Preliminary Data on Post Market Safety Profiles of COVID 19 Vaccines in Rheumatic Diseases: Assessments on Various Vaccines in Use, Different Rheumatic Disease Subtypes, and Immunosuppressive Therapies: A Two-Centers Study.

Cinzia Rotondo,Francesco Paolo Cantatore,Nicola Maruotti,Florenzo Iannone,Addolorata Corrado,Lucia Lops,Daniela Cici,Valeria Rella,Ripalta Colia,Francesca D’Onofrio,Stefania Sciacca,Giuseppe Busto,Marco Fornaro

doi:10.3390/vaccines9070730

Cinzia Rotondo, Francesco Paolo Cantatore + Show 11 more

Open Access

https://doi.org/10.3390/vaccines9070730

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Abstract

An increased risk of developing severe infections has been evidenced in rheumatic disease (RD) patients, and anti-COVID-19 vaccination is strictly recommended for RD patients. However, up to now, no data are available on safety, immunogenicity and efficacy of COVID-19 vaccinations in RD patients. The possible development of adverse events (AEs), including the flare-up of underlying RD, represents a matter of growing importance. The aim of our study is to assess, in RD patients, the safety profile of different types of approved vaccines and the possible influence of immunosuppressive therapies and clinical or demographic characteristics of RD patients on development of AEs. Participants (n = 185; 30.7%) received anti-COVID-19 vaccinations, 137 with autoimmune/chronic inflammatory RD (Au/cIn-RD) and 48 with nonautoimmune/chronic inflammatory RD (no-Au/cIn-RD). AEs were recorded in 42% of patients after the first dose of vaccine, and in 26% of patients after the second dose. The most common reported AEs after anti-COVID 19 vaccines were site injection pain (17%), headache (12%), fever (12%), myalgia (10%) and fatigue (10%). Relapses of the underlying Au/c-In-RD were recorded in 2.2% of patients after the first dose of vaccine. In Au/c-In-RD the risk of developing AEs after the first dose of vaccine was lower in older patients (OR = 0.95; p = 0.001), and in the group of patients with complete control of RD (OR: 0.2; p = 0.010). A lower percentage of AEs was observed in patients with complete control of their Au/cIn-RD (29%) compared to those with low (57%) or moderate-high disease activity (63%) (p = 0.002 and p = 0.006 respectively). In this study all types of COVID-19 vaccines in use in Italy seemed safe in RD patients. The results of this study might provide reassuring information for Au/cIn RD patients and clinicians and could strengthen the data on vaccine safety to guide the use of COVID-19 vaccines in Au/cIn-RD on immunosuppressive agents.

Highlights

Due to the lack of appropriate and effective treatments for COVID-19, vaccination seems to be only reliable preventive method to avoid hospitalization and severe complications of SARS-COV 2 infection [1]
In this study all types of COVID-19 vaccines in use in Italy seemed safe in rheumatic disease (RD) patients
The results of this study might provide reassuring information for Au/cIn RD patients and clinicians and could strengthen the data on vaccine safety to guide the use of COVID-19 vaccines in Au/cIn-RD on immunosuppressive agents

Summary

Introduction

Due to the lack of appropriate and effective treatments for COVID-19, vaccination seems to be only reliable preventive method to avoid hospitalization and severe complications of SARS-COV 2 infection [1]. An increased risk of developing severe infections caused by immune system dysregulation and use of immunosuppressive drugs has been evidenced in Au/cIn-RD patients [5,6,7,8,9,10,11,12]. The American College of Rheumatology (ACR) has recently proposed recommendations for COVID-19 vaccination in RD patients and a practical guidance for immunosuppressive treatment management during the period of immunization. Up to now, no data are available on safety, immunogenicity and efficacy of COVID-19 vaccinations in autoimmune RD patients on immunomodulatory treatments, due to the exclusion of these patients from clinical trials of COVID-19 vaccines. Nonlive vaccines seem to be safer in Au/cIn RD patients, but no data are available on the safety of vaccines based on mRNA in these patients, due to the fact that it is the first time the mRNA technology is being used for vaccine production [16]

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