V-safe System
Bartolome Beacham
V-safe originally launched in December 2020 to monitor the safety of COVID-19 vaccines and later expanded to include mpox vaccines. Since its launch, 10.1 million V-safe participants completed more than 151 million health surveys about their experiences following COVID-19 and mpox vaccination, and V-safe data have been included in more than 20 scientific publications. V-safe is one of several complementary safety systems CDC uses to closely monitor the safety of vaccines in the United States. It lets vaccine recipients self-report how they feel after receiving a vaccine.
Vaccination Providers: Let your patients know about V-safe. Download and print information sheets and a poster so they can learn more about V-safe, including instructions on how to register and how to complete health check-ins.
Enrollment for the COVID-19 Vaccine Pregnancy Registry is closed to new participants. However, CDC experts are still collecting data and requesting medical records for some participants. People who enrolled in the v-safe after vaccination health checker and reported getting a COVID-19 vaccine during pregnancy or within 30 days before their last menstrual period before the pregnancy were invited to participate in the COVID-19 Vaccine 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.
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.
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.
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.
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.
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 in...@VAERS.org or call 1-800-822-7967.
The federal government has various systems to monitor the safety of vaccines as well as other pharmaceutical products once they reach the marketplace. For starters, the Vaccine Adverse Event Reporting System, jointly run by the CDC and the Food and Drug Administration, since 1990 has served as a repository for reports on health problems that may be side effects of vaccines. Health care providers are required by federal law to report certain adverse events, but patients, their family members or caregivers can also submit a report online.
VAERS receives tens of thousands of reports each year, which are stripped of personal identifiers and publicly shared in an online database. These reports, which frequently lack details and sometimes contain errors, are not enough to establish a causal relationship between the vaccine and an adverse event, but they offer the agencies, along with scientists and researchers, a chance to identify and investigate unusual patterns.
VAERS helped spot unexpected cases of rare blood clots in several people who received the Johnson & Johnson vaccine. After studying the VAERS reports, the CDC listed what experts later identified as thrombosis with thrombocytopenia syndrome as a serious but rare health problem associated with the J&J vaccine.
CDC scientists then study responses, looking for patterns of problems that go beyond what the clinical trials predicted. And the data may provide a fuller snapshot of vaccine outcomes because it reflects not only reports of side effects but also of people who had no complaints, said Carceln.
More than 9.2 million people have enrolled in v-safe as of Aug. 9, or roughly 5% of the U.S. population who received at least one dose of a covid vaccine. This seemingly low participation rate is often linked to weak advertising and public education programs about v-safe. Also, a segment of the vaccinated public likely considered it tedious or had privacy concerns. The number also excludes people who do not have smartphones.
KHN is an editorially independent program of KFF (Kaiser Family Foundation). You can support KHN by making a contribution to KFF, a non-profit charitable organization that is not associated with Kaiser Permanente.
Since the emergence of COVID-19 vaccines, however, the database has garnered more dubious notoriety. Anti-vaccination fringe groups have attempted to spin false stories using VAERS data, adding to misinformation about the safety of COVID-19 vaccinations.
Moreover, additional studies show the risk of myocarditis to be 16 times greater among those infected with COVID-19 than the uninfected, suggesting that full vaccination is helpful in preventing myocarditis and other complications of the disease.
VAERS is a publicly available, searchable database of reports that have not been verified. It simply contains whatever people have voluntarily reported. Moreover, the CDC and FDA do not restrict what people can report, as long as it happened at some point following a vaccination.
When researchers notice a pattern, such as an uptick in side effects after a particular vaccination or among a particular group of patients, such as women over 65 or people with diabetes, they can follow up by investigating with other safety monitoring systems, such as the Vaccine Safety Datalink, which can connect adverse events to medical records and reports from health care facilities and practitioners. Importantly, in addition to being verified, this data includes controls, Talaat says. That's because medical data for women over 65 or diabetics would include reports from both vaccinated and unvaccinated patients.
c80f0f1006