Prevenar 13 (Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)) is indicated for:
- Active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants and children 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.
The use of Prevenar 13 should be determined on the basis of official recommendations taking into consideration the risk of invasive disease and pneumonia in different age groups, underlying comorbidities as well as the variability of serotype epidemiology in different geographical areas.
Current Recommendations in the UK
The Department of Health recommends Prevenar 13 for particular groups:
- The Prevenar 13 vaccine should be administered according to the schedule within the routine immunisation programme.
- For children under 10 years of age in any clinical risk group*
- For children 10 years onwards and adults in a clinical risk group**
- For children under the age of two with unknown or incomplete vaccination histories
The British HIV Association (BHIVA) guidance recommends all adults who are HIV positive should receive a single dose Prevenar 13, irrespective of CD4 cell count, antiretroviral (ART) use or viral load.
*Asplenia or splenic dysfunction, chronic respiratory disease, chronic heart disease, chronic kidney disease, chronic liver disease, diabetes, immunosuppression, individual cochlear implants, individuals with cerebrospinal fluid leaks, bone marrow transplant patients, patients with acute and chronic leukaemia, multiple myeloma or genetic disorders affecting the immune system (e.g. IRAK-4, NEMO, complement deficiency).
** Bone marrow transplant patients, patients with acute and chronic leukaemia, multiple myeloma or genetic disorders affecting the immune system (e.g. IRAK-4, NEMO, complement deficiency)
The safety of Prevenar 13® was assessed in controlled clinical studies and the safety profile of Prevenar 13® was similar to Prevenar®.
For Prevenar 13® 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.
Adverse reactions reported in clinical studies or from the postmarketing experience for all age groups can be found in the summary of product characteristics for Prevenar 13 available at https://www.medicines.org.uk.