Outcomes of pregnant women and infants with SARS-CoV-2 vaccine and infection exposure

Emerging infectious disease events, such as the current global SARS-CoV-2 pandemic, are often associated with disproportionately negative health outcomes for pregnant women and infants. Significant delays in implementation and reporting of robust research findings on SARS-CoV-2 vaccine safety and efficacy, as well as infection outcomes, has led to considerable vaccine hesitancy in the vulnerable pregnant population. Primarily, this research project will use extensive demographic, epidemiological, and clinical data from an established large prospective cohort study (the P3 cohort study) on 4000 pregnant women and their infants in Alberta, Canada, with follow-up continuing until 1 year postpartum. A sub-study on vaccine willingness and perceptions will also be done. Analysis of this data will provide accurate estimates of the risk of various health outcomes (e.g. pregnancy complications, neonatal complications) following SARS-CoV-2 infection in pregnant women and infants. It will give vital information on the real-world safety and efficacy of vaccination in a representative Canadian population, along with key insights into the necessity and timing of 'booster' shots. Secondarily, electronic medical record (EMR) data for participants will be compared to similar data from the prospective P3 cohort study. A validation will be done of the EMR data to see if it can be used in the future for rapidly implementing robust research on emerging infections in pregnancy. In areas (i.e. certain data types) where EMR is not valid, statistical approaches will be trialed to facilitate optimal use of this information for pandemic preparedness. The results of this study will be shared with other researchers as well as with the public through internal (University of Calgary), regional (SARS-CoV-2 and perinatal epidemiology networks within Alberta and Canada), and international (World Health Organization) collaborations. This research will be completed over a period of two years.