Adverse drug reactions to the three doses of the severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) mRNA-1273 vaccine in a cohort of cancer patients under active treatment of a tertiary hospital in Madrid, Spain

Abstract

Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines efficacy and safety have been tested in phase 3 studies in which cancer patients were not included or were underrepresented. 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. We selected from our records all 18-years or older solid cancer patients under active treatment vaccinated with the complete three-dose schedule mRNA-1273 vaccine whose adverse drug reactions (ADRs) after each dose were recorded. Medical records were reviewed retrospectively to collect data between April 19, 2021, and December 31, 2021. Patients with documented previous infection by SARS-Cov-2 were excluded. Results: A total of 93 patients met the inclusion criteria. Local 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 followed the opposite pattern (16.1%, 34.4% and 52.6% of the patients respectively). We found a statistically significant association between sex and systemic adverse reactions after the third dose, p < 0.001 and between systemic adverse reactions after the second dose and systemic adverse reactions after the third dose, p = 0.001 A significant linear trend, p = 0.012, with a higher Eastern Cooperative Oncology Group (ECOG) score associated with a lower proportion of patients suffering from systemic side effects was found. Women 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: The 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.

Pharmacovigilance of vaccines against COVID-19 in community pharmacies. Results after the second dose and comparison between both

“…Both the percentage of vaccinated participants who reported suspected ARs (63%/45%), the number of these (1367/972) and the number of ARs per vaccine (1.8/1.4) decreased significantly after administration of the second dose compared to the first dose. This result also coincides with that of Quiroga et al (25) where 75% of those vaccinated suffered some AR after the first dose, and only 57% of those vaccinated with the second dose, which is not common, as it differs from that found by many other authors (14,17,(22)(23)(24)26,27), in which the percentage of subjects manifesting ARs increases with successive doses of vaccines.…”

“…Therefore, the mean age of people without ARs is approximately 64 years, while that of those who report having experienced ARs is 12 years younger. This inverse relationship between age and reactivity to vaccine administration is also found in numerous reports consulted (8,17,27,28,33,34).…”

Clinical and Serological Follow-Up of 216 Patients with Hematological Malignancies after Vaccination with Pfizer-BioNT162b2 mRNA COVID-19 in a Real-World Study

“…In patients with cancer, tolerance has only been reported in association with immunogenicity studies also based on self-reported analyses [ 15 ]. In a recent study of 93 cancer patients, local adverse drug reactions were recently reported more frequently after the first and second doses than after the third, while systemic symptoms were observed to be more frequent after the third dose [ 16 ]. However, patients with hematological malignancies generally had higher levels of immunosuppression, which may increase toxicity in the context of novel vaccines.…”