Immunogenicity and safety of the BNT162b2 mRNA COVID‐19 vaccine in haematopoietic stem cell transplantation recipients

Shem‐Tov, Noga; Yerushalmi, Ronit; Danylesko, Ivetta; Litachevsky, Vladislav; Levy, Itzchak; Olmer, Liraz; Lusitg, Yaniv; Avigdor, Abraham; Nagler, Arnon; Shimoni, Avichai; Rahav, Galia

doi:10.1111/bjh.17918

Cited by 56 publications

(97 citation statements)

References 24 publications

(58 reference statements)

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“…However, 76% of patients obtained sufficient immunogenicity. Recent studies have reported that seroconversion after two doses of vaccination reaches 75-86% in allogeneic HSCT patients [7,12,[15][16][17][18]; our present results are consistent with this level. In one previous report, the main factor influencing vaccination response was the time elapsed from HSCT, with lower responses occurring within one year of HSCT [15].…”

Section: Discussionsupporting

confidence: 92%

“…In our present subjects, one of the four patients vaccinated within one year from transplantation had an apparently low antibody titer, and no association with antibody titer was seen for the interval between transplantation and first dose, possibly due to the small number of patients who underwent allogeneic stem cell transplantation within 1 year before vaccination. Immunosuppressive therapy [16][17][18] and chronic GVHD [16,18] at vaccination are reported to be associated with a low response to SARS-CoV-2 vaccination. In our cohort, only three patients had developed chronic GVHD and were taking steroids.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2022

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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.

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Section: Discussionsupporting

confidence: 92%

Section: Discussionmentioning

confidence: 99%

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

et al. 2022

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“…Overall, 82 studies were included for meta-analysis ( table 1 , supplementary table 2). 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 …”

Section: Resultsmentioning

confidence: 99%

Efficacy of covid-19 vaccines in immunocompromised patients: systematic review and meta-analysis

Lee

Wong

Chai

et al. 2022

BMJ

347

313

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Objective To compare the efficacy of covid-19 vaccines between immunocompromised and immunocompetent people. Design Systematic review and meta-analysis. Data sources PubMed, Embase, Central Register of Controlled Trials, COVID-19 Open Research Dataset Challenge (CORD-19), and WHO covid-19 databases for studies published between 1 December 2020 and 5 November 2021. ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform were searched in November 2021 to identify registered but as yet unpublished or ongoing studies. Study selection Prospective observational studies comparing the efficacy of covid-19 vaccination in immunocompromised and immunocompetent participants. Methods A frequentist random effects meta-analysis was used to separately pool relative and absolute risks of seroconversion after the first and second doses of a covid-19 vaccine. Systematic review without meta-analysis of SARS-CoV-2 antibody titre levels was performed after first, second, and third vaccine doses and the seroconversion rate after a third dose. Risk of bias and certainty of evidence were assessed. Results 82 studies were included in the meta-analysis. Of these studies, 77 (94%) used mRNA vaccines, 16 (20%) viral vector vaccines, and 4 (5%) inactivated whole virus vaccines. 63 studies were assessed to be at low risk of bias and 19 at moderate risk of bias. After one vaccine dose, seroconversion was about half as likely in patients with haematological cancers (risk ratio 0.40, 95% confidence interval 0.32 to 0.50, I 2 =80%; absolute risk 0.29, 95% confidence interval 0.20 to 0.40, I 2 =89%), immune mediated inflammatory disorders (0.53, 0.39 to 0.71, I 2 =89%; 0.29, 0.11 to 0.58, I 2 =97%), and solid cancers (0.55, 0.46 to 0.65, I 2 =78%; 0.44, 0.36 to 0.53, I 2 =84%) compared with immunocompetent controls, whereas organ transplant recipients were 16 times less likely to seroconvert (0.06, 0.04 to 0.09, I 2 =0%; 0.06, 0.04 to 0.08, I 2 =0%). After a second dose, seroconversion remained least likely in transplant recipients (0.39, 0.32 to 0.46, I 2 =92%; 0.35, 0.26 to 0.46), with only a third achieving seroconversion. Seroconversion was increasingly likely in patients with haematological cancers (0.63, 0.57 to 0.69, I 2 =88%; 0.62, 0.54 to 0.70, I 2 =90%), immune mediated inflammatory disorders (0.75, 0.69 to 0.82, I 2 =92%; 0.77, 0.66 to 0.85, I 2 =93%), and solid cancers (0.90, 0.88 to 0.93, I 2 =51%; 0.89, 0.86 to 0.91, I 2 =49%). Seroconversion was similar between people with HIV and immunocompetent controls (1.00, 0.98 to 1.01, I 2 =0%; 0.97, 0.83 to 1.00, I 2 =89%). Systematic review of 11 studies showed that a third dose of a covid-19 mRNA vaccine was associated with seroconversion among vaccine non-responders with solid cancers, haematological cancers, and immune mediated inflammatory disorders, although response was variable in transplant recipients and inadequately studied in people with HIV and those receiving non-mRNA vaccines. Conclusion Seroconversion rates after covid-19 vaccination were significantly lower in immunocompromised patients, especially organ transplant recipients. A second dose was associated with consistently improved seroconversion across all patient groups, albeit at a lower magnitude for organ transplant recipients. Targeted interventions for immunocompromised patients, including a third (booster) dose, should be performed. Systematic review registration PROSPERO CRD42021272088.

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“…Overall, all studies conclude worse response in case of early vaccination, especially when initiated before 12 months post-HSCT (OR = 5.72; p = 0.048) [ 50 ]. This was also seen in the available response rates for COVID vaccination: 37–50% <12 months post-HSCT [ 48 , 56 ] versus 68–94% >12 months post-HSCT [ 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 ]. One study reported on vaccination < 6 months post-HSCT with only 12.5% response ( n = 8) [ 57 ].…”

Section: Resultsmentioning

confidence: 87%

“…Only 1 article was included through snowballing. This resulted in 10 articles being suitable for this analysis, which are shown in Table 3 in order of timing of the vaccination post-HSCT [ 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 ].…”

Section: Resultsmentioning

confidence: 99%

Vaccine Responses in Adult Hematopoietic Stem Cell Transplant Recipients: A Comprehensive Review

Janssen

Bruns

Kuball

et al. 2021

Cancers

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Consensus on timing of post-hematopoietic stem cell transplantation (HSCT) vaccination is currently lacking and is therefore assessed in this review. PubMed was searched systematically for articles concerning vaccination post-HSCT and included a basis in predefined criteria. To enable comparison, data were extracted and tables were constructed per vaccine, displaying vaccine response as either seroprotection or seroconversion for allogeneic HSCT (alloHSCT) and autologous HSCT (autoHSCT) separately. A total of 33 studies were included with 1914 patients in total: 1654 alloHSCT recipients and 260 autoHSCT recipients. In alloHSCT recipients, influenza vaccine at 7–48 months post-transplant resulted in responses of 10–97%. After 12 months post-transplant, responses were >45%. Pneumococcal vaccination 3–25 months post-transplant resulted in responses of 43–99%, with the response increasing with time. Diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b at 6–17 months post-transplant: 26–100%. Meningococcal vaccination at 12 months post-transplant: 65%. Hepatitis B vaccine at 6–23 months post-transplant: 40–94%. Measles, mumps and rubella at 41–69 months post-transplant: 19–72%. In general, autoHSCT recipients obtained slightly higher responses compared with alloHSCT recipients. Conclusively, responses to childhood immunization vaccines post-HSCT are poor in comparison with healthy individuals. Therefore, evaluation of response might be indicated. Timing of revaccination is essential for optimal response. An individualized approach might be necessary for optimizing vaccine responses.

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Immunogenicity and safety of the BNT162b2 mRNA COVID‐19 vaccine in haematopoietic stem cell transplantation recipients

Cited by 56 publications

References 24 publications

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

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

Efficacy of covid-19 vaccines in immunocompromised patients: systematic review and meta-analysis

Vaccine Responses in Adult Hematopoietic Stem Cell Transplant Recipients: A Comprehensive Review

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