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Grading of recommendations, assessment, development, and evaluation (GRADE) : Pfizer-BioNTech COVID-19 vaccine for persons aged 12-15 years
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May 14, 2021
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Description:A Grading of Recommendations, Assessment, Development and Evaluation (GRADE) review of the evidence for benefits and harms for Pfizer-BioNTech coronavirus disease 2019 (COVID-19) vaccine for persons aged 12-15 years was presented to the Advisory Committee for Immunization Practices (ACIP) on May 12, 2021. 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 Pfizer-BioNTech COVID-19 vaccine be recommended for persons 12-15 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), SARS-CoV-2 seroconversion (important), and asymptomatic SARS-CoV-2 infection (important). The two pre-specified harms were serious adverse events (critical) and reactogenicity grade ≥3 (important).
A systematic review of evidence on the efficacy and safety of a two-dose regimen of Pfizer-BioNTech COVID-19 vaccine among persons aged 12-15 years was conducted. The quality of evidence from one Phase II/III randomized controlled trial was assessed using a modified GRADE approach.
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Content Notes:Overview -- Introduction -- Methods -- Results -- GRADE Summary.
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