Pneumococcus, Purified Polysaccharide Antigen Conjugated (PCV)

Registered South African indications:

• Prevention of pneumooccal disease (including pneumonia and invasive disease) caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B,7F, 9V, 14, 18C, 19A, 19F and 23F (adults >18 years)
• Prevention of invasive disease, pneumonia, and otitis media caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (in infants, children and adolescents)

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to diphtheria toxoid
• Acute, severe febrile illness

Cautions

• Breastfeeding
• Thrombocytopenia
• Coagulation disorders 
• Sickle cell disease
• Patients on a low-sodium diet
• Immunocompromised patients
• Premature infants

Forms avail. in SA and covered in this monograph: inj

Active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae

• IM: 0.5ml, as a single dose

- In individuals with an haematopoietic stem cell transplant (HSCT), the recommended immunisation series consists of:

• IM: 1st dose: 0.5ml, given 3-6 months after transplantation; 2nd and 3rd dose: 0.5ml, given at intervals of at least 1 month between doses; Booster: 0.5ml, given 6 months after 3rd dose

DO NOT administer intravascularly

Immunisation schedules should be based on official  recommendations

See additional prescribing points

Paed. forms avail. in SA and covered in this monograph: inj

EPI Schedule 2016

Prevention of invasive disease, pneumonia, and otitis media caused by Streptococcus pneumoniae - Primary immunisation

Between 6 weeks - 6 months

• IM: 1st dose: 0.5ml, given at 6-8 weeks of age; 2nd and 3rd dose: 0.5ml, given at intervals of 4-8 weeks; Booster dose: 0.5ml, given at 11-15 months of age

The above schedule is preferred in preterm infants

OR

If given as part of routine infant immunisation program

• IM: 1st dose: 0.5ml, given at 8 weeks of age; 2nd dose: 0.5ml, given 2 months after the 1st; Booster dose: 0.5ml, given at 11-15 months of age

Prevention of invasive disease, pneumonia, and otitis media caused by Streptococcus pneumoniae - Previously unvaccinated infants

Between 7-12 months

• IM: 1st dose: 0.5ml; 2nd dose: 0.5ml, given at an interval of at least 4 weeks; 3rd dose: 0.5ml, given in the second year of life (at least 8 weeks after 2nd dose)

Between 1-2 years

• IM: 1st dose: 0.5ml; 2nd dose: 0.5ml, given at an interval of at least 8 weeks

Older than 2 years

• IM: 0.5ml, as a single dose

DO NOT administer intravascularly

See additional prescribing points

Pregnancy

• Caution
• There are no data from the use of pneumococcal 13-valent conjugate vaccine in pregnant women. Therefore the use of pneumococcal 13-valent conjugate vaccine should be avoided during pregnancy

Breastfeeding

• Caution
• It is unknown whether the pneumococcal 13-valent conjugate vaccine is excreted in human milk

Fertility

• Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity

Renal Impairment

• No dose adjustment recommended 

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended 

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Convulsions
• Hypotonic-hyporesponsive episode 
• Irritability
• Somnolence
• Poor quality sleep

Gastrointestinal Disorders

• Decreased appetite
• Vomiting
• Diarrhoea

Skin and Subcutaneous Tissue Disorders

• Rash
• Urticaria 
• Urticaria-like rash

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions
• Pyrexia
• Vaccination-site erythema, induration/swelling or pain/tenderness

Others

• Crying

No information available

None routine

Administration directions

• Infants: Preferred site is the anterolateral aspect of the thigh (vastus lateralis muscle)
• Children and adults: Preferred site is the deltoid muscle of the upper arm
• The vaccine is not to be mixed with other vaccines or products in the same syringe

Previous vaccinations with 7-valent pneumococcal conjugate vaccine (PCV)

• Infants and children who have begun immunisation with PCV-7 may switch to PCV-13 at any point in the schedule
• If PCV-7 valent was previously administered, give PCV-13 valent ≥8 weeks after that dose
• Even after complete immunisation with PCV-7, a single dose of PCV-13 recommended stimulate immunity to the 6 additional serotypes

Promotes active immunization against seven S. pneumoniae capsular serotypes, all of which are individually conjugated to CRM197 protein. B-cells produce antibodies in response to antigenic stimulation via T-dependent and T-indepent mechanisms.

Injection (per 0.5ml) 28μg

• Prevenar 13 (Pfizer) originator