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CDC COVID-19 Vaccine Pregnancy Registry: Design, data collection, response rates, and cohort description
Sabrina A Madni1, Andrea J Sharma2, Lauren Head Zauche1
1Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, CDC, Atlanta, GA, USA.
Insights
The CDC COVID-19 Vaccine Pregnancy Registry (C19VPR) monitored the safety of COVID-19 vaccines in pregnant individuals. The registry collected data through interviews and medical records, providing crucial safety information for this population.
Area of Science:
- Public Health
- Vaccinology
- Epidemiology
Background:
- Pregnant individuals were excluded from initial COVID-19 vaccine trials, necessitating specific safety monitoring.
- The U.S. Centers for Disease Control and Prevention (CDC) established the CDC COVID-19 Vaccine Pregnancy Registry (C19VPR) to address this data gap.
- Monitoring vaccine safety in pregnancy is crucial due to increased risks of severe outcomes from infections in this population.
Purpose of the Study:
- To describe the protocol, development, and implementation of the CDC COVID-19 Vaccine Pregnancy Registry (C19VPR).
- To outline data collection methods, including participant interviews and medical record abstraction.
- To report initial demographics and vaccination status of enrolled participants.
Main Methods:
- The CDC C19VPR enrolled pregnant individuals vaccinated against COVID-19 or up to 30 days prior to their last menstrual period.
- Data were collected via phone interviews and confirmed/supplemented by medical record review and clinical assessment.
- The registry monitored health outcomes for both participants and their infants.
Main Results:
- From January to mid-June 2021, 123,609 potential participants were identified, with 23,339 eligible and enrolled.
- Over 85% consented to medical record review for themselves and/or their infants.
- Enrolled participants were predominantly non-Hispanic White (79.1%), urban residents (93.3%), aged 30-34 (48.3%), and 89.7% completed primary vaccination by pregnancy end.
Conclusions:
- The CDC C19VPR successfully collected safety data on COVID-19 vaccines in pregnant individuals.
- The registry provides essential safety information for a population not included in initial clinical trials.
- Lessons learned can inform future vaccine safety surveillance for pregnant populations and their infants.
Abstract:
The U.S. Centers for Disease Control and Prevention (CDC) developed and implemented the CDC COVID-19 Vaccine Pregnancy Registry (C19VPR) to monitor vaccine safety. Potential participants who received a COVID-19 vaccine in pregnancy or up to 30 days prior to their pregnancy-associated last menstrual period were eligible to participate in the registry, which monitored health outcomes of participants and their infants through phone interviews and review of available medical records. Data for select outcomes, including birth defects, were reviewed by clinicians. In certain cases, medical records were used to confirm and add detail to participant-reported health conditions. This paper serves as a description of CDC C19VPR protocol. We describe the development and implementation for each data collection aspect of the registry (i.e., participant phone interviews, clinical review, and medical record abstraction), data management, and strengths and limitations. We also describe the demographics and vaccinations received among eligible and enrolled participants. There were 123,609 potential participants 18-54 years of age identified from January 2021 through mid-June 2021; 23,339 were eligible and enrolled into the registry. Among these, 85.3 % consented to medical record review for themselves and/or their infants. Participants were majority non-Hispanic White (79.1 %), residents of urban areas (93.3 %), and 48.3 % were between 30 and 34 years of age. Most participants completed the primary series of vaccination by the end of pregnancy (89.7 %). Many participants were healthcare personnel (44.8 %), possibly due to the phased roll-out of the vaccination program. The registry continues to provide important information about the safety of COVID-19 vaccination among pregnant people, a population with higher risk of poor outcomes from COVID-19 who were not included in pre-authorization clinical trials. Lessons learned from the registry may guide development and implementation of future vaccine safety monitoring efforts for pregnant people and their infants.
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