Safety and Tolerability of SARS-CoV2 Emergency-Use Authorized Vaccines for Allogeneic Hematopoietic Stem Cell Transplant Recipients

Abstract

Background : The safety and efficacy of the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) emergency-use authorized (EUA) vaccines has been confirmed in general population. However, there is no data on its safety/tolerability or efficacy in recipients of allogeneic hematopoietic stem cell transplant (HCT). Objectives : We performed this study to identify the incidence of adverse events following SARS-CoV2 EUA vaccines and the incidence of new onset GVHD or worsening of existing GVHD after EUA vaccine administration and the incidence SAR-CoV2 positivity in vaccinated HCT patients. Study Design : We retrospectively reviewed 113 HCT patients who received at least one dose of EUA vaccine to describe the safety/tolerability, any impact on graft-versus-host disease (GVHD), and 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 received at least one dose of vaccine in the post HCT setting. Results : 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, injection-site rash and swelling. Liver function abnormalities occurred in 18.6% of patients. The incidence of neutropenia, thrombocytopenia, and lymphopenia occurred at 13.3%, 11.5%, and 8.8% respectively. Forty percent of patients who had active chronic GVHD at the time of vaccination where worsening chronic GVHD occurred in 3.5% of patients. New chronic GVHD developed in 9.7% of patients after vaccination. Conclusion : In conclusion, the SARS-CoV2 EUA vaccines were well-tolerated in allogeneic HCT recipients.

The COVID-19 mRNA BNT163b2 Vaccine Was Well Tolerated and Highly Immunogenic in Young Adults in Long Follow-Up after Haematopoietic Stem Cell Transplantation

“…According to Centers for Disease Control and Prevention (CDC) data the percentages of people affected by side effects after the first and the second vaccine dose were, respectively: redness 4.5% and 7.25%; swelling 5.8% and 7.5%; pain 83.1% and 66,1%; fever 3.7% and 15.8%; fatigue 47.4% and 59.4%; headache 41.9% and 51.7%; chills 14.0% and 35.1%; muscle pain 21.3% and 37.3%; joint pain 11% and 21.9% [ 9 ]. The comparison of our study results with this data may suggest that young adults after bone marrow transplantation tolerate mRNA COVID-19 vaccine no worse than the general population, which was also seen by other authors [ 10 ]. However, this comparison should be taken with caution considering significantly smaller number of patients involved in this study in comparison with reports describing general population.…”

Humoral Immunity After mRNA SARS-CoV-2 Vaccination in Allogeneic HCT Recipients—Room for Improvement and Much to Learn

“…Another study demonstrated a similar spectrum of adverse effects and concluded that mRNA SARS-CoV-2 vaccines appear to be relatively safe after allogeneic HCT. 4 The findings of these first observational reports are consistent with expected vaccine responses in allogeneic HCT recipients based on studies using other vaccines. Guidelines generally recommend administering routine nonlive vaccines at least 6 months after HCT given the pattern of immune reconstitution and relatively poor response rates (<50%) at earlier time points, although earlier vaccination can be considered for pathogens such as influenza in the context of community outbreaks.…”

Safety and efficacy of the mRNA BNT162b2 vaccine against SARS-CoV-2 in five groups of immunocompromised patients and healthy controls in a prospective open-label clinical trial

“…Similarly, Ali et al. reported recently in a retrospective study that 9.7% of HSCT patients developed new chronic GvHD and 3.5% experienced worsened chronic GvHD after vaccination with mRNA vaccines [29] . Moreover, Ram et al.…”