Expanding V-safe COVID-19 Vaccine Pregnancy Registry
Highlights
- CDC needs data on COVID-19 vaccine safety for pregnant people.
- Abt collects information about pregnancy/birth outcomes for CDC.
- Abt provides data weekly to inform CDC’s analyses.
COVID-19 may put pregnant people at risk for severe illness or death, but data are limited on the safety of COVID-19 vaccines for them. To monitor potential safety issues, the Centers for Disease Control and Prevention (CDC) created the v-safe COVID-19 Vaccine Pregnancy Registry to collect data on adverse outcomes such as miscarriage, stillbirth, and pregnancy complications. CDC’s preliminary findings show that mRNA COVID-19 vaccines administered during pregnancy are safe. However, more data are needed to inform clinical and policy decisions.
Abt’s call-center staff enroll vaccinated pregnant people into the registry to collect information about adverse outcomes following vaccination. Interviewers administer telephone surveys to participants once during each trimester, at the end of pregnancy, and when the newborn is three months old. Interviewers seek information about healthcare providers for the pregnant person and infant, which CDC uses to collect medical record data for a subset of registry participants. Interviewers enter all data in real-time into CDC’s REDCap online data collection and management platform.
Abt generates weekly analytic datasets and call metrics dashboard reports to keep CDC apprised of study progress and provide data for ongoing analyses.