The COVID-19 vaccine evidence gap: Decisions without data for pregnant and breastfeeding women

Abstract

On March 11th, 2020, the Word Health Organization officially declared the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) outbreak a pandemic, setting in motion an unprecedented modern-day global public health response [1, 2]. Since that time, COVID-19’s impact has been wide-reaching and complex; influenced by a diverse set of biologic, clinical, psychologic, and sociodemographic factors [3, 4]. Indeed, not all members of society are at equal risk of SARS-CoV-2 infection or experiencing severe infection-related outcomes [3, 4]. For example, older adults and individuals with comorbid conditions (e.g., cardiovascular disease) are at increased risk for severe disease [5]. Further, males are at higher risk of serious COVID-19 outcomes compared to females, underscoring the importance of including sex as a fundamental variable in the design and conduct of COVID-19 research [6]. Certainly, without sex-disaggregated data, it is impossible to know if, or to what extent, sex-specific approaches to the care and prevention of SARS-CoV-2 infection should be employed [7].