Background: Whether COVID-19 vaccination and the associated immune response increases susceptibility to immune-related adverse events (irAEs) among patients treated with immune checkpoint inhibition (ICI) remains unknown. Short-term follow-up can assess the safety of concurrent administration of the vaccine and ICI treatment. Methods: We conducted an electronic health record analysis of a cohort of 408 patients with cancer receiving ICI therapy and who were vaccinated for COVID-19 between January 16 and March 27, 2021. Patients were seen in follow-up for 90 days from the day of the first dose in this single-institution tertiary care center. We evaluated the incidence of irAEs and the frequency of each event type and grade among patients who experienced an irAE. We also evaluated the incidence of irAEs in patients who began a new immunotherapy agent after vaccination. Results: Among 408 patients with cancer receiving ICI therapy (median age, 71 years; 217 [53%] male), administration of a COVID-19 mRNA vaccine within 90 days of ICI treatment was not associated with an increased incidence of irAEs. A total of 27 (7%) patients experienced a new irAE within the observation period. Among patients with previous irAEs from ICIs (n=54), 3 (6%) experienced a recurrent irAE, and of those initiating a new immunotherapy (n=52), 9 (17%) experienced an irAE. No excess risk of COVID-19 diagnosis was seen in this subset of patients receiving ICI therapy, and no breakthrough COVID-19 cases were seen after full COVID-19 vaccination. Conclusions: These findings should reassure providers that COVID-19 vaccination during ICI therapy is safe and efficacious.
Submitted May 12, 2022; final revision received June 23, 2022; accepted for publication June 23, 2022.
Author contributions: Study design: Widman, Cohen, Wolchok, Kamboj. Data collection: Widman, Park, McClure, Kamboj. Data analysis: Widman, Cohen, Kamboj. Manuscript preparation: Widman, Cohen, Park, McClure. Manuscript editing: Wolchok, Kamboj.
Disclosures: Dr. Kamboj has disclosed serving on a speakers’ bureau for Medscape/WebMD. Dr. Wolchok has disclosed receiving grant/research support from Bristol Myers Squibb; serving as a consultant for Apricity, CellCarta, Ascentage Pharma, AstraZeneca, Astellas Pharma, Bicara Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Dragonfly, Georgiamune, Imvaq Therapeutics, Larkspur, Maverick Therapeutics, Psioxus, Recepta, Tizona, Sellas Life Sciences Group, and Werewolf Therapeutics; having equity/ownership in Apricity, Arsenal IO, Ascentage, Beigene, Imvaq, Linneaus, Georgiamune, Maverick, Tizona Pharmaceuticals, and Trieza; receiving royalties for patents: Xenogeneic (Canine) DNA vaccines (US 7,556,805), myeloid-derived suppressor cell (MDSC) assay (PCT/US2013/027475), and Newcastle disease virus for cancer therapy (US 10,251,922); and being a coinventor on a patent application related to prediction of responsiveness to treatment with immunomodulatory therapeutics and method of monitoring abscopal effects during such treatment (US14/380,837). The remaining authors have disclosed that they have not received any financial considerations from any person or organization to support the preparation, analysis, results, or discussion of this article.
Funding: Research reported in this publication was supported by the Division of Cancer Prevention, the NCI of the NIH under award number P30 CA008748.
Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.