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 (BS:109, FMF: 90, RD: 343, and HC: 334) or BioNTech (BS: 147, FMF:157, 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%, RD:2.7% 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 (BS:5.5%, FMF:3.3%, RD:2.9% and HC:3.3%) or BioNTech (BS:5.4%, FMF:1.9%, RD:4.7% and HC:4.7%). 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.
ABSTRACT
Background: As of January 2021 the COVID-19 pandemic has been responsible for more than 2.2 million deaths worldwide (1). Potential vaccines against COVID-19 have been developed swiftly and vaccination programs were started in many countries. Turkey agreed to use inactivated vaccine candidate, 'CoronaVac' produced by Chinese biopharmaceutical company (3). Many of our patients having a rheumatic diseases (RD) call us for permission to get vaccination, while some express their concerns about the efficacy and safety issues. Objectives: We therefore assessed the willingness to get vaccination among patients with RD compared to health workers and a sample from general population. Methods: A web-based questionnaire study was conducted in a cross-sectional design in 3 groups of participants: 1. patients with RD, 2. hospital workers and 3. General population. The questionnaire sought socio-demographic variables, COVID-19 related risk factors, willingness to get vaccination, and concerns and thoughts about vaccine. COVID-19 related anxiety (CAS) was also evaluated through the questionnaire. Results: We studied in total 732 (258 M/ 474 F) patients with RD, 320 (88 M/ 232 F) hospital workers and 763 (258 M/ 505 F) individuals representing general population. Patients with RD were significantly older and less educated and spent less time using social media compared to both control groups (Table 1). CAS scores were similar between the study groups. Of the patients with RD, 29.2% were willing to be vaccinated, 19% were unwilling and 51.8% were undecided. These were similar among the general population (34.6%, 23.3% and 42.1%, respectively), whereas hospital workers were significantly more willing (52.5%, 20.9% and 26.6%, respectively) (p<0.0001). About a third in each group thought that vaccination should be obligatory.The major concerns associated with vaccine were fear from side effects, unknown scientific results and lack of confidence. Being male, older age, working in a hospital and increased anxiety levels were found to be independently associated with willingness. Conclusion: Only about one third of the patients with RD were willing to get vaccination, which was somewhat similar to that observed among the general population. This could be due to rushed vaccine development as well as negative news on vaccines on the social media. Our study also reveals that, after almost one year after the pandemic, about 95% in all study groups did not express dysfunctional anxiety related with COVID-19.