Anti-COVID-19 Vaccination in Patients with Autoimmune-Autoinflammatory Disorders and Primary/Secondary Immunodeficiencies: The Position of the Task Force on Behalf of the Italian Immunological Societies

Abstract

The Coronavirus disease 2019 (COVID-19) pandemic has represented an unprecedented challenge for humankind from health, economic, and social viewpoints. In February 2020, Italy was the first western country to be deeply hit by the pandemic and suffered the highest case/fatality rate among western countries. Brand new anti-COVID-19 vaccines have been developed and made available in <1-year from the viral sequence publication. Patients with compromised immune systems, such as autoimmune-autoinflammatory disorders (AIAIDs), primary (PIDs) and secondary (SIDs) immunodeficiencies, have received careful attention for a long time regarding their capacity to safely respond to traditional vaccines. The Italian Immunological Societies, therefore, have promptly faced the issues of safety, immunogenicity, and efficacy/effectiveness of the innovative COVID-19 vaccines, as well as priority to vaccine access, in patients with AIADs, PIDs, and SIDs, by organizing an ad-hoc Task Force. Patients with AIADs, PIDs, and SIDs: (1) Do not present contraindications to COVID-19 vaccines if a mRNA vaccine is used and administered in a stabilized disease phase without active infection. (2) Should usually not discontinue immunosuppressive therapy, which may be modulated depending on the patient’s clinical condition. (3) When eligible, should have a priority access to vaccination. In fact, immunizing these patients may have relevant social/health consequences, since these patients, if infected, may develop chronic infection, which prolongs viral spread and facilitates the emergence of viral variants.

T-Cell Defects Associated to Lack of Spike-Specific Antibodies after BNT162b2 Full Immunization Followed by a Booster Dose in Patients with Common Variable Immune Deficiencies

“…Since vaccination became available, Italian CVID patients have been immunized mostly with mRNA COVID-19 vaccines [ 19 ]. We have previously shown a low rate of immune response after full immunization, as one third of CVID did not seroconvert and one third did not generate specific T cells, while the antibody response was boosted in convalescent patients by immunization [ 4 , 5 ], a figure similar to that described earlier by Hagin et al in SARS-CoV.2 infected patients [ 20 ].…”

The Immune Response to SARS-CoV-2 Vaccination: Insights Learned From Adult Patients With Common Variable Immune Deficiency

“…As for all immunizations, the efficacy has been linked to the production of specific antibodies, which increase in response to all vaccines in use ( 21 ). It should be underlined that in the study population of the pre-approval studies, no patients with primary immune deficiencies were included ( 11 ). In immunocompetent subjects, the level of neutralizing antibodies is highly predictive of immune protection, and mRNA vaccination generated robust, multi-component humoral and cellular immune memory to SARS-CoV-2 for at least 6 months after mRNA vaccination ( 22 ).…”

Absent or suboptimal response to booster dose of COVID-19 vaccine in patients with autoimmune systemic diseases

“…Since the early 2021, the course of the pandemic was dramatically changed by the mass vaccination campaign. Importantly, the frail patients’ populations, such as ASD patients, were prioritized in several countries, including Italy ( https://www.trovanorme.salute.gov.it/norme/renderPdf.spring?seriegu=SG&datagu=24/03/2021&redaz=21A01802&artp=1&art=1&subart=1&subart1=10&vers=1&prog=002 ) [ 9 ]. Overall, COVID-19 vaccines in ASD patients revealed good safety profile and immunogenicity [ [10] , [11] , [12] , [13] ], with some limitations in patient receiving immune-modifier therapy, mainly rituximab (RTX), high glucocorticoid dosages, in the elderly and in particular ASD subsets [ [11] , [12] , [13] , [14] ].…”