pneumococcal vaccine 13-valent

Pneumococcal vaccine 13-valent vaccine (PCV13) is an inactivated bacterial vaccine used for routine immunization in children, and in adults. PCV13 protects from invasive disease and pneumonia caused by 13 strains of Streptococcus pneumoniae, including serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. Inactivated bacterial vaccines are sterile biologic products that provide acquired immunity against specific bacterial infections by stimulating the production of antibodies by the body’s immune system.

Inactivated bacterial vaccines, including PCV13, are made from protein or carbohydrate fragments of the disease-causing bacteria grown in culture and then killed (inactivated) to prevent them from causing disease. If exposed to S. pneumoniae infection later in life, the immune system of the vaccinated person identifies the bacteria by the molecule (antigen) specific to the particular strain of bacteria, attacks and kills the bacteria, preventing illness. The vaccine does not protect against disease caused by serotypes that are not in the vaccine.

Pneumococcal vaccine 13-valent vaccine is a sterile suspension of the saccharides of 13 serotypes of the S. pneumoniae capsular antigens. The bacterial saccharides are individually conjugated to CRM197, a carrier protein made from a non-toxic variant of diphtheria toxin. The conjugated particles are then suspended in a buffer solution.

Pneumococcal vaccine 13-valent vaccine is recommended for administration in:

• Children 6 weeks through 5 years of age for:
  • Active immunization for the prevention of invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
  • Active immunization for the prevention of middle ear infection (otitis media) caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. No otitis media efficacy data are available for serotypes 1, 3, 5, 6A, 7F, and 19A.
• Children 6 years through 17 years of age for:
  • Active immunization for the prevention of invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
• Adults 18 years of age and older for:
  • Active immunization for the prevention of pneumonia and invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.

• Do not administer pneumococcal vaccine 13-valent to individuals with severe allergic reactions (anaphylaxis) to pneumococcal vaccine, any of its components, or any diphtheria toxoid-containing vaccine.
• Epinephrine and other appropriate agents must be available at the vaccine administering facility, to treat an acute anaphylactic reaction, should it occur.
• Vaccination administered too high on the arm can cause shoulder injury and pain. Exercise care to administer the injection using proper technique.
• PCV13 may have reduced antibody response in immunocompromised persons, including those at higher risk for invasive pneumococcal disease such as individuals with congenital or acquired splenic dysfunction, human immunodeficiency virus (HIV) infection, malignancy, hematopoietic stem cell transplant, and nephrotic syndrome.
• Antibody response was lower in preterm infants compared to full-term infants, and in adults 65 years of age or older, compared to adults 50 to 59 years of age.
• Apnea was noticed in some preterm infants, following IM vaccination. Decision to administer IM vaccinations, including PCV13 should be based on the clinical status of the infant, and potential benefits and risks of vaccination.
• Fainting (syncope) has been reported in some individuals, following vaccination. Follow precautions to prevent falling and injury.
• Vaccine administration to individuals with minor illnesses without fever may be acceptable, but defer the vaccine in febrile illnesses until the illness is resolved.
• Intramuscular injections may cause hematoma in people with bleeding disorders, use with caution.
• Use of pneumococcal conjugate vaccine does not replace use of the 23-valent pneumococcal polysaccharide vaccine in children 24 months or older with:
  • Chronic illness
  • Sickle cell disease
  • HIV infection
• PCV13 does not provide protection against diphtheria.
• PCV13 is only for prevention of pneumococcal disease and should not be used to treat active infections.
• Vaccination may not provide effective immunity to 100% of vaccinated individuals.

Common side effects of pneumococcal vaccine 13-valent include:

• Injection site reactions including:
  • Redness
  • Swelling
  • Tenderness
• Decreased range of motion in the injected arm
• Irritability
• Increased or decreased sleep
• Reduced appetite
• Fever
• Chills
• Drowsiness
• Fatigue
• Skin rash
• Hives (urticaria)
• Muscle pain (myalgia)
• Joint pain (arthralgia)
• Vomiting
• Diarrhea

Less common side effects of pneumococcal vaccine 13-valent include:

• Abnormal crying
• Hypersensitivity reactions including:
  • Bronchospasm
  • Shortness of breath (dyspnea)
  • Facial swelling (edema)
  • Swelling beneath the skin and in mucous tissue (angioedema)
  • Severe allergic reaction (anaphylaxis)
  • Anaphylactic shock
• Injection site inflammation (dermatitis)
• Injection site urticaria
• Injection site itching (pruritus)
• Pallor
• Bluish skin color from low oxygen (cyanosis)
• Severe skin reaction (erythema multiforme)
• Seizure
• Seizure from high temperature (febrile seizure)
• Low muscle tone (hypotonia)
• Pause in breathing (apnea)

Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

• Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
• Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
• Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

Suspension for intramuscular (IM) injection

• 0.5 mL/syringe

Streptococcus pneumoniae Immunization

Adult:

• Pneumococcal vaccine 13-valent (PCV13) is indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F
• Adults aged 19-64 years: ACIP guidelines recommend use for adults with certain medical conditions
• Immunocompetent adults aged 65 years and above: Need for vaccination based on shared decision making between patient and clinician (i.e., no longer routinely recommended for all adults aged 65 years and above)

Adults aged 19-64 years with certain medical conditions

• 1 dose PCV13 followed by 1 dose PPSV23 at least 1 year later; repeat regimen when aged 65 years or above

Immunocompetent adults aged 65 years and above

• Based on shared clinical decision making
• If both PCV13 and PPSV23 administered, PCV13 should be administered first
• PCV13 and PPSV23 should be administered at least 1 year apart
• Do not administer during the same visit

Dosing Considerations

Specific medical conditions for individuals aged 19-64 years

• Alcoholism
• Chronic heart, liver, or lung disease
• Cigarette smoking
• Diabetes mellitus
• Cochlear implant
• CSF leak
• Congenital or acquired asplenia
• Sickle cell disease or other hemoglobinopathies
• Chronic renal failure
• Congenital or acquired immunodeficiencies
• Generalized malignancy
• HIV infection
• Hodgkin disease, leukemia, lymphoma, multiple myeloma
• Iatrogenic immunosuppression
• Nephrotic syndrome
• Solid organ transplant

Pediatric:

• Routine vaccination: 4-dose series at ages 2, 4, and 6 months and at age 12-15 months
• Aged 6 weeks through 17 years: Indicated for active immunization to prevent invasive disease caused by S pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F
• Aged 6 weeks through 5 years: Also indicated for prevention of otitis media caused by S pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F
• Dose: 0.5 mL IM
• Up-to-date vaccination schedules available at http://www.cdc.gov/vaccines/schedules/hcp/index.html

ged 6 weeks through 5 years

• Routine vaccination: 4-dose series at ages 2, 4, and 6 months and at age 12-15 months
• May administer 1st dose as early as age 6 weeks
• Dosing intervals between 1st and 2nd doses, and 2nd and 3rd doses are 4-8 weeks
• Administer 4th dose at approximately age 12-15 months, and at least 2 months after 3rd dose
• For children aged 14 through 59 months who have received an age-appropriate series of 7-valent PCV (PCV7), administer a single supplemental dose of 13-valent PCV (PCV13)
• Catch-up vaccination: Administer 1 dose of PCV13 to all healthy children aged 24 through 59 months who are not completely vaccinated for their age

ACIP Guidelines, Aged 2-5 Years with High Risk

Any of the following conditions:

• Chronic heart disease (particularly cyanotic congenital heart disease and cardiac failure)
• Chronic lung disease (including asthma if treated with high-dose oral corticosteroid therapy)
• Diabetes mellitus
• Cerebrospinal fluid leak
• Cochlear implant
• Sickle cell disease and other hemoglobinopathies
• Anatomic or functional asplenia
• HIV infection
• Chronic renal failure
• Nephrotic syndrome
• Diseases associated with immunosuppressive drugs or radiation therapy, including malignant neoplasms, leukemias, lymphomas, and Hodgkin disease; solid organ transplantation; or congenital immunodeficiency

Dosage for high risk 2-5 years olds

• Administer 1 dose of PCV13 if 3 doses of PCV (7- or 13-valent) were received previously
• Administer 2 doses of PCV at least 8 weeks apart if fewer than 3 doses of PCV13 were received previously
• Administer 1 supplemental dose of PCV13 if 4 doses of PCV7 or other age-appropriate complete PCV7 series was received previously
• The minimum interval between doses of PCV is 8 weeks
• For children with no history of PPSV23 vaccination, administer PPSV23 at least 8 weeks after the most recent dose of PCV13

ACIP Guidelines, Aged 6-17 Years with High Risk

Any of the following conditions:

• Cerebrospinal fluid leak
• Cochlear implant
• Sickle cell disease and other hemoglobinopathies
• Anatomic or functional asplenia
• Congenital or acquired immunodeficiencies
• HIV infection
• Chronic renal failure
• Nephrotic syndrome
• Diseases associated with immunosuppressive drugs or radiation therapy, including malignant neoplasms, leukemias, lymphomas, and Hodgkin disease; generalized malignancy; solid organ transplantation; or multiple myeloma
  • If neither PCV13 nor PPSV23 has been received previously, administer 1 dose of PCV13 now and 1 dose of PPSV23 at least 8 weeks later
  • If PCV13 has been received previously but PPSV23 has not, administer 1 dose of PPSV23 at least 8 weeks after the most recent dose of PCV13
  • If PPSV23 has been received but PCV13 has not, administer 1 dose of PCV13 at least 8 weeks after the most recent dose of PPSV23

Heart, lung, diabetes, liver diseases in 6-17 year olds

Any of the following conditions:

• Chronic heart disease (particularly cyanotic congenital heart disease and cardiac failure)
• Chronic lung disease (including asthma if treated with high-dose oral corticosteroid therapy)
• Diabetes mellitus
• Alcoholism
• Chronic liver disease
• If the patient has not received PPSV23, administer 1 dose of PPSV23
• If PCV13 has been received previously, then PPSV23 should be administered at least 8 weeks after any prior PCV13 dose

Dosing Considerations

Use in preterm infants

• U.S. vaccine schedule: Immune response has not been studied
• Non-U.S. vaccine schedule: When preterm infants (below 37 weeks gestational age, N = 100) were administered 4 doses, the serotype-specific IgG antibody responses after the 3rd and 4th doses were lower compared to responses among term infants (37 weeks and above gestational age, N = 100) for some serotypes; effectiveness cannot be established from this study

Overdose

• Overdose of pneumococcal vaccine 13-valent is unlikely because it is administered in a clinical setting with a pre-filled syringe. However, there have been reports of overdose in infants and children when subsequent doses were administered in shorter intervals than recommended after the previous dose. The adverse effects were consistent with the side effects profile of the drug with recommended intervals.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Severe interactions of pneumococcal vaccine 13-valent include:
  • belimumab
• Pneumococcal vaccine 13-valent has serious interactions with at least 40 different drugs.
• Moderate interactions of pneumococcal vaccine 13-valent include:
  • certolizumab pegol
  • cyclosporine
  • dengue vaccine
  • ibrutinib
  • ifosfamide
  • lomustine
  • mechlorethamine
  • melphalan
  • onasemnogene abeparvovec
  • oxaliplatin
  • procarbazine
  • satralizumab
  • tralokinumab
  • ublituximab
  • ustekinumab
  • voclosporin
• Mild interactions of pneumococcal vaccine 13-valent include:
  • chloroquine
  • ozanimod

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.

• Available data on administration of pneumococcal vaccine 13-valent in pregnant women does not show vaccine-associated risks to the fetus, and animal reproductive studies do not show evidence of fetal harm.
• There is no data on the presence of pneumococcal vaccine 13-valent in breastmilk, or its effect on milk production or the breastfed infant. Decision to breastfeed should be made after considering the developmental and health benefits of breastfeeding, along with the potential adverse effects to the infant from the vaccine or the mother’s susceptibility to contracting the disease that the vaccine prevents.

• Complete your pneumococcal vaccination as recommended. Getting vaccinated is the best way to prevent pneumococcal disease.
• Complete the routine immunization program recommended for your child without missing any of the series of primary and booster doses.
• Full information on vaccine schedules is available at http://www.cdc.gov/vaccines/schedules/hcp/index.html