A Grading of Recommendations, Assessment, Development and Evaluation (GRADE) review of the evidence for benefits and harms for Moderna coronavirus disease 2019 (COVID-19) vaccine for persons aged 12-17 years was presented to the Advisory Committee for Immunization Practices (ACIP) on June 23, 2022. GRADE evidence type indicates the certainty in estimates from the available body of evidence. Evidence certainty ranges from type 1 (high certainty) to type 4 (very low certainty) [1]. The policy question was, “Should vaccination with Moderna COVID-19 vaccine (2 doses, 100 µg) be recommended for persons 12-17 years of age during an Emergency Use Authorization?” The potential benefits pre-specified by the ACIP COVID-19 Vaccines Work Group included prevention of symptomatic laboratory-confirmed COVID-19 (critical), hospitalization due to COVID-19 (important), multisystem inflammatory syndrome in children (MIS-C) (important), and asymptomatic SARS-CoV-2 infection (important). The two pre-specified harms were serious adverse events (SAEs) (critical) and reactogenicity grade ≥3 (important). A systematic review of evidence on the efficacy and safety of a two-dose regimen of Moderna COVID-19 vaccine among persons aged 12-17 years was conducted. The quality of evidence from one Phase II/III randomized controlled trial was assessed using a modified GRADE approach. A lower risk of symptomatic COVID-19 was observed among the vaccine group compared with the placebo group (Relative risk [RR]: 0.11; 95% Confidence Interval [CI]: 0.02, 0.50; evidence type 2). Immunobridging data were also assessed in support of efficacy. Among adolescents ages 12 – 17 years, the immune response to vaccine was non-inferior to that observed in adults ages 18-25 years ( GMR: 1.1; 95% CI: 0.9, 1.2; evidence type 2). Additionally, a lower risk of asymptomatic SARS-CoV-2 infection was observed among the vaccine group compared with the placebo group, though the confidence interval was wide and crossed the null (RR: 0.61 (0.24, 1.54); evidence type 3). The available data indicated that SAEs were more common in vaccine recipients, but certainty in the estimate was very low (RR 1.50; 95% CI: 0.30, 7.40; evidence type 4), and none of these SAEs were assessed by the Food and Drug Administration (FDA) as related to study intervention. Reactogenicity grade ≥3 was associated with vaccination (RR 5.23; 95% CI: 4.05, 6.76; evidence type 1). About 25% of vaccine recipients and 5% of placebo recipients reported any grade ≥3 local or systemic reactions following either dose 1 or dose 2.