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Slide 17

The safety of 7-PCV was assessed in a number of controlled clinical trials in which more than 18 000 healthy infants (6 weeks to 18 months) were included. The majority of the safety experience comes from the NCKP efficacy trial in which 17 066 infants received 55 352 doses of Prevenar. In all studies, 7-PCV was administered concurrently with the recommended childhood vaccines. The safety profile of the vaccine is further confirmed by experience with the vaccine in the United States where over 42 million doses have now been distributed. 7-PCV is now widely used in the United States to prevent childhood pneumococcal infection as part of their primary immunisation schedule.

Reference
Black S et al. Pediatr Infect Dis J 2000; 19: 187-195
Choo S et al Pediatr Infect Dis J 2000; 19: 854-862
Eskola J et al. N Engl J Med 2001; 344: 403-409

Slide 18

Pneumococcal vaccine is recommended for all those aged 65 years and over, as well as all those aged over 2 months in the following clinical risk groups (with examples, decision based on clinical judgement): 1. Asplenia or dysfunction of the spleen: This also includes conditions such as homozygous sickle cell disease and coeliac disease that may lead to splenic dysfunction. 2. Chronic respiratory disease: This includes chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema; and such conditions as bronchiectasis, cystic fibrosis, interstitial lung fibrosis, pneumoconiosis and bronchopulmonary dysplasia (BPD). Asthma is NOT an indication, unless so severe as to require continuous or frequently repeated use of systemic steroids (as defined in the immunosuppression section). Children with respiratory conditions caused by aspiration, or a neuromuscular disease (e.g. cerebral palsy) with a risk of aspiration. 3. Chronic heart disease: This includes those requiring regular medication and/or follow up for ischaemic heart disease, congenital heart disease, hypertension with cardiac complications, and chronic heart failure. 4. Chronic renal disease: Including nephrotic syndrome, chronic renal failure, renal transplantation. 5. Chronic liver disease: Including cirrhosis. 6. Diabetes: Diabetes mellitus requiring insulin or oral hypoglycaemic drugs. 7. Immunosuppression: Due to disease or treatment. Including asplenia or splenic dysfunction, HIV infection at all stages. Patients undergoing chemotherapy leading to immunosuppression. Individuals on or likely to be on systemic steroids for more than a month at a dose equivalent to prednisolone at 20mgs or more per day (any age) or for children under 20kgs a dose of 1mg or more per kg per day. However, some immunocompromised patients may have a sub optimal immunological response to the vaccine. 8. Individuals with cochlear implants. 9. Individuals with the potential for cerebrospinal fluid leaks: Including cerebrospinal fluid shunts and other conditions where leakage of cerebrospinal fluid can occur. 10. Children under 5 years of age who have previously had invasive pneumococcal disease: e.g. children who have previously had pneumococcal meningitis or pneumococcal bacteraemia.


Reference
Chief Medical Officer (March 31st 2005). www.doh.gov.uk/cmo/index

Slide 19

Pneumococcal vaccine is recommended for all those aged 65 years and over, as well as all those aged over 2 months in the following clinical risk groups (with examples, decision based on clinical judgement): 1. Asplenia or dysfunction of the spleen: This also includes conditions such as homozygous sickle cell disease and coeliac disease that may lead to splenic dysfunction. 2. Chronic respiratory disease: This includes chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema; and such conditions as bronchiectasis, cystic fibrosis, interstitial lung fibrosis, pneumoconiosis and bronchopulmonary dysplasia (BPD). Asthma is NOT an indication, unless so severe as to require continuous or frequently repeated use of systemic steroids (as defined in the immunosuppression section). Children with respiratory conditions caused by aspiration, or a neuromuscular disease (e.g. cerebral palsy) with a risk of aspiration. 3. Chronic heart disease: This includes those requiring regular medication and/or follow up for ischaemic heart disease, congenital heart disease, hypertension with cardiac complications, and chronic heart failure. 4. Chronic renal disease: Including nephrotic syndrome, chronic renal failure, renal transplantation. 5. Chronic liver disease: Including cirrhosis. 6. Diabetes: Diabetes mellitus requiring insulin or oral hypoglycaemic drugs. 7. Immunosuppression: Due to disease or treatment. Including asplenia or splenic dysfunction, HIV infection at all stages. Patients undergoing chemotherapy leading to immunosuppression. Individuals on or likely to be on systemic steroids for more than a month at a dose equivalent to prednisolone at 20mgs or more per day (any age) or for children under 20kgs a dose of 1mg or more per kg per day. However, some immunocompromised patients may have a sub optimal immunological response to the vaccine. 8. Individuals with cochlear implants. 9. Individuals with the potential for cerebrospinal fluid leaks: Including cerebrospinal fluid shunts and other conditions where leakage of cerebrospinal fluid can occur. 10. Children under 5 years of age who have previously had invasive pneumococcal disease: e.g. children who have previously had pneumococcal meningitis or pneumococcal bacteraemia.

Reference
Chief Medical Officer (March 31st 2005). www.doh.gov.uk/cmo/index


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