V-safe COVID-19 Vaccine Pregnancy Registry
People who are pregnant or were recently pregnant are more likely to get severely ill from COVID-19 than people who are not pregnant. Additionally, people who have COVID-19 during pregnancy are more likely to experience preterm birth and stillbirth and might be more likely to have other pregnancy complications.
COVID-19 vaccination is recommended for all people who are pregnant, breastfeeding, trying to get pregnant now, or might become pregnant in the future. The growing body of evidence about the safety and effectiveness of COVID-19 vaccination during pregnancy suggests that the benefits of receiving a COVID-19 vaccine outweigh any known or potential risks of vaccination during pregnancy. CDC established the v-safe COVID-19 Vaccine Pregnancy Registry to continue to increase our knowledge on this issue.
Participation in the Registry
CDC is inviting people who received any dose of COVID-19 vaccine in the periconception period (within 30 days before last menstrual period) or during pregnancy to participate in the v-safe COVID-19 Vaccine Pregnancy Registry. Pregnant people who would like to participate must be enrolled in v-safe. If people enrolled in v-safe report that they were pregnant at the time of vaccination or became pregnant shortly after vaccination, the registry staff* may call them to learn more about their pregnancy course and outcome. Even if you are no longer pregnant, you may still be eligible to enroll in the registry.
*CDC has contracted Abt Associatesexternal icon to contact participants for CDC’s v-safe COVID-19 Vaccine Pregnancy Registry.
V-safe and the V-safe COVID-19 Vaccine Pregnancy Registry: What’s the Difference?
v-safe is a smartphone-based system that uses text messaging and web surveys to provide personalized health check-ins after you receive a COVID-19 vaccine. The v-safe COVID-19 Vaccine Pregnancy Registry is for v-safe participants who self-identify as pregnant at the time of vaccination or shortly thereafter (within 30 days of vaccination). The registry activities are in addition to the v-safe after vaccination health check-ins that participants receive via text message.
What to Expect If You Participate in the Registry
Phone Call Health Check-ins
Abt Associatesexternal icon, the registry staff contracted by CDC, will contact people by phone to invite them to participate in the registry.
People who choose to enroll in the registry will receive calls from Abt Associates several times throughout their pregnancy for additional health check-ins. During these check-ins, they will be asked questions about their pregnancy and medical history. After delivery, participants might be contacted for more information when their babies are about three months old.
Requesting Permission to Contact Your Healthcare Provider
Participants will also be asked if they would be willing to provide permission for Pregnancy Registry staff to review their medical records for additional details about their pregnancies. Personal information and responses given to the registry are confidential and will be protected to the full extent allowed by law. Having information on details, like medications or clinical laboratory results, provides a complete picture of your pregnancy. Your healthcare provider(s) can help provide this information, which is important as we try to understand any potential effects of COVID-19 vaccination during pregnancy. If you choose not to give your permission for CDC to access medical records, you can still participate in the registry.
Participation Is Voluntary
Participants are not paid for their participation in the registry, and not all people reporting pregnancy will be contacted to participate. Participation is completely voluntary, and you can opt out at any time. However, in general, many people feel good about participating in activities to help answer critical scientific questions, which can help inform recommendations for the public.
Registry Data Collection and Use
Who Is Participating in the Registry
CDC is currently enrolling eligible participants and analyzing data to better understand how COVID-19 vaccines affect pregnant people and their babies. As of May 2, 2022, the registry has enrolled 23,779 pregnant people in the United States.
Why CDC Is Collecting Registry Information
If you participate in the registry, the information you and other participants provide will be evaluated and used to educate the public about how COVID-19 vaccines might affect pregnant people and their babies. In addition, this information will be used by CDC and the Food and Drug Administration (FDA) to guide recommendations on COVID-19 vaccination during pregnancy.
Specific health effects that scientists will be looking at include:
- Pregnancy outcomes, like miscarriage and stillbirth
- Pregnancy complications, like preeclampsia and gestational diabetes
- Problems with the newborn, like preterm delivery, poor growth, or birth defects
Data for the registry are kept on a CDC system that employs strict security measures to keep personally identifiable information private. Your name and any identifying information will not be includedpdf icon in any reports. Your responses and personal information will be protectedexternal icon to the full extent allowed by law.
How CDC Is Using Data from the Registry
In April 2021, CDC released the first U.S. dataexternal icon on the safety of mRNA COVID-19 vaccines administered during pregnancy based on analyses of data from three vaccine safety-related databases, including the v-safe COVID-19 Pregnancy Registry. The analyses did not identify any safety concerns for pregnant people who were vaccinated or for their babies. Additional follow-up is needed, particularly among those vaccinated in the first or second trimesters of pregnancy; however, these preliminary findings are reassuring. Thanks to the participation of thousands of people, information gathered through the v-safe COVID-19 Vaccine Pregnancy Registry is helping to build the evidence base about the safety of COVID-19 vaccination during pregnancy.
Data collectedpdf icon from the registry is also presented in published reports and at Advisory Committee on Immunization Practices (ACIP) meetings, which are open to the public. However, gathering data on potential effects of COVID-19 vaccination during pregnancy is expected to take some time. People are being vaccinated at different times during their pregnancies. Given the natural length of pregnancy, it takes time to follow pregnancies and learn about any potential effects on babies. CDC is committed to sharing information learned about potential effects of COVID-19 vaccination during pregnancy as soon as possible.
Vaccine Safety Monitoring in People Who Are Breastfeeding
Based on how these vaccines work in the body, the authorized COVID-19 vaccines are not thought to be a risk to lactating people or their breastfeeding babies. Although this project is not looking at potential effects during breastfeeding, other researchers across the nation are working to better understand the effects of COVID-19 vaccination in people who are breastfeeding.
- Preliminary Findings of mRNA COVID-19 Vaccine Safety in Pregnant Personsexternal icon
- Receipt of mRNA COVID-19 Vaccines and Risk of Spontaneous Abortionexternal icon
- COVID-19 vaccine safety in pregnancy: Updates from the v-safe COVID-19 vaccine pregnancy registrypdf icon (ACIP meeting slides)
- Updates on COVID-19 and Pregnancypdf icon (ACIP meeting slides)
- Monitoring the safety of COVID-19 vaccines in pregnancy in the U.S.external icon
How to Report Adverse Events
You or your medical provider can report any adverse eventsexternal icon or health problems after COVID-19 vaccination to the Vaccine Adverse Event Reporting System (VAERS) by filling out a form that can be found on the VAERS websiteexternal icon. FDA requires healthcare providers to report certain adverse eventsexternal icon that occur after administering COVID-19 vaccine, but anyone can submit a report to VAERS. Reports to VAERS are invaluable to understanding the safety of COVID-19 vaccines as more people receive them over time. If you need further assistance with reporting to VAERS, please email [email protected] or call 1-800-822-7967.