ABSTRACT
Background: SARS-CoV-2 vaccines efficacy and safety have been tested in phase 3 studies which did not include cancer patients. Information is scarce regarding COVID-19 vaccines 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 Hospital Clínico San Carlos (Madrid, Spain) who had received the three dose schedule of the mRNA9 1273 vaccine. Patient electronic 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: 93 patients met inclusion criteria. 31 patients (33%) were male and 62 patients (66%) were female. Mean age was 61 [SD 8]. 33% of the study population had metastatic disease. The majority of patients (60%) had ECOG 0 whereas 32% and 8% of the population had ECOG 1 and 2 respectively. Most common tumors were breast (33%) and gastrointestinal (17%). Treatment modalities included chemotherapy (37%), targeted therapy (23%), immunotherapy (12%) and combined therapy (28%). Local adverse effects at the site of injection and systemic adverse reactions had different trends, local adverse reactions were reported more frequently after the first and second dose than after the third (42%, 50% and 36% respectively), while systemic adverse reactions were reported less frequently after the first and second dose than after the third (16%, 35% and 53% respectively). Most common systemic adverse effect was fever followed by malaise and myalgia. No grade 4 or 5 adverse events were reported. We found a statistically significant association between sex and systemic adverse reactions after the third dose with a moderate correlation assessed by Cramer's V. 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 adverse events after the third dose (p = 0.01) compared to males. Increasing age was associated with a decreased likelihood of exhibiting adverse events (p = 0.016). ECOG scores didn't show a statistically significant association. Conclusions: mRNA-1273 vaccine shows a tolerable safety profile, which is similar to the non-oncologic population. The likelihood of adverse reactions appears to be associated with gender and age. Its association with ECOG scores is less evident. Further studies are needed to elucidate the safety profile of COVID-19 vaccines in cancer patients.
ABSTRACT
Objective: To quantify, characterize and compare the studies presented to the HCSC CEIm from 2017 to 2020, dividing 2020 into four periods according to the evolution of the COVID-19 pandemic. Material and/or methods: A retrospective analysis was carried out with extraction of the data from the studies from the FUNDANET platform;they were coded and classified according to the type of study, evaluation committee and medical research area. Data were compared via STATA 16. Results: The number of studies during 2017, 2018, 2019 and 2020 were: 636, 726, 725 and 830 respectively. The category with the highest number of studies is Medical Services. The number of studies evaluated in 2020 was higher during the period of confinement and the first wave of the pandemic compared to the rest of the periods studied. It should be noted a statistically significant increase in the number of clinical trials belonging to the Infectious Medical Service, and a non-significant increase in the studies belonging to Central Services. Conclusions: The health crisis derived from the COVID- 19 pandemic has generated the need to reshape the internal work processes of the CEIm to respond in an agile, efficient and rigorous way to the demand for research on SARS-COV2. Despite the limitations, it can be stated that in 2020 an increase in the number of studies in relation to COVID- 19 is observed, although this fact has not constituted a detriment to the research in the other medical areas evaluated. In order to expand the information and make it as reliable and generalizable as possible, it is intended to update the data by collecting information in the next years 2021 and 2022. In addition, it would be appropriate that a research process is started on the subject studied and comparisons with other centres can be established in the future.