The Safety and Immunogenicity of the BNT162b2 mRNA COVID-19 Vaccine in Japanese Patients after Allogeneic Stem Cell Transplantation
Marika Watanabe,
Kimikazu Yakushijin,
Yohei Funakoshi,
Goh Ohji,
Wataru Hojo,
Hironori Sakai,
Miki Saeki,
Yuri Hirakawa,
Sakuya Matsumoto,
Rina Sakai,
Shigeki Nagao,
Akihito Kitao,
Yoshiharu Miyata,
Taiji Koyama,
Yasuyuki Saito,
Shinichiro Kawamoto,
Mitsuhiro Ito,
Tohru Murayama,
Hiroshi Matsuoka,
Hironobu Minami
Affiliations
Marika Watanabe
Division of Medical Oncology/Hematology, Department of Medicine, Kobe University Graduate School of Medicine, Kobe 650-0017, Japan
Kimikazu Yakushijin
Division of Medical Oncology/Hematology, Department of Medicine, Kobe University Graduate School of Medicine, Kobe 650-0017, Japan
Yohei Funakoshi
Division of Medical Oncology/Hematology, Department of Medicine, Kobe University Graduate School of Medicine, Kobe 650-0017, Japan
Goh Ohji
Division of Infectious Disease Therapeutics, Department of Microbiology and Infectious Diseases, Kobe University Graduate School of Medicine, Kobe 650-0017, Japan
Wataru Hojo
R&D, Cellspect Co., Ltd., Morioka 020-0857, Japan
Hironori Sakai
R&D, Cellspect Co., Ltd., Morioka 020-0857, Japan
Miki Saeki
Division of Medical Oncology/Hematology, Department of Medicine, Kobe University Graduate School of Medicine, Kobe 650-0017, Japan
Yuri Hirakawa
Division of Medical Oncology/Hematology, Department of Medicine, Kobe University Graduate School of Medicine, Kobe 650-0017, Japan
Sakuya Matsumoto
Division of Medical Oncology/Hematology, Department of Medicine, Kobe University Graduate School of Medicine, Kobe 650-0017, Japan
Rina Sakai
Division of Medical Oncology/Hematology, Department of Medicine, Kobe University Graduate School of Medicine, Kobe 650-0017, Japan
Shigeki Nagao
Division of Medical Oncology/Hematology, Department of Medicine, Kobe University Graduate School of Medicine, Kobe 650-0017, Japan
Akihito Kitao
Division of Medical Oncology/Hematology, Department of Medicine, Kobe University Graduate School of Medicine, Kobe 650-0017, Japan
Yoshiharu Miyata
BioResource Center, Kobe University Hospital, Kobe 650-0047, Japan
Taiji Koyama
Division of Medical Oncology/Hematology, Department of Medicine, Kobe University Graduate School of Medicine, Kobe 650-0017, Japan
Yasuyuki Saito
Division of Molecular and Cellular Signaling, Kobe University Graduate School of Medicine, Kobe 650-0017, Japan
Shinichiro Kawamoto
Division of Medical Oncology/Hematology, Department of Medicine, Kobe University Graduate School of Medicine, Kobe 650-0017, Japan
Mitsuhiro Ito
Division of Medical Oncology/Hematology, Department of Medicine, Kobe University Graduate School of Medicine, Kobe 650-0017, Japan
Tohru Murayama
Division of Medical Oncology/Hematology, Department of Medicine, Kobe University Graduate School of Medicine, Kobe 650-0017, Japan
Hiroshi Matsuoka
BioResource Center, Kobe University Hospital, Kobe 650-0047, Japan
Hironobu Minami
Division of Medical Oncology/Hematology, Department of Medicine, Kobe University Graduate School of Medicine, Kobe 650-0017, Japan
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 (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.