ABSTRACT
This study reports the incidence of chronic graft versus host disease (GvHD) in allogeneic hematopoietic stem cell transplant (alloHCT) recipients who received SARS-CoV2 vaccination. The overall rates of new and worsening chronic GvHD combined were 14%, with median time from vaccination to GVHD being approximately three to four weeks. A majority of the cases were of mild to moderate severity and primarily localized to either the skin, mouth, or joints. Prior chronic GVHD and recent transplant were associated with higher GVHD rates following COVID-19 vaccination. More prospective studies are needed to provide a definitive mechanism for the impact of SARS-CoV2 vaccination on alloHCT patients.
Subject(s)
COVID-19 Vaccines , COVID-19 , Graft vs Host Disease , Hematopoietic Stem Cell Transplantation , Humans , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Graft vs Host Disease/epidemiology , Graft vs Host Disease/prevention & control , Graft vs Host Disease/etiology , Incidence , Retrospective Studies , RNA, Viral , SARS-CoV-2ABSTRACT
INTRODUCTION: In November 2020, the FDA issued an emergency use authorization (EUA) for monoclonal antibody (mAb) therapy in patients with mild-to-moderate COVID-19 at high risk for disease progression. METHODS: We retrospectively reviewed 38 adult hematology patients who received mAbs from 11/2020 to 2/2021. RESULTS: Thirty (79%) patients received bamlanivimab and 8 (21%) casirivimab-imdevimab. Four (11%) patients were hospitalized due to COVID-19, two (5%) progressed to severe disease and one patient (3%) died within 30 days from COVID-19 disease. Most patients (n = 34, 89%) ultimately tested negative for SARS-CoV-2, with 34% (n = 13) clearing the virus within 14 days after mAb infusion. The median time to clearance of viral shedding was 25.5 days (range: 7-138). After mAb infusion, most patients with hematological malignancies (HM) (n = 10/15; 67%) resumed therapy for underlying disease with a median delay of 21.5 days (range: 12-42). We observed a significant difference in hospitalization among patients who received a HCT versus non-HCT (0% n = 0/26 and 36% n = 4/11, respectively; p < 0.01). CONCLUSIONS: This study demonstrates that SARS-CoV-2 specific mAb was safe and may reduce hospitalization compared to what is reported in malignant hematology patients at high risk for disease progression. Our HCT cohort patients had less hospitalization rate compared with HM cohort patients.
Subject(s)
COVID-19 , Hematologic Neoplasms , Hematology , Adult , Humans , Retrospective Studies , SARS-CoV-2 , Antibodies, Monoclonal/adverse effects , Antibodies, Viral , Disease Progression , Hematologic Neoplasms/drug therapySubject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Leukemia, Myeloid, Acute/drug therapy , Neoplasms, Second Primary/drug therapy , Adult , Aged , Bridged Bicyclo Compounds, Heterocyclic/administration & dosage , Combined Modality Therapy , Cytarabine/administration & dosage , Daunorubicin/administration & dosage , Female , Hematopoietic Stem Cell Transplantation , Humans , Kaplan-Meier Estimate , Leukemia, Myeloid, Acute/mortality , Leukemia, Myeloid, Acute/therapy , Liposomes , Male , Middle Aged , Neoplasms, Second Primary/mortality , Neoplasms, Second Primary/therapy , Remission Induction , Retrospective Studies , Sulfonamides/administration & dosage , Treatment OutcomeABSTRACT
The safety and efficacy of the severe acute respiratory syndrome coronavirus-2 (SARS-CoV2) emergency-use authorized (EUA) vaccines have been confirmed in the general population. However, there are no data on its safety and tolerability or efficacy in recipients of allogeneic hematopoietic stem cell transplant (HCT). We performed this study to identify the incidence of adverse events following SARS-CoV2 EUA vaccines, the incidence of new-onset graft-versus-host disease (GVHD) or worsening of existing GVHD after EUA vaccine administration, and the incidence SARS-CoV2 positivity in vaccinated HCT patients. We retrospectively reviewed 113 HCT patients who received at least one dose of EUA vaccine to describe the safety and tolerability, any impact on GVHD, and the incidence of SARS-CoV2 PCR positivity after vaccination. Patients received either Pfizer (BNT162b2) or Moderna (mRNA-1273) vaccines. Patients were included if they were 18 years or older and had received at least one dose of vaccine in the post-HCT setting. Most patients presented with myalgias/arthralgias (first dose, 7.7%; second dose, 14.6%), fatigue (first dose, 15.4%; second dose, 29.2%), and injection site pain (first dose, 40.4%; second dose, 43.8%). Other side-effects experienced by patients included nausea, vomiting, diarrhea, headache, and injection-site rash and swelling. Liver function abnormalities occurred in 18.6% of patients. Neutropenia, thrombocytopenia, and lymphopenia occurred in 13.3%, 11.5%, and 8.8% of patients, respectively. Forty percent of patients had active chronic GVHD at the time of vaccination, and worsening chronic GVHD occurred in 3.5% of the patients. New chronic GVHD developed in 9.7% of patients after vaccination. The SARS-CoV2 EUA vaccines were well tolerated in allogeneic HCT recipients.