ICAN,
through its attorneys, has written to HHS Acting Secretary Norris
Cochran and Rochelle Walensky, the new Director of the Centers for
Disease Control and Prevention, to demand that all adverse events
following COVID-19 vaccination which are reported to the CDC’s new
V-safe tool also be automatically reported to the Vaccine Adverse Events
Reporting System (VAERS). As discussed in prior legal updates, the issue of underreporting to VAERS has been highlighted for over 30 years and is still an
ongoing problem, making reliable statistics regarding vaccine adverse
reactions hard to come by. The CDC has now created a new
smartphone-based tool used to track adverse events following COVID-19
vaccines called V-safe.
At first glance, V-safe may seem like a welcome development: a modern
tool that should easily allow vaccine recipients to report, and CDC to
track, any adverse events experienced following a vaccination. However,
there are serious potential problems created by V-safe. For
all intents and purposes, V-safe intercepts reports that would have
otherwise been made by vaccine recipients into VAERS. Only if the CDC
deems an adverse event reported to V-safe worthy will it be added to the
VAERS database. This leaves a large universe of data regarding adverse
events outside of VAERS and outside the public’s view. When vaccinated for COVID-19, vaccine recipients are given a handout
with information about what V-safe is, how it works, and how they can
register for and use the program. V-safe is also explained in the FactSheets
given out by both manufacturers at the time of vaccination. This
“after vaccination health checker” uses text messages and web surveys to
gather data about vaccine recipients following vaccination. Once
enrolled, individuals will receive one text message per day for the
first week after vaccination inquiring about how they are feeling. For
the next five weeks, users will be sent one text message per week. The
user responds to questions and prompts and, depending on the answers, may receive a call from someone at CDC to follow-up. If the CDC reaches out to a user and if the CDC feels that person’s adverse events rise to the level of “clinically important,” then a report may be submitted to VAERS. This is unacceptable and is why ICAN has reached out
to the acting director of the HHS and the new CDC Director to demand
that all adverse events reported through V-safe are added to the VAERS
database. This is absolutely
necessary for complete and consistent data as well as for transparency
as the public does not have access to any information exchanged through
V-safe. Especially
where clinical trials for COVID-19 vaccines are not capturing all
adverse reactions and the companies selling these products have no
liability for injuries, the American public must be confident that
safety surveillance is the highest priority with these vaccines. For
this and the other reasons above, ICAN has demanded that all adverse events be systematically collected and tracked in one database that the public can access: VAERS. ICAN
will continue to take additional legal steps to hold HHS, FDA, and CDC
accountable for vaccine safety. ICAN will never stop fighting for true
informed consent and for transparency. |
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