Skip to main content

Master of Public Health

COVID-19 vaccine efficacy in participants with weakened immune systems from four randomized-controlled trials

AUTHORS

Sherman A , Tuan J , Cantos VD , Adeyiga O , Mahoney S , Ortega-Villa AM , Tillman A , Whitaker J , Woodward Davis AS , Leav B , Hirsch I , Sadoff J , Dunkle LM , Gilbert PB , Janes HE , Kublin JG , Goepfert PA , Kotloff K , Rouphael N , Falsey AR , El Sahly HM , Sobieszczyk ME , Huang Y , Neuzil KM , Corey L , Grinsztejn B , Gray G , Nason M , Baden LR , Gay CL , . Clinical infectious diseases : an official publication of the Infectious Diseases Society of America. 2024 4 10; ().

ABSTRACT

BACKGROUND: Although the SARS-CoV-2 vaccines are highly efficacious at preventing severe disease in the general population, current data are lacking regarding vaccine efficacy (VE) for individuals with mild immunocompromising conditions.

METHODS: A post-hoc, cross-protocol analysis of participant-level data from the blinded phase of four randomized, placebo-controlled, COVID-19 vaccine phase 3 trials (Moderna, AstraZeneca, Janssen, and Novavax) was performed. We defined a “tempered immune system” (TIS) variable via a consensus panel based on medical history and medications to determine VE against symptomatic and severe COVID-19 cases in TIS participants versus non-TIS (NTIS) individuals starting at 14 days after completion of the primary series through the blinded phase for each of the four trials. An analysis of participants living with well-controlled HIV was conducted using the same methods.

RESULTS: 3,852/30,351 (12.7%) Moderna participants, 3,088/29,868 (10.3%) Novavax participants, 3,549/32,380 (11.0%) AstraZeneca participants, and 5,047/43,788 (11.5%) Janssen participants were identified as having a TIS. Most TIS conditions (73.9%) were due to metabolism and nutritional disorders. Vaccination (versus placebo) significantly reduced the likelihood of symptomatic and severe COVID-19 for all participants for each trial. VE was not significantly different for TIS participants vs NTIS for either symptomatic or severe COVID-19 for each trial, nor was VE significantly different in the symptomatic endpoint for participants with HIV.

CONCLUSIONS: For individuals with mildly immunocompromising conditions, there is no evidence of differences in VE against symptomatic or severe COVID-19 compared to those with non-tempered immune systems in the four COVID-19 vaccine randomized controlled efficacy trials.

Tags: