How Everyday People Help the CDC Track the Safety of COVID Vaccines on Mobile Phones

This initiative was created for the COVID-19 vaccine, which complements the Centers for Disease Control and Prevention’s vaccine safety monitoring system.Known as v-safeThe registry allows vaccinated people to report their experiences, including suspected serious side effects, directly to the CDC via their smartphones and add them to data collected from clinical trials and other safety monitoring systems. ..

So how does v-safe enhance the country’s existing safety checks and how well it works?

Upon entering, some public health experts questioned its effectiveness. However, the reviews have been mostly positive since the December 13th release of the tool.

“It’s a really good way to make everyone part of the process,” he said. Kathryn Edwards, Founder of the Vanderbild Vaccine Research Program, CDC-funded clinical immunization safety assessment network..

“We have never had so many vaccine scrutiny, so many reports, and so many coordinated information,” she added.

How is vaccine safety traditionally monitored?

Federal government Various systems To monitor the safety of vaccines and other medicines after they are on the market. For starters Vaccine Adverse Event Reporting SystemIs jointly run by the CDC and the Food and Drug Administration and has been serving as a repository of reports on health problems that may be side effects of vaccines since 1990.Health provider Mandatory by federal law NS Report a specific adverse eventHowever, patients, their families, or caregivers can also submit reports online.

VAERS Receive tens of thousands of reports each year, The personal identifier will be removed and shared publicly in the online database.These reports, Often lacking details and may contain errors, Although not sufficient to establish a causal link between vaccines and adverse events, it does provide institutions with the opportunity to work with scientists and researchers to identify and investigate anomalous patterns.

VAERS helped find unexpected cases of rare blood clots in several people who received the Johnson & Johnson vaccine. After reviewing the VAERS report, CDC It is listed Experts later identified thrombosis with thrombocytopenia as a serious but rare health problem associated with the J & J vaccine.

next, Vaccine safety data linkUses electronic health data from nine large healthcare organizations across the country, including various Kaiser Permanente systems on the West Coast and Harvard Pilgrim Healthcare in Massachusetts. according to For another participating organization, Minnesota-based HealthPartners, the VSD network examines data on 3% of the US population, or about 12 million people. This is everything from medical and pharmacy billing to important records. National Geographic Since the analysis is conducted weekly, it is reported that signs of adverse events will be recorded immediately.

What does V-safe add to the mix?

Launched the day before the COVID vaccine was first released to the public, v-safe allows the CDC to track people over time and check their fares.

Some vaccine safety experts have criticized The United States relies on people reporting problems that may or may not be related to shots, as opposed to “active” surveillance, which scans large amounts of electronic health data to compare adverse events. Receive the vaccine for those who have not been overly devoted to the system.

V-safe requires individuals to opt in and there is no control group for comparison. However, some people still see the tool as a step forward.

“This is a slightly more proactive surveillance system,” he said. Andrea Calceren, Johns Hopkins Bloomberg Assistant Scientist at the International Vaccine Access Center at the School of Public Health.

The mechanism is as follows. People enroll in the v-safe program on their smartphones or computers after receiving their first vaccination. The CDC sends daily text messages during the first week and then weekly text messages for the next 6 weeks. Additional follow-up text will be sent at 3, 6, and 12 months.

Every message includes a simple health survey that always asks, “How are you feeling today?” In the first week, participants will be asked if they have experienced chills, headaches, joint pain, or any symptoms not listed. You will also be asked if you couldn’t go to work or school, if you couldn’t do “normal daily life”, or if you couldn’t see a doctor.

Over time, check-in will focus on new or worsening symptoms or health status and compare the health status of participants before and after vaccination. Participants will also be asked if they have been positive for COVID since the last survey.

CDC scientists then look for patterns of problems that exceed those predicted in clinical trials and study the response. Carcelén also said that the data reflect not only reports of side effects, but also reports of people who are not dissatisfied, which may provide a more complete snapshot of the results of the vaccine.

As these investigations progress, the person reporting the problem will not be contacted directly by the CDC and v-safe is not intended to provide medical advice. CDC spokesman Martha Sharan said the CDC is requesting and reviewing medical records, death certificates, and autopsy reports only for serious adverse events. “If the report is a hoax, it’s caught right away,” she said.

And what has v-safe shown so far? “The findings of regular vaccinated regulars were a good reflection of what you saw in clinical trials,” said Edwards of Vanderbild. Edwards also participated in an independent safety data monitoring committee for the Pfizer-BioNTech vaccine, which is now branded as Comirnaty.

How is v-safe data used?

Unlike VAERS, v-safe data is not exposed without context. That is, you cannot sort the database and interpret the numbers the way you like. As many people do with VAERS data. However, it will be publicly shared through the CDC’s research and presentations during a meeting held by the CDC’s independent expert committee, the Immunization Implementation Advisory Board.

Also, like the VAERS report, v-safe data is easily misunderstood. One post disseminated on social media incorrectly stated that “3,150 people were paralyzed” based on the ACIP presentation slides.Reuters Uncovered the post, Says it is a “misunderstanding of the CDC health event”.

The information collected from v-safe is used in several safety analyses. Including those focused on adolescents.. The analysis, published on August 6, found that serious adverse events were rare in adolescence, based in part on a v-safe survey of tens of thousands of people aged 12 to 17 years. rice field. The day after receiving the second dose.

V-safe was probably the most helpful in providing real-world evidence that the COVID-19 vaccine is safe during pregnancy. This is important because Dr. Dana Meaney-Delman, a member of the CDC’s Vaccine Task Force, had little information about how the vaccine affected pregnancy when the vaccine was first approved. On a recent phone call with a clinician..

Pregnant women were excluded from the first clinical trials leading to an emergency use authorization for Pfizer, Modana and the J & J vaccine, and false information was rampant.

According to Meaney-Delman, pregnant health care workers are vaccinated and registered with v-safe, so much more. evidence This shows that the benefits of vaccination during pregnancy outweigh the potential risks. Following the announcement of the analysis based on the v-safe vaccine pregnancy registry, the CDC Recommended On August 11, pregnant, lactating, or about to become pregnant will be vaccinated against COVID.

Currently low uptake — as of mid-August 23% of pregnant women aged 18-49 are at least partially vaccinated..

Who participates in v-safe?

As of August 9, more than 9.2 million people are registered with v-safe. Or about 5% of the US population Those who have been vaccinated with the COVID vaccine at least once. This seemingly low participation rate is often associated with weakness in v-safe advertising and public education programs. Also, some vaccinated civilians may have thought it was boring or a privacy concern. Excludes those who do not have a smartphone.

Dr. Matthew Lawrence, a vaccine researcher at the University of Maryland School of Medicine, sees this as an important gap in the report. About a quarter of adults with an annual income of less than $ 30,000 — Or estimate 16% of US households — They say they don’t own a smartphone.

People in line with additional vaccine doses (often called boosters, but representing the same prescriptions that were previously given) have another opportunity to sign up for v-safe.

Meanwhile, as national vaccination efforts continue, some v-safe participants said they participated in the effort because they wanted to help.

John Beerer, 44, of Atlanta considered it a “public good.” He reported experiencing tinnitus, a condition that was part of his medical history, after receiving the first moderna dose. He has never been contacted, but hopes his report was helpful. Still, even though it was automated, I appreciated that it was checked.

“Dr. Fauci hasn’t read my reply, but that feeling is there,” Beerer said.