Efficacy, immunogenicity, and safety of the Novavax COVID-19 vaccine in immunocompromised patients: A targeted literature review

Abstract

Individuals who are immunocompromised (IIC) may have impaired infection prevention/resolution, potentially causing increased disease severity, complications, and healthcare-system strain. Exclusion of IIC from COVID-19 vaccine trials and limited real-world Novavax COVID-19 vaccine assessments have resulted in a data gap. This article provides a review of literature on IIC who received the Novavax COVID-19 vaccine. A targeted literature search of BIOSIS Previews®, Embase®, Embase Preprints, MEDLINE®, and publicly available content was performed to identify published clinical data assessing efficacy, immunogenicity, and safety of the Novavax COVID-19 vaccine in IIC, with predefined terms for immune-modifying diseases/conditions and medications. Identified publications were screened to ensure they described study data from IIC who received the Novavax COVID-19 vaccine. The search (through October 2024) identified 137 reports indicating use of the Novavax COVID-19 vaccine in IIC. Screening resulted in 10 publications for review; exclusionary reasons included a lack of vaccine-specific data (i.e., limited [<0.2% or n < 3] vaccine recipients, pooled/aggregated cohorts) and/or IIC population. Conditions described include HIV, multiple sclerosis, inflammatory rheumatic diseases, transplant recipients, and hematologic malignancies. Overall, the Novavax COVID-19 vaccine was immunogenic and had a tolerable safety profile across diverse populations of IIC; some outcomes varied based on condition, disease, and/or concomitant medication(s). Limited efficacy data indicates that the Novavax COVID-19 vaccine may help protect IIC against symptomatic/severe COVID-19; however, additional studies with larger sample sizes are needed. Future research should include disease-specific populations to assess how individual characteristics (e.g., disease state, concomitant medications, prior COVID-19 vaccination) impact vaccine response.