Prevenar 13 is a conjugated polysaccharide pneumococcal vaccine that is used to prevent invasive bacterial infections caused by pneumococci.

Prevenar PCV 13 indications:

• It is advised for use in the active immunisation of babies older than 6 weeks, kids, teenagers, and adults in order to avoid invasive streptococcal pneumonia infections brought on by the specific serotypes included in the vaccine.
• Additionally, it can protect adults and teenagers older than 18 from developing pneumonia brought on by S. pneumoniae serotypes that are present in the vaccination.
• In children between the ages of 6 weeks and 6 years, it is used to prevent otitis media caused by serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F of streptococcal pneumonia.

The ACIP (Advisory Committee on Immunization Practices) recommends routine vaccination for the following groups of individuals:

• All infants and children aged 2 months to 5 years of age
• All adults 65 years of age and older
• Children 5 to 65 years of age with underlying medical conditions including:
• Metastatic malignancies
• Solid organ transplant patients
• Chronic lung disease (including asthma that is treated with high-dose glucocorticoids)
• Diabetes
• Heart disease (heart failure or cyanotic heart disease
• leukaemia
• Cochlear implants
• Cerebrospinal fluid leak
• Chronic renal failure
• nephrotic syndrome
• Immunodeficiency from birth (B and T cell deficiency, complement deficiency, and phagocytic disorders)
• HIV infections
• Either anatomical or functional asplenia (including sickle cell disease, hemoglobinopathies, congenital or acquired asplenia, or splenic dysfunction)
• lymphoma
• Hodgkin disease
• other conditions that require systemic corticosteroids and radiation therapy.

Prevenar 13 vaccine Dose in Adults

Prevenar 13 Vaccine Dose for Immunization:

• 0.5 mL intramuscular as a single dose.
• Adults 65 years of age and older:
  • 0.5 mL Intramuscular as a single dose.
• Pneumococcal vaccine-unvaccinated or unvaccinated:
  • Prevenar PCV 13 should be given first, then Pneumovax 23 at least eight weeks later.
• Prevenar PCV 13 was previously administered, but not Pneumovax 23:
  • Prevenar PCV 13 dosages cannot be increased.
• Pneumovax 23 was previously administered but not Prevenar PCV13:
  • Prevenar should be given more than a year apart after Pneumovax 23 doses.
• Revaccination:
  • Adults should not receive additional doses of vaccination through revaccination.
• Pneumococcal vaccine-naive or unvaccinated patients 65 years of age or older:
  • Prevenar PCV 13 is given, then Pneumovax 23 is given a year later (minimum interval of 8 weeks for certain high-risk groups)
• Pneumovax 23 but not PCV13 was previously administered to patients 65 years of age and older:
  • One year after the last dosage of Pneumovax 23, administer Prevenar PCV 13.
• Pneumovax 23 but not PCV13 was previously administered to patients 65 years of age and older: 
  • Approximately a year following the previous dosage of Pneumovax 23, administer Prevenar PCV 13.
• Previously received PCV13:
  • Additional PCV13 doses are not needed

Prevenar Dose in the treatment of hematopoietic stem cell transplantation:

• 0.5 mL intramuscular for a total of three doses, with the first dosage given 3–6 months following HSCT, the second dose given at least one month later, and the third dose given at least two months later.

Prevenar 13 vaccine Dose in Children

Prevenar 13 vaccine Dose in all patients for Primary immunization:

• Infants and Children 6 weeks-15 months:
  • 0.5 mL intramuscular per dosage given four times as follows:
    • The suggested period between doses is 4 to 8 weeks.
    • The final three doses are usually given at 4, 6, and 12 to 15 months of age. Although it can be given as early as 6 weeks, the first dosage is frequently given at 8 weeks (2 months).
    • The minimum interval between the third and fourth doses for infants under the age of one year is eight weeks, and they should take their prescriptions every four weeks.
  • o Canadian recommendations for a healthy infant's Prevenar PCV 13 vaccine schedule:
    • Administered intramuscularly at the age of two months, 0.5 mL
    • The second dose is administered at 4 months, followed by the third dose at 12 months.

Dose as Catch-up immunization, healthy infants and children 4 months to six years of age:

• ACIP suggestions:
  • 0.5 mL each dose, up to a maximum of 4 doses.

Dose in the High-risk conditions; catch-up or revaccination:

• Infants over 4 months and Children over 24 months:
  • 1 to 4 doses totaling 0.5 mL per dose
• Children 2 to 5 years:
  • Previously vaccinated with PCV13:
    • Previously received 3 doses:
      • 0.5 mL as a solitary dosage administered at least 8 weeks after the most previous dose
    • Previously received less than 3 doses:
      • 0.5 mL IM, divided into two doses, at least eight weeks apart from one another, and given at least eight weeks after the preceding dose.
  • Pneumococcal vaccine-naïve (no previous PCV13):
    • 0.5 mL IM, totalling 2 doses spaced no less than 8 weeks apart.
• Children and Adolescents 6 to 18 years:
  • Pneumococcal vaccine-naïve (no previous PCV13 or PPSV23 vaccine):
    • A single dose of 0.5 mL IM
  • Previously vaccinated with PPSV23 vaccine:
  • Give PCV13 vaccination if it has never been given:
    • 8 weeks or longer after the last dose of the Pneumovax 23 vaccine, administer one dose of 0.5 mL intramuscularly.

Pregnancy Risk Factor: B

• It has not yet been tested in pregnant women.
• Pregnancy is safe for inactivated vaccines.
• The vaccine may be given to pregnant women at high risk for pneumococcal infections.

PCV13 use during breastfeeding:

• It is unknown if the drug will be excreted into breast milk.
• The manufacturer suggests that breastfeeding mothers be given the vaccine with caution.
• It has no impact on the mother's or the child's ability to breastfeed safely and comfortably.
• The vaccine administration does not increase the infant's immunity. The recommended schedule should be followed when vaccinating children.

Prevenar 13 Vaccine dose in Renal disease:

The manufacturer has not listed any dose adjustment in patients with kidney disease.   

Prevenar 13 Vaccine dose in Liver disease:

The manufacturer has not listed any dose adjustment in patients with liver disease.   

Side Effects of Prevenar 13 Vaccine (PCV13):

• Central Nervous System:
  • Insomnia
  • Irritability
  • Fatigue
  • Chills
  • Drowsiness
  • Headache
• Gastrointestinal:
  • Decreased Appetite
• Dermatologic:
  • Skin Rash
• Neuromuscular & Skeletal:
  • Myalgia
  • Decreased Range Of Motion
  • Arthralgia
• Local:
  • Swelling At Injection Site
  • Erythema At Injection Site
  • Pain At Injection Site
  • Tenderness At Injection Site
• Miscellaneous:
  • Fever

Side Effects Of Prevenar 13 (PCV13) vaccine (Less common):

• Dermatologic:
  • Urticaria
• Gastrointestinal:
  • Diarrhea
  • Vomiting

Contraindication to PCV13 includes:

• Toxic reactions to any vaccination ingredient, even those that contain diphtheria toxoid.

Warnings and precautions

• Anaphylactoid reactions and hypersensitivity reactions

  • Pneumococcal vaccination should only be given in an environment that allows for the management of allergic reactions.
  • Anaphylactoid and/or hypersensitivity reactions following vaccination are possible and may require rapid epinephrine 1 mg/mL treatment.

• Syncope

  • The vaccine may cause syncope, which can lead to serious secondary injuries (such as a skull injury or intracranial bleeding).
  • It is important to administer the vaccine in an area that prevents injuries and allows for syncope by restoring cerebral perfusion.

• Acute illness:

  • A severe or acute condition should not be treated with the vaccine. It should be administered 2 weeks after the acute illness.

• Asplenia:

  • Prevenar 13 is not an alternative to Pneumovax 23, for children aged >=24 months with asplenia.
• Bleeding disorders:
  • Patients with bleeding disorders should not be given intramuscular vaccines. Hematoma and bleeding may occur at injection sites.
  • Patients should be given the proper antihemophilic or clotting factors, and the vaccine should subsequently be given as quickly as feasible.

• Chronic illness:

  • Individuals with chronic diseases should not use Prevenar 13 as a substitute for Pneumovax 23, especially if they have a history of chronic illness.

• HIV:

  • Prevenar 13 is not an alternative to Pneumovax 23, but it can be used in HIV-positive patients.

• Pneumococcal Infections:

  • It is not recommended to be used during active infections.

• Sickle cell disease:

  • Prevenar 13 is not an alternative to Pneumovax 23, for children with sickle cell disease older than 2 years.

Pneumococcal conjugate vaccine (13-valent) (PCV13): Drug Interaction

Monitor:

• 15 minutes after the vaccination, keep an eye on the patient for anaphylaxis and syncope.
• To restore appropriate cerebral perfusion in the event of seizure-like activity linked to syncope, the patient should be kept in the supine or Trendelenburg posture.

How to administer Prevenar 13 (PCV13)?

• It is administered as an intramuscular injection in the deltoid muscle.
• It should not be injected intravenously, subQ, or intradermally since these methods may result in negative local reactions.
• It should be delivered with a different needle and syringe and should not be combined with other shots or vaccinations.
• Shake the vaccine prior to administration.
• Do not administer the vaccine if a white homogenous suspension is not formed.
• To administer the vaccine, make the patient lie down or seated to prevent syncope-related injuries associated with the vaccine.
• It should not be mixed with other vaccines and injections. concomitant administration with Pneumovax 23 vaccine is not recommended.
• Patients with haemophilia should receive Factor VIII and receive the vaccine shortly after the factors are administered.
• A 23 gauge needle should be used to deliver it, and a firm pressure should be sustained for at least two minutes without rubbing.
• Patients on anticoagulants have a similar risk as those with bleeding disorders.
• These patients should be informed of the risks of hematoma from the injection site.   

Mechanism of action of Prevenar 13 (PCV13) Vaccine:

PrevenarPCV13 is a pneumococcal vaccine. It promotes active immunization against S. pneumonia capsular serotypes 1, 3, 5, 6, 6B, 7F and 9V. It is a common condition in adults. 50 to 80 percent efficiency invasive pneumococcal illnesses can be avoided. Antibodies to the antigens of pneumococcal disease Take 2 - 3 Weeks After its administration, which lasts for five years in the body. A few patients, such as those living with HIV, liver disease and malnutrition, may have an inadequate antibody response. In these cases, a rapid decline of antibodies could occur in certain groups.     

Brand Names of PCV13 (International):

• Prevenar 13

PCV 13 Vaccine brand Names in Pakistan:

Prevenar PCV 13