Influenza Vaccination and Myo-Pericarditis in Patients Receiving Immune Checkpoint Inhibitors: Investigating the Likelihood of Interaction through the Vaccine Adverse Event Reporting System and VigiBase

Milo Gatti; Emanuel Raschi; Ugo Moretti; Andrea Ardizzoni; Elisabetta Poluzzi; Igor Diemberger

doi:10.3390/vaccines9010019

Influenza Vaccination and Myo-Pericarditis in Patients Receiving Immune Checkpoint Inhibitors: Investigating the Likelihood of Interaction through the Vaccine Adverse Event Reporting System and VigiBase

Vaccines (Basel). 2021 Jan 4;9(1):19. doi: 10.3390/vaccines9010019.

Authors

Milo Gatti¹, Emanuel Raschi¹, Ugo Moretti², Andrea Ardizzoni³, Elisabetta Poluzzi¹, Igor Diemberger⁴

Affiliations

¹ Department of Medical and Surgical Sciences, Alma Mater Studiorum-University of Bologna, 40138 Bologna, Italy.
² Department of Public Health and Community Medicine, University of Verona, 37134 Verona, Italy.
³ Medical Oncology Unit, Department of Experimental, Diagnostic and Specialty Medicine, Policlinico S. Orsola-Malpighi, Alma Mater Studiorum-University of Bologna, 40138 Bologna, Italy.
⁴ Cardiology Unit, Department of Experimental, Diagnostic and Specialty Medicine, Alma Mater Studiorum-University of Bologna, 40138 Bologna, Italy.

Abstract

Background: Evidence on whether the influenza vaccine could exacerbate immune-related adverse events, including myopericarditis (MP), in patients treated with immune checkpoint inhibitors (ICIs), is still conflicting. We explored this issue through a global real-world approach.

Methods: We queried the Vaccine Adverse Event Reporting System (VAERS) and VigiBase to retrieve cases of MP in which the influenza vaccine and ICIs were recorded as suspect and were concomitantly reported. For the included cases, causality assessment and Drug Interaction Probability Scale (DIPS) algorithms were applied.

Results: There were 191 and 399 reports of MP with the influenza vaccine that were retrieved (VAERS and VigiBase, respectively). No case of MP reporting the concomitant use of ICIs and the influenza vaccine was found in VAERS, while three cases of myocarditis were retrieved in VigiBase. All of the cases were unclassifiable for a causality assessment because of the lack of data concerning latency. According to the DIPS, one report was categorized as possible and two as doubtful.

Conclusion: The paucity of cases coupled with the doubtful causality assessment make the potential interaction between influenza vaccines and ICIs in cancer patients negligible from clinical and epidemiological standpoints. These findings support the cardiovascular safety of the influenza vaccination, which remains strongly recommended in cancer patients, especially in the current COVID-19 era.

Keywords: adverse event following immunization; drug–vaccine interaction; immune checkpoint inhibitors; influenza vaccine; myocarditis; pericarditis; pharmacovigilance.