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.
Highlights
The safety of vaccines and medications is a current global safety issue
We investigated the likelihood of interaction between the influenza vaccination and immune checkpoint inhibitors (ICIs) by analyzing spontaneous reports of MP collected from the Vaccine Adverse Event Reporting System
To the best of our knowledge, this is the first real-world study investigating the potential interactions between influenza vaccines and ICIs resulting in myocarditis or pericarditis in cancer patients, by assessing spontaneous reports submitted to the Vaccine Adverse Event Reporting System (VAERS) and VigiBase®
Summary
The safety of vaccines and medications is a current global safety issue. The annual vaccination against the influenza virus is the primary means of preventing influenza and its complications in high-risk subjects, including adult cancer patients, as described by observational studies, suggesting lower mortality and infection-related outcomes with influenza vaccination [1]. Immune checkpoint inhibitors (ICIs), such as anti-PD1, anti-PDL1, and anti-CTLA4 monoclonal antibodies, are approved as first-line agents in the management of melanoma and non-small cell lung cancer They may cause a variegate spectrum of cardiovascular events, including MP, with a higher mortality compared with other immunerelated adverse events (irAEs) [9,10,11,12,13]. 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
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