A SINGLE CENTER COVID-19 VACCINE EXPERIENCE IN FAMILIAL MEDITERRANEAN FEVER PATIENTS

Background: To prevent COVID-19 disease SARS-CoV 2 vaccines put into use worldwide with emergency use authorizations despite ongoing safety concerns. Since pyrin mediated inflammasome response is dysregulated in FMF, exposure to SARS-CoV 2 proteins via vaccination may potentially trigger inflammation, leading to attacks and/or increased rate of adverse events (AE). Objectives: Aim of this study to investigate frequency of adverse events and attacks related to vaccination in recipients of CoronaVac and BNT162b2 comparatively in our FMF patients. Methods: Data regarding, number of vaccine doses, types of vaccines (CoronaVac or BNT162b2), presence of AEs and/or FMF attacks after any vaccine dose within a month, history of COVID-19 infection before or after vaccination, adherence to FMF treatment during vaccination were collected from hospital database or via telephone. Results: A total of 161 vaccinated FMF patients were included. Mean ± SD age was 40.5 ± 11.7 years. 57.1% was female. 10.6% of the patients had chronic kidney disease and 9.3% had amyloidosis. Most common MEFV mutations were M694V heterozygous (27%) and M694V homozygous (21.6%). 93.2% of the patients were under colchicine, 21.8% under anti-interleukin 1 agents, 2.5% under TNF-a inhibitors. 96.3% of the patients adhered to FMF treatment during vaccination. Vaccination properties and data regarding adverse events are presented in Table 1 . 57.8% of patients reported to suffer from an AE/attack after a vaccine dose. Number of patients with AE after BNT162b2 was significantly higher (p<0.001). None of the patients had severe AEs. 39 patients had COVID-19 infection prior to primary vaccination. 61.5% of these suffered from an adverse reaction/attack after vaccination, in comparison to 56.6% of the patients without prior COVID-19 infection (p=0.584). When patients with and without AEs/attacks were compared, no significant differences were observed regarding age, gender, body mass index, comorbidities, FMF treatments and total vaccine doses. Table 1. Adverse events and FMF attacks in a total of 161 vaccine recipients BNT162b2 CoronaVac p Total vaccine doses, n 213 140 Patients ever vaccinated with BNT162b2 and CoronaVac, n (% ) 117 (72.7) 67 (41.6) Dose per patient, median (min-max ) 2 (1-4) 2 (1-4) Patients with primary vaccination completed with BNT162b2 or CoronaVac, n (%)* 88 (54.7) 57 (35.4) Patients with a booster with BNT162b2 or CoronaVac, n (% ) 23 (14.2) 14 (8.6) Patients vaccinated with BNT162b2 or CoronaVac alone, n(% ) 94 (58.4) 44 (27.3) Patients with an adverse event after any vaccine dose of n (% ) 64/117 (54.7) 20/67 (29.9) <0.001 Adverse events, n (% )  Fever 13 (11.1) 6 (9.0) 0.644  Malaise 21 (17.9) 4 (6.0) 0.023  Local pain/arm pain 17 (14.5) 4 (6.0) 0.079  Arthralgia 19 (16.2) 4 (6.0) 0.043  Myalgia 6 (5.1) 0 (0.0) 0.059  Headache 11 (9.4) 0 (0.0) 0.010  Nausea 6 (5.1) 1 (1.5) 0.215  Vomiting 4 (3.4) 1 (1.5) 0.439  Others 22 (18.9) 7 (10.4) Patients with FMF attack within one month after any vaccine dose, n (% ) 26 (22.2) 13 (19.4) 0.653 Time from vaccine dose to FMF attack, days, median (IQR ) 7.0 (12.5) 10.0 (13.5) 0.758 *9.9 % of the patients had only single dose of either vaccine, Over 117 ever vaccinated with BNT162b2 and 67 ever with CoronaVac Conclusion: We observed considerable number of FMF patients suffered from vaccine related AEs/attacks, particularly with BNT162b2. However, no serious AE was detected. Demographics, clinical characteristics and prior history of vaccination did not significantly affect AE/attack occurrence. Acknowledgements: I have no acknowledgements to declare. Disclosure of Interests: None declared Citation: , volume 81, supplement 1, year 2022, page 973Session: COVID-19 (POSTERS only)