Dataset Information

Safety and Reactogenicity of 2 Doses of SARS-CoV-2 Vaccination in Solid Organ Transplant Recipients.

ABSTRACT:

Background

We studied the safety and reactogenicity SARS-CoV-2 mRNA vaccines in transplant recipients because immunosuppressed patients were excluded from vaccine trials.

Methods

US transplant recipients were recruited into this prospective cohort study through social media; those who completed the full vaccine series between December 9, 2020 and March 1, 2021 were included. We collected demographics, medical history, and safety information within 7 d after doses 1 and 2 (D1, D2). Associations between characteristics and reactions were evaluated using modified Poisson regression.

Results

We studied 741 transplant recipients who underwent BNT162b2 (54%) or mRNA-1273 (46%) vaccination. Median (interquartile range) age was 60 (44-69) y, 57% were female, and 10% were non-White. Although local site reactions decreased after D2 (85% D1 versus 78% D2, P < 0.001), systemic reactions increased (49% D1 versus 69% D2, P < 0.001). Younger participants were more likely to develop systemic symptoms after D1 (adjusted incidence rate ratio [aIRR] per 10 y = 0.850.900.94, P < 0.001) and D2 (aIRR per 10 y = 0.910.930.96, P < 0.001). Participants who experienced pain (aIRR = 1.111.662.47, P = 0.01) or redness (aIRR = 1.833.928.41, P < 0.01) were more likely to develop an antibody response to D1 of mRNA vaccines. No anaphylaxis, neurologic diagnoses, or SARS-CoV-2 diagnoses were reported. Infections were minimal (3% after D1, <0.01% after D2). One patient reported incident acute rejection post-D2.

Conclusions

In solid organ transplant recipients undergoing mRNA vaccination, reactogenicity was similar to that reported in the original trials. Severe reactions were rare. These early safety data may help address vaccine hesitancy in transplant recipients.

SUBMITTER: Ou MT

PROVIDER: S-EPMC8487696 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThis is a descriptive study to characterize rates of SARS-CoV-2 infection in pediatric solid organ transplant (SOT) recipients during the early days of the pandemic. We hypothesized that asymptomatic infection may represent a large proportion of SARS-CoV-2 infection in ped SOT recipients.MethodsWe queried OTTR for all pediatric SOT recipients followed at our center and reviewed medical records to identify patients tested for SARS-CoV-2 between March 15, 2020 through June 30, 2021. Patients were tested by PCR: prior to planned procedures or because of symptoms; OR: tested by measurement of IgG to spike protein with their routine labs q 2-monthly. A positive PCR was called acute infection. A positive IgG with negative PCR was called convalescence. For immunologic studies, blood was obtained when the PCR or IgG was positive. Statistical comparisons were made between (i) acute infection vs. convalescence; (ii) acute infection vs. SOT recipients without infection (called healthy controls); (iii) LT vs. SB/MVT; (iii) positive vs. negative test result.ResultsOf 257 liver transplant (LT) recipients, 99 were tested: 6 were PCR positive,13 were antibody positive. Of 150 small bowel (SB)/ multi-visceral transplant (MVT) recipients, 55 were tested: 4 were PCR positive, 6 were antibody positive. Of 8 simultaneous liver, kidney transplant recipients, 3 were tested: 1 was PCR positive. Symptoms when present were mostly mild. Patients with a positive test result were younger (6.3 vs. 10.0-years; p=0.017). We observed a rapid decline in viral load within 96-hours without a change in immunosuppression. Antibody lasted >8-months beyond the time it was monitored. Acute infection was associated with increased CD4 and CD8 TEM cell frequency (p=0.04, p=0.03 respectively), decreased IFN-γ production from T-cells (2.8% vs.11.3% p=0.006), and decreased CD8 TEMRA frequency (4.56% vs.11.70% p=0.006).ConclusionEarly in the pandemic, COVID-19 disease was mostly mild in pediatric SOT recipients with no rejection, patient death, or graft loss observed.