The Suspicious Timing of FDA’s Approval of Pfizer’s Side-Effect Fix
Updated
Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) is an autoimmune disorder where the immune system attacks the protective myelin sheaths of peripheral nerves. Closely related to Guillain-Barré syndrome (GBS), CIDP is a well-documented severe adverse reaction to the experimental mRNA COVID-19 vaccines, causing worsening muscle weakness and impaired sensation in the arms and legs. In April 2020—before the start of its COVID-19 mRNA jab clinical trials—Pfizer submitted an application to the U.S. Food and Drug Administration (FDA) requesting to market its immunodeficiency drug called Panzyga as a treatment for CIDP. Interestingly, for nearly a year, the FDA ignored Pfizer’s request. However, just two months after the rollout of the COVID-19 jabs, the FDA granted Pfizer approval to market Panzyga for the treatment of CIDP. The obvious question in this peculiar sequence of events, as posed by Del Bigtree’s Informed Consent Action Network, or ICAN, is:
“Could data from Pfizer’s COVID-19 vaccine preclinical animal trials have pointed to neurological issues (such as CIDP), even then, possibly prompting Pfizer’s desire to market this drug for that condition?”
As indicated by ICAN, the FDA gave Panzyga its stamp of approval to treat serious COVID-19 vaccine side effects a mere two months after the rollout of the dangerous mRNA COVID-19 jabs. Was it a coincidence that the FDA sat quietly on Pfizer’s request to market Panzyga to treat CIDP for nearly a year before suddenly approving it on February 12, 2021? Upon its approval, Pfizer stated in a press release that “the gradual onset of CIDP can delay diagnosis by several months or even years,” noting that most individuals would require long-term treatment, insisting that, if not treated with its drug, nearly a third of CIDP patients will progress to wheelchair dependence. In other words, they will become lifelong customers.
At the time of the FDA’s approval of Panzyga, again, nearly a year after Pfizer’s request for approval, the lives of both Maddie de Garay and Brianne Dressen had been forever changed after both were injured with debilitating CIDP in COVID-19 vaccine clinical trials. Maddie de Garay (then 12 years old) was injured in Pfizer’s clinical trial for those ages 12 to 15, and 39-year-old wife and mother Brianne Dressen was injured in AstraZeneca’s adult clinical trial. Along with their injuries (which were well-publicized by independent news organizations, including The Highwire), the COVID-19 shots had been administered by any coercive means necessary to more than 42 million Americans. According to ICAN, at that point, V-safe and VAERS data documenting adverse events was “rolling in,” and the FDA may have observed an early safety signal for CIDP and recognized the need for the drug.
In an effort to find out if that was indeed the case—that the FDA recognized an early safety signal for CIDP following the administration of the mRNA COVID jabs (but yet did not warn the public)—on April 9, 2024, attorney Aaron Siri, Managing Partner of Siri & Glimstad LLP, requested from the FDA all clinical trial documents relied upon by the agency to approve the use of Pfizer’s drug Panzyga for the treatment of adults with CIDP. ICAN’s request to the FDA was made through the Freedom of Information Act (FOIA), outlining that it is seeking the information in its FOIA request “to allow it to contribute to the public understanding of governmental programs and any potential effects of the same on public health.”
Indeed, with the widespread path of destruction resulting from nearly all facets of the government’s handling of the COVID-19 pandemic now fully visible in the rearview mirror, understanding how governmental programs make public health decisions that impact all citizens is crucial. After all, Maddie de Garay’s mother documented every detail of Maddie’s nightmare vaccine injury, which, within 24 hours of her second dose in Pfizer’s clinical trial, turned a previously healthy, energetic, full of life child into a terrified young trial participant left in crippling, screaming pain feeling as though someone was “ripping [her] heart out through [her] neck.”
Not surprisingly, given the reality of the blatant disregard for those injured (seriously or otherwise) by the experimental shots, the principal investigator for the Pfizer trial at Cincinnati Children’s Hospital first attempted to treat Maddie as a “mental patient,” as shared by Siri, informing her family that her pain was all in Maddie’s imagination. Then, they insisted it was unrelated to the vaccine. When that argument didn’t cut it, Pfizer reported Maddie’s traumatic, life-altering adverse event to the FDA as “functional abdominal pain.” Akin to Pfizer, AstraZeneca also ignored Brianne Dressen’s pleas for help after suffering severe neurological harm while participating in its COVID-19 vaccine clinical trial.
In June 2021, Maddie de Garay’s mother contacted the CDC and the FDA via VAERS regarding her daughter’s vaccine-related injury. Tellingly, not one person from either agency bothered to contact Ms. de Garay to dig deeper into Maddie’s situation. The timing alone of Maddie’s injury—24 hours after receipt of the second dose—should have been cause enough for genuine concern from both agencies. Ms. de Garay also emailed Dr. Nath, a Chief in the National Institute of Health’s (NIH) National Institute of Neurological Disorders and Stroke. His reply? A polite “sorry about your daughter’s illness” and a vague nod to knowing about “a lot of cases” of neurological issues from the vaccine, offering to “share our experience.” But guess what: that sharing never happened.
Beyond a single call set up by Maddie’s neurologist, the NIH and every other federal health agency went radio silent. The silence continued even after Ms. de Garay took her daughter’s story public at a June 28, 2021, press event with Senator Ron Johnson. Indeed, neither Pfizer nor any health agency reached out following the press conference to learn more about Maddie’s injury. No questions, no concern for her serious vaccine injuries. Instead, Pfizer and these government agencies have had no problem turning their back on Maddie and her family. This kind of treatment is unacceptable. And let’s not forget—we already know that, under the leadership of Peter Marks, despite being made aware of over 1,000 neurological complications connected to the mRNA COVID-19 jabs, the FDA blatantly dismissed vaccine injuries.
Thank God for ICAN and its mission to raise public awareness about vaccine safety, other medical treatments, environmental pollutants and toxins, and overall health choices, and then to provide the public with the information we need to give informed consent for experimental drugs like the dangerous mRNA gene-damaging jabs. ICAN recently shared information about its FOIA request to the FDA surrounding the approval of Panzyga, and we look forward to finding out the details regarding the FDA’s decision to suddenly approve Panzyga for CIDP nearly a year after Pfizer’s application was submitted as a treatment.
