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
- The recommended immunisation series consists of four doses, each of 0.5 ml.
- 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.
- 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,
- 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.
- The first dose may be administered from the age of 2 months, with a second dose 2 months later.
- 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
- 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.
- Children aged 12-23 months Two doses, each of 0.5 ml, with an interval of at least 2 months between doses.
- Children and adolescents aged 2-17 years One single dose of 0.5 ml.
- Children and adolescents 5–17 years
- 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.
- 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
- One single dose. The need for revaccination with a subsequent dose of Prevenar 13 has not been established.
- Regardless of prior pneumococcal vaccination status, if the use of 23-valent pneumococcal polysaccharide vaccine is considered appropriate, Prevenar 13 should be given first
- 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.