Prevenar-13 Vaccination

Prevenar 13 – Pfizer

Indication and Usage –

• Active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to 17 years of age.
• Active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in adults ≥18 years of age and the elderly.

Dosage and Administration –

• The vaccine should be given by intramuscular injection.
• The preferred sites are the anterolateral aspect of the thigh (vastus lateralis muscle) in infants or the deltoid muscle of the upper arm in children and adults.
• Infants aged 6 weeks-6 months

Three-dose primary series

1. The recommended immunisation series consists of four doses, each of 0.5 ml.
2. The primary infant series consists of three doses, with the first dose usually given at 2 months of age and with an interval of at least 1 month between doses.
3. The first dose may be given as early as six weeks of age. The fourth (booster) dose is recommended between 11 and 15 months of age.

Two-dose primary series alternatively, 

1. When Prevenar 13 is given as part of a routine infant immunisation programme, a series consisting of three doses, each of 0.5 ml, may be given.
2. The first dose may be administered from the age of 2 months, with a second dose 2 months later.
3. The third (booster) dose is recommended between 11 and 15 months of age.

• Unvaccinated infants and children ≥ 7 months of age Infants aged 7-11 months

1. Two doses, each of 0.5 ml, with an interval of at least 1 month between doses. A third dose is recommended in the second year of life.
2. Children aged 12-23 months Two doses, each of 0.5 ml, with an interval of at least 2 months between doses.
3. Children and adolescents aged 2-17 years One single dose of 0.5 ml.

• Children and adolescents 5–17 years

1. Children 5 to 17 years of age may receive a single dose of Prevenar 13 if they have been previously vaccinated with one or more doses of Prevenar.
2. This dose of Prevenar 13 should be administered at least 8 weeks after the final dose of Prevenar (7-valent)

• Adults ≥18 years of age, and the elderly

1. One single dose. The need for revaccination with a subsequent dose of Prevenar 13 has not been established.
2. Regardless of prior pneumococcal vaccination status, if the use of 23-valent pneumococcal polysaccharide vaccine is considered appropriate, Prevenar 13 should be given first

Contraindications –

• Hypersensitivity to the active substances, to any of the excipients listed in section 6.1, or to diphtheria toxoid.
• As with other vaccines, the administration of Prevenar 13 should be postponed in subjects suffering from acute, severe febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination.

Adverse reactions –

• The most commonly reported adverse reactions in children 6 weeks to 5 years of age were vaccination-site reactions, fever, irritability, decreased appetite, and increased and/or decreased sleep.

Drug interactions and other interactions –

• Prevenar 13 can be given concomitantly with any of the following vaccine antigens, either as monovalent or combination vaccines: diphtheria, tetanus, acellular or whole cell pertussis, Haemophilus influenzae type b, inactivated poliomyelitis, hepatitis B, meningococcal serogroup C, measles, mumps, rubella, varicella and rotavirus vaccine.
• Prevenar 13 can also be given concomitantly between 12-23 months with the tetanus toxoid conjugated meningococcal polysaccharide serogroups A, C, W and Y vaccine to children who have been adequately primed with Prevenar 13.
• No data are currently available regarding concomitant use with other vaccines.
• In clinical studies when Prevenar 13 was given 1 year after 23-valent pneumococcal polysaccharide vaccine the immune responses were lower for all serotypes compared to when Prevenar 13 was given to subjects not previously immunised with 23-valent pneumococcal polysaccharide vaccine. The clinical significance of this is unknown.
• Different injectable vaccines should always be given at different vaccination sites.
• There are no data from the use of pneumococcal 13-valent conjugate vaccine in pregnant women. Therefore the use of Prevenar 13 should be avoided during pregnancy.