Incidence of corneal transplant rejection following BNT162b2 SARS-CoV-2 messenger RNA vaccination

Purpose: We report seven cases of corneal allograft rejection following immunization with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) messenger RNA (mRNA) vaccine BNT162b2, and describe the implications for the management of transplant recipients post-vaccination for coronavirus disease 2019 (COVID-19). Methods: This retrospective observational study included 66 patients post-keratoplasty between 98 and 2054 days following transplantation. Data on the incidence of rejection, time series of the onset of rejection, corneal transplantation, and vaccination with the SARS-CoV-2 mRNA vaccine BNT162b2 were collected. In addition, the use of ophthalmic solutions including topical steroids and immunosuppressants at the time of rejection, and background including systemic diseases, such as autoimmune or allergic disease, were collected. Results: The incidence of rejection following BNT162b2 vaccination was observed in seven cases (observational period following vaccination was 74.0 ± 28.4 days), while no vaccination was observed in 2 cases (observational period following keratoplasty was 938.3 ± 1501.5 days). The odds ratio of rejection related to vaccination was 5.57 (95% confidence interval [CI], 1.18–25.57; p =0.036; Fisher’s exact test). The relative risk of rejection related to vaccination is 4.47 (95% CI, 1.15–18.34). Conclusion: A temporal association between corneal transplant rejection following immunization against COVID-19 was suspected. A possible mechanism could be the allogeneic response initiated by the host antibody following vaccination.