Has America’s medical watchdog backed itself into a corner?
Allegations have been made that the US Food and Drug Administration (FDA) has deliberately misled America and the world over the purported safety of the COVID-19 vaccines being currently rolled out at breakneck speed.
America’s health watchdog allegedly knew about the dozens of potentially deadly adverse side effects of the vaccines but kept mum.
Worse, they are now trying to fast-track COVID-19 boosters as they find the original vaccines are not working to prevent people from catching and spreading the COVID-19 virus.
And the FDA appears to be playing a game with their recent green light to a Pfizer vaccine – sending a message that their “approval of a vaccine may now instill additional confidence to get vaccinated,” as their staff reportedly squabble over dangers and efficacy behind closed doors.
CENSORED NARRATIVE
The true horror of the COVID-19 vaccine rollout is being revealed by doctors, researchers and lawyers aware of the alleged fraud – not by the media, which continues to hype up the fear around the virus and what they say is the need for masking, social distancing and lockdowns, attempting - with success - to funnel people towards taking the vaccine.
Largely hidden from view by governments and the media, hundreds of thousands of people have been suffering and many dying from the COVID-19 vaccines – a casualty rate tallied on adverse reporting systems publicly available for all to see if they know where to look.
And if a prime culprit is to be identified, it is the America’s FDA that allegedly through the sin of omission – failing to expose the adverse effects that they knew about back in October 2020 - gave the green light in December 2020 to the emergency use of vaccines that are potential killers.
NO EMERGENCY?
According to critics, the whole COVID-19 pandemic response has been fraudulently handled by governments around the world, the pandemic based on a faulty PCR Test that is misused and typically comes up with 90 percent false positives, and the fearful stage-managed restrictions based on a virus which – while dangerous to some - has a 99.5 percent survival rate.
The public have been misled. With adequate virus treatment protocols available, there is no “emergency” and no need for a vaccine – particularly a vaccine that does not work and has the potential to kill people in large numbers.
The FDA’s alleged culpability and the horrific predicament they have put vaccine recipients in is now coming back to haunt them as they struggling to explain and gloss over their role.
FDA KNEW THE DANGERS IN 2020
Just how America’s health watchdog found itself in hot water can best be analyzed by focusing on three main developments as they sought to fast-track the COVID-19 vaccines to the American public and send a message about what they claimed were the “safety” and “efficacy” of these shots.
October 22, 2020 should go downs in the annals of history as the day the FDA discussed and then moved to cover up arguably “the biggest health threat to the American public in modern-day history” – its repercussions rattling around the world given how the USA has haphazardly led the charge in tackling the pandemic.
When it comes to playing with people’s lives, the leaked video of an internal FDA meeting in October 2020 on the safety and efficacy of the COVID-19 vaccines – a recording how available to the public - is chilling viewing.
At the Vaccines and Related Biological Products Advisory Committee (VRBPAC) Meeting, Steve Anderson, PhD, MPP Director, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research (CBER) gave a presentation on CBER “Plans for Monitoring COVID-19 Vaccine Safety and Effectiveness”.
His presentation on this Zoom video call included Slide 16 (see image), about COVID-19 vaccine adverse event outcomes - injuries and deaths - which the FDA and Centers for Disease Control and Prevention (CDC) would be specifically monitoring. But he did not show the slide to VRBPAC, or the viewing public. He clicked right by it.
OVER 100 ADVERSE EFFECTS
Dr Bryan Ardis takes issue with this, as do a growing number of health professionals and lawyers doing their own research into how governments and medical authorities have been misleading the public about the nature of the pandemic, the testing and counting of cases, and the potential dangers of the vaccines.
“In this presentation on slide number 16 the FDA listed 110 possible diseases and neurological conditions and deaths, listed as expected side effects from the vaccines. These (were) expected to be reported when COVID-19 vaccines (became) available in December 2020. This FDA report was published in October two months before the Emergency Use Authorization (EUA) was published by the FDA (in December), which includes none of the Serious Listed Side Effects listed in their internal report in October,” Dr Ardis says.
Dr Ardis, an American doctor and head of Ardis Labs, has spent over a year researching the pandemic and its treatment, initially sparked by anomalies he saw in the medical treatment of his father-in-law who he alleges died from an inappropriate medical protocol.
Slide 16 shows the predicted 110 adverse effects (including subsects of disease) include Guillain-Barre syndrome, Myocarditis, Autoimmune disease and death that some recipients of the vaccines could expect from taking the vaccines the FDA was set to approve under emergency use.
As Dr Ardis points out, this list includes a new disease never seen before – Multisystem Inflammatory Syndrome in Children, or MIS-C. This can attack the main organs of children.
Vaccines typically take five to 15 years to test and develop for safety and efficacy but the vaccines under discussion by the FDA were only months in development – and could only get the green light for use if they could block the promotion of any other effective COVID-19 treatments.
Examination of the leaked video of this meeting in October shows the chairperson of the meeting deliberately cutting panelists short and forcing them to move on – notably when slide 16, the adverse effects slide, was shown. Although some panelists appeared to try to raise safety concerns, the chairperson cut them short.
Despite the long list of possible adverse effects detailed in this presentation, none of them were disclosed by the FDA when they gave the green light to the vaccine programme in December 2020.
“Why would they exclude these expected horrible side effects in December, that they knew were to be expected in the October report?” Dr Ardis asks.
NUMBERS TICK UP ON VAERS
During the October 2020 internal FDA presentation, Dr Anderson said these side effect choices were not random. He explained they were based on evidence from the clinical trial data and from known science on the vaccine platform and components.
What is clear now, nearly one year later, is the exact same adverse side effects are publicly showing up on the reporting systems that indicate the extent of the adverse effects of vaccines.
The Voluntary Adverse Effects Reporting System (VAERS) in the United States now shows that over a million people have suffered adverse effects and 14,000 people have died from the COVID-19 vaccines as of August 2021.
But, as Dr Ardis and many other health professionals point out, this VAERS tally is just the tip of the iceberg.
VAERS is a voluntary reporting system that is hard to use and is often skipped over by doctors – in part due to their heavy workload and a possible reluctance to admit they administered a vaccination that had a negative effect, according to Dr Ardis. Members of the public can use the system but, again, it is hard to use.
What this means is there is a massive underreporting of adverse effects from vaccines.
According to a study in 2010 by MIT, it is estimated that less than one percent of the adverse effects of vaccines are recorded in the voluntary reporting systems.
With this in mind, a cursory glance at the VAERS figures should prompt serious alarm.
Health professionals, lawyers, researchers and journalists are raising concerns about the potential dangers of the COVID-19 vaccines given the large numbers coming in.
Ohio attorney Thomas Rens has joined other lawyers and doctors in filing a lawsuit against the US federal government for covering up the true number of deaths from the COVID-19 vaccines. According
to Rens, a whistle-blower – referred to as Jane Doe – who is an insider and has seen information on VAERS allegedly passed on the numbers and relevant information to him. At an event hosted by Awaken America, Renz said: “We have someone that has sworn under penalty of perjury that there have been at least 45,000 deaths.”
And these deaths reportedly happened within four days of receiving the shot.
This is just one of thousands of legal challenges being made around the world concerning the alleged dangers posed by the COVID-19 vaccines still in trial.
Dr. Michael Yeadon former VP and chief science officer for Pfizer has testified countless times about the dangers of the COVID-19 vaccines and the irresponsibility of its emergency use authorization. He is angry at the collapse of medical ethics that permitted the dangerous experimental “vaccine” to be administered to two billion people so far.
As Dr Robert Malone, inventor of the mRNA vaccines, points out, the COVID-19 vaccines are not vaccines. They are, as the manufacturers admit, gene therapy. They do not prevent a person from catching COVID-19 or passing it on.
Rather, they could be a vaccinologist’s worst nightmare, a vaccine that comes with the risk of antibody-dependent enhancement (ADE), Dr Malone says. These therapies may actually increase the ability of a virus to enter cells and cause a worsening of disease through the mechanism of ADE.
In simple terms, COVID-19 vaccine recipients may be setting themselves up for their bodies to overreact to viruses and pathogens, causing serious damage to their body and possible death.
FDA GIVES GREEN LIGHT TO PFIZER
The second major worry with the behavior of the FDA concerns their latest messaging on the alleged safety of the COVID-19 vaccines.
Last month, the FDA publicly approved the use of the Pfizer vaccine, a move that would appear to indicate their COVID-19 vaccine is off the “emergency use” list and now safe to use.
As the FDA said in their 23 August press release, the vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the US.”
As the FDA notes, since 11 December 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.
BAIT & SWITCH?
The message from the FDA appears to indicate that the Pfizer vaccine is safe. Comirnaty has been given the green light, but this is new product and stocks are not yet available. The Pfizer-BioNTech COVID-19 Vaccine is available – but it is still under emergency use.
Just how this process in the FDA was worked out under the acting commissioner is unclear, but two top FDA vaccine regulators resigned — a decision that one former official said was rooted in anger over the agency’s lack of autonomy in the booster planning so far. A current health official said the pair, Marion Gruber and Philip Krause, left over differences with FDA’s top vaccine official Peter Marks. Now the agency is facing a potential mutiny among its staff and outside vaccine advisers, several of whom feel cut out of key decisions and who view the plan to offer boosters to all adults as premature and unnecessary, according to news reports.
The FDA appears to be backing itself into a corner as more evidence of their wrongdoing is revealed. The approval of a vaccine – as against the opaqueness provided by “emergency use” - means they have to outline both what is in the vaccine and the potential adverse effects.
It is unclear whether full transparency will be provided.
NOW BOOSTERS
As the official COVID-19 narrative continues to collapse and more information on the fraud is revealed, the FDA and the medical authorities are now pushing for vaccine boosters – compounding the original problem surrounding the alleged dangers of the vaccines.
As researchers have pointed out, during this COVID-19 crisis, both America’s FDA and CDC have made decisions that have not been in the best interests of the population or individuals. They have approved investigational products without sufficient safety or efficacy data, and they have actively censored or ignored existing treatments and natural immunity. They are actively partnering with the COVID-19 vaccine makers. And they are pushing back against medical products and treatments that help cure COVID-19.
Researchers claim that ever since the 1986 National Vaccine Injury Act passed in the USA, removing from vaccine makers liability for injury or death for products recommended to children and pregnant women, the CDC has been in charge of vaccine safety and utterly failed in their duties. Biological studies are almost non-existent. The CDC prefers to use weaker epidemiological studies that are easily manipulated to desired outcome, to try to claim reported events are not associated.
The FDA and CDC have clearly failed in their duty to protect the public and their handling of the COVID-19 vaccine rollout is leading to a barrage of legal challenges.
Fortunately, during the COVID-19 pandemic, researchers around the world have been awakened to the capture and corruption of public health agencies and they are beginning to do their own, independent studies. They are starting their own journals that have no ties to governments or the drug industry.
A revolution is beginning within the ranks of doctors and scientists who believe in honest and ethical science and medicine.
This may be encouraging. But it may be too late for the millions lured by the false promises of safety and efficacy of the vaccines by the FDA. Only time will tell how these recipients will fare.
As Dr Joel S. Hirschhorn, author of Pandemic Blunder, put it: “The FDA is leading the way for many thousands of Americans and other people worldwide to suffer and die from the Pfizer vaccine and its competitors that will also surely get approved. Many will die from ‘breakthrough infections’ after taking these vaccines.”
Jan Raphael is the pseudonym of a writer who covers Asian and world affairs.
The views expressed here do not necessarily reflect the views of Mizzima Media.
