Paxlovid: What we should know about Pfizer’s new COVID treatment medicine
By Joel S Hirschhorn | December 24, 2021
The pro-drug industry mainstream media are insanely positive over the newly FDA approved Pfizer antiviral COVID treatment pills.
The drug, Paxlovid, received an emergency use authorization by FDA for use in patients 12 years old and up who have tested positive for COVID-19 and are at high risk.
Now is the time to speak calmly and accurately about Paxlovid. First, everyone should appreciate that there was very little testing of the short- and long-term safety of this product, exactly what happened with COVID vaccines. Really good testing of a new drug should take many months or even years.
All you get is positive news for this new drug – actually a combination of drugs.
Here are brief summary statements about this new product:
It was approved by the FDA without any external meetings, serious reviews of test data or opportunity for public input. Pretty much all the regulatory work was done behind closed doors. Terrific for Pfizer. Bad for the public.
Of importance, note that in the trials only 21% of people had a comorbidity, while in reality 94% of COVID deaths have at least one comorbidity, and the average number of underlying medical conditions is four.
As to antiviral science, protease enzymes must be present for the virus to successfully infect by completing the cycle before taking the cell over. Paxlovid or any drug classified as a ‘Protease Inhibitor’ will inhibit or decrease the protease enzyme interfering with the virus. Paxlovid blocks the 3CLPro protease from chopping up the long protein into pieces. The virus can’t separate out which pieces to cut out and assemble. It can’t make copies of itself. The covid infection quickly stops
Contrary to what the government says, ivermectin is the most successful and proven protease inhibitor in use worldwide. Just as with Paxlovid, ivermectin decreases the protease enzyme but… there are benefits of ivermectin in covid treatment that are not present in Paxlovid. Additional actions of ivermectin include anti-coagulant action and anti-inflammatory actions, both observed in covid infections. And IVM has been safely used for decades and there have been many medical studies as well as clinical results showing its antiviral and anti-inflammatory effectiveness.
Paxlovid requires combination with an HIV/AIDS drug, Ritonavir, preventing the breakdown of the Paxlovid so it may inhibit or decrease the enzyme interrupting the viral life cycle. Ritonavir acts as a booster for Paxlovid, keeping it active inside a person’s body. Ritonavir also has its own black box warning and side effects include life-threatening liver, pancreas and heart issues. Does the public really want to take an HIV/AIDS drug?
A course of the treatment is 20 Paxlovid pills and 10 ritonavir pills taken over five days. Taking 6 pills daily can pose challenges for many elderly people in particular.
According to Pfizer’s press release, for people with proven COVID infection, Paxlovid reduces hospitalization/death by 89% when taken within three days of symptom onset. So in the treatment group there was 5 of 697 hospitalized with no deaths compared to 44/682 hospitalized with 9 subsequent deaths.
Also reported was an approximate 10-fold decrease in viral load at day 5, relative to placebo, indicating robust activity against SARS-CoV-2 and representing (supposedly) the strongest viral load reduction reported to date for a COVID-19 oral antiviral agent.
How interesting it would have been to test the Pfizer drug against an ivermectin protocol.
For example, how does the Pfizer drug compare with the Dr. George Fareed and Dr. Brian Tyson protocol? Well, Fareed and Tyson had many more patients (about 7,000) taking the drug combo and yet they had fewer hospitalizations (4) and the same number of deaths (0). So, you’re way better off with the Fareed and Tyson protocol. And the safety protocol of IVM after billions of uses globally is far better proven than for the Pfizer product.
For a good discussion on how IVM compares to Paxlovid see this article. Especially on scientific evidence of ivermectin’s ability to block 3CL protease.
In terms of safety, the most common side effects reported during treatment and up to 34 days after the last dose of Paxlovid were dysgeusia (taste disturbance), diarrhea and vomiting. But what more serious side effects may turn up months or years later?
Paxlovid must not be used with certain other medicines [but it has not been said exactly which ones], either because due to its action it may lead to harmful increases in their blood levels, or because conversely some medicines [which ones?] may reduce the activity of Paxlovid itself. The list of medicines that must not be used with Paxlovid is included in the proposed conditions for use [not yet fully disclosed]. Paxlovid must also not be used in patients with severely reduced kidney or liver function.
Paxlovid is not recommended during pregnancy and in people who can become pregnant and who are not using contraception. Breastfeeding should be interrupted during treatment. These recommendations are because laboratory studies in animals suggest that high doses of Paxlovid may impact the growth of the fetus.
As to availability, Pfizer CEO Bourla recently said the company can manufacture 80 million courses in 2022, with 30 million available in the first half of the year. That is not enough to serve many millions of Americans coming down with symptoms and a positive test result.
This too was said, tens of thousands of the pills will ship in the US before the end of 2021 and hundreds of thousands more are expected at the beginning of 2022, a Pfizer spokesperson told the Wall Street Journal. The US government is paying Pfizer $5.3 billion for 10 million treatment courses that will be delivered by the end of next year, according to the paper. Will medical insurance cover $530 per course?
Always follow the money. A month ago, SVB Leerink analyst Geoffrey Porges projected the drug will generate $24.2 billion in 2022 sales. Together with the company’s megablockbuster COVID-19 vaccine, Pfizer could be looking at $50 billion in peak pandemic vaccine and drug sales, Cantor Fitzgerald analyst Louise Chen wrote earlier this month. No surprise that some top Pfizer executives have become billionaires.
Pfizer Vaccine Clinical Trials Poorly Designed From the Start, Analysis Shows
By Madhava Setty, M.D. | The Defender | December 22, 2021
The disagreements around whether COVID-19 vaccinations are “safe and effective” stem not only from the subjective nature of such descriptors but also from the lack of consensus around the data used to substantiate or refute such a claim.
The Centers for Disease Control and Prevention’s (CDC) Morbidity and Mortality Weekly Reports (MMWR) often draw from limited observations, and their assessment of vaccine effectiveness is based on relatively small subsets of our population.
Their conclusions are sometimes reflective of outdated data and conflict with their own recommendations.
For example, here the CDC’s latest estimation of vaccine effectiveness is upwards of 80% in preventing COVID-19 (i.e. the risk of becoming infected is 5 times less if vaccinated). Why then the recommendation for boosters?
Note that this latest metric is based on the CDC’s most recent data from more than one month ago and represents data drawn only from 27 jurisdictions.
Eric Topol, a professor of molecular medicine at Scripps Research, is a former advisory board member of the Covid Tracking Project, a team that worked to collect and synthesize local COVID-19 during the peak of the pandemic.
Politico recently quoted Topol:
“I think we’ve done a horrible job from day one in data tracking for the pandemic. We’re not tracking all the things that we need to to get a handle on what’s going on. It is embarrassing.”
Meanwhile, vaccine injuries continue to accumulate in the Vaccine Adverse Event Reporting System (VAERS) and go unacknowledged, making any constructive discussion around risk impossible.
In order to find common ground, it is perhaps most appropriate to focus on published data from the vaccine trials themselves.
Was Emergency Use Authorization justified? Was the current confusion around vaccine effectiveness and safety predictable from the beginning?
A presentation by the Canadian COVID Care Alliance
Canadian COVID Care Alliance (CCCA) is a group of “Independent Canadian doctors, scientists and healthcare professionals committed to providing top quality and balanced evidence-based information to the Canadian public about COVID-19 so that hospitalizations can be reduced, lives saved and our country restored as safely as possible.”
CCCA assembled a presentation that comprehensively demonstrates how Pfizer’s purported randomized placebo-controlled, double-blinded study veered away from methodologies that would have answered the safety and efficacy questions definitively.
In this concise slide deck with an explanatory video, CCCA powerfully summarized why Pfizer’s trial was not designed to adequately demonstrate its product’s safety and efficacy.
Here are a few key points from the CCCA presentation:
- Initial data demonstrated a high relative risk reduction of infection yet this amounted to an absolute risk reduction of only 0.84%. It is the absolute risk reduction that determines the risk-benefit ratio required to make informed decisions around inoculation.
- Early unblinding: Several months before publishing six-month observational results Pfizer opted to offer its product to those participants who received the placebo. By eliminating nearly all participants in the placebo wing Pfizer effectively closed the curtain on its experiment because long-term comparisons can no longer be made.
- All-cause mortality and morbidity, the only sensible outcomes to use in determining efficacy and risk, were not considered. Indeed, all-cause mortality was higher in the vaccinated group after six months.
- Severe adverse events outnumbered cases of severe COVID prevented after six months of observation.
- Trial participants were not reflective of the most vulnerable members of our population — more than 50% of people dying from COVID are 75 years of age or older. This age group made up only 4.4% of trial participants. Also, 95% of those who have died from COVID had one or more comorbidities. Nearly 80% of trial participants had none.
- Not every trial participant was tested for COVID. Asymptomatic or paucisymptomatic (presenting few symptoms) cases were missed.
Questions regarding unblinding and data integrity
The CCCA presentation also resurrects a puzzling observation mentioned in a briefing document Pfizer submitted only to the FDA’s Vaccine and Related Biologic Products Advisory Committee (VRBPAC) of the FDA, but nowhere else — including the widely cited summary of the trial reported in New England Journal of Medicine.
According to the document, 3,410 participants were suspected from their clinical presentation of having COVID but they were excluded from efficacy calculations because a diagnosis could not be confirmed through PCR testing.
The CCCA presentation presumes this large group of participants was never tested. The wording in the VRBPAC briefing document is indeed vague, stating the participants were “not PCR-confirmed” in one sentence and “unconfirmed” in another.
Assuming Pfizer’s investigators followed their study protocol, these participants were in fact tested. Yet that forces us to accept that more than 3,400 participants who had symptoms of COVID were suffering from other illnesses, not COVID.
In other words, there were 3,580 participants who clinically presented with COVID (3,410 suspected and 170 confirmed). Of these, more than 95% tested negative. This is difficult to accept in a group where clinical suspicion is high.
However, with no further testing by the investigators, we are left to accept these numbers as reported.
Peter Doshi, Ph.D., senior editor at The BMJ, explained the implications of this result in detail, in an opinion piece published nearly one year ago.
In his widely discussed commentary, Doshi noted another baffling finding in the Pfizer data. Within 7 days of administration of the second of two doses, 371 (310 in the vaccinated group and 61 in the placebo group) trial participants were withdrawn from the study due to “important protocol deviations.”
Of course, protocol deviations occur, but why were five times more vaccine recipients excluded than placebo recipients at that point in the study?
Although there were nearly 40,000 participants in the evaluable population, only 170 contributed to the efficacy calculation with regard to protection from infection, and only 10 with regard to protection from severe infection.
In other words, just a handful of incorrectly diagnosed and categorized participants could easily result in a substantially different estimation of the vaccine’s efficacy and safety.
Statistician and educator Mathew Crawford pointed out the likelihood of such a disparity between groups is exceedingly unlikely. However, because the investigators should have been blinded, we must accept this as an extraordinary coincidence.
Incredibly, the very same disparity occurred in the pediatric trials (ages 5 to 11). Table 12 from the corresponding summary to the FDA’s VRBPAC indicated 3.1% of children were removed from the trial if they received the vaccine compared to 0.5% if they received the placebo.
Once again, there is a factor of 5 difference at exactly the same point in the trial (within 7 days of dose 2). It is true that the vaccine formulation requires steps prior to administration that are not required with the placebo, but why didn’t these protocol deviations happen with the first dose as well? What happened to these vaccine recipients soon after they received their second dose?
These remarkable “coincidences” can be best explained if we are willing to consider the possibility that the investigators were not, in fact, blinded. This is precisely the most damning allegation by whistleblower Brook Jackson, formerly a regional director at Ventavia, one of several clinical research organizations conducting Pfizer’s vaccine trials in 2020.
In addition to the unblinding of investigators, Jackson also accused Ventavia of falsifying data.
These are weighty accusations. Why should we believe her? Because her story is corroborated by the trial data themselves.
She was fired within a day of reporting her concerns directly to the FDA. Her story was covered in The BMJ Nov. 2. Mainstream media has yet to report on it.
Conclusion
Though public health authorities continue to proclaim these products are safe and effective, every week brings more and more evidence to the contrary.
A thorough analysis of data from Pfizer’s vaccine trials reveals more questions than answers. Claims the vaccine maker’s product is performing “as expected” may not be so far from the truth.
© 2021 Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.
Ex-Pfizer Employee Warns Vaccine Increases COVID By Over 300%
By Lance D Johnson | Humans Are Free | October 1, 2021
The fraudulence of covid-19 vaccines is on full display, and the evidence is sitting right out in the open. The full FDA approval for Pfizer’s COMIRNATY vaccine contained clinical proof that the inoculation increases COVID infection by over 300 percent!
Varitage.com
A former Pfizer employee named Karen Kingston is blowing the whistle on her former employer. Kingston is currently a pharmaceutical marketing expert and biotech analyst. When she scrutinized the full FDA approval for COMIRNATY, she found blatant fraud in Pfizer’s clinical studies.
FDA Approves Pfizer’s Covid-19 Vaccine, Even Though It Increases Infection By 300 Percent
Kingston brought forth a Briefing Document from the FDA’s advisory committee meeting that took place on September 17, 2021. The title of the document is, “Application for licensure of a booster dose for COMIRNATY (COVID-19 Vaccine, mRNA).” The document includes clinical studies conducted by Pfizer. These studies track the durability of immunity offered by the COMIRNATY vaccine and compare it to immunity observed in unvaccinated people.
“If you get the Pfizer vax, you’re more likely to get COVID” said Kingston, “So, when they weren’t injected, their infection rate was 1.3% and when they got injected, it was 4.34%. It went up by over 300%.” How could the FDA have glossed over this evidence and approved blatant fraud?
Since the vaccine was officially approved, the federal government started applying pressure on businesses across the US, threatening them with extortion and fines if they do not impose vaccine mandates on their employees.
The covid-19 vaccines have been injected almost 225 million times into the arms of Americans, causing severe injury and death along the way. Real world observations also support clinical data showing that the vaccines increase one’s susceptibility to covid-19.
In fact, the vaccines increase viral load in the nostrils of the vaccinated. An August 26 article by Dr. Peter McCullough shows that the covid vaccines allow the vaccinated to carry 251 times the viral load of covid-19 in their nostrils, turning them into the asymptomatic super spreaders they once feared.
Pfizer Studies Show That Being Unvaccinated Offers Greater Protection
Medical freedom rights attorney, Thomas Renz, went public with the Pfizer fraud. The Pfizer study involved over 36,000 people. Those who were injected earlier in the study were more likely to come down with covid infections later on, showing a clear trend of waning immunity. Those put in “high priority” groups, who were vaccinated earlier on, have a 36 percent greater chance of infection, compared to the group that vaccinated later on.
The group that vaccinated later on went unvaccinated for 5.1 months longer than the group that got vaccinated early on. This placebo group did not have high rates of infection while they were unvaccinated, even though they went longer without any “protection.”
Because of this, Kingston stated that the vaccinated group “have an even higher chance of being infected with COVID-19 than the 36 percent difference indicated by this portion of the study.”
The study even admitted in its conclusion: “An additional analysis appears to indicate that incidence of COVID-19 generally increased in each group of study participants with increasing time post-Dose 2.” Kingston clarified that infection rates “increase over time” when people get two doses of Pfizer mRNA.
Most shocking was the data on the placebo group. In the first four months, the placebo group had “no vaccine protection” and recorded an infection rate of 12.6 cases per 1,000 person-years. The infection rate for the unvaccinated was a meager 1.3 percent.
After their placebo period, the group got “fully vaccinated.” In just a few months, this group became more infectious and showed 43.4 cases per 1,000 person-years. Their infection rate went UP by over 300 percent to a 4.34% infection rate. Mrs. Kingston called this “super alarming.”
“They had less infection when they had no protection. So, that’s a problem,” she said.
References:
Pfizer Says COVID Vaccine ‘Safe’ for Kids — But Pfizer Has Lied About Kids and Drugs Before
In 1996, Pfizer’s drug, Trovan, was still in the clinical stage of development when the drugmaker tested it, without parents’ consent, on about 200 children.
By Chelli Stanley | The Defender | September 30, 2021
Pfizer last week told the public and the U.S. Food and Drug Administration (FDA) its new experimental COVID vaccine is safe for young children.
It’s a familiar story, similar to one the vaccine maker told in the past about another drug it tested on children — a story that had a terrible outcome.
Both stories began with this simple claim: “These drugs are safe for your children.”
In 1996, Pfizer, the transnational multi-billion-dollar pharmaceutical company, was working to bring a new drug — Trovan — to market. The drug was still in the clinical stage of development, when Pfizer made a decision that reportedly cost the lives of many children, and triggered an international firestorm.
Pfizer took its unlicensed Trovan to Kano, Nigeria, during a meningitis outbreak — though Trovan had never been tested in children or against meningitis.
According to Pfizer whistleblower, Dr. Juan Walterspiel, Pfizer sent unskilled doctors to Kano, who were unlicensed to practice medicine in Nigeria, and who had limited experience treating meningitis in children.
Walterspiel also reported the staff were so unskilled they could not place IV lines, and quickly resorted to orally administering the drug to children.
In the short two weeks Pfizer was in Kano, staff worked with 200 children, and gave 99 of the children unlicensed Trovan, despite the children’s desperate state. Pfizer did this even though Doctors Without Borders was operating in the same Kano hospital, treating children for free, with medicine proven to work well against bacterial meningitis.
Doctors Without Borders realized what Pfizer was doing and in a statement said they “were shocked Pfizer continued the so-called scientific work in the middle of hell.” They “communicated their concerns to both Pfizer and the local authorities.”
Pfizer gave the other 101 children ceftriaxone, which is proven effective for meningitis. However, many children were “low-dosed,” with only one-third of the recommended amount. Because Pfizer didn’t have enough skilled medical personnel to administer ceftriaxone by IV, staff injected it directly into the children’s butts or thighs.
But “the shots were severely painful, leading to ‘great fear and sometimes dangerous struggles with children.’” So Pfizer lowered the dose significantly to ease the severe pain caused by the shots.
Pfizer said available data indicated the dose remained more than sufficient, but the drug’s manufacturer, Hoffmann-La Roche, said the reductions could have sapped the drug’s strength.
“A high dose is essential,” Mark Kunkel, Hoffmann-La Roche’s medical director, told the Washington Post. “Clinical failures … and perhaps deaths of children could have resulted from the low dosing.”
According to a lawsuit against Pfizer, “five of the children who received Trovan and six of the children who were ‘low-dosed’ with ceftriaxone died, and others treated by Pfizer suffered very serious injuries, including paralysis, deafness and blindness.”
Of the 200 children treated by Pfizer, 181 were gravely injured, and 11 died.
The Washington Post investigated Pfizer’s ethics, stating, “Some medical experts questioned why the company did not switch to the proven pills when it was clear the young patients were approaching death.”
“It could be considered murder,” said Evariste Lodi, the leading Doctors Without Borders physician in Kano, after reading a report that Pfizer kept a child solely on Trovan until the child died.
In a statement about the child’s death, a Pfizer spokeswoman said “researchers had no reason to suspect the experimental medicine was not working.” Pfizer also said Trovan was “at least as effective as the gold standard treatment,” despite it having never been used in children, or for meningitis.
Pfizer designed the clinical trial in Kano “in six weeks, though the risks and complications of such a trial would typically require a year to adequately assess,” The Atlantic reported.
The parents in Kano have maintained they were not notified of an experiment, and that Pfizer did not have their consent to use their children in a drug trial in the middle of a health crisis. They organized to sue the drugmaker, while caring for children injured during the experiment.
Pfizer maintains the Nigerian parents gave full consent for their critically ill children to be used in an experiment, though even Pfizer admits no parent ever signed a consent form.
The lawsuits dragged on for years, as Pfizer refused to admit to any wrongdoing. “We are fed up with this case,” said a father who lost his daughter. “Our children are dead and some are maimed.”
Pfizer said “the trial was conducted appropriately, ethically and with the best interests of patients in mind; and it helped save lives.”
However, even the approval letter Pfizer submitted to the FDA about the Kano trial was exposed by a Nigerian doctor, who “said that his office backdated an approval letter and this may have been written a year after the study had taken place.”
The community of Kano has been profoundly affected — “the experiment shaped public perception of Western drugs in the region. Parents told their children about it. Teachers lectured about Pfizer in classrooms. Pundits spoke of Western physicians seeking human guinea pigs.”
Pfizer acknowledged the severe nature of the meningitis outbreak to a Nigerian investigative committee, then said, “Pfizer’s intervention was therefore strictly a humanitarian gesture aimed at saving lives. It was totally devoid of any commercial undertones.” The company called it “the humanitarian trial.”
“If I had the power, I would take away their medical licenses,” said Lodi.
Pfizer’s Trovan history gets worse
In the initial development of Trovan, Walterspiel reported that Pfizer tried another study and:
“ … the study failed and several patients developed severe post-operative infections and one woman had her uterus removed. Pfizer dispatched risk managers and asked affected patients and relatives to fill out checks for whatever amount they felt right against their signature to keep the payments confidential.”
Pfizer made no such offer in Kano. The families of Kano had to sue Pfizer repeatedly, and received no compensation until nearly 15 years after the incident occurred.
Pfizer did not let these mere setbacks of death, maiming and international scandals deter the company. Within a few short years, the drugmaker brought Trovan to market in both the United States and Europe.
Expecting to reap financial windfalls, Pfizer aggressively marketed Trovan — until it discovered the public in both the EU and U.S. was reeling from liver damage, liver failure and death as a result of taking Trovan.
Reports of adverse reactions grew until Europe took Trovan off the market completely, and the FDA severely restricted the public’s access in the U.S.
A New York Times article detailed how Trovan’s serious side effects became known only after it was given to the public. “The case showed how a new drug, marketed by an expert like Pfizer, could be swiftly prescribed to thousands of patients before all the side effects were known. Pfizer said its tests of Trovan had not revealed any serious problems.”
In 2000, William C. Steere Jr., then chairman of Pfizer, acknowledged some side effects only become known after a drug is approved, saying, ”You put the drug in the general population, and then everyone is taking it. We just hold our breath and wait to see if there is something unique with the drug.”
‘If I had an enemy, I would not let him take their drugs’
Pfizer was repeatedly sued in Nigeria and the U.S. for its actions in Kano. In 2009, Pfizer agreed to pay $75 million, despite initially being sued for $8.5 billion.
The company got involved in several more scandals that exploded when Wikileaks published several U.S. Embassy cables detailing Pfizer’s communications.
A Pfizer lawyer described in the cables that “Pfizer has worked closely with former Nigerian Head of State Yakubu Gowon. Gowan spoke with Kano State Governor Mallam Ibrahim Shekarau, who directed the Kano AG to reduce the settlement demand from $150 million to $75 million.”
In another cable, a top Pfizer representative in Nigeria said:
“Pfizer had hired investigators to uncover corruption links to Federal Attorney General Michael Aondoakaa to expose him and put pressure on him to drop the federal cases. Pfizer’s investigators were passing this information to local media. A series of damaging articles detailing Aondoakaa’s ‘alleged’ corruption ties were published in February and March.”
A cable showed a Pfizer representative commenting that “Doctors Without Borders administered Trovan to other children during the 1996 meningitis epidemic, and the Nigerian government has taken no action.”
The accusation prompted Doctors Without Borders to publish a strongly worded press release stating that they did not give anyone Trovan, and were in fact the first to speak out about Pfizer’s unethical actions.
Finally, the cables showed that “Pfizer was not happy settling the case, but had come to the conclusion that the $75 million figure was reasonable because the suits had been ongoing for many years, costing Pfizer more than $15 million a year in legal and investigative fees.”
The original lawsuit also sought prison terms for Pfizer officials.
Scandals continued even after the case was settled, when Pfizer demanded that anyone collecting the money give a sample of their DNA. Several people refused, distrusting what Pfizer may do with their DNA. They were not allowed to get compensation as a result.
Pfizer said it “always acted in the best interest of the children involved, using the best medical knowledge available.”
Najib Ibrahim of Kano said of Pfizer, “If I had an enemy, I would not let him take their drugs.” Abdul Murtala said, “Pfizer reminds me of recklessness with human lives.”
The pattern continues, with 12-year-old injured during Pfizer COVID trial
Maddie de Garay was 12 when she voluntarily participated in Pfizer’s COVID-19 vaccine trial for 12- to 15-year-olds in Ohio. After she took the second dose on January 20, 2021, her life changed.
Her mother, Stephanie de Garay, spoke at press conference in June, held by Sen. Ron Johnson (R-Wis.), during which she described the maiming of her child and Pfizer’s disregard towards Maddie and the family — despite Maddie being part of the trial in order to determine whether Pfizer’s covid vaccine is safe for children.
Stephanie said:
“All we want is for Maddie to be seen, heard, and believed, because she hasn’t been. And we want her to get the care that she desperately needs so that she can go back to normal. She was totally fine before this. They’re not helping her.”
Stephanie said within 24 hours of the second dose, Maddie “developed severe abdominal and chest pain. She had painful electrical shocks down her neck and spine that forced her to walk hunched over. She had extreme pain in her fingers and toes.”
Maddie went to the ER immediately, as instructed by Pfizer’s vaccine trial administrator. After doctors ran few tests, she was sent home with a diagnosis: “Adverse effect of vaccine initial encounter.”
In the first five months after getting her second dose, Maddie would return to the ER eight more times.
“Over the next 2.5 months, her abdominal, muscle and nerve pain became unbearable. She developed additional symptoms that included gastroparesis, nausea and vomiting, erratic blood pressure and heart rate, memory loss, brain fog, headaches, dizziness, fainting, and then seizures.
“She developed verbal and motor tics, she had loss of feeling from the waist down and muscle weakness, drastic changes in her vision, urinary retention and loss of bladder control, severely irregular and heavy menstrual cycles, and eventually she had to have an NG tube put in to get nutrition. All of these symptoms are still here today. Some days are worse than others.”
Maddie’s doctors began to suggest she had “functional neurological disorder due to anxiety” and even tried to admit her to a mental hospital. Her family fought it.
It took five months for Maddie to get an MRI of her brain and appropriate blood tests, which she got when her family went elsewhere for medical advice after talking to others who were adversely affected by the COVID vaccines.
Stephanie said:
“What I want to ask is: Maddie volunteered for the Pfizer trial. Why aren’t they researching her to figure out why this happened so other people don’t have to go through this? Instead, they’re just saying it’s ‘mental.’”
The de Garay family has joined with emerging grassroots advocacy groups whose members’ lives suddenly changed after they got a COVID vaccine. They are asking the CDC and FDA to recognize their injuries, the medical community to believe and help them, the media to share their stories, for the public to know about these injuries as part of informed consent, and for their injuries to be studied so that solutions can be found.
Since being injured by new vaccines still in phase 3 trials, they have been subjected to stonewalling, cover-ups, bullying, refusal to collect the data and blanket denials.
Pfizer has not commented publicly on Maddie’s case.
At the September FDA advisory meeting on Pfizer COVID boosters in the U.S., Steve Kirsch, executive director of the COVID-19 Early Treatment Fund, said Pfizer did not record Maddie’s extensive injuries in its clinical trial results. Kirsch also noted Pfizer marked the entirety of Maddie’s injuries as “abdominal pain.”
Kirsch reported Pfizer’s fraud to FDA acting Commissioner Dr. Janet Woodcock, but no investigation has been launched into Pfizer for allegedly erasing Maddie’s extensive injuries from its trial data for children.
© 2021 Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.
You cannot be forced to get the Covid vaccine. Here is the way out.
By Meryl Nass, MD | August 26, 2021
Let me show you how FDA, Pfizer and BioNTech colluded to fool everyone about the EUA status of the vaccine Americans will be offered. But close reading of their document gives you an escape route.
The “Fact Sheet for Recipients, “dated August 23, 2021, is approved by FDA and is on FDA’s website, and is signed by BioNTech and Pfizer.
Direct quotes from this easy to read 8 page document are below, and I suggest you print the document out, as it will help you avoid a vaccine mandate. Pay close attention. I added numbers to the most interesting excerpts.
After stating that you might receive the licensed vaccine or a vaccine under EUA in item 2, item 6 indicates that both the licensed vaccine AND the EUA vaccine are both under EUA. (This may be the way chosen to shield the licensed vaccine from liability.) Item 5 says that while under EUA, it is your choice whether or not to receive the vaccine.
Show this document to your college, your hospital, your boss. They cannot force you to receive either of these vaccines!
—————–
1. The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine under Emergency Use Authorization (EUA) have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series.[1]
2. You are being offered either COMIRNATY (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine to prevent Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2.
3. The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.
4. WHAT IF I DECIDE NOT TO GET COMIRNATY (COVID-19 VACCINE, mRNA) OR THE PFIZER-BIONTECH COVID-19 VACCINE?
5. Under the EUA, it is your choice to receive or not receive the vaccine. Should you decide not to receive it, it will not change your standard medical care.
6. This EUA for the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY will end when the Secretary of HHS determines that the circumstances justifying the EUA no longer exist or when there is a change in the approval status of the product such that an EUA is no longer needed.
Manufactured by Pfizer Inc., New York, NY 10017
Manufactured for BioNTech Manufacturing GmbH An der Goldgrube 12 55131 Mainz, Germany LAB-1451-7.2 Revised: 23 August 2021
Israel and Covid: Is the drug deadlier than the disease?
By Neville Hodgkinson – The Conservative Woman – July 30, 2021
ISRAEL’S nine million people, and Gibraltar’s 34,000, are among the most Covid-19 vaccinated in the world, almost entirely using the Pfizer mRNA injection. But after a fall in cases, both communities are now once again seeing a rapid rise in infections.
Sacrifices made in life and liberty are beginning to look less worthwhile – a fact that French legislators seem to have overlooked this week in requiring Covid vaccine passports for a wide range of normal life activities.
Governments and media commentators internationally praised Israelis and Gibraltarians as they did their best to support scientists and politicians trying to minimise damage wrought by SARS-COV-2, the genetically engineered virus (see here and here and here) first identified in Wuhan, China.
Less attention was given to the fact that Gibraltar suffered the highest Covid mortality rate in the world, proportional to its small population, during the first three weeks of a vaccine rollout that began on January 10 this year.
Despite the opportunity for a focused inquiry that could have shed light on the vaccine’s safety, regulators failed to look into claims that the jab itself, in the frail and elderly people who received it first, contributed to this tragic loss of life, the worst in Gibraltarians in over 100 years.
More than 78,000 doses were administered, reaching close to 100 per cent of the population, as well as some visiting tourists and workers.
Residents went along with promises that the jab would prevent a renewal of the lockdowns they suffered last year, which were hugely socially and economically damaging.
But today Gibraltar is experiencing a surge in breakthrough infections. More than 700 people are in self-isolation, and there are over 260 active Covid cases, although only seven of those are receiving treatment in hospital.
Globally, regulators have downplayed deaths and injuries associated with the Covid vaccines, insisting that the protection they offer against the disease offers the best way out of the crisis.
In Israel this week, however, the health ministry reported that 2,260 new infections were diagnosed on Tuesday alone, a high not seen since mid-March.
Across Israel there are now 14,365 confirmed cases, described as ‘skyrocketing’ by the Israeli newspaper Arutz Sheva. Of those, 258 are in hospital, 153 in a serious condition, and 35 are critically ill.
It has not been revealed how many of these cases had received the vaccine. More than five million Israelis have had both doses, but ‘vaccine hesitancy’ has grown, as news of the apparent dangers has spread, and the rate of full vaccination has slowed to a crawl.
A study by the Hebrew University of Jerusalem, reported this week by The Times of Israel, indicated however a fall in the Pfizer vaccine’s effectiveness over time, with those vaccinated in January having just 16 per cent protection against infection now. Since elderly people, who respond less to the vaccine, were among the first to receive the jab, that failure is unlikely to be as great across the population as a whole.
Nevertheless, the phenomenon of so-called breakthrough infections is causing mounting concern in the scientific community.
The Israeli government has recognised the harm caused by lockdowns and to try to curb the resurgence in infections is focusing instead on mask-wearing, social quarantining, and reinstatement of a vaccine passport for events of more than 100 people in closed venues.
It has also announced a continuing programme of vaccinations, and health ministry officials met on Wednesday to decide whether a third, booster dose should be provided to all elderly people. Israel set a world precedent by administering a third shot two weeks ago to those with severely compromised immune systems.
If the world goes down the route of regular Covid jabs, as with the (largely ineffective) flu vaccine, it will be great news for Pfizer shareholders, but not for those who suffer the resulting injuries and deaths from the vaccine.
Nearly 6,500 deaths have been attributed to Covid in Israel, but one study claimed there were ‘orders of magnitude’ increases in death rates during a massive vaccination campaign beginning in mid-December.
In the two months to mid-February, 2,337 deaths occurred, leading the study authors to conclude that ‘vaccinations have caused more deaths than the coronavirus would have caused during the same period.’
The Israeli People’s Committee, a team of doctors, lawyers, and scientists of various disciplines concerned at the impact of both the vaccine drive and civil rights restrictions on ‘our people’s welfare and the destiny of our country’, has announced an inquiry into what it called ‘suspected governmental and institutional criminality’ during the crisis.
It says the state has ‘systematically shut down all monitoring and tracking systems’ designed to identify vaccine adverse events, despite the experimental nature of the product.
The result has been ‘an unprecedented flood of thousands of serious adverse event reports after the vaccine on social media, which seems to be the only forum that still allows people to share their experiences’.
The gap between this reality and information published by the Israeli ministry of health and the media, is ‘inconceivably large’, the committee says, raising concerns of ‘a dangerous deception not only of Israeli citizens, but of citizens of the entire world, who view Israel as the research laboratory of Pfizer’s corona vaccine.
‘Such a deception, whether negligent or premeditated, could create additional cycles of harm to humans around the globe.
‘We wish to say to the Israeli government and governments throughout the world: A lack of transparency kills people. Deception and concealment lead to disability and loss of life. Remove all confidentiality, create transparent and controlled reporting mechanisms; only then can lives be saved and further damage avoided from the very tool that is supposed to preserve health.
‘Is this a case where the drug is more deadly than the disease? Or is it equally, or less, deadly? We can only come to a true conclusion if comprehensive data is revealed in real time and if the press, which is supposed to be free and a watchdog of democracy, will remain on guard and raise the alarm when necessary. And it is indeed very necessary.’
Meanwhile, Pfizer has applied to US regulators for full approval of its jab, arguing that the company’s data ‘confirm the favourable efficacy and safety profile of our vaccine’.
The FDA cover-up that led to the approval of the Pfizer vaccine
By Jon Rappoport | No More Fake News | May 25, 2021
As I’ve been documenting for the past year, the COVID experts have been contradicting themselves six ways from Sunday. As charlatans, they’re abject failures. They can’t keep their own story straight.
Thanks to an alert reader, I’ve come across a new blockbuster.
BY THEIR OWN STANDARDS, the FDA should never have allowed the Pfizer COVID vaccine to be shot into a single arm. The Agency’s Emergency Use Authorization was a crime—according to their own data.
Here we go.
The document, posted on the FDA website, is titled, “Vaccines and Related Biological Products; Advisory Committee Meeting; FDA Briefing Document Pfizer-BioNTech COVID-19 Vaccine.” [1]
It is dated December 10, 2020. The date tells us that all the information in the document is taken from the Pfizer clinical trial, based on which the FDA authorized the vaccine for public use.
A key quote is buried on page 42: “Among 3410 total cases of suspected but unconfirmed COVID-19 in the overall study population, 1594 occurred in the vaccine group vs. 1816 in the placebo group [who received a saltwater shot].”
Those shocking numbers have never seen the light of day in news media.
The comparative numbers reveal that the vaccine was not effective at preventing COVID-19. It was certainly not 50% more effective than no vaccine at all—the standard for FDA Emergency Use Authorization.
To make all this clear, I need to back up and explain the theory of the vaccine clinical trial.
The researchers assumed the SARS-CoV-2 virus was spreading everywhere in the world, and during the clinical trial, it would descend on some volunteers.
The billion-dollar question was: how many people receiving the vaccine would become infected, vs. how many people in the placebo group?
If it turned out that FAR FEWER people getting the vaccine became infected with SARS-CoV-2, the vaccine would be hailed as a success. It protected people against the virus.
But as you can see from the numbers above, that wasn’t the case at all.
So now we come to the vital weasel-phrase in the FDA document I just quoted: “suspected but unconfirmed COVID-19 [cases].”
“Well, you see, we can’t say these were ACTUAL COVID-19 cases. Maybe they were, maybe they weren’t. They’re in limbo. We want to keep them in limbo. Otherwise, our clinical trial is dead in the water, and we’ll never get approval for the vaccine.”
What does “suspected cases” mean? It can only mean these people all displayed symptoms consistent with the definition of COVID-19, but they’re unconfirmed cases because…their PCR tests were negative, not positive.
However, if their tests were negative, why would they be called “suspected cases” instead of “NOT CASES”?
Something is wrong here. The FDA is hedging its bets, muddying the waters, obscuring facts.
By FDA/CDC rules, a case of COVID-19 means: a person has tested positive, period.
That’s the way cases are counted.
These several thousand volunteers in the Pfizer clinical trial were either COVID-19 cases or they weren’t. Which is it?
The official response to that question is obvious: the FDA decided to throw the data from all those suspected cases in the garbage and ignore them. Poof. Gone.
Why do I say that?
Because if the FDA had paid serious attention to the several thousand “suspected cases,” they never would have authorized the vaccine for public use. They would have stopped the clinical trial and undertaken a very deep and extensive investigation.
Which they didn’t.
This is called a crime.
“But…but it’s not that simple. This is a complex situation. It’s a gray area.”
“No. It isn’t. If you were running a clinical trial of a new drug, and a few thousand people in the trial, who were given the drug, nevertheless came down with the disease symptoms the drug was supposed to cure, wouldn’t you cancel the trial and go back to the drawing board?”
“You mean if we were being honest? That’s a joke, right? We’re not honest. Don’t you get it?”
Yes. I get it. You’re criminals. Killers.
But wait. There’s more. The FDA document also states: “Suspected COVID-19 cases that occurred within 7 days after any vaccination were 409 in the vaccine group vs. 287 in the placebo group.”
That’s explosive. Right after vaccination, 409 people who received the shots became “suspected COVID cases.” This alone should have been enough to stop the clinical trial altogether. But it wasn’t.
In fact, the FDA document tries to excuse those 409 cases with a slippery comment: “It is possible that the imbalance in suspected COVID-19 cases occurring in the 7 days post vaccination represents vaccine reactogenicity with symptoms that overlap with those of COVID-19.”
Translation: You see, a number of clinical symptoms of COVID-19 and adverse effects from the vaccine are the same. Therefore, we have no idea whether the vaccinated people developed COVID or were just reacting to the vaccine. So we’re going to ignore this whole mess and pretend it’s of no importance.
Back in April of 2020, I predicted the vaccine manufacturers would use this strategy to explain away COVID cases occurring in the vaccine groups of their clinical trials.
It’s called cooking the data. It’s a way of writing off and ignoring COVID symptoms in the vaccine group—and instead saying, “The vaccine is safe and effective.”
And the FDA document, as I stated above, just puts an impenetrable cloud over all the volunteers in the Pfizer clinical trial by inventing a category called “suspected but unconfirmed COVID-19 cases,” and throwing those crucial data away, never to be spoken of again.
I’m speaking about them now. Any sensible person, looking at them, would conclude that the vaccine should never have been authorized.
Unless fraud, deception, profits, and destruction of human life via the vaccine were and are the true goals.
Finally: When you have “suspected cases,” and their ultimate status depends on doing a test, you do the test. You do it as many times as you need to, until it registers positive or negative. Then each “suspected case” becomes an actual case or no case at all.
Perhaps these “suspected cases” in the clinical trial were tested, and many of them came up positive, revealing they were actual COVID cases—but the researchers lied and covered up the fact that they were tested.
Or if you really don’t want to know whether “suspected cases” are actual cases, you don’t test them. You leave them in a convenient limbo and park them, never to be seen again.
Either way, the situation is patently absurd. By official standards, the PCR test decides whether a person is a case or not a case. Just do the test. Saying “we don’t know” is nothing more than a con and a hustle.
I’d love to hear the researchers try to talk their way out of this one. Here is how the conversation might go:
“So you’re saying these several thousand suspected COVID cases couldn’t be adjudicated one way or another?”
“That’s right. Their PCR tests were ‘indeterminate’.”
“That says something devastating about the test itself.”
“Well, sometimes you just can’t tell whether it’s positive or negative.”
“I see. And this ‘indeterminate’ result occurred in SEVERAL THOUSAND suspected cases.”
“I guess so, yes.”
“You know, you could have done something else with these suspected cases. A different test. You could have taken tissue samples and looked for the virus itself in a more direct way.”
“No. That wouldn’t work.”
“Why not?”
“Because…the actual virus…”
“Because no one has been able to come up with a specimen of the actual SARS-CoV-2 virus.”
“Right.”
“So tell me—what does that indicate? I’ll tell you what it indicates. You can’t prove the SARS-CoV-2 virus exists.
“I have to go. I’m late for a meeting.”
“You’re late for more than just a meeting. Is it true a person becomes a virologist by cutting out a coupon from the back of a comic book and mailing it to a PO Box in Maryland?’
“Absolutely not. That’s outrageous.”
“What then?”
“The PO Box is in Virginia.”
SOURCES:
[1] https://www.fda.gov/media/144245/download
Jon Rappoport is the author of three explosive collections, THE MATRIX REVEALED, EXIT FROM THE MATRIX, and POWER OUTSIDE THE MATRIX.
Pfizer Ducks Criminal Prosecution Using Shell Companies
Principia Scientific | May 6, 2021
You first heard of ‘too big to fail’ banks in 2008 when the global economic collapse destroyed lives and businesses and few, if any fraudster bankers went to jail.
Don’t be surprised to learn that ‘too big to fail‘ also applies to those Big Pharma entities in cahoots with corrupt politicians. This short video explains how Pfizer, conspiring with bent regulators, uses shell companies to get away with their vaccine crimes.
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In 2014, Michael Parenti Wrote A Prophetic Article About Ukraine
The Dissident | January 28, 2026
This week, the influential left-wing scholar Michael Parenti passed away at the age of 92.
Parenti was well known for his sharp criticism of U.S. foreign policy and U.S. imperialism throughout his life, waking up many to the reality of it and the lies used to justify it.
This is best underscored in one of his last published articles, “Ukraine and Regime Change”, which was published in the book “Flashpoint In Ukraine: How the U.S. Drive for Hegemony Risks World War III”, where he predicted to a tee what the result of the 2014 U.S. backed coup in Ukraine would be. … continue
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Aletho News- In One Of His Final Pieces, Written in 2014, Michael Parenti Wrote A Prophetic Article About Ukraine
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