TY  -  JOUR
AU  -  Rasi, Virginia
AU  -  Tsiasiotis, Emmanouil
AU  -  Bevilacqua, Elisa
AU  -  Lanzone, Antonio
AU  -  Rasi, Guido
T1  -  Existing evidence on sex-based differences in safety and effectiveness of COVID-19 vaccines: a narrative review
PY  -  2023
Y1  -  2023-01-01
DO  -  10.1723/4031.40063
JO  -  Journal of Sex- and Gender-Specific Medicine
JA  -  J Sex Gender Specif Med
VL  -  9
IS  -  1
SP  -  14
EP  -  34
PB  -  Il Pensiero Scientifico Editore
SN  -  2974-8623
Y2  -  2026/04/26
UR  -  http://dx.doi.org/10.1723/4031.40063
N2  -  Summary. Sex-based differences are expected both in vaccine effectiveness (VE) and adverse events (ADEs) for COVID-19 vaccines, with higher levels of humoral immune response and a general higher report of ADEs from females, on the basis of different genetic background and different innate and adaptive immune response. In the EU, COVID-19 vaccines process of approval relied on robust RCTs and disclosed an overall prevalence of non-systemic ADEs in female, meanwhile no differences were found for vaccine efficacy. However, rare events and long-term efficacy (effectiveness) can only be detected by studies from the post approval phase, where a general paucity of studies designed to assess sex-based differences is well known. The number of articles generated during the COVID-19 pandemic was impressive but still, we found difficult to draw conclusions about sex-based differences in ADEs and VE due to the fragmentation and heterogeneity of studies where only 33.6% had a balanced sex representation, with an overrepresentation of women in 50 studies and an underrepresentation in 25 studies. This review evaluated the existing evidence on sex-based difference in VE and ADEs for COVID-19 vaccines and assessed whether there was an equal representation of females and males and if the outcome of interest for each study was analysed by sex and/or gender.
ER  -