Statement on the Use of Conjugate Pneumococcal Vaccine - 13 Valent in Adults (Pneu-C-13): An Advisory Committee Statement (ACS) National Advisory Committee on Immunization (NACI).

Abstract

This statement will supplement previous conjugate pneumococcal statements (1–3) and provide information regarding a newly authorized indication for the use of the 13-valent conjugate vaccine against pneumococcal disease, Prevnar® 13 (PNEU-C-13): As of January 2012, PNEU-C-13 has been authorized for use in adults aged 50 years and older for the prevention of invasive pneumococcal disease (IPD), including sepsis, meningitis, bacteremia, and pneumonia (with or without empyema) with bacteremia. As new data becomes available on the use of PNEU-C-13 in adults, NACI will review these data and provide new guidance as required. The 23-valent polysaccharide vaccine (PNEU-P-23) will not be discussed at length in this statement. Recommendations for its use remain unchanged. www.phac-aspc.gc.ca/publicat/cig-gci/index-eng.php This statement will: • Update the epidemiology of pneumococcal disease in Canada relevant to the introduction of PNEU-C-13; • Provide a review of the literature on the use of conjugate pneumococcal vaccines in adult populations (PNEU-C-7 and PNEU-C-13 when available); and • Provide recommendations for the use of the 13-valent conjugate vaccine in adults (PNEU-C-13), and on the use of PNEU-P-23 related to the use of PNEU-C-13. Although PNEU-C-13 was authorized for use in adults aged 50 years and over, we will be considering adults (all age groups) with high-risk conditions for IPD and the healthy 65 years and older age group because of the burden of illness that led to the recommendation of PNEU-P-23 use in this age group. II. Methods NACI reviewed (4) such considerations as the burden of disease and the target population, safety, immunogenicity, efficacy, effectiveness of the vaccine(s), vaccine schedules, and other aspects of the overall immunization strategy. Following critical appraisal of individual studies, summary tables with ratings of the quality of the evidence were prepared using NACI’s methodological hierarchy (Tables 6 and 7​7),), and proposed recommendations for vaccine use were developed. The Working Group chair presented the evidence and proposed recommendations to NACI. Following thorough review of the evidence and consultation at NACI meetings, the committee voted on specific recommendations. The description of relevant considerations, rationale for specific decisions, and knowledge gaps are described in the text of this statement. PHAC maintains documentation of these processes throughout knowledge synthesis and recommendation development.