To the Editor:
The coronavirus disease (COVID‐19), caused by severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2), has been a major burden on healthcare systems and communities worldwide. It required fast response, transformation of hospitals, and a change of our habits.
Many studies have found that chronic kidney disease (CKD) is a risk factor for a more severe course of COVID‐19, unfavorable outcomes, with patients receiving dialysis having the highest mortality across all studied factors. 1 , 2 , 3
In addition to higher mortality, more adverse outcomes, and severe course of the disease, COVID‐19 was more prevalent in patients with CKD receiving dialysis. A cross‐sectional study in the United States proved that seroprevalence of SARS‐CoV‐2 spike protein antibodies was higher in dialysis patients compared to the general public. This demonstrates that patients on dialysis may also be the source of community spread of COVID‐19. 4 , 5 Patients receiving in‐center hemodialysis cannot isolate or pause their treatments, resulting in interrupted dialysis schedules or emergent dialysis sessions and even death. 6
With safe vaccination options becoming widely available across the world, there is no doubt that patients with end‐stage renal disease (ESRD) should be among the first to be immunized. After extensive discussions, Lithuanian policymakers agreed to prioritize COVID‐19 vaccination for patients on dialysis, kidney transplant recipients and patients with a cancer.
The study population included 170 patients undergoing dialysis in the area of Vilnius, Lithuania. Six patients included in the study were on peritoneal dialysis. The patients have never been diagnosed with COVID‐19 (PCR negative), had negative anti‐SARS‐CoV‐2 (2019‐nCoV) Spike S1 antibodies in serum (<200 AU/ml) by enzyme‐linked immunosorbent assay (ELISA) (Architect i2000SR PLUS; Abbot Laboratories), and were willing to vaccinate. Nine patients were hesitant to vaccinate and refused the offer. Patients fitting the inclusion criteria were vaccinated against SARS‐CoV‐2 with two doses of the BNT162b2 COVID‐19 mRNA vaccine. One patient tested positive for SARS‐CoV‐2 after the first dose and therefore was excluded from the study. One month after the second dose, blood tests were taken to evaluate anti‐SARS‐CoV‐2 (2019‐nCoV) Spike S1 antibodies in serum. Positive results were considered to be >200 AU/ml by ELISA.
There were 99 (58.2%) males and 71 (41.8%) females included in the study. The average age was 60.5 years ± 16.68 SD. The median time on dialysis was 4.3 years (interquartile range 2‐20 years). 28.7% (n = 48) patients had diabetes mellitus (DM), 82.6% (n = 138) had hypertension, 13.1% (n = 22) with a past history of cancer, and 19.3% (n = 32) were smokers.
One month after the second dose, 92.2% (n = 142) patients had positive anti‐SARS‐CoV‐2 (2019‐nCoV) Spike S1 antibodies in serum and only 7.8% (n = 12) had a negative result. The minimum number of antibodies was 1 AU/ml and the maximum was 38,399.7 AU/ml; the average was 7089.9 AU/ml. Out of the 7.8% without a sufficient number of circulating antibodies, 91.7% had hypertension, 33.3% had DM or were smokers, and 8.3% were on immunosuppressive therapy or had a cancer diagnosis.
Frequencies of reactions to the vaccine are summarized in Table 1.
TABLE 1.
Frequency of adverse reactions in patients on dialysis after vaccination with BioNTech, Pfizer (Comirnaty) mRNA vaccine against SARS‐CoV‐2
| First dose | Statistical significance, χ 2 test | Second dose | Statistical significance, χ 2 test | |||
|---|---|---|---|---|---|---|
| Group 1 | Group 2 | Group 1 | Group 2 | |||
| <55 years | >55 years | <55 years | >55 years | |||
| Fever | 10% (n = 5) | 1.7% (2) | p = 0.016 | 20.4% (n = 10) | 12.9% (n = 15) | p > 0.05 |
| General weakness | 6% (n = 3) | 1.7% (2) | p > 0.05 | 11.8% (n = 6) | 3.4% (n = 4) | p = 0.003 |
| Headache | 10% (n = 5) | 0 | p = 0.001 | 15.7% (n = 8) | 3.4% (n = 4) | p = 0.004 |
| Muscle aches | 2% (n = 1) | 3.4% (n = 4) | p > 0.05 | 11.8% (n = 6) | 1.7% (n = 2) | p = 0.005 |
| Pain at injection site | 42% (n = 21) | 25.9% (n = 30) | p = 0.039 | 40% (n = 20) | 37.1% (n = 43) | p > 0.05 |
| Nausea, vomiting | 2% (n = 1) | 0 | p > 0.05 | 0 | 3.4% (n = 4) | p > 0.05 |
Note: Values in bold font are statistically significant.
Our data showed that majority of patients on dialysis developed significant amounts of antibodies against SARS‐CoV‐2. The adverse reactions that patients felt after the vaccine were mild. Pfizer BioNTech published very similar results about adverse reactions to their vaccine. Vaccinating this specific population is both safe and effective, as patients undergoing dialysis treatments are more suspectable to SARS‐CoV‐2, have a higher risk of complications, higher mortality but develop immunity after being vaccinated for COVID‐19.
Patients on in‐center hemodialysis have long ambulatory visits typically delivered 3‐4 times a week. Dialysis sessions always include other patients and there is no a sufficient possibility for isolation in a case of contact with a COVID‐19 positive patient. In addition, dialysis staff is put at risk for infection.
After successful vaccination of patients with ESRD, we saw a dramatic decrease in hospitalization rates, and there were no deaths related to COVID‐19 in vaccinated population within last 5 months.
Taken together, dialysis patients are at a very high risk of infection and they should be prioritized when it comes to vaccinating against SARS‐CoV‐2. Follow‐up of vaccinated dialysis patients is important to evaluate the remaining levels of antibodies and to determine further immunization schedules.
CONFLICT OF INTEREST
The authors declare that there is no conflict of interests regarding the publication.
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