Of the 203 million people who have received at least one dose of a covid-19 vaccine, more than 9 million have enrolled in a program to share information about their health since getting the shot.
The initiative was created for the covid-19 vaccines to complement the Centers for Disease Control and Prevention鈥檚 vaccine safety monitoring system. Known as , the registry lets inoculated people report their experiences, including serious suspected side effects, directly to the CDC through smartphones, adding to the data gathered from clinical trials and other safety monitoring systems.
So how does v-safe strengthen the nation鈥檚 existing safety checks and how well is it working?
Going in, some public health experts expressed doubts about its effectiveness. But since the tool鈥檚 Dec. 13 release, reviews have mostly been positive.
鈥淚t’s a really good way to make everybody part of the process,鈥 said Dr. , founder of the Vanderbilt Vaccine Research Program and principal investigator for the .
鈥淭here never has been so much scrutiny of vaccines and so much reporting and so much tailored information,鈥 she added.
How Is Vaccine Safety Traditionally Monitored?
The federal government has to monitor the safety of vaccines as well as other pharmaceutical products once they reach the marketplace. For starters, the , 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 to , but patients, their family members or caregivers can also submit a report online.
VAERS , which are stripped of personal identifiers and publicly shared in an online database. These reports 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 what experts later identified as thrombosis with thrombocytopenia syndrome as a serious but rare health problem associated with the J&J vaccine.
Then there鈥檚 the , which uses electronic health data from nine large health care organizations across the country, including various Kaiser Permanente systems on the West Coast and Harvard Pilgrim Health Care in Massachusetts. to Minnesota-based HealthPartners, another participating organization, the VSD network looks at data for 3% of the U.S. population, or roughly 12 million people 鈥 everything from medical and pharmacy claims to vital records. reported that analyses are done weekly so signals of adverse events are quickly noted.
What Does V-Safe Add to the Mix?
Launched the day before covid vaccines were first available to the public, v-safe allows the CDC to track people over time to see how they fare.
the U.S. for leaning too heavily on a 鈥減assive鈥 system that relies on people reporting issues that may or may not be related to the shots as opposed to 鈥渁ctive鈥 surveillance that scans large volumes of electronic health data and compares adverse events in people who receive the vaccine to those who didn鈥檛.
V-safe requires individuals to opt in, with no control group for comparison. But some still view the tool as a step forward.
鈥淚t is a little bit more of a proactive monitoring system,鈥 said , an assistant scientist at the International Vaccine Access Center at Johns Hopkins Bloomberg School of Public Health.
Here鈥檚 how it works: People register with the v-safe program on their smartphone or computer after receiving their first vaccine dose. The CDC then sends them daily text messages the first week, and weekly ones for six weeks after that. Additional follow-up texts are sent at the three-, six- and 12-month marks.
Every message includes a brief health survey, always asking: 鈥淗ow are you feeling today?鈥 The first week, participants are asked whether they have experienced symptoms 鈥 chills, headache, joint pain or something not listed. They are also asked if they were unable to work or attend school or perform 鈥渘ormal daily activities,鈥 or if they sought a physician鈥檚 care.
Over time, the check-ins focus on new or worsening symptoms or health conditions and compare participants鈥 health before and after vaccination. Participants are also asked whether they have tested positive for covid since the previous survey.
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 Carcel茅n.
Even as these investigations proceed, people who reported a problem may not ever hear directly from the CDC, and v-safe is not intended to offer medical advice. The CDC requests and reviews medical records, death certificates and autopsy reports only for serious adverse events, said Martha Sharan, a CDC spokesperson. 鈥淚f a report is a hoax, it is quickly caught,鈥 she said.
And what has v-safe shown so far? 鈥淭he findings in normal, regular people that got the vaccine were pretty reflective of what you saw in the clinical trials,鈥 said Vanderbilt鈥檚 Edwards. Edwards also served on an independent safety data monitoring committee for the Pfizer-BioNTech vaccine, now branded as Comirnaty.
How Is the V-Safe Data Used?
Unlike VAERS, v-safe data is not published without context. Meaning, no one can just sort through the database and interpret the numbers as they please, data. It is, however, publicly shared through CDC studies and presentations given during meetings held by the CDC鈥檚 independent panel of experts, the Advisory Committee on Immunization Practices.
And like VAERS reports, v-safe data is susceptible to misinterpretation. One post that circulated on social media inaccurately said 鈥3,150 persons were paralyzed鈥 based on an ACIP presentation slide. Reuters , saying it is a 鈥渕isinterpretation of the CDC health events.鈥
Information gleaned from v-safe has been used in several safety analyses, . That analysis, published Aug. 6, found that serious adverse events are rare among adolescents, partly based on v-safe surveys from tens of thousands of people ages 12 to 17. The analysis also found that a minority reported being unable to perform 鈥渘ormal daily activities鈥 the day after receiving a second dose.
V-safe has perhaps been most helpful at providing real-world evidence that the covid-19 vaccines are safe during pregnancy. This is important because there was little information on how the vaccines affected pregnancy when they were first authorized, said Dr. Dana Meaney-Delman, a member of the CDC鈥檚 vaccine task force,.
Pregnant women were excluded from the initial clinical trials that led to the emergency use authorization of the Pfizer, Moderna and J&J vaccines, and misinformation was rampant.
Because pregnant health care workers got vaccinated and enrolled in v-safe, Meaney-Delman said, there is more that indicates the benefits of getting vaccinated during pregnancy outweigh any potential risks. Following the publication of an analysis that leaned on v-safe鈥檚 vaccine pregnancy registry, the CDC on Aug. 11 that people who are pregnant, lactating or trying to become pregnant get vaccinated against covid.
Currently, uptake is low 鈥 as of mid-August,.
Who Is Participating in V-Safe?
More than 9.2 million people have enrolled in v-safe as of Aug. 9, 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.
Dr. Matthew Laurens, a vaccine researcher at the University of Maryland School of Medicine, considers this an important gap in reporting. 鈥 or an estimated 鈥 say they do not own a smartphone.
People who line up for an additional vaccine dose 鈥 often referred to as a booster but representing the same formula as previously administered 鈥 will have another opportunity to sign up for v-safe.
Meanwhile, as nationwide vaccination efforts continue, some v-safe participants said they joined the effort because they wanted to help.
John Beeler, 44, of Atlanta, considered it a 鈥減ublic good.鈥 He reported experiencing tinnitus 鈥 a condition that was part of his medical history 鈥 after receiving his first Moderna dose. He was never contacted but hopes his report proved helpful. Still, he appreciated being checked on, even via automation.
鈥淒r. Fauci is not reading my response. But the feeling is there,鈥 said Beeler.
