patients (e.g. chronic liver disease or alcoholism):
    Intramuscular or Subcutaneous dosage (Pneumovax 23):
    Children and Adolescents 6 to 17 years who are PPSV23-naive: 0.5 mL IM or subcutaneously of PPSV23 once at least 8 weeks after PCV13 administration.
    -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):
    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.
    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).
    Intramuscular or Subcutaneous dosage (Pneumovax 23):
    Children and Adolescents 2 to 17 years who are PPSV23-naive: 0.5 mL IM or subcutaneously as a single dose at least 8 weeks after the last dose of PCV13. A second 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. cerebrospinal fluid leak, cochlear implant):
    Intramuscular dosage (Prevnar 13):
    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.
    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.
    Intramuscular or Subcutaneous dosage (Pneumovax 23):
    Children and Adolescents 2 to 17 years who are PPSV23-naive: 0.5 mL IM or subcutaneously as a single dose at least 8 weeks after the last dose of PCV13.

    For otitis media prophylaxis in infants and children younger than 6 years:
    Intramuscular dosage (Prevnar 13 only):
    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.
    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.
    Children 12 to 23 months of age at first dose: 0.5 mL IM for 2 doses administered at least 2 months apart.
    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.

    Maximum Dosage Limits:
    -Neonates
    Use not recommended.
    -Infants
    < 6 weeks: Use not recommended.
    >= 6 weeks: 0.5 ml/dose IM of PCV13 (Prevnar 13). Do not use PPSV23 (Prevnar 23); safety and efficacy have not been established in this age group.
    -Children
    1 year: 0.5 ml/dose IM of PCV13 (Prevnar 13). Do not use PPSV23 (Pneumovax 23); safety and efficacy have not been established in this age group.
    2-12 years: 0.5 ml/dose IM of PCV13 (Prevnar 13); 0.5 ml/dose IM or SC of PPSV23 (Pneumovax 23).
    -Adolescents
    0.5 ml/dose IM of PCV13 (Prevnar 13); 0.5 ml/dose IM or SC of PPSV23 (Pneumovax 23).

    Patients with Hepatic Impairment Dosing
    Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

    Patients with Renal Impairment Dosing
    Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed. However, consult current immunization schedules for recommended vaccines for use in young dialysis patients; the ACIP states that all routine vaccinations are likely effective in patients with chronic renal disease.

    *non-FDA-approved indication

    Monograph content under development

    Mechanism of Action: Pneumococcal vaccine, polyvalent confers immunity against the bacteria that cause pneumococcal disease. Levels of antibodies that correlate with disease protection have not been clearly defined.

    Non-conjugate pneumococcal vaccine, polyvalent (Pneumovax 23): The high virulence of the pneumococcal organism is largely due to its polysaccharide capsule, which inhibits phagocytosis by white blood cells. Pneumococcal non-conjugated polysaccharide vaccine stimulates 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 antibodies produced by the vaccine are predominantly IgM; the antibodies do not induce T-cell dependent responses associated with immunologic memory. After revaccination, antibody titers increase, but an anamnestic response does not occur.

    Conjugated pneumococcal vaccine (Prevnar 13): The high virulence of the pneumococcal organism is largely due to its polysaccharide capsule, which inhibits phagocytosis by white blood cells. In conjugated pneumococcal vaccine, 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: Pneumococcal vaccine, polyvalent is administered intramuscularly. The PPSV23 (Pneumovax 23) formulation of the vaccine may also be administered subcutaneously. In some individuals, immune response to the vaccine may not be sufficient to prevent pneumococcal infection. The distrubution, metabolism, and excretion of the vaccines have not been well defined.


    -Special Populations
    Pediatrics
    Premature Neonates < 37 weeks
    In a study of 100 premature neonates (< 37 weeks gestational age) who received 4 doses Prevnar 13 on a non-United States dosing schedule, serotype-specific IgG antibody responses were lower after the 3rd and 4th doses compared to responses among term infants (>= 37 weeks gestational age) for some serotypes. Immune responses elicited by the vaccine administered on the ACIP-recommended schedule to premature neonates are not known.

    Infants and Children 2 to 15 months
    In the pivotal U.S. non-inferiority trial comparing PCV13 (Prevnar 13) to PCV7 (Prevnar), non-inferiority criterion was met for 10 of 13 serotypes after the third dose; the exceptions were serotypes 6B, 9V, and 3. For serotype 6B, 87.3% (95% CI, 82.5% to 91.1%) of children who received PCV13 achieved an antibody concentration >= 0.35 mcg/mL one month after the third dose compared to 92.8% (95% CI, 88.9% to 95.7%) of those who received PCV7. For serotype 9V, 90.5% (95% CI, 86.2% to 93.8%) of children who received PCV13 met the 0.35 mcg/mL threshold compared to 98.4% (95% CI, 96% to 99.6%) of those who received PCV7. Although the criterion for non-inferiority was not met for serotypes 6B and 9V, the clinical significance of this is unknown. Of children who received PCV13, 63.5% (95% CI, 57.1% to 69.4%) achieved an antibody concentration of >= 0.35 mcg/mL after the third dose. Serotype 3 is not included in the original PCV7 vaccine. After the fourth dose of PCV13, non-inferiority criterion was met for 12 of 13 serotypes; the exception was serotype 3. Functional antibody responses, as measured by opsonophagocytic assay (OPA), were elicited for all 13 serotypes after 3 doses of PCV13, and after the fourth dose, the OPA response was quantitatively greater than the responses after the third dose for each serotype.

    Other
    Children with Sickle Cell Disease
    In an open-label study, 2 doses of Prevnar 13 were administered 6 months apart to children and adolescents (6 to 17 years of age) with sickle cell disease. All patients had been previously vaccinated with Pneumovax 23 at least 6 months prior to enrollment. After the first Prevnar 13 dose, anti-pneumococcal opsonophagocytic activity (OPA) geometric mean antibody titers (GMTs) for all vaccine serotypes were higher than pre-vaccination concentrations. OPA GMTs after the first and second dose were comparable.

    Patients with Hematopoietic Stem Cell Transplant (HSCT)
    In an open-label study, 4 doses of Prevnar 13 were administered to patients (age 2 to 71 years) who had received an allogeneic hematopoietic stem cell transplant 3 to 6 months prior to enrollment. All had a history of stable engraftment and did not have uncontrolled graft versus host disease. The first 3 doses were administered a month apart and the fourth dose was administered 6 months after the third dose. Sera were obtained approximately one month after each vaccination. Immune responses (IgG GMCs) were numerically higher after the first dose of Prevnar 13 compared with baseline. Similarly, IgG GMCs were numerically higher after each subsequent dose compared to the previous dose. A post hoc analysis of immune response (measured by OPA antibody assay) showed the pattern of functional antibody response to be consistent with IgG response for each serotype.

    Children with HIV Infection
    In an open-label study, 3 doses of Prevnar 13 were administered 1 month apart to HIV-infected patients >= 6 years of age, with CD4 counts >= 200 cells/microliter and serum HIV RNA titer < 50,000 copies/mL, who had not been previously vaccinated with Pneumovax 23. After the first dose, anti-pneumococcal OPA GMTs for all vaccine serotypes were higher than pre-vaccination concentrations (N = 197 to 257). OPA GMTs after the first, second, and third doses were generally comparable.

DISCLAIMER: This drug information content is provided for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment. Drug information is sourced from GSDD (Gold Standard Drug Database ) provided by Elsevier.

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