Grading of Recommendations, Assessment, Development, and Evaluation (GRADE): Janssen COVID-19 Vaccine

As of December 19, 2020, two vaccines had been recommended for prevention of COVID-19, caused by the SARS-CoV-2 virus which emerged in late 2019.

On February 27, 2021, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Janssen COVID-19 (Ad26.COV2.S) vaccine for prevention of symptomatic COVID-19 for persons aged ≥18 years [8]. As part of the process employed by the ACIP, a systematic review and GRADE evaluation of the evidence for Janssen COVID-19 vaccine was conducted and presented to ACIP. There were no conflicts of interest reported by CDC and ACIP COVID-19 Vaccines Work Group members involved in the GRADE analysis.

The ACIP adopted a modified GRADE approach in 2010 as the framework for evaluating the scientific evidence that informs recommendations for vaccine use, including those for the Janssen COVID-19 vaccine. Evidence of benefits and harms were reviewed based on the GRADE approach.

The primary policy question was, “Should vaccination with Janssen COVID-19 vaccine be recommended for persons 18 years of age and older during an Emergency Use Authorization?” (Table 1).