Evidence of benefits, harms, values and preferences, and cost effectiveness were reviewed in accordance with GRADE methods to determine the recommendation category (Ahmed F, Temte JL, Campos-Outcalt D, Schünemann HJ; for the ACIP Evidence Based Recommendations Work Group (EBRWG). Methods for developing evidence-based recommendations by the Advisory Committee on Immunization Practices (ACIP) of the U.S. Centers for Disease Control and Prevention (CDC). Vaccine 29(49):9171-6, 2011). Pooled data from 6 placebo-controlled randomized trials (5798 subjects) indicated a relative risk for hepatitis B infection events of 0.37 (95% CI 0.29, 0.48) among vaccinated subjects, although evidence type was downgraded for indirectness as trials did not focus on subjects with diabetes. Pooled data from 5 observational studies (285 subjects with diabetes) indicated 91.6% of subjects with diabetes achieved seroprotection, although evidence type was downgraded for imprecision due to small numbers. No serious vaccine-related adverse events were reported in any study. The Institute of Medicine found evidence supporting a causal relationship between hepatitis B vaccination and anaphylaxis in yeast-sensitive individuals; the risk of anaphylaxis following hepatitis B vaccine is estimated at 1.1 per million doses. [IOM (Institute of Medicine). 2011.

Adverse Effects of Vaccines:

Evidence and Causality. Washington, DC: The National Academies Press; Bohlke K, Davis RL, Marcy SM, Braun MM, DeStefano F, Black SB, Mullooly JP, Thompson RS; Vaccine Safety Datalink Team. Risk of anaphylaxis after vaccination of children and adolescents. Pediatrics 2003;112:815-20].