Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) for Pneumococcal Vaccines for Adults aged ≥65 years

    MMWR recomm. rep; 63 (37), 2014
    Año de publicación: 2014

    GRADE was used to evaluate 13-valent Pneumococcal Conjugate Vaccine (PCV13) for routine use among adults aged ≥65 years. Evidence of benefits, harms, values and preferences, and cost-effectiveness were reviewed in accordance with GRADE methods.[1] The primary policy question was “Should PCV13 be administered routinely to all adults aged ≥65 years?” The intervention evaluated was a single dose of PCV13 compared to a dose of 23-valent polysaccharide vaccine (PPSV23). The benefits considered critical outcomes in GRADE included prevention of invasive pneumococcal disease (IPD), pneumococcal community-acquired pneumonia, and hospitalizations due to pneumococcal disease. Evidence used to evaluate efficacy of PCV13 against IPD and pneumococcal pneumonia was from the randomized placebo-controlled trial (RCT) conducted among approximately 85,000 adults aged ≥65 years in Netherlands (CAPiTA).[2] Evidence was not available for the critical outcome of hospitalizations due to pneumococcal disease. In addition, vaccine-induced immunogenicity was considered as an important outcome; immunogenicity evidence was assessed using two phase III RCTs of PCV13 compared to PPSV23, which measured antibody responses by opsonophagocytic assay (OPA) and four RCTs of PCV7 compared to PPSV23, which measured antibody responses by enzyme-linked immunosorbent assay (ELISA).[3-8] The harms considered were overall serious adverse events (SAE), deaths and systemic adverse events including fatigue, rash, new generalized muscle pain, and use of medications to treat fever. Safety of PCV13 was evaluated based on 6 RCTs in immunocompetent adults, compared to PPSV23.[9] Evidence type for each critical outcome was derived through a review of study design, risk of bias, inconsistency, indirectness, and imprecision.