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COVID-19 Vaccination in Autoimmune Disease (COVAD) Survey Protocol

February 3, 2022

In the setting of the COVID-19 pandemic that is linked to infection with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), immunocompromised patients with systemic autoimmune rheumatic diseases (AIRD) are potentially at risk of developing severe clinical outcomes and are highly encouraged to get vaccinated. 

However, since most AIRD patients were excluded from initial COVID-19 vaccine trials, vaccine hesitancy remains among this group based on concerns regarding the vaccine’s potential long-term effects. Therefore, more evidence is needed to gain a better understanding of how vaccination affects AIRD patients.

Rohit Aggarwal, MD, MS, from the Division of Rheumatology and Clinical Immunology, collaborated with colleagues from other institutions to report the protocol of the “COVID-19 Vaccination in Autoimmune Diseases (COVAD)” study. 

The COVAD study consisted of a patient self-report survey that collected data on post-vaccination outcomes in patients with AIRD. The survey included 36 questions that asked about previous COVID-19 infection; vaccination status; short-term minor and major adverse effects; diagnosis and current symptom status; functional status; treatment history; and demographic information.

An international group of 110 rheumatologists, internists, neurologists, and immunologists from more than 80 health care centers in over 50 countries conducted this e-survey. 

The survey opened to AIRD patients and their non-AIRD family members in early 2021. The survey was also posted on social media platforms and online patient support groups. By August 2021, 16,327 responses had already been collected. The survey remained open until December 31, 2021.

While data from the survey have yet to be analyzed, it is believed that results from this study may provide federal and regulatory agencies with a better understanding of the concerns surrounding vaccination, especially among individuals with an autoimmune disease. As a result, communication between providers and patients regarding the efficacy of the vaccine may be improved, leading to a potential increase in vaccination among this vulnerable group.

Read the full report here