As of February 16, 2021, more than 30,000 v-safe participants have indicated they were pregnant at the time they received COVID-19 vaccination. CDC is currently enrolling eligible participants and analyzing data to better understand how COVID-19 vaccination affects pregnant people. As CDC learns more about the effects of vaccination during pregnancy, data will be presented at the Advisory Committee on Immunization Practices (ACIP) meetings, which are open to the public, and in published reports.
*Recommendations for routine use of vaccines in children, adolescents, and adults are developed by the Advisory Committee on Immunization Practices (ACIP). ACIP is chartered as a federal advisory committee to provide expert external advice and guidance to the Director of the Centers for Disease Control and Prevention (CDC) on use of vaccines and related agents for the control of vaccine-preventable diseases in the civilian population of the United States.
v-safe and the v-safe COVID-19 Vaccine Pregnancy Registry: What’s the difference?
V-safe is a smartphone-based tool 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 report vaccination in the periconception period or during pregnancy. The registry activities are in addition to the v-safe after vaccination health check-ins that participants receive via text message. Pregnant participants in the registry will be contacted to answer questions about their pregnancy and medical history. Participants will also be asked for permission to contact their healthcare provider(s).
Note: Participants are not paid for their participation. 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.
How CDC is using the information
The information you provide will be combined with information from other participants in the registry. Together, this information will be evaluated and used to educate the public about how COVID-19 vaccination might affect pregnancy. 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
Your name and any identifying information will not be included in any reports. Your responses and personal information will be protected to the full extent allowed by law. Data for the registry are kept on a CDC system that employs strict security measures to keep personally identifiable information private.
CDC may need permission to contact your healthcare provider
Having information on details, like medications or clinical laboratory results, can help provide a more complete picture about 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.
Vaccine safety monitoring in people who are breastfeeding
Breastfeeding is rarely a safety concern with vaccines, and the three authorized COVID-19 vaccines are not thought to be a risk to a breastfeeding infant. 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.
CDC will present data from the registry
Data collected from the registry will be regularly presented at the ACIP meetings, which are open to the public, and in published reports. However, findings on potential effects of COVID-19 vaccination during pregnancy are 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 infants. CDC is committed to sharing information learned about potential effects of COVID-19 vaccination during pregnancy as soon as possible.
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 info@VAERS.org or call 1-800-822-7967.