The safety of mRNA vaccine in patients with common variable immunodeficiency

ABSTRACT

Background: Common variable immunodeficiency (CVID) is a heterogeneous group of disorders characterized by the disturbed production of immunoglobulin and specific antibodies. CVID usually manifests with recurrent bacterial respiratory tract infections, although broad spectrum of non-infectious complications affecting lungs and many other vital organ systems may develop. Therefore, CVID patients may be recognized as a risk group for Covid-19 infection and the vaccination should be considered despite of the terrain of humoral immunodeficiency. However, only limited data are available on the safety of mRNA vaccine in CVID patients Method: A single-center prospective observational study focused on the safety of mRNA vaccine Comirnaty administration in a cohort of CVID patients. Only patients who had met inclusion and exclusion criteria were enrolled upon signed written informed consent. Total blood count with differential, coagulation, biochemistry and immunologic parameters were assessed before a first dose of the vaccine (Day 0), then at Day 21 (before a second dose) and at Day 51. The study was approved by Motol University Hospital Ethic Committee. Results: Together 25 CVID patients were included into the study. The most reported adverse events were local pain, fatigue, myalgia, arthralgia or increased body temperature. Neither severe adverse events nor anaphylaxis were reported. No safety concern were also revealed in the evaluated laboratory parameters. Conclusion: The administration of mRNA vaccine Comirnaty in the terrain of CVID-severely impaired humoral immunity is safe. However, there is an open question of its efficacy, particularly from the point of view of T cell response that plays crucial role in antiviral immunity.