Reactogenicity of MRNA-1273 Vaccine in Patients on Haemodialysis

ABSTRACT

BACKGROUND AND AIMS mRNA-1273 vaccine (previously known as vaccine Moderna) has shown 94.1% efficacy at preventing COVID-19 illness in the general population. Vaccine-related adverse events (AEs) were usually mild or moderate in intensity and resolved within a few days. Nevertheless, the fear of developing AEs led some patients on haemodialysis to deny vaccination or additional booster doses. No studies have been conducted to evaluate the reactogenicity of the mRNA-1273 vaccine in dialysis patients. To inform public health and clinical practice, we investigated the safety of the mRNA-1273 vaccine in a cohort of patients on haemodialysis. METHOD We conducted a retrospective analysis of in-centre haemodialysis patients without a prior COVID-19 diagnosis who underwent mRNA-1273 vaccine from 1 March to 30 April 2021. mRNA-1273 vaccine was performed in all patients without signs of ongoing infection or COVID-19 who provided written consent from 24 March to 30 April 2021. AEs occurring after the first and the second doses were collected and classified as local or systemic. RESULTS Overall, 126 patients on chronic maintenance dialysis were vaccinated with two doses of mRNA-1273 vaccine. Mean age was 68 (IQR, 54.7–76) years and 53.6% of patients were aged ≥65 years (Table 1). AEs occurred in 57.9% and 61.9% of patients after the first dose and second dose, respectively. The most common AEs were injection-site pain (61.9%), erythema (4.8%), itching (4.8%), swelling (16.7%), axillary swelling/tenderness (2.4%), fever (17.5%) headache (7.9%), fatigue (23.8%), myalgia (17.5%), arthralgia (12.7%), dyspnoea (2.4%), nausea/vomiting (7.1%), diarrhoea (5.6%), shivers (4%) and vertigo (1.6%).Table 1. Demographic and clinical characteristics of haemodialysis patients who underwent RNA-1273 vaccine administrationBasal characteristicsAll patients(n = 126) Age (year)68 (54.7–6) (range)19–92 ≥ 65 years71 (56.3) Males, n (%)71 (56.31) Ethnic origin, n. (%)  Caucasian110 (87.3) African15 (11.9) Hispanic1 (0.8)Etiology of ESRD, n. (%)  Nephrosclerosis54 (42.9) Glomerulonephritis26 (20.6) Diabetes14 (11.1) ADPKD4 (3.2) Nephrotoxic4 (3.2) Pyelonephritis4 (3.2) Interstitial3 (2.4) HIVAN2 (1.6) Others10 (7.9) NA5 (4)HD treatment schedule, n (%)  3 times per week115 (91.2) 2 times per week7 (5.5) 4 times per week4 (3.1)Infectious disease, n. (%)  HBV3 (2.3) HCV3 (2.3) HIV2 (1.5)Time elapsed from the first to the second dose of vaccine, day28 (28–28)Follow-up, day68 (66–70) ESRD, end-stage renal disease;HBV, hepatitis B virus;HCV, hepatitis C virus. The rates of local AEs were similar after the first and second doses (P = .8), whereas systemic AEs occurred more frequently after the second dose (P = .001). Fever (P = .03), fatigue (P = .02) and nausea/vomiting (P = .03) were significantly more frequent after the second dose of the vaccine (Figure 1). Analysis of the data detected statistically significant differences in duration of axillary swelling/tenderness (P = .07) and diarrhoea (P = .02) between the first and second. In both cases, these symptoms lasted longer after the second dose of the vaccine. There were no age-related differences in the rate of AEs between older (≥65 years) and younger participants (18–64 years). Lastly, we noted a lower rate of AEs in hemodialysis patients after the first dose (57.9% versus 84.2%) and second doses (61.9% versus 88.6%) compared to the general population.FIGURE 1 Number of patients who experienced AEs after the two doses. CONCLUSION RNA-1273 vaccine was associated with the development of transient AEs after the first (57.9%) and second doses (61.9%) in patients on haemodialysis. Systemic AEs were more common after the second dose than the first dose of vaccine. The duration of AEs lasted for a few days, without any apparent consequences. These data confirm the safety of the RNA-1273 vaccine in haemodialysis patients and support the promotion of COVID-19 vaccination in h sitant patients.