Biden's FDA Ignored Safety Signals and Health Agency Regulations to Mandate COVID-19 Vaccine

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  • Source: UncoverDC
  • 06/27/2024

Despite evidence of significant harm from the EUA Pfizer COVID-19 vaccine, documents and interviews reveal officials in the FDA and the CDC ignored safety signals, critical procedures, and regulations to mandate the shots. A June 24 report from the House Judiciary shows pushing the mandates became more important than recognizing vaccine injuries or reporting truthfully about the safety and efficacy of the EUA vaccine. The vaccine was rushed to market and, in an unprecedented move, the FDA and Dr. Peter Marks "became advocates for the Pfizer vaccine," not the CDC. It was unprecedented for the FDA to serve in a leading role during a health emergency. The investigation also revealed that the agency operated "outside the proper function of the FDA as authorized by Congress."

According to the report, Joe Biden and Kamala Harris sought to undermine federal COVID-19 responses during the Trump administration. However, once Biden took office in 2021, his administration allegedly "pressured agencies to go beyond their legal authorities" while it ignored the risks and mandated vaccines for the military and federal employees. The administration also pushed "tactics not supported by science," such as "universal mask mandates, vaccine mandates, social-distancing mandates, school closures, and censorship."


Administrative State Ignored Safety Signals and Failed to Test Pfizer mRNA Shots Properly

Most egregiously, the report reveals Peter Marks told the committee in his private interview that "the administrative state mishandled reports of vaccine injury, despite requirements to actively obtain, synthesize, and report feedback on the safety and efficacy of the EUA vaccine. Biases seemed to emerge that discounted evidence of vaccine injury."

When vaccines are rolled out under EUA authorization and rapid response, ongoing evaluation and controls are critical because the standards for EUA-approved products are lower. However, the Biden administration decided to "pivot away" from safety monitoring "to ensure the EUA vaccine received full licensure" to help fulfill its wish to impose mandates.

During the House Judiciary hearing on June 26, one of the expert witnesses was Dr. Vaughn, an internist with an extensive practice in Birmingham, Alabama. Vaughn did what the Biden administration should have been doing with its "science." He monitored the safety of his treatment protocols, researched available data on the untested vaccines, and adjusted his protocols accordingly. Vaughn said: 

"Based on my reading and clinical experience, especially deadly in this vaccine was the spike protein, specifically the S1 subunit of this protein is pathogenic. It's immuno-toxic, cytotoxic, coagulopathic, amyloidogenic, and is every word you probably don't want to be associated with whatever disease somebody tells you about. The proposed solution was a novel mechanism of injecting lipid nanoparticle-coated modified messenger RNA that encoded for stabilized form of this very thing. That worried me."

Vaughn got his information from the National Library of Medicine, a library to which every scientist has access, including the scientists working with the FDA and CDC. The question is why there was such a strong wish to "pivot away" from best practices with an experimental vaccine.

Acting FDA Commissioner Dr. Janet Woodcock, a long-time FDA staffer, and Dr. Peter Marks who was head of the FDA's Center for Biologics Evaluation and Research (CBER), oversaw a process that "cut corners in its usually rigorous Biologics Licensing Application (BLA) process to brand the Pfizer EUA vaccine as the only fully licensed 'safe and effective' COVID-19 vaccine on the market at the time," according to the report.

At the time, experts in vaccine development at the FDA voiced their concerns about the risks of Pfizer's vaccine for healthy young people. In particular, they were worried about the "risk of myocarditis." Despite their objections, the vaccine was approved.

According to the report, Dr. Marks felt pressured by outsiders advocating for an approved vaccine. He knew the Biden administration "could not mandate any vaccine unless the FDA first approved a BLA." According to the Judiciary's investigation, Woodcock and Marks knew injuries were occurring and that data would interfere with a rushed approval process. Their solution was to remove the experts voicing concerns during the BLA process. Needless to say, Woodcock and Marks met the tight deadline set by the Biden White House. 

It is now well-known that the CDC undermined efforts in Congress to "clarify CDC statements about the efficacy of the vaccine." More troubling is the fact that the CDC concurrently "actively censored speech" from those who questioned the efficacy of the vaccines. The CDC coordinated its efforts with Big Tech by asking social media platforms to flag accounts allegedly spreading "misinformation." Unfortunately, that very "misinformation" might have saved countless lives had it been allowed to circulate.

The most chilling paragraph in the report speaks to the dangers of an administrative state with unbridled power to dictate public health policy. Mandating an experimental vaccine has had devastating consequences for the American military and workforce.

"This episode is an example of the administrative state engaging in dangerous behavior beyond its authority and without accountability. Dr. Marks testified that he believed his actions were justified because people wanted more confidence in the vaccine, but by ignoring warnings, his actions served to reduce confidence in the entire FDA approval program. Dr. Marks testified that he was justified in his decisions made in July 2021 because of increases in COVID-19 deaths,  but the data at the time show lower levels of hospitalizations and deaths. Reflecting on the FDA's handling of the vaccine approval process three years later, now-former Acting FDA Commissioner Woodcock said she is "disappointed in [her]self" and her involvement as it relates to vaccine-related injury as the FDA did not do enough to address this important concern."

Woodcock's disappointment in herself is no consolation to the millions who have been harmed or who have died because they were pressured to take the experimental shots. There continue to be no material consequences for the agencies that purposefully ignored safety signals, imposed mandates, and stood in the way of life-saving information by censoring any whiff of dissent about the COVID-19 measures.

Aaron Siri Testimony: We Must Hold Agencies and Pharmaceutical Companies Accountable

During his testimony on Wednesday, Attorney Aaron Siri explained why the vaccine approval process during COVID-19 went so far afield. He has devoted a large part of his practice to vaccine-injured individuals. Through discovery, he has confirmed COVID-19 trials were "anemic" at best. He believes there is simply no economic incentive to do things differently in the case of vaccines.

Siri's chart below shows the stark difference between regular drug trials and vaccine trials. When pharmaceutical companies develop drugs, the market incentivizes them to at least attempt to ensure their safety. However, Siri explains that vaccines are in a different category altogether because of the "regulatory regime around vaccines in this country." 

On the left are Pfizer's top-selling drugs, which have more robust controls and follow-up. On the right are vaccines, which have almost no safety controls or follow-up. When you add the element of an EUA vaccine and non-transparent agency control of an emergency rollout, dangers abound. 


In the case of the COVID-19 vaccine, HHS and "conflicted" regulators of the vaccines were in charge. Siri continued:

"The second far weaker way that we assure safety is through regulators. And, in this instance, unfortunately, regulators are structurally conflicted. When there is an agency that's responsible for promoting a product and for safety—we separate when we do that with transportation, with DOT and NTSB. You do that nuclear energy, but we don't do that with vaccines.

Safety and promotion are both in the same department, not only that, HHS is responsible for defending against all claims of vaccine injury in the vaccines. You can't sue for vaccine injury. You just sue the federal government, you sue the federal health authorities and that creates an incredible conflict. This is the only product I'm aware of where the government defends the company and the product against the consumer versus the other way around."

Siri and his law firm are still embroiled in COVID-19 vaccine lawsuits, fighting for data from the CDC and FDA. While he has been ultimately successful at obtaining the data, the process has been arduous. At every turn, HHS, the FCA, and the CDC have obfuscated the data and resisted their FOIA requests. When the data on the dangers of the vaccines became apparent, Siri says they "shrugged and whitewashed" the harms to his clients and continued to protect the drug companies.

Siri continued, "Looking at the forest to solve a lot of the ills that plague what we're going to talk about today is we need to restore liability back to the manufacturers. We must hold them accountable for the injuries" inflicted by their vaccines.

Interestingly, during Wednesday's hearing, expert witness and epidemiologist Dr. Pavia defended the mRNA vaccines despite the data now available. His stance may be more understandable when you realize he served two terms on the CDC Board of Scientific Counselors, is a frequent advisor for the CDC, and "has served on several Institute of Medicine Committees including "Antivirals for Pandemic Influenza: Guidance on Developing and Distribution and Dispensing System," and "Prepositioned Medical Countermeasure for the Public," according to his online bio. It is funny how difficult it is to "follow the science" for those whose work is directly connected with the very agencies who dictate public health policy.

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