COVID-19 Vaccine Pregnancy Registry

V-safe and the COVID-19 Vaccine Pregnancy Registry: What’s the Difference?

• The v-safe after vaccination health checker is a smartphone-based system that uses text messaging and web surveys to provide personalized health check-ins after a participant receives a COVID-19 vaccine. Enrollment in v-safe for COVID-19 vaccines closed on May 19, 2023.
• The COVID-19 Vaccine Pregnancy Registry enrolled v-safe participants who reported they were pregnant at the time of vaccination or shortly thereafter. The COVID-19 Vaccine Pregnancy Registry-related text messages and interviews* are separate from the v-safe check-ins that participants received via text message.

*CDC competed and awarded a contract to Abt Associates to contact participants for CDC’s COVID-19 Vaccine Pregnancy Registry.

Pregnancy Registry Data Collection and Use

Who Is Participating in the Pregnancy Registry

Approximately 23,000 people who reported a pregnancy into the v-safe after vaccination health checker from December 2020 to June 2021 were enrolled in the pregnancy registry. The COVID-19 Vaccine Pregnancy Registry enrolled participants from January 2021 through August 2022. Data are currently being analyzed to better understand how COVID-19 vaccines may affect pregnant people and their babies. The COVID-19 Vaccine Pregnancy Registry is conducting follow-up interviews among enrolled participants that will focus on longer-term maternal and infant outcomes through 15 months after the pregnancy outcome or delivery. These follow-up interviews began in November 2022 and are expected to continue through August 2023.

What to Expect If You Participate in the COVID-19 Vaccine Pregnancy Registry

Phone Call Health Check-ins

Abt Associates, a company contracted by CDC, contacted people by phone to invite them to participate in the pregnancy registry.

People who chose to enroll in the pregnancy registry received up to five calls from staff at CDC or Abt Associates during and after their registry-eligible pregnancies and completed short interviews about their health. During these calls, participants were asked questions about their pregnancies and medical histories, and about their babies’ health through three months of age. The second phase of follow-up began in November 2022. Staff at Abt Associates began calling enrolled participants at least 15 months after their pregnancies ended to ask questions about the participants’ health after the pregnancies ended and their infants’ health.

Requesting Permission to Contact Pregnancy Registry Participants’ Healthcare Providers

Participants are asked for permission to allow CDC staff to obtain and review medical records for additional details about their registry-eligible pregnancies and their infants’ health. Personal information and responses given to the registry are confidential and will be 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 chooses not to give permission for CDC to access medical records, they may still participate in the pregnancy registry.

Participation Is Voluntary

Participants are not paid for their participation in the pregnancy registry, and not all people reporting a pregnancy into v-safe were contacted to participate in the COVID-19 Vaccine Pregnancy Registry. Participation is completely voluntary, and participants may 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.

Why CDC Is Collecting Pregnancy Registry Information

The information that participants provide is being monitored and evaluated and used to inform the public about COVID-19 vaccines and pregnancy. In addition, this information is being used by CDC, the Food and Drug Administration (FDA), and clinical advisory groups to guide recommendations on COVID-19 vaccination during pregnancy.

Specific health effects that scientists are looking at include:

• Pregnancy outcomes (e.g., miscarriage and stillbirth)
• Pregnancy complications (e.g., hypertensive disorders in pregnancy and gestational diabetes)
• Infant outcomes (e.g., birth defects)

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.

How CDC Is Using Data from the Registry

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 people who were vaccinated or for their babies. Additional follow-up is ongoing, particularly among those vaccinated in the first or second trimesters of pregnancy; preliminary findings have identified no safety concerns after administration of COVID-19 vaccines to pregnant people.

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. Gathering 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 people received their COVID-19 vaccines during pregnancy. CDC will continue to share results as they become available.

Vaccine Safety Monitoring in People Who Are Breastfeeding

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

How to Report Adverse Events

The Vaccine Adverse Event Reporting System, or VAERS, collects reports of possible adverse events that happen after vaccination. Anyone can submit a report to VAERS, including patients, parents or caregivers, healthcare providers, and vaccine manufacturers.

There are two ways to report an adverse event to VAERS: report online or report using a writable pdf form. If you need further assistance with reporting to VAERS, please email info@VAERS.org or call 1-800-822-7967.

For healthcare providers – Under Emergency Use Authorization, FDA required healthcare professionals to report to VAERS certain adverse events that occur after COVID-19 vaccination. CDC also encourages reporting of any medically important adverse event even if it isn’t clear if the vaccine caused the health problem.