Safety and Immunogenicity of the BNT162b2 mRNA Covid-19 Vaccine in Patients after Allogeneic HCT or CD19-based CART therapy – a Single Center Prospective Cohort Study

Ram, Ron; Hagin, David; Kikozashvilli, Nino; Freund, Tal; Amit, Odelia; Bar-On, Yael; Beyar-Katz, Ofrat; Shefer, Gabi; Moshiashvili, Miguel Morales; Karni, Chen; Gold, Ronit; Kay, Sigi; Glait-Santar, Chen; Eshel, Rinat; Perry, Chava; Avivi, Irit; Apel, Arie; Benyamini, Noam; Shasha, David; Ben-Ami, Ronen

Data are scarce regarding both safety and immunogenicity of the BNT162b2 mRNA COVID-19 vaccine in patients undergoing immune cell therapy, thus we prospectively evaluated these 2 domains in patients receiving this vaccine after allogeneic HCT (n=66) or after CD19-based CART therapy (n=14). Overall, vaccine was well tolerated, with mild non-hematologic vaccine-reported adverse events in minority of the patients. 12% (after first dose) and 10% (after second dose) of the patients developed cytopenia and there were 3 cases GVHD exacerbation after each dose. A single case of impending graft rejection was summarized as possibly related. Evaluation of immunogenicity showed that 57% of patients after CART infusion and 75% patients after allogeneic HCT had evidence of humoral and/or cellular response to the vaccine. On cox regression model, longer time from infusion of cells, female sex, and higher CD19(+) cells were associated with a positive humoral response, whereas higher CD4(+)/CD8(+) ratiowas correlated with a positive cellular response, confirmed by ELISpot test. We conclude that BNT162b2 mRNA COVID-19 vaccine has impressive immunogenicity in patients after allogeneic HCT or CART. Adverse events were mostly mild and transient, but some significant hematologic events were observed, hence, patients should be closely monitored.