Sex Differences in Safety and Tolerability of a M-Rna-1237 Moderna Covid-19 Vaccine Booster Dose (Fourth Dose) in Cancer Patients: Our Experience

ABSTRACT

Background: COVID-19 is a disease due to a new form of coronavirus called SARS-CoV2 which causes an acute infection with respiratory symptoms. This new virus is different from those that cause SARS (severe acute respiratory syndrome) or MERS (respiratory syndrome of Middle East). Clinical manifestations can range from asymptomatic infection to life-threatening disease. By November 2021, more than 250 million people have had confirmed covid-19 and more than four million have died worldwide. Literature data show increased mortality from COVID-19 in cancer patients (pts). Moreover, cancer pts often fail to respond adequately to the initial vaccination. The aim of our study was to evaluate, sex differences in safety and tolerability of m-RNA-1237 Moderna COVID- 19 vaccine booster dose (fourth dose) in oncology pts, focusing on the first week after vaccination. Material(s) and Method(s) We have retrospectively analyzed sex differences on safety and tolerability of m-RNA-1237 Moderna COVID-19 vaccine booster dose (fourth dose) in 37 cancer patients (pts). All pts were vaccinated in March 2022 while undergoing active cancer therapy. There were 21 men (56.7%), 16 women (43.2%) Mean age 70 years (range 48-82) We analyzed the following adverse events (AE) fever, joint pain, injection site pain, lymphadenopathies, chills, nausea and vomiting, headache, diarrhea. AE were analyzed and stratified in grades from G1 to G4 according to CTCAE scale. Result(s) Of 37 pts analyzed, 9 (24.3%) developed AE and all within one week of vaccination. All pts with AE were female All AE were G1 and G2.No pts presented G3-G4 AE. The AE found in the 9 pts were fever (100%) and injection site pain (100%) No pts had joint pain, lymphadenopathy, chills, nausea and vomiting, headache and diarrhea. Using the Fischer test we found that the difference in the two sexes between the development of adverse events related to vaccination was statistically significant (p 0.0001) Conclusion(s) Our results demonstrate that m-RNA-1237 Moderna COVID-19 vaccine second booster dose (fourth dose) is usually well tolerated among cancer pts All AE were G1 and G2. No pts presented G3-G4 AE. In addition, despite the limited number of pts, we found a statistically significant difference between male and female pts in the development of adverse events related to vaccination.