• 2021 OCT 22 •
The should not authorize the Pfizer jab for younger children until it conducts a proper trial
ICAN’s lead attorney, Aaron Siri, is representing the de Garay family whose 12-year-old daughter was
seriously injured in the clinical trial for Pfizer’s Covid-19 vaccine … and
then the FDA buried the data on this injury!
Published by Aaron Siri, Esq.
When Stephanie and Patrick de Garay enrolled their 12-year-old child Maddie
and her two brothers in Pfizer’s Covid-19 clinical trial, they believed they
were doing the right thing.
That decision has turned into a nightmare. Maddie, a previously healthy,
energetic, full of life child, was within 24 hours of her second dose reduced
to crippling, scream-inducing pain that landed her in the emergency room where
she described feeling like someone was “ripping [her] heart out though [her]
neck.”
Over the next several months the nightmare continued, during which Maddie was
hospitalized several times and suffered numerous systemic injuries, requires a
tube through her nose that carries her food and medicine, and a wheelchair for
assistance.
Ms. de Garay documented every detail of Maddie’s injury and reported it to the
principal investigator for the Pfizer trial at Cincinnati Children’s Hospital
where the vaccine clinical trial was occurring and where Maddie was treated
and admitted. They first tried to treat Maddie as “a mental patient,”
telling the family it was psychological and in Maddie’s imagination.
Then they claimed it was unrelated to the vaccine (copy of recording with
hospital below), and when that argument failed, Pfizer listed this traumatic
adverse event as “functional abdominal pain” when reporting to the FDA.
Ms. de Garay reported what occurred to the CDC and FDA through VAERS in June
2021 but nobody from these agencies sought additional information or
followed-up with the de Garays. Ms. de Garay also reached out to Dr.
Nath, a Chief in the NIH’s National Institute of Neurological Disorders and
Stroke, responded by stating he was “Sorry to hear of your daughter’s illness”
and that “We have certainly heard of a lot of cases of neurological complications
form [sic] the vaccine and will be glad to share our experience with them.” (Copy of this email is below.) Unfortunately, other than a
call arranged by Maddie’s neurologist, there was no follow-up or response from
NIH or any other federal health agency. Even after Ms. de Garay did a
press event on June 28, 2021 with Senator Ron Johnson, neither Pfizer nor any
health agency reached out in any manner to address Maddie’s injury or obtain
any additional information.
This story is extremely troubling. Pfizer’s clinical trial for children
aged 12-15 included only 1,131 children who were vaccinated and at least one
of those children suffered a devastating, life-altering injury which, despite
incontrovertible proof and the cries of both the victim and her
parents, has not been appropriately acknowledged by Pfizer or the FDA. Putting aside that one serious injury in a small trial should alone
raise blaring alarm bells, one must ask: what other serious adverse events
have been hidden and ignored by regulators?
For a virus that rarely harms children, the need to assure safety of the
Covid-19 vaccine is high. A study with only 1,131 children is
underpowered. It will not pick up anything but the most common adverse
events. If what Maddie suffered will occur in 1/1,000 children, that
would result in 75,000 children in this country suffering this serious
injury. If it happens 1/10,000 children, that is 7,500 suffering this
serious injury. It could be that the cure is worse than the
disease. But that will only be known if there is a properly powered
(a.k.a., sized) clinical trial with children.
International scientists have declared that “inadequately powered studies should themselves be considered a
breach of ethical standards.” Without a clinical trial of sufficient
size that reviews all potential adverse events, such as that experienced by
Maddie, for a sufficient duration, this potentially catastrophic result will
not be identified prior to authorization or licensure.
And as Dr. Woodcock and Dr. Marks have said, “because young children are still growing and developing, it’s critical that thorough and robust clinical trials of adequate size are
completed to evaluate the safety and the immune response to a COVID-19 vaccine in this population.
Children are not small adults – and issues that may be
addressed in pediatric vaccine trials can include whether there is a need for
different doses or different strength formulations of vaccines already used
for adults.”
The de Garay family are truly brave to come forward with their story and are
doing so in the hope of preventing other children from being injured like
their Maddie. My firm has sent a letter to the FDA regarding Maddie, a
copy of which is below. The de Garay family also released its
communication with the NIH and recorded conversations with the trial’s
principal investigator - links to both are below.
Will the FDA require Pfizer to actually conduct a properly powered
study? Unlikely. To do so would be for its leadership, and
especially Dr. Janet Woodcock and Dr. Marks, to self-inflict a wound. It
reflects the danger of placing safety in hands of government officials that
have been promoting a product, because to admit a safety issue now requires
them to effectively cut off their own hands.
The real lesson is not that pharmaceutical companies, or the FDA should act
better or do a better job. That just won’t always be the
case. The real lesson is that civil and individual rights should
never be contingent upon a medical procedure. Never. Preserving
those rights to choose whether to get a medical product, without any
government coercion, is the final and ultimate safeguard. Removing
that right results in dangerous authoritarianism because just as the FDA
will not admit to Maddie’s serious injury after having promoted this
vaccine, politicians that mandate the vaccine will not want to later admit a
mistake by repealing the mandate.
Letter to Federal Health Authorities Regarding Maddie
Stephanie de Garay’s Email Exchange with NIH
Patrick and Stephanie de Garay’s Phone Call with Pfizer trial Principal
Investigator on May 17, 2021
June 28, 2021 Press Conference with U.S. Senator Ron Johnson,
R-Wisconsin
Interview with C19 Vax Reactions
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