INTRODUCTION
The coronavirus disease 2019 (COVID-19) outbreak has affected over 500
million individuals and caused over 6 million deaths worldwide since its
emergence in 2019 . Severe COVID-19 infections with poorer outcomes have
been reported in immunocompromised patients, such as those with inborn
errors of immunity (IEI) . Conversely, Marcus et al. reported neither
more severe disease nor excess hospital admissions in a cohort of
patients with IEI and implied a high awareness level, extra precautions,
and even self-isolation as possible explanations . However, preventive
measures only provide short-term protection; therefore, vaccination may
offer a long-term effective and safe solution.
At present, two mRNA (BNT162b2, also known as Comirnaty,
Pfizer/BioNTech; mRNA-173, also known as Spikevax, Moderna), one
recombinant-subunit (Novaxovid, Novavax), and two viral-vector (AZD1222,
also known as Vaxzevria, AstraZeneca; Ad26.COV2.S, also known as
COVID-19 Vaccine Janssen, Janssen/Johnson & Johnson) vaccines have been
approved by the European Medicines Agency for COVID-19prevention. The
vaccines induce high levels of immunogenicity and efficacy, ranging from
66.9% to 90.4%, and demonstrate a favorable safety profile, with a
dominant prevalence of local reactions in the general population .
However, severe AEs, such as thromboembolic events or peri- and
myocarditis, have been reported . Additionally, evidence regarding their
use in specific patient populations is limited, particularly those with
heavily impaired antibody production, disturbed cellular immunity,
and/or immune system dysregulation.
Common variable immunodeficiency (CVID) is the most prevalent IEI,
characterized by impaired vaccination-induced specific antibody
production , immune dysregulation, and partially impaired T-cell
phenotype and function . Therefore, this study investigated the
immunogenicity, safety, and clinical outcomes of the mRNA vaccine
BNT162b2 in a cohort of patients with CVID.