More vaccinated individuals can now report side-effects directly related to the vaccine.
The Centers for Disease Control and Prevention (CDC) created a voluntary tool for reporting known as the Vaccine Safety Assessment for Essential Workers, “V-SAFE,” an app that uses text messaging and web surveys to give personalized health check-ins after receiving a COVID-19 vaccine.
The app initially rolled out in Oct. 2020, but was limited to healthcare workers. Now parents and guardians can enroll vaccinated children age 12 and older, as well as themselves, in the program after smartphone verification is completed.
Reported information helps the CDC monitor the safety of vaccines in near real time, according to the press release. Aside from reminding vaccinated individuals to seek additional doses if eligible, someone from the CDC may potentially reach out for more information if reported information requires a follow up.
Registration on the app is on a voluntary basis. Although users can use the tool to enter their vaccination information, it isn’t considered legal documentation nor can it schedule, reschedule or cancel vaccination appointments.
V-Safe may sound similar to the Vaccine Adverse Event Reporting System (VAERS), but CDPHE Joint Information Center (JIC) spokesperson Brian Spencer notes that VAERS reporting doesn’t determine if adverse events are caused by the vaccine, but is only a report of adverse events that occurred after the vaccine was administered. These reports can be made by anyone for any reason.
“While very important in monitoring vaccine safety, VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness,” Spencer reported.
“The reports may contain information that is incomplete, inaccurate, coincidental or unverifiable. In large part, reports to VAERS are voluntary, which means they are subject to biases. This creates specific limitations on how the data can be used scientifically. Data from VAERS reports should always be interpreted with these limitations in mind.”
Vaccine providers are still required to report any adverse events, defined by the FDA’s Code of Federal Regulations, as “any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.”
VAERS is co-managed by the CDC and FDA, who are both responsible for reviewing COVID-19 vaccine safety data and conducting ongoing safety monitoring of vaccines.
A recently continued study conducted by the CDC between August 12 – Sept. 19, 2021 determined that among 12,591 V-SAFE users who completed a health check-in survey after receiving all three doses of an mRNA COVID-19 vaccine, 79.4% and 74.1% reported local or systemic reactions, respectively.
After the third dose, 77.6% and 76.5% reported local or systemic reactions after the second dose, respectively. The study, entitled “Safety Monitoring of an Additional Dose of COVID-19 Vaccine,” confirmed that findings previously reported held true.
Researchers had already found that among 306 Pfizer-BioNTech clinical trial participants, adverse reactions after the third dose were similar to those after the second dose.
The study concluded that voluntary reports from V-SAFE users during the research period found no unexpected patterns of adverse reactions after an additional dose of COVID-19 vaccine.
After the recent study, 74.9% of participants reported local reactions and 69.9% reported systemic reactions during the week following an additional dose of a COVID-19 vaccine. Reactions were most commonly reported the day after vaccine administration, common reactions including injection site pain, fatigue and a headache.
While the findings concluded that most reported reactions were mild to moderate and mostly occurred the day after the vaccine was administered, the CDC study also noted some limitations to the tool:
• Because enrollment is voluntary, the app is likely not representative of the vaccinated population in the U.S. The majority of participants identified themselves as White and non-Hispanic.
• During the study period, additional dose recommendations were limited to people with immunocompromising conditions who completed a primary mRNA COVID-19 vaccination series. V-SAFE doesn’t include immune state input and additional-dose recipients most likely include people with and without immunocompromising conditions.
• The app cannot determine a causal relationship between a vaccine and a reported clinically serious adverse event.
• Insufficient data were available to determine patterns of adverse reactions after administration of an additional dose from a manufacturer different from the primary series or for the Janssen vaccine.
V-SAFE registration can be found at https://vsafe.cdc.gov/en/
Cassie Knust is a staff writer for the Montrose Daily Press.