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V-safe COVID-19 Vaccine Pregnancy Registry

For pregnant women, nursing mothers, and those who are trying to become pregnant, COVID-19 vaccinations are recommended. No evidence has been found that vaccines, including COVID-19 cause fertility problems. There is increasing evidence that COVID-19 vaccinations during pregnancy are safe and effective. This suggests that the potential risks associated with vaccinations during pregnancy outweigh the benefits. To learn more, visit the CDC’s v-safe COVID-19 Vaccine Pregnancy Register.

The registry collects health information about people who have received COVID-19 vaccine during the periconception period (within the 30 days preceding the last period) and during pregnancy. This information is vital to help people and their healthcare providers make informed choices about COVID-19 vaccine. Participants can opt out at any time. Participation is voluntary.

Participation at the Registry

The CDC invites people who have received COVID-19 vaccine during the periconception period (30 days prior to last menstrual period) and pregnancy to register in the vsafe COVID-19 Vaccine Birth Registry. Participation in v-safe is only available to pregnant women. If a person enrolled in V-safe reports that they were pregnant at the vaccination time or after, the registry staff* may contact them by telephone to find out more. You may still be eligible for the registry even if your pregnancy has ended.

People who sign up for the registry will be contacted via phone multiple times during their pregnancy to schedule additional health checks-ins. Participants will be asked questions regarding their pregnancy and past medical history during these check-ins. Participants may be contacted after their babies turn three months. Participants may also be asked permission to review their medical records in order to obtain a fuller picture of their pregnancies. Even if you do not give permission for the registry to view your medical records, you can still register in the registry. Personal information and responses to v-safe are protected to the maximum extent permitted by law.

*Abt Associatesexternal icons has been contracted to contact participants for the CDC’s vsafe COVID-19 Vaccine Birth Registry.

Registry Monitoring and V-safe Pregnancy Reporting People

v-safe After Vaccination Health Checker

Pregnant people reported, United States,

February 14, 2022


v-safe COVID-19 Vaccine Pregnancy Registry

Pregnant people enrolled, United States,

February 14, 2022


More than 201 000 v-safe participants indicated that they were pregnant as of February 14, 2022. CDC is currently enrolling qualified participants and analyzing data in order to better understand the effects of COVID-19 vaccination on pregnant women. Data from the CDC will be presented to the Advisory Committee on Immunization practices (ACIP) meetings and published reports as the agency learns more about vaccine effects during pregnancy.

* There are many factors that explain the large gap between the number who self-identify as being pregnant in vsafe and the number of people in the vsafe pregnancy registry. 1) There was some delay in the introduction of COVID-19 vaccine and the launch the v-safe registry. 2) It takes some time for registry staff members to contact pregnant women who self-identify as v-safe. Not all people who are pregnant through v-safe meet the criteria for being in the registry. The registry can only enroll certain numbers of pregnant women who have been vaccinated at different times during pregnancy.

**Recommendations regarding routine vaccinations for children, adolescents and adults were developed by the Advisory Committee on Immunizing Practices (ACIP). ACIP is a federal advisory body that provides expert advice and guidance for the CDC Director regarding the use of vaccines.

What is the difference between Vsafe and the COVID-19 Vaccine Pregnancy Register?

v-safe, a smartphone-based tool, uses text messaging and surveys to offer personalized health checks-ins. Participants who are pregnant and self-identify as such within 30 days after vaccination can use the vsafe COVID-19 vaccine pregnancy registry. Participants receive a text message with the registry information in addition to their v-safe after-vaccination health check-ins. Participants in the registry who are pregnant will be contacted to answer any questions about their medical history and pregnancy. Participants will be asked permission to contact their healthcare provider (s ).).

Not all participants will be contacted for participation. Participants are not paid. Participation is voluntary and you have the right to opt out at any time. Participation in scientific activities that help answer important questions is a positive thing. This can inform public recommendations.

How CDC Uses the Information

Your information will be combined with other registry participants. This information, together with other participants in the registry, will be evaluated. It will then be used to educate public about the possible effects of COVID-19 vaccine on pregnancy. This information will also be used by the CDC and Food and Drug Administration (FDA), to guide recommendations for COVID-19 vaccine during pregnancy.

Scientists will examine the following health effects:

  • Pregnancy outcomes like stillbirth and miscarriage
  • Pregnancy complications like preeclampsia or gestational diabetes
  • Issues with newborns, such as preterm birth, poor growth or congenital disabilities

Any reports will not include any pdf icons containing your name or any other identifying information. Your responses and personal information will be protected to the maximum extent permitted by law. The registry data are stored on a CDC system, which employs strict security measures in order to protect personally identifiable information.

CDC May Require Permission to Contact Your Healthcare Provider

Information on details such as medications and laboratory results can give you a full picture of your pregnancy. This information is essential for understanding the potential side effects of COVID-19 vaccine during pregnancy. You can still join the registry even if you don’t give permission for the CDC to access your medical records.

Monitoring of Vaccine Safety in Breastfeeding

The body’s response to these vaccines is so that they are safe for breastfeeding mothers and their babies, it is not possible to determine if the COVID-19 approved vaccines pose a risk. While this study does not address potential side effects in breastfeeding, other researchers from across the country are trying to better understand the effects of COVID-19 vaccines on breastfeeding.

CDC Uses Data From the Registry

The CDC has released the first U.S. external icon for the safety of mRNA COVID-19 vaccinations during pregnancy. It is based on data analysis from three vaccine safety-related databases including the vsafe pregnancy registry. These analyses didn’t identify safety concerns for pregnant women who had been vaccinated, or their infants. These preliminary results are encouraging, but more research is necessary, especially for those who were vaccinated during the first and second trimesters. Through the vsafe COVID-19 Pregnancy Registry, thousands of individuals contributed information that is contributing to building the evidence base on the safety of COVID-19 vaccine during pregnancy.

The ACIP meetings will regularly present data from the registry, which will be open to the public and published in reports. It is expected that it will take some time to collect data about the possible effects of COVID-19 vaccine during pregnancy. Different times are used to vaccinate women during pregnancies. It takes time to monitor pregnancies and find out about potential effects on babies due to the length of pregnancy. The CDC is committed sharing as much information as possible about the possible effects of COVID-19 vaccine during pregnancy.

Reporting Adverse Events

By filling out a form on the VAERS website, you or your doctor can report any adverse reactions external icon or other health problems following COVID-19 vaccination. FDA requires that healthcare providers report adverse events outside icon that occur following the administration of COVID-19 vaccine. However, anyone can submit a VAERS report. The VAERS reports are vital in understanding the safety of COVID-19 vaccinations.

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