Received May 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | — | OT |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
allograft rejection; Background: Studies in adults have demonstrated a risk for allograft rejection or development of donor-specific antibodies (DSA) following SARS-CoV-2 vaccination. We examined the incidence of acute rejection and de novo DSA following COVID-19 vaccination or infection among pediatric kidney transplant patients. Method: Retrospective analysis of 23 pediatric kidney transplant recipients without prior history of rejection, DSA, or COVID-19 infection who received the SARS-CoV-2 mRNA vaccine. Risk for rejection was evaluated via monitoring of serum creatinine, DSA, and donor-derived cell-free DNA per center protocol. Results concerning for rejection prompted allograft biopsy, graded by the Banff classification system. Results: Eight of 23 (34.8%) received two doses of SARS-CoV-2 mRNA vaccine, 15 (65.3%) received three doses. Two (8.7%) had rejection; one with de novo DSA, another without. There was no difference in the number of doses of COVID-19 vaccine received in those with rejection vs. no rejection (p = 0.53). 13 (56.5%) developed SARS-CoV-2 infection, with no difference in the number of vaccines received between those infected with COVID-19 vs. those who were not (p = 0.69). No adjustments were made to the maintenance immunosuppression during SARS-CoV-2 infection, and there was no evidence of rejection or DSA formation after infection. Median follow-up time was 29.9 months (IQR 25.0-33.4 months) after the first vaccine dose. Conclusion: In our small single-center cohort, SARS-CoV-2 vaccination or infection is unlikely to increase the risk for rejection or de novo DSA in pediatric kidney transplant recipients. Larger prospective studies with a control group are needed to further understand the immune effects of the COVID-19 vaccine and disease in this population. Initial information received via healthcare professional on 14-May-2025 regarding a unsolicited valid serious case issued from a literature article: This case involves an unknown age and gender patient who experienced allograft rejection (Kidney transplant rejection) while receiving vaccine influenza vaccine and COVID-19 Vaccine (Latency: Unknown). The patient's past medical treatment(s), vaccination(s) and family history were not provided. The patient's past medical history included Renal transplant. On an unknown date, the patient received influenza vaccine and COVID-19 vaccine (Dose, formulation, frequency, expiry date: Unknown) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed rejection received their influenza vaccine 73days prior to COVID-19 (coronavirus disease-2019) vaccination. Relevant laboratory test results included: Immunology test - On an unknown date: [Patient had both de novo DSA]. Seriousness Criteria: Medically significant Action Taken: Not applicable Corrective treatment: Not provided Outcome: Unknown Allograft Rejection is considered to be related to influenza vaccine by the reporter and unassessable by the company based on company causality assessment.; Sender's Comments: Sanofi company comment dated 20-MAY-2025: This case involves an unknown age and gender patient who experienced allograft rejection (Kidney transplant rejection) while receiving vaccine influenza vaccine and COVID-19 Vaccine. Based on the information provided regarding this case along with compatible temporal relationship, the causal role of the company suspect product cannot be excluded in the occurrence of the reported event. However, lack of information of past and concomitant medication, any family history, any relevant medical history, any concurrent conditions and risk factors precludes comprehensive case assessment.
Medical History/Concurrent Conditions: Kidney transplant
Test Name: DSA (donor-specific antibodies); Result Unstructured Data: Patient had both de novo DSA