1. The AD26.COV2.S vaccine provided protection against moderate to severe-critical Covid-19.
2. The AD26.COV2.S vaccine provided protection against severe Covid-19 and lasted for 6 months or longer.
Evidence Rating Level: 1 (Excellent)
Study Rundown: The AD26.COV2.S (Johnson&Johnson-Janssen or JJJ) vaccine was previously shown to have a 66.9% efficacy against moderate to severe-critical Covid-19 and greater than 85% efficacy against severe-critical disease after a median follow-up of 58 days. However, there is a gap in knowledge as to understanding the final analysis of the JJJ vaccine’s efficacy. This study reports the final analysis of the JJJ vaccine double-blind trial and found that the JJJ vaccine is safe and highly effective against severe Covid-19, hospitalization, and death, and lasted for 6 months or longer. This study was limited by the premature discontinuation of follow-up in the placebo-controlled phase and variable follow-up times among countries, as well as limited data for the delta and omicron variants. Nevertheless, this study’s findings are significant, as they demonstrate that a single dose of the JJJ vaccine provided protection against severe Covid-19 disease and hospitalization.
In-Depth [randomized control study]: This randomized control study occurred as a multinational, randomized, placebo-controlled trial in which patients were assigned in a 1:1 ratio to receive either the JJJ vaccine or placebo. Patients who were 18 years or older, in good or stable health, and without coexisting conditions or well-controlled coexisting conditions were included in the study. Patients who had the previous receipt of a Covid-19 vaccine or abnormal immune system function were excluded from the study. The primary outcome was vaccine efficacy against moderate to severe-critical Covid-19 with onset at least 14 days after administration and at least 28 days after administration. Outcomes in the primary analysis were assessed via per-protocol efficacy analysis. Based on the analysis, vaccine efficacy against moderate to severe-critical Covid-19 was 56.3% at 14 days after administration (95% confidence interval [CI], 51.3 to 60.8), and vaccine efficacy was 52.9% at 28 days after administration (95% CI, 47.1 to 58.1). Efficacy was 74.6% against severe-critical Covid-19 (95% CI, 64.7 to 82.1) and 75.6% against Covid-19 leading to medical interventions such as hospitalization (95% CI, 54.3 to 88.0). Efficacy was 82.8% against Covid-19 related death, with protection lasting 6 months or longer (95% CI, 40.5 to 96.8). Additionally, efficacy in the United States was 69.7% against the reference strain and alpha variant (95% CI, 60.7 to 76.9). No new safety concerns were identified and the JJJ vaccine was primarily associated with only mild-to-moderate adverse events. Overall, this study demonstrated that a single dose of the JJJ vaccine provides protection against severe Covid-19 disease, hospitalization, and death, and could prove essential to populations with poor adherence to two-dose regimens, supporting the use of the JJJ vaccine to help combat the ongoing Covid-19 pandemic.
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