COVID-19 Vaccine Use During Pregnancy: Accelerating Innovative Evidence Generation Platforms to Meet Current and Future Challenges

Background: Early evidence during the SARS-CoV-2 pandemic suggested that COVID-19 during pregnancy was associated with adverse obstetric outcomes. In an abundance of caution, pregnant people were excluded from pivotal COVID-19 vaccine randomized clinical trials. Observational research designs were required to generate evidence of vaccine safety and effectiveness in pregnant people in an agile fashion, in order to meet the evidentiary standards required by multiple health authorities (HAs) during a dynamic global pandemic

Objectives: The main objective of this Symposium is to present an innovative, digital, global Real World Evidence (RWE) design for a multi-product COVID-19 vaccine pregnancy registry (NCT04705116) highlighting the operational elements and methods used to meet evidence gaps efficiently. The speakers will discuss a collaborative approach across marketing authorization holders (MAH) to implement a harmonized protocol, Statistical Analysis Plan, and integrated adverse event reporting process in accordance with HA and Ethics Committee (EC) requirements, including those of low and middle income countries (LMIC). The symposium targets attendees from industry, government and academic sectors responsible for the design, implementation and/or evaluation of pregnancy-related RWE.

Description: The Symposium will review (1) COVID-19 vaccine Risk Management Plan guidance from HAs related to pregnant and lactating populations, (2) pregnancy registry / RWE designs and challenges to implementation during the COVID-19 pandemic, (3) attributes of the COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER) digital platform, such as flexibility to enroll both (a) pregnant people uploading EHR-based information in any country where COVID-19 vaccines are used and EC approval or clearance has been granted and (b) a matched comparator cohort of people unvaccinated during pregnancy, and (4) experience with enrollment and retention to date. The members of this cross-MAH working group will present examples of how they overcame design implementation challenges together with the sponsor to meet HA commitments internationally, e.g. interaction with ECs, managing expedited reporting timelines, and defining appropriate statistical approaches given evolving vaccination schemes. Finally, in the context of increased guidance for inclusion of pregnant and lactating persons earlier in clinical development, a panel discussion including all speakers will focus on generalized learnings from this experience to inform the design and implementation of future real world studies to characterize the benefit-risk of product use during pregnancy.