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Review
. 2024 Mar 7;42(7):1469-1477.
doi: 10.1016/j.vaccine.2023.11.061. Epub 2023 Dec 6.

CDC COVID-19 Vaccine Pregnancy Registry: Design, data collection, response rates, and cohort description

Affiliations
Review

CDC COVID-19 Vaccine Pregnancy Registry: Design, data collection, response rates, and cohort description

Sabrina A Madni et al. Vaccine. .

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.

Keywords: COVID-19; COVID-19 vaccine; Immunization; Pregnancy; Pregnancy surveillance; Vaccination; Vaccine safety.

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Conflict of interest statement

Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1.
Fig. 1.
CDC COVID-19 Vaccine Pregnancy Registry Data System Components and Data Flow.
Fig. 2.
Fig. 2.
Data collection forms completed at each interview for Phase 1 of the CDC COVID-19 Vaccine Pregnancy Registry, by timing of enrollment. * Participant refers to the pregnant person enrolled into the COVID-19 Vaccine Pregnancy Registry through v-safe. ** Completed only for stillbirths and live births. *** Completed only for live births. † Completed only for live births where participant reported that the infant is no longer living. †† Call completed only for live births with infant still living at last contact. ††† Form completed only for live births with infant still living. ^ Only one interview was possible for retrospectively enrolled participants if at the time of the initial call the pregnancy did not result in a live birth, or the live-born infant had died, or the infant was older than three months of age. A maximum of two interviews were possible if the part icipant had a live birth and their infant was younger than three months old at the time of the initial call
Fig. 3.
Fig. 3.
Demographic distribution among participants eligible and enrolled in the CDC COVID-19 Vaccine Pregnancy Registry, January 2021 – August 2022. * Participant refers to the pregnant person enrolled into the COVID-19 Vaccine Pregnancy Registry through v-safe. ** Other includes non-Hispanic (NH) American Indian or Alaskan Native (0.2%), NH Native Hawaiian or Pacific Islander (0.1%), NH Multi-racial (2.4%), and Unknown (0.2%)

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