Safety of COVID-19 Vaccines in Patients with Autoimmune Diseases, in Patients with Cardiac Issues, and in the Healthy Population

Abstract

The coronavirus disease 2019 (COVID-19) has been a challenge for the whole world since the beginning of 2020, and COVID-19 vaccines were considered crucial for disease eradication. Instead of producing classic vaccines, some companies pointed to develop products that mainly function by inducing, into the host, the production of the antigenic protein of SARS-CoV-2 called Spike, injecting an instruction based on RNA or a DNA sequence. Here, we aim to give an overview of the safety profile and the actual known adverse effects of these products in relationship with their mechanism of action. We discuss the use and safety of these products in at-risk people, especially those with autoimmune diseases or with previously reported myocarditis, but also in the general population. We debate the real necessity of administering these products with unclear long-term effects to at-risk people with autoimmune conditions, as well as to healthy people, at the time of omicron variants. This, considering the existence of therapeutic interventions, much more clearly assessed at present compared to the past, and the relatively lower aggressive nature of the new viral variants.

Effect of the COVID‐19 pandemic on disease activity in multiple sclerosis patients treated with hematopoietic stem cell transplantation

“…These may produce a complex interplay of potential triggers of disease activity, based on high immunogenicity and putative molecular mimicry with nervous system antigens (including myelin proteins), the latter suggested for both SARS‐CoV‐2 [13] and the SARS‐CoV‐2 spike protein from mRNA vaccines [14]. In this scenario, it could be argued that the type and schedule of vaccination should be tailored to the evolving COVID‐19 pandemic and the individual risk profile [15]. Finally, if a causal relationship was ascertained between these cases of MS reactivation and the putative trigger, this could have relevant implications for the long‐term management of such patients, and stringent monitoring may be needed.…”

“…In this scenario, it could be argued that the type and schedule of vaccination should be tailored to the evolving COVID-19 pandemic and the individual risk profile [15]. Finally, if a causal relationship was ascertained between these cases of MS reactivation and the putative trigger, this could have relevant implications for the longterm management of such patients, and stringent monitoring may be needed.…”

The anti-SARS-CoV-2 BNT162b2 vaccine suppresses mithramycin-induced erythroid differentiation and expression of embryo-fetal globin genes in human erythroleukemia K562 cells

“…In this Report it was determined that that COVID-19 is now an established and ongoing health issue which no longer constitutes a public health emergency of international concern [11]. Accordingly, it has been suggested that it is time for further and more extensive evaluations of the short- and long-term effects of the COVID-19 vaccines on human tissue systems [12].…”

“…Concerning this very important issue, studies have hypothesized that the SARS-CoV-2 Spike protein (S-protein) is a major factor accounting for side effects of the COVID-19 mRNA vaccines [7][8][9][10][11][12][13], such as the BNT162b2 from Pfizer-BioNTech [14] and the mRNA-1273 from Moderna [15], as recently discussed by Trougakos and colleagues [16,17].…”

“…Relevant to this issue are reported evidences of circulating Spike Protein detected in post-COVID-19 mRNA vaccinated subjects [18][19][20][21][22][23], and several reports outlining that Sprotein affects cellular metabolism and gene expression in a variety of tissue systems [12,[24][25][26][27][28][29], including the hematopoietic system [28,29]. Accordingly, the effects of SARS-CoV-2 infection and/or vaccination on the hematopoietic system should be carefully considered [28][29][30].…”