SAFETY of the PFIZER/BIONTECH and SINOVAC/CORONAVAC VACCINES among PATIENTS with BEHCET'S SYNDROME and FAMILIAL MEDITERRANEAN FEVER

ABSTRACT

Background: Since frst emerged in December 2019, the COVID-19 pandemic has resulted in a death toll surpassing 5.5 million worldwide and had severe consequences on the global economy, environment, public health and social life [1, 2]. Multiple potential vaccines against COVID-19 have been developed swiftly and as shown in several phase 3 clinical trials, they demonstrated considerable efficacy without an unusual safety signal in healthy individuals. Objectives: In this study, we aimed to evaluate vaccine reactivity and disease fare following vaccination with either Sinovac/CoronaVac or Pfzer/BioNTech among BS and FMF patients compared with patients with various diagnosis of RD and healthy controls. Methods: Only those patients and healthy controls who rece,ved at least one single shot of either CoronoVac or BioNTech against COVID-19 were included in the study. We tried to contact all of these patients and controls consecutively by telephone and attempted to make interviews with the eligible ones. Results: We studied the efficacy, side effects and disease fares after COVID-19 vaccination in 256 patients with Behcet's syndrome (BS), 247 with familial Mediterranean fever (FMF), 601 with rheumatic diseases (RD) and 612 healthy controls (HC). Study participants were vaccinated either with CoronaVac (BS109, FMF 90, RD 343, and HC 334) or BioNTech (BS 147, FMF157, RD 258 and HC 278). BioNTech ensured a signifcantly better efficacy than CoronaVac against COVID-19 in all patient groups (BS 1.4% vs 10.1%;FMF 3.2% vs 12.2%, RD2.7% vs 6.4%). Those with at least one adverse event (AE) were signifcantly more frequent among those vaccinated with BioNTech than those with Coro-naVac (BS 86.4% vs 45%;FMF 83.4% vs 53.3%;RD 83.3% vs 45.5% and HC 86.3% vs 52.1%). The majority of AEs were mild to moderate and transient and this was true for either vaccine. There were also AEs that required medical attention in all study groups following CoronaVac (BS5.5%, FMF3.3%, RD2.9% and HC3.3%) or BioNTech (BS5.4%, FMF1.9%, RD4.7% and HC4.7%). The main causes for medical assistance were disease fare, and cardiovascular events. Disease fares after vaccination were signifcantly more frequent among BS (41/256;16.0%) and FMF (43/247;17.4%) patients compared to patients with RD (36/601;6.0%). This was true for both CoronaVac (BS 11.0%, FMF 24.4% and RD 5.2%, p<0.001) and BioNTech (BS 19.7%, FMF 13.4% and RD 7.0%, p=0.001)(Table 1). Conclusion: Our study demonstrates that BS and FMF patients vaccinated with either CoronaVac or BioNTech demonstrated almost similar AE profile and frequency compared to RD patients and HC. AEs that required physician consultation or hospitalization occurred in all study groups after either CoronaVac or BioNTech. Caution should be required when monitoring these patients after vaccination. Increased frequency of fares in BS and FMF compared to that seen in RD might refect defects in innate immunity and deserves further investigation.