CDC COVID-19 Vaccine Pregnancy Registry: Design, data collection, response rates, and cohort description
- PMID: 38057207
- PMCID: PMC11062484
- DOI: 10.1016/j.vaccine.2023.11.061
CDC COVID-19 Vaccine Pregnancy Registry: Design, data collection, response rates, and cohort description
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.
Published by Elsevier Ltd.
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.](https://cdn.statically.io/img/www.ncbi.nlm.nih.gov/pmc/articles/instance/11062484/bin/nihms-1988464-f0001.gif)
![Fig. 2.](https://cdn.statically.io/img/www.ncbi.nlm.nih.gov/pmc/articles/instance/11062484/bin/nihms-1988464-f0002.gif)
![Fig. 3.](https://cdn.statically.io/img/www.ncbi.nlm.nih.gov/pmc/articles/instance/11062484/bin/nihms-1988464-f0003.gif)
Similar articles
-
Safety monitoring of bivalent mRNA COVID-19 vaccine among pregnant persons in the vaccine adverse event reporting System - United States, September 1, 2022 - March 31, 2023.Vaccine. 2024 Apr 2;42(9):2380-2384. doi: 10.1016/j.vaccine.2024.02.084. Epub 2024 Mar 11. Vaccine. 2024. PMID: 38462432 Review.
-
The v-safe after vaccination health checker: Active vaccine safety monitoring during CDC's COVID-19 pandemic response.Vaccine. 2023 Feb 10;41(7):1310-1318. doi: 10.1016/j.vaccine.2022.12.031. Epub 2023 Jan 23. Vaccine. 2023. PMID: 36697313 Free PMC article. Review.
-
Folic acid supplementation and malaria susceptibility and severity among people taking antifolate antimalarial drugs in endemic areas.Cochrane Database Syst Rev. 2022 Feb 1;2(2022):CD014217. doi: 10.1002/14651858.CD014217. Cochrane Database Syst Rev. 2022. PMID: 36321557 Free PMC article.
-
Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices, United States, 2021-22 Influenza Season.MMWR Recomm Rep. 2021 Aug 27;70(5):1-28. doi: 10.15585/mmwr.rr7005a1. MMWR Recomm Rep. 2021. PMID: 34448800 Free PMC article.
-
A randomized, double-blind, placebo-controlled phase III clinical trial to evaluate the efficacy and safety of SARS-CoV-2 vaccine (inactivated, Vero cell): a structured summary of a study protocol for a randomised controlled trial.Trials. 2021 Apr 13;22(1):276. doi: 10.1186/s13063-021-05180-1. Trials. 2021. PMID: 33849629 Free PMC article.
Cited by
-
Prenatal Maternal Immunization for Infant Protection: A Review of the Vaccines Recommended, Infant Immunity and Future Research Directions.Pathogens. 2024 Feb 23;13(3):200. doi: 10.3390/pathogens13030200. Pathogens. 2024. PMID: 38535543 Free PMC article. Review.
References
Publication types
MeSH terms
Substances
Grants and funding
LinkOut - more resources
Full Text Sources
Medical