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Dryad

Adverse drug reactions to the three doses of the SARS-COV-2 mRNA-1273 vaccine in a cohort of cancer patients of a tertiary hospital

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Mar 31, 2022 version files 48.53 KB

Abstract

Introduction: SARS-CoV-2 vaccines efficacy and safety have been tested in phase 3 studies in which cancer patients were not included or underrepresented. Information is scarce regarding safety in this population. 

Methods: The objective of this study is to evaluate the safety profile of the mRNA-1273 vaccine across cancer  patients and its relationship to patients’ demographics. This cross sectional study included patients 18-years or older with solid malignancies receiving active treatment in our hospital who had received the three dose schedule of the mRNA9 1273 vaccine and whose side effects after each dose were recorded. Patient electronic medical records were reviewed retrospectively to collect tha available information in 2021. Patients with documented previous infection by SARS-Cov-2 were excluded from the study.

Results: 93 patients met inclusion criteria. Local adverse drug reactions (ADRs) were reported more frequently after the first and second dose than after the third (41.9%, 43% and 31.1% of the patients respectively), while systemic ADRs were reported less frequently after the first and second dose than after the third (16.1%, 34.4% and 52.6% of the patients respectively). We found  a statistically significant association between sex and systemic ADRs after the third dose.  Cochran-Armitage test showed a statistically significant linear trend, p = 0.012, with higher ECOG score associated with a lower proportion of patients suffering from systemic side effects. A logistic regression showed that females had 5.79 times higher odds to exhibit systemic ADRs after the third dose (p=0.01)  compared to males. Increasing age was associated with a decreased likelihood of exhibiting ADRs (p=0.016).

Conclusion: mRNA-1273 vaccine shows a tolerable safety profile. The likelihood of ADRs appears to be associated with gender and age. Its association with ECOG scores is less evident. Further studies are needed to elucidate this data in cancer patients.