The Safety and Immunogenicity of the BNT162b2 mRNA COVID-19 Vaccine in Japanese Patients after Allogeneic Stem Cell Transplantation

Abstract

Patients who have undergone hematopoietic stem cell transplantation (HSCT) for hematological disease experience high mortality when infected by coronavirus disease 2019 (COVID-19). However, the safety and efficacy of the COVID-19 vaccine in HSCT patients remain to be investigated. We prospectively evaluated the safety and immunogenicity of the BNT162b2 mRNA COVID-19 vaccine (Pfizer BioNTech) in 25 Japanese allogeneic HSCT patients in comparison with 19 healthy volunteers. While anti-S1 antibody titers in almost all healthy volunteers after the second dose were higher than the cut-off value reported previously, levels in HSCT patients after the second dose were diverse. Nineteen patients (76%) had seroconversion of anti-S1 IgG. The median optical density of antibody levels in HSCT patients with low IgG levels (<600 mg/dL), steroid treatment, or low lymphocytes (<1000/μL) was significantly lower than that in the other HSCT patients. There were no serious adverse events (>Grade 3) and no new development or exacerbation of graft-versus-host disease after vaccination. We concluded that the BNT162b2 mRNA vaccine is safe and effective in Japanese allogeneic HSCT patients.

Serologic response and safety of COVID-19 vaccination in HSCT or CAR T-cell recipients: a systematic review and meta-analysis

“…S4). Firstly, time interval from HSCT or CAR T to vaccination was shown to be an impactor factors on seropositivity rate in 14 included studies [ 25 , 26 , 28 – 33 , 36 , 37 , 43 , 45 , 46 , 49 ], and no significant correlation in 6 included studies [ 23 , 24 , 34 , 38 , 47 , 48 ]. Subgroup analysis also showed a possibly positive effect of time interval on seropositivity rate (Fig.…”

“…14 of the included studies reported adverse events or reactions after COVID-19 vaccination in patients receiving HSCT or CAR T-cell therapy (Additional file 1 : Table S4). Common (incidence rates higher than 10%) local reactions at injection site included pain, swelling and redness, and common systemic adverse reactions included fever, chills, fatigue, myalgias and arthralgias, which were reported in at least four studies [ 23 , 28 , 32 , 38 ]. Most adverse reactions were mild (grade 1 or 2) and could be resolved within a few days [ 23 , 25 , 28 , 32 , 38 , 46 ].…”

“…Common (incidence rates higher than 10%) local reactions at injection site included pain, swelling and redness, and common systemic adverse reactions included fever, chills, fatigue, myalgias and arthralgias, which were reported in at least four studies [ 23 , 28 , 32 , 38 ]. Most adverse reactions were mild (grade 1 or 2) and could be resolved within a few days [ 23 , 25 , 28 , 32 , 38 , 46 ]. Two studies found the presence of vaccine-related hematologic adverse reactions, including cytopenia exacerbation (12.5%) and GVHD exacerbation (4.5%), and the reactions were also resolved quickly [ 24 , 36 ].…”

Predictors of Covid-19 Vaccination Response After In-Vivo T-Cell–Depleted Stem Cell Transplantation

“… 6 As summarized in Table 4 , responses are consistently worse in those vaccinated within the first six months to one year after transplantation. 8 , 9 , 14 , 16 , 18 , 22 , 23 , 24 , 25 , 30 , 66 Low lymphocyte counts, 8 , 23 , 29 , 66 low B cell 22 , 24 , 25 , 28 or NK cell counts, low CD4 counts 28 , low CD/CD8 ratio 24 , or low immunoglobulin levels 12 , 28 , 29 are all associated with poor response. Worse responses are found in those with GVHD, 9 , 10 , 23 , 30 those receiving immunosuppressants (particularly ibrutinib and ruxolitinib) 8 , 11 , 12 , 17 , 21 , 22 , 26 , 30 , 66 and those under active treatment for their underlying disease.…”

“…Recent reports on covid-19 vaccination in allogeneic transplant recipients have shown encouraging results. 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 But nearly all published data pertain to patients undergoing stem cell transplantation from adult donors. Conditioning regimens or graft versus host disease (GVHD) prophylaxis are usually not detailed.…”