key: cord-0842236-9k59g9q7 authors: Miele, Monica; Busà, Rosalia; Russelli, Giovanna; Sorrentino, Maria Concetta; Di Bella, Mariangela; Timoneri, Francesca; Mularoni, Alessandra; Panarello, Giovanna; Vitulo, Patrizio; Conaldi, Pier Giulio; Bulati, Matteo title: Impaired anti‐SARS‐CoV‐2 humoral and cellular immune response induced by Pfizer‐BioNTech BNT162b2 mRNA vaccine in solid organ transplanted patients date: 2021-06-18 journal: Am J Transplant DOI: 10.1111/ajt.16702 sha: 1ba391c6ef44d0678c2b97d060e913df990f7f69 doc_id: 842236 cord_uid: 9k59g9q7 SARS-CoV-2 vaccine is considered the primary health strategy able to end the current COVID-19 pandemic. This viral infection impacts more severely solid organ transplant recipients (SOTRs) than general population, but the effect of vaccination in this subgroup of immunosuppressed patients is not known due to their exclusion from vaccination trials. Preliminary reports suggest a lower antibody production after BNT162b2 Pfizer/BioNTech mRNA-vaccine1,2,3,4 , but no data are currently available on the elicited virus-specific T cell responses. To the Editor: SARS-CoV-2 vaccine is considered the primary health strategy able to end the current COVID-19 pandemic. This viral infection impacts more severely solid organ transplant recipients (SOTRs) than general population, but the effect of vaccination in this subgroup of immunosuppressed patients is not known due to their exclusion from vaccination trials. Preliminary reports suggest a lower antibody production after BNT162b2 Pfizer/BioNTech mRNA-vaccine, [1] [2] [3] [4] but no data are currently available on the elicited virus-specific T cell responses. To better characterize the effect of vaccination on the immune response in SOTRs, we assessed the B-cell and T cell responses in 16 SOTRs and in 23 immunocompetent subjects (ICs), after the second dose of BNT162b2 vaccine (subjects' characteristics are showed in Table 1 ). All subjects included in this study were vaccinated between The horizontal bars correspond to the median value, respectively, 3.8 AU/ml in SOTRs and 212 AU/ml in immunocompetent subjects (ICs). Samples with anti-SARS-CoV-2 S1/S2 IgG concentration >15 AU/ml were considered positive. The dotted line corresponds to threshold. (B) T cell responses (IFNγ ELISpot SFC per 10 6 PBMC) to Spike (Mix I and II, respectively, of 158 and 157 peptides derived from a peptide scan, 15mers with 11 aa overlap) (p < .0001), or CEF (p = .08), were compared between ICs (n = 23) and SOTRs (n = 16). Each dot plot represents normalized mean spot count from duplicate wells (2.5 ± 0.5 × 10 5 PBMC/well) for each subject, after subtraction of spots count of unstimulated cells (the medium with peptides pool diluent-only). Circles under the graphics are representative of ELISpot from each group against Spike and CEF peptide pools. Bold black line represents the median and dotted line the experimental threshold (95 SFC per 10 6 PBMC). The significance was determined using a Mann-Whitney U-test (two-sides), ****p < .0001 The future of SARS-CoV-2 vaccines in transplant recipients: to be determined Immunogenicity of a single dose of SARS-CoV-2 messenger RNA vaccine in solid organ transplant recipients Immunogenicity of SARS-CoV-2 BNT162b2 vaccine in solid organ transplant recipients Reduced humoral response to mRNA SARS-CoV-2 BNT162b2 vaccine in kidney transplant recipients without prior exposure to the virus Alternative strategies of posttransplant influenza vaccination in adult solid organ transplant recipients Impaired anti-SARS-CoV-2 humoral and cellular immune response induced by Pfizer-BioNTech BNT162b2 mRNA vaccine in solid organ transplanted patients