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We read with great interest the article by Machado et al who describe safety of vaccination against SARS-CoV-2 in people with rheumatic and musculoskeletal disease.1 The authors observed that vaccine against SARS-CoV-2 is well tolerated with rare report of I-RMD flare and very rare reports of serious adverse events.
We observed that the authors included only 27 patients with autoinflammatory diseases. We thus propose to complete their observation with the result of our study about 190 patients with autoinflammatory disease (AID).
A web survey assessing adverse effects after COVID-19 vaccination was sent on 7–30 June 2021 to patients with AID followed in the French national adult AID reference centre, and already included in the Juvenile Inflammatory Rheumatism (JIR) cohort. The patients were asked whether they had received a COVID-19 vaccination, the type of vaccine and number of injections. Severe adverse events were defined by the need for hospitalisation. Local reaction, fever, headache, arthralgia, myalgia, allergic reaction, fatigue, nausea, adenopathy, heart disorder, venous thromboembolism and stroke were monitored after the first and the second injection.
The survey was sent by email to 445 patients with AID: 225 (50%) patients answered it, 168 aged between 18 and 55 years old and 57 aged above 55 years old. Among the 190 patients who received two doses of COVID-19 vaccines (online supplemental table), most patients had familial Mediterranean fever (FMF) (n=128, 67.4%); other AID were undefined systemic AID (n=20), TNF-α receptor-associated periodic syndrome (n=13), cryopyrin-associated periodic syndrome (n=9), adult-onset still disease (n=9), mevalonate kinase deficiency (n=7) and A20 haploinsufficiency (n=4). Eleven patients declared also having AA amyloidosis (5.7%). Colchicine was the most used treatment (n=138, 72.6%); 37 (19.5%) patients were on biotherapy, mostly interleukin-1 inhibitors (n=33) and 15 patients were not taking any treatment. Forty-six patients had already contracted SARS-CoV-2.
Out of the 190 (84.4%) vaccinated patients with AID, BNT162b2 (Pfizer/BioNTech) (n=157, 82.6%) and ChAdOx1 nCoV-19 (AstraZeneca) (n=22, 11.5%) were the most common vaccines; few patients received CX-024414 (Moderna) (n=11, 5.8%). Eighty-eight patients (46%) developed mild adverse events after the first injection and 70 patients (54%) after the second injection. Among the 153 patients who received BNT162b2, tenderness at the injection site was the most reported event (n=39, 25.5%); others were myalgia (n=28, 18.3%), fever (n=20, 13%) and headache (n=16, 10.5%). Concerning ChAdOx1 nCoV-19, reported events were fever (n=13, 59%), myalgia (n=11, 50%) and intense fatigue (n=2, 9%). Concerning CX-024414, four patients reported fever and myalgia (36%). No severe adverse event requiring hospitalisation has been reported. Twelve patients with FMF (9.3%) reported a mild flare after the first injection, which did not require hospitalisation. No vaccinated patient had developed COVID-19 after the second vaccine injection.
Altogether, this study shows that adverse event of COVID-19 vaccination in patients with AID are similar to the expected adverse effects reported in the general population.2 Especially among patients with FMF on colchicine treatment, the vaccine is very safe and should be highly recommended to patients with risk factors of severe COVID-19, since we previously reported death among such patients with FMF.3 It also suggests that COVID-19 vaccination does not usually trigger an AID flare; these data were also reported in patients with autoimmune diseases4 and AID.5 To our knowledge, this is the largest study describing the effects of COVID-19 vaccination among patients with AID: the vaccine is well tolerated; these data combined with the results from Machado et al 1 could reassure patients displaying immune systemic disorders including AID patients who are still hesitant about COVID-19 vaccination, especially in the actual context of the resurgence of the epidemy.
Data availability statement
All data relevant to the study are included in the article.
Patient consent for publication
This study involves human participants and was approved by DR2015-218. Participants gave informed consent to participate in the study before taking part.
Handling editor Josef S Smolen
Twitter @Rimbourguiba1, @SophieGeorgin
Contributors All authors contributed in writing and conception of the manuscript.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Provenance and peer review Not commissioned; internally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.