COVID-19 Vaccine Pregnancy Registry

Key points

  • COVID-19 Vaccine Pregnancy Registry data helps us better understand how COVID-19 vaccines may affect pregnant women and their babies.

Why information was collected

  • Monitor, evaluate and inform the public about COVID-19 vaccines and pregnancy.
  • Guide CDC, FDA and clinical advisory groups' recommendations on COVID-19 vaccination during pregnancy.

Fact

Data are currently being analyzed to better understand how COVID-19 vaccines may affect pregnant women and their babies.

Who participated

  • Approximately 23,000 women who reported getting a COVID-19 vaccine during pregnancy or within 30 days before their last menstrual period before the pregnancy into V-safe between December 2020 to June 2021.

Enrollment is closed to new participants, but CDC experts are still collecting data and requesting medical records for some participants.

Keep in mind

Participants were not paid for their participation in the pregnancy registry, and not all people reporting a pregnancy into V-safe were contacted to participate. Participation was completely voluntary, and participants could opt out at any time.

Many people feel good about participating in activities to help answer critical scientific questions, which can help inform recommendations for the public.

Data collection process

Phase one

January 2021 - August 2022

  1. Abt Associates, a company contracted by CDC, contacted people by phone to invite them to participate in the pregnancy registry.
  2. Women who chose to enroll completed up to five short phone interviews about their health with staff at CDC or Abt Associates during and after their registry-eligible pregnancies. Participants were asked about:
    1. Their pregnancies and medical histories.
    2. Their babies' health through three months of age.

Phase two

November 2022 - August 2023

  1. Staff at Abt Associates began calling enrolled participants at least 15 months after their pregnancies ended to ask about:
    1. The participants' health after the pregnancies ended.
    2. Their infants' health.

Disclaimers

The COVID-19 Vaccine Pregnancy Registry-related text messages and interviews are separate from the v-safe check-ins that participants receive via text message.

What was included

  • Pregnancy outcomes (such as miscarriage and stillbirth).
  • Pregnancy complications (such as hypertensive disorders in pregnancy and gestational diabetes).
  • Details from medical records (such as medications or clinical laboratory results).
  • Infant outcomes (such as birth defects).
  • Infant health through three months of age.

Fact

Personal information and responses given to the registry are confidential and protected to the fullest extent allowed by law. Having information on details, like medications or clinical laboratory results, provides a more complete picture of a person's health, which is important as we try to understand more about COVID-19 vaccination during pregnancy. If a participant chose not to give permission for CDC to access medical records, they may still participate in the pregnancy registry.

What was not included

Based on how vaccines build protection in the body, the authorized COVID-19 vaccines are not thought to be a risk to lactating women or their breastfeeding babies. Although the COVID-19 Vaccine Pregnancy Registry does not look at COVID-19 vaccination and breastfeeding, other researchers across the United States are working to better understand COVID-19 vaccination and breastfeeding.

The benefit to public health

In April 2021, CDC released the first U.S. data on the safety of mRNA COVID-19 vaccines administered during pregnancy based on analyses of data from three vaccine safety-related databases, including the COVID-19 Vaccine Pregnancy Registry. The analyses did not identify any safety concerns for pregnant women who were vaccinated or for their babies.1Additional follow up is ongoing, particularly among those vaccinated in the first or second trimesters of pregnancy.234

Fact

Preliminary findings have identified no safety concerns after administration of COVID-19 vaccines to pregnant women.

Data collected from the COVID-19 Vaccine Pregnancy Registry have also been presented in published reports and at publicly open Advisory Committee on Immunization Practices (ACIP) meetings. 56Gathering and reporting on data that focuses on chronologically later outcomes are expected to take some time, given the natural length of pregnancy and the variation in trimesters during which women received their COVID-19 vaccines during pregnancy. CDC will continue to share results as they become available.

Data management

Data for the COVID-19 Vaccine Pregnancy Registry are kept on a CDC server that employs strict security measures to keep personally identifiable information private. Names and any identifying information will not be included in any reports. Participants' responses and personal information are protected to the fullest extent allowed by law.

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Content Source:
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
  1. Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons. (2021). The New England journal of medicine, 385(16), 1536. https://doi.org/10.1056/NEJMx210016
  2. Zauche, L. H., Wallace, B., Smoots, A. N., Olson, C. K., Oduyebo, T., Kim, S. Y., Petersen, E. E., Ju, J., Beauregard, J., Wilcox, A. J., Rose, C. E., Meaney-Delman, D. M., Ellington, S. R., & CDC v-safe Covid-19 Pregnancy Registry Team (2021). Receipt of mRNA Covid-19 Vaccines and Risk of Spontaneous Abortion. The New England journal of medicine, 385(16), 1533–1535. https://doi.org/10.1056/NEJMc2113891
  3. Moro, P. L., Panagiotakopoulos, L., Oduyebo, T., Olson, C. K., & Myers, T. (2021). Monitoring the safety of COVID-19 vaccines in pregnancy in the US. Human vaccines & immunotherapeutics, 17(12), 4705–4713. https://doi.org/10.1080/21645515.2021.1984132
  4. Madni, S. A., Sharma, A. J., Zauche, L. H., Waters, A. V., Nahabedian, J. F., 3rd, Johnson, T., Olson, C. K., & CDC COVID-19 Vaccine Pregnancy Registry Work Group (2024). CDC COVID-19 Vaccine Pregnancy Registry: Design, data collection, response rates, and cohort description. Vaccine, 42(7), 1469–1477. https://doi.org/10.1016/j.vaccine.2023.11.061
  5. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-09-22/09-COVID-Olson-508.pdf
  6. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-09-22/11-COVID-Meaney-Delman-508.pdf