Entangled evidence epistemic injustice, and systemic neglect in the assessment of menstrual disorders following COVID-19 vaccines

In the context of the COVID-19 pandemic, pharmacovigilance activities detected and assessed symptoms, such as rare blood clotting disorders, myocarditis, and erythema multiforme, potentially linked to some adenovirus-based and mRNA-based vaccines. While some presumed side effects were swiftly assessed, others, such as menstrual disorders following mRNA vaccination, were subjected to prolonged debates. This paper explores the EMA’s assessment process of menstrual disorders, which initially resisted but eventually acknowledged a possible connection between Heavy Menstrual Bleeding (HMB) and the mRNA COVID-19 vaccine Comirnaty (also known as Pfizer). Through an analysis of the PRAC evaluation process, I suggest that epistemic injustice and the systemic neglect of menstruation contributed to the challenges in this assessment. This paper emphasizes that structural bias in healthcare, health research, and policy accumulates at different stages of pharmacovigilance, shaping the evidence about vaccine safety. Although vaccines are generally safe, they may, in fact, be safer – or at least known to be safer – for some groups. To address these issues, a pluralist and transdisciplinary approach to knowledge should play a crucial role, questioning how evidence is produced and acknowledging potential intersectional biases.