CDC Director Violates FDA’s Emergency Use Authorizations and Posts Misinformation about COVID-19 Vaccines
ICAN | June 23, 2022
While Twitter has suspended and permanently blocked numerous individuals for posting so-called “misinformation” concerning COVID-19 vaccines, it has not done so to “health” authorities – those who arguably should be held to an even higher standard – when they blatantly share inaccurate information.
On June 18, 2022, CDC Director Rochelle Walensky posted a tweet with a video of herself discussing the CDC’s recent recommendation of the COVID-19 shots for children under 5. In the video, Dr. Walensky made the following two claims:
- “We now know based on rigorous scientific review that the vaccines available here in the United States can be used safely and effectively in children under 5.”
- “We have taken another important step together on our fight against COVID-19 by making safe and effectivevaccines available for our little ones.”
But as Dr. Walensky should certainly be aware, in issuing Emergency Use Authorizations (EUAs), the FDA has not(under its ridiculously low standards) made a finding that these vaccines are “safe and effective.” Instead, the grant of an EUA means only that the FDA has determined “it is reasonable to believe that [each vaccine] may be effective” and that “it is reasonable to conclude, based on the totality of scientific evidence available, that the known and potential benefits of [each vaccine] outweigh the known and potential risks of the vaccine.”
By claiming – two separate times – that these vaccines are “safe and effective,” Dr. Walensky is misleading the public by suggesting these vaccines have met the legal standard required for licensure.
Worse yet, because her tweet is “descriptive printed matter” that is both advertising and promoting Pfizer’s and Moderna’s vaccines, the tweet itself is in violation of both EUAs issued to these companies because it does not “clearly and conspicuously” contain the required disclaimer that these products have not yet been licensed as safe and effective by the FDA.
ICAN, through its attorneys, has sent Dr. Walensky a formal letter demanding that she immediately remove the misleading tweet and we will keep you posted on the CDC’s response.
Birx Had a Tough Day in Congress
“Hope” is no basis for health mandates or treatment policy
by el gato malo – bad cattitude – june 24, 2022
leaders do not, mostly, lead. they follow the public mood. and as that mood is shifting, it’s becoming OK to ask the pointy questions and start getting to the bottom of things.
debbie had a tough outing here and gets pinned on a simple and vital issue:
when public health officials and agencies stridently told america that the covid vaccines would be a “dead end for the virus” and stop infection and spread, upon what did they base that claim and how did they get it so wrong?
once jordan gets a hold of her, this is like a tuna filled piñata in a tiger cage.
jj: was the government lying when they said this?
db: i don’t know. i was not part of the taskforce discussions
strong start. non-denial denial, offers up others for the trip under the bus. both evasive and self-protective. politics 101.
she then speaks of her family still using “layered protection” because she knew that vaccine immunity would wane like natural immunity. this is both inaccurate and deeply dishonest. if she and her compatriots “knew” that, they certainly were not saying it in public.
and boy oh boy do we have the receipts on that one…
jj: when the government told us the vaccinated could not transmit it (covid), was that a lie or a guess?
db: “i think it was hope”
see, now that seems like a pretty poor pretext for pushing vaccination as social duty, mandating jabs, and endless campaigns of vilification, othering and claims to be on the “side of science.”
“we did it cuz hope.”
digging further into this is going to get really good. it’s clear these people are neither smart nor informed. they hipshot and hoped. and all the carnage and calamity it drove is going to land on them.
it’s clear they lack basic justification for their towering, condescending certitude.
this fallback to “and that’s why i think scientists and public health leaders always have to be at the table being very clear what we know and don’t know” is awe inspiring in its manipulative mendacity.
sure, the statement is true, but could anyone produce a standard that less describes what was actually done?
they expressed as iron bar certainty that which they now admit was “a hope.”
they attacked viciously anyone who dared call their narrative into question.
i seriously cannot believe she just said that.
that she did not actually burst into flame getting that out is near certain proof that she’s wearing asbestos underpants.
jordan ends on a wonderful high note:
“i’m just struck with the irony. we’ve got government agencies guessing, hoping, or lying with the information they’re presenting to the american people and this is the same administration that wants to set up the disinformation governance board and want to talk about misinformation. they are the biggest purveyor of misinformation, false information, hopeful information, but not accurate and true information…”
take that, scary poppins!
this is, of course, 100% correct.
and just who the liars and suppressors of science here were is going to keep coming out.
trust in government is dropping like tropical sunset: slowly at first then suddenly, darkness.
the lesson is everywhere an always the same.
let’s make sure it sinks in.
EU Renews Digital Covid Pass Despite 99% Negative Public Feedback
BY ROBERT KOGON | BROWNSTONE INSTITUTE | JUNE 24, 2022
Acting on a proposal of the European Commission, the European Parliament, as expected, voted yesterday to renew the EU Digital Covid Certificate for another year. The vote was 453 for, 119 against and 19 abstentions.
The certificate regulation had been scheduled to expire on June 30. Earlier this month, a delegation from the parliament had already reached a “political agreement” with the Commission on renewing the certificate, thus making yesterday’s vote virtually a foregone conclusion.
The certificate regulation was originally adopted in June of last year, ostensibly to facilitate “safe travel” between EU member states. But the EU digital certificate quickly evolved into the model and sometimes infrastructure for the domestic “health” or Covid passes that would serve to restrict access to many other areas of social life over the following year.
The EU has opted to extend the covid certificate despite the overwhelmingly negative results of a public consultation on the subject that was launched by the European Commission under the heading of “Have Your Say” and that was open to the public from February 3 to April 8. The consultation elicited over 385,000 responses – almost all of which appear to be opposed to renewal!
In a letter to the European Ombudsman that the French member of the parliament Virginie Joron posted on her Twitter feed, Joron writes:
I read hundreds of responses at random with my team. I did not find any in favor of extending the QR code [i.e. the digital certificate]. Based on this large survey, it seems obvious that virtually all the responses were negative.
The overwhelmingly negative tendency of the responses was indeed evident from the outset. The first full page of responses, all of them dating from February 4, is available here. They are, of course, in a variety of European Union languages: French, German, Italian, and also one in English.
To provide readers an idea of the tenor, here is a translation of just the first line or two of the first several responses (starting from the bottom of the page):
I am completely opposed to the establishment of this certificate given what is currently happening with the EU’s disastrous handling of Covid…
I want this cst [probably a reference to Belgium’s “Covid Safe Ticket”] or vaccine passport simply to be eliminated…
There are claims made in the draft document that are not scientifically supported. For example, it is claimed that the Covid certificate represents effective protection against the spread of the virus – what data can support this claim?…
Hello, I am shocked and disgusted by the freedom-killing decisions taken in the EU … as regards this “European certificate” …
The covid certificate or green pass SHOULD BE ABOLISHED immediately as discriminatory and unconstitutional and not supported by any scientific data, because it is exclusively based on PUNITIVE measures for citizens…
I am opposed to the extension of the green pass, which serves no purpose other than creating discrimination…
I never want to be subjected to a discriminatory certificate again…
And, finally, the English-language entry:
The digital Covid certificate should end immediately. There is so much data that supports the fact that digital passports have zero positive impact on transmission rates and in fact in the most vaccinated and highly regulated countries, there [sic.] covid rates are insane…
And so on and so forth through 385,191 responses.
The renewal of the Digital Covid Certificate does not mean that it will be immediately applied, but that the infrastructure will remain in place and that it can be applied if and when member states see fit to do so.
The current rules for holding a valid EU Digital Covid Certificate do not only, needless to say, discriminate against the unvaccinated, but also against natural immunity, which is treated as more ephemeral than vaccine-induced immunity.
Proof of completed primary vaccination makes a certificate valid for 270 days; proof of having received a booster dose confers unlimited validity for the moment. On the other hand, proof of “recovery” – with a positive PCR test being the only accepted proof – only confers 180 days of validity.
“Polio Outbreak” – The WHO, Bill Gates, emergency vaccines & more of the same
By Kit Knightly | OffGuardian | June 24, 2022
Polio is on the front pages of British newspapers again for the first time in decades. What a time to be alive.
For those who missed it, two days ago the UK government declared a “national incident” after traces of the polio virus were detected in sewage from North London.
Yes, a “national incident”… for traces… found in sewage.
This is a massive escalation, even compared to the pandemic. Covid and Monkeypox at least had the good taste to wait for a single person to actually have the disease (allegedly) before hitting the big red panic button.
In a somewhat startling coincidence, just two days before the “polio in London” news broke, Forbes published an article headlined…
There May Be A New Polio Epidemic On Its Way- If So, What We Can Do
It’s totally unrelated, talking about a “polio-like” enterovirus that hasn’t yet had a vaccine approved in the US, and never mentions London once.
The same (or similar) news hitting headlines around the world for (supposedly) totally different reasons makes my inner-cynic twitch.
So, what’s going on here?
While it may look like polio is suddenly back in the news, it’s actually been there longer than you’d think and has been building to this point.
The truth is it all fits into a very predictable pattern.
In November of 2020, a new “genetically engineered” and “triple-locked” polio vaccine was the first vaccine to be granted “emergency use listing” by the World Health Organization, despite there being only around five thousand cases of polio in the world over the last decade.
In October 2021, the government of Ukraine declared a “biological emergency” due to the “re-emergence” of polio, which was blamed on low vaccine uptake.
This was steadily reported in back pages of the news for months. Culminating in headlines like “Polio Makes a Comeback in Ukraine as War Halts Vaccination Campaign”, following Russia beginning its “special operation”.
Later, in March of this year, Israel reported they too had a “re-emergence” of polio after allegedly detecting “vaccine-derived” polio in the stool of a young girl suffering from paralysis.
At this point, the Global Polio Eradication Initiative (GPEI) started speaking out. GPEI is a project co-funded by the WHO, the US CDC, GAVI the vaccine alliance and the Bill and Melinda Gates Foundation.
… in other words, exactly who you’d expect.
Following the reported case in Israel, GPEI released a statement calling for “enhanced surveillance”…
The GPEI partnership urges all health authorities to enhance surveillance for poliovirus and implement enhanced vaccination response to prevent further transmission, so that no child is at risk of lifelong paralysis from a disease that can so easily be prevented. GPEI is committed to assisting the health authorities in their efforts to stop the cVDPV3 outbreak.
A month later, in April of this year, using alleged “re-emergence” as a springboard, GPEI called for “renewed efforts” to combat polio, launching their new “Strategy” and claiming to need a further 4.8 billion dollars in funding.
Then in late May, at the WHO’s 75th World Health Assembly, “global health leaders” called for “urgent action to end polio once and for all before a unique window of opportunity closes for good.”
The same week, the WHO’s Director-General Tedros Adhanom Ghebreyesus addressed the assembly regarding polio [emphasis added]:
“Worrying developments in recent months highlight how fragile this progress [of eradicating polio] is […] This year, we have the real opportunity to halt wild poliovirus transmission. At the same time, we must respond faster and better to cVDPV outbreaks, to interrupt all transmission by end-2023.”
… which brings us to June, and scare-stories on both sides of the Atlantic warning of “low vaccination rates”
Note that the WHO report claims the virus entered the UK on someone who received a “live vaccination” overseas, and the alleged outbreak in Israel is “vaccine-derived”.
Do you see how this works yet?
- The WHO approves “emergency use vaccine”, bypassing need for trials and safety data
- A handful of cases of polio are reported (as they are every year)
- Gates/WHO funded thinktank calls for “increased surveillance”, meaning more testing (using PCR tests)
- More testing inevitably finds more “cases”
- Cases are blamed on the old vaccines
- New “modern” and “safer” vaccines are rolled out.
- Everyone makes a LOT of money.
In October, at the World Health Summit in Germany, GPEI is launching a “pledging moment” to try and raise around 5 billion dollars to “achieve a polio-free world”.
Given the headlines, they should pass that mark pretty easily, wouldn’t you think?
It’s interesting to note that market researchers found the polio vaccine market had “stagnated” through 2020 and 2021, due to the Covid19 “pandemic”.
No more stagnation now.
Media, health officials should ‘just tell the truth’ about COVID shots for kids, says Vinay Prasad, M.D.
By Susan C. Olmstead | The Defender | June 23, 2022
Vinay Prasad, M.D., MPH, this week addressed misleading information about kids and COVID-19 vaccines coming from four sources: The New York Times, former Biden COVID-19 response advisor Andy Slavitt, head of COVID-19 response Dr. Ashish Jha, and the Brown University School of Public Health.
Prasad made the comments in his videotaped response to news coverage of the June 15 decision to recommend Pfizer and Moderna’s COVID-19 vaccines for infants and young children.
Prasad had a message for the “experts” hoping to convince parents to have their young children vaccinated against COVID-19: “You’re not persuading anybody.”
“You’re laying it on a little thick and you’re not being honest about it, and in the process you’re discrediting yourself,” Prasad said.
Prasad, a hematologist-oncologist and associate professor in the department of epidemiology and biostatistics at the University of California, San Francisco, has been critical of COVID-19 vaccines — and especially their use in children — since the vaccines’ introduction.
He cited a New York Times article that stated:
“Some parents may be uninterested [in the vaccines] because their children were among the 75 percent thought to have already been infected.
“But vaccination provides more powerful and consistent protection even if a child has already been infected, [Centers for Disease Control and Prevention] scientists noted on Saturday.”
“The truth is … they don’t know that to be true,” Prasad said. “If a child has already had COVID, [and] recovered from COVID, we do not know that they have a further reduction in MIS-C [Multisystem Inflammatory Syndrome in Children], death, hospitalization, etc., from a potential reinfection.”
“It’s a lie,” he added. “The best they could say is that although some people speculate that to be the case, we currently have no large-scale randomized evidence to support that claim. We don’t even have observational data to support that claim in this age group.”
Prasad then addressed a tweet from Slavitt:
Now polls say only 20% of parents will vaccinate their < 5 year olds.
I will address that in a second, but the most important point for parents is that anyone who wants to can do it. And that is a game changer.
We know it protects against serious illness & long COVID. 9/
“Well, actually, you don’t know that, Andy,” said Prasad, addressing Slavitt’s claim that the vaccine protects against serious illness and “long COVID.”
In fact, “People should report this to Twitter for misinformation,” he said.
Vaccine trials in young children were too small to lead to any comment about serious illness, he said.
“Severe disease is [so] infrequent that no one can say anything about that, and you certainly don’t know about long COVID — that wasn’t even a measured endpoint in these studies.”
“And … what’s even the definition of long COVID in kids?” he asked. “We’ll have to sort that out first.”
“It’s a lie, it’s an exaggeration, it’s trying to get somebody to do something but it’s not being perfectly honest.”
Prasad also examined a statement Jha made Monday on “Good Morning America”: “The evidence is really clear that vaccinations prevent hospitalizations and serious illness, including in kids.”
This was in response to host George Stephanopoulos asking if a child younger than 5 who has already had COVID-19 and recovered should get a COVID-19 vaccine.
This answer is factually incorrect and an exaggeration to achieve a policy goal, said Prasad. “The real answer is we don’t know.”
“We do not have any evidence that would support that claim,” he said. “We do not have evidence that vaccination improves any health outcome for [children], and we certainly don’t have the evidence that it prevents hospitalization serious illness in those kids.”
Prasad then tackled a Brown University School of Public Health “tip sheet” titled “Talking About Covid-19 Vaccines for Children Six Months to Four Years Old.”
The tip sheet was produced “in an effort to provide timely knowledge and evidence-based talking points for public health professionals, healthcare workers and others” on COVID-19 vaccines for children as young as 6 months.
Prasad called the tip sheet “the opinions of a few people who are self-anointed experts masquerading as evidence.”
The authors of the sheet claim: “We know from vaccinations in 5- 17-year-olds that hospitalization, critical illness and deaths are all more common among kids and teens who are not vaccinated than kids and teens who are vaccinated and boosted.”
Prasad disagreed. Due to poor study design, he said, “We really don’t know, especially in kids 5 to 11, if [vaccination] actually lowers hospitalization or MIS-C.”
“I haven’t yet seen a good study to persuade me, particularly in kids who’ve had COVID,” he said.
The tip sheet also says that in studies conducted by Pfizer and Moderna, vaccines “reduced the rate of ANY infection by between 37-80%. Although the overall number of cases were low, both vaccines are expected to decrease hospitalizations and ICU stays, as well.”
Prasad responded, “You may expect that to be the case, but some of us want data, not expectations by people who have a certain point of view.”
“That claim that these vaccines have been found to be 37% to 80% effective is a lie. It’s untrue,” he added.
Prasad summed up the treatment of people with concerns about the vaccine with a tweet from Eric Weinstein:
I was listening to NPR just the other day. It was phrased in something like the following way as I remember it: “Good news for parents, the long wait for vaccines for their young children is finally over.”
Completely dissing parents with concerns about vaccinating low risk kids.
The way I hear it: we assume the argument that all good parents agree:
“COVID vaccines = Clear Pure Good. Slam dunk. Costless & Riskless. No Brainer. Science.”
“Vaccine concerns = Right Wing / AltRight, anti-science mental illness. Fox Newsesque. MAGA Adjacent. Anti-American.”
“I think Eric Weinstein is right,” said Prasad. “Nobody likes the feeling of somebody selling you something. Everyone can tell the evidence is sparse.”
“People are just proselytizing and exaggerating on TV and there’s not really a dialogue about what’s known or not known.”
If health experts had just presented the public with both known and unknown information about the vaccines, he said — if they had admitted that most likely, both the risks and the benefits of the vaccine are “probably pretty low” — we would have more trust in their guidance.
“Just tell the truth,” Prasad urged.
Instead, health authorities “are exaggerating and lying and distorting the truth.”
Susan C. Olmstead is the assistant editor of The Defender.
© 2022 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.
Pfizer Classified Almost All Severe Adverse Events During COVID Vaccine Trials ‘Not Related to Shots’
By Michael Nevradakis, Ph.D. | The Defender | June 22, 2022
The latest release by the U.S. Food and Drug Administration (FDA) of Pfizer-BioNTech COVID-19 vaccine documents reveals numerous instances of participants who sustained severe adverse events during Phase 3 trials. Some of these participants withdrew from the trials, some were dropped and some died.
The 80,000-page document cache includes an extensive set of Case Report Forms (CRFs) from Pfizer Phase 3 trials conducted at various locations in the U.S., in addition to other documentation pertaining to participants in Pfizer-BioNTech vaccine trials in the U.S. and worldwide.
The FDA on June 1 released the documents, which pertain to the Emergency Use Authorization (EUA) of the vaccine, as part of a court-ordered disclosure schedule stemming from an expedited Freedom of Information Act (FOIA) request filed in August 2021.
Public Health and Medical Professionals for Transparency (PHMPT), a group of doctors and public health professionals, submitted the FOIA request.
CRFs show deaths, severe reactions to the vaccines during Phase 3 trials
The CRFs included in this month’s documents contain often vague explanations of the specific symptoms experienced by the trial participants.
They also reveal a trend of classifying almost all adverse events — and in particular severe adverse events (SAEs) — as being “not related” to the vaccine.
For example:
- A female in her early 50s (randomization number 86545) who participated in the trial at the Sterling Research Group in Cincinnati, Ohio, died of an apparent myocardial infarction on Nov. 4, 2020. She had received two doses of the vaccine, on Sept. 10 and Sept. 29, 2020.
The patient had a medical history of chronic obstructive pulmonary disease, hypertension, hypothyroidism, osteoarthritis of the knees and attention deficit disorder. Her death was listed as “not related” to the vaccine, and was instead attributed to “hypertensive cardiovascular disease.”
- A female in her late 50s (randomization number 220496), who participated in the trial at Cincinnati Children’s Hospital Medical Center, died of cardiac arrest on Oct. 21, 2020. Her death, however, was indicated as “not related” to her vaccinations (which occurred on July 30, 2020, and Aug. 20, 2020) as it “occurred 2 months after last receipt of study agent,” according to her CRF.
The participant’s medical history included obesity, placement of a gastric sleeve, gastroesophageal reflux, sleep apnea, supraventricular tachycardia, hypothyroidism, depression and asthma.
- A male in his mid-60s (randomization number 221076) who participated in the trial operated by the Texas-based Ventavia Research Group died of an apparent myocardial infarction on Nov. 28, 2020. He had received the two doses of the vaccine on July 31, 2020, and Aug. 19, 2020.
The participant had a medical history that included a previous myocardial infarction, high blood pressure, high cholesterol, anxiety, bilateral hip pain, type 2 diabetes, fluid retention, angina (intermittent), restless leg syndrome, Vitamin D deficiency, tobacco dependency and the placement of a coronary arterial stent in 2017.
According to the CRF, he sustained the myocardial infarction on Oct. 27, 2020, and was diagnosed with pneumonia the following day. While both diagnoses were classified as “serious” in his CRF, they were both listed as “not related” to the vaccination, with his myocardial infection attributed to a “failed cardiac stent” and the pneumonia simply attributed to “infection.”
- A female in her teens (randomization number 104650) was diagnosed with right lower extremity deep vein thrombosis on Nov. 15, 2020, which was still ongoing as of Mar. 29, 2021, the date of the CRF. She was hospitalized and her condition was classified as “serious,” but it was indicated as “not related” to the vaccine, instead attributed to a “fracture” occurring prior to her vaccination on Sept. 11, 2020.
The patient had a medical history including asthma, attention deficit hyperactivity disorder, Charcot-Marie-Tooth disease and obesity.
- A male in his mid-70s (randomization number 227629) participating in the trial at Clinical Neuroscience Solutions Inc. (operating in Florida and Tennessee) sustained a series of adverse events following his vaccinations on Aug. 13 and Oct. 7, 2020.
He was diagnosed with COVID-19 on Aug. 30, 2020, which coincided with several other diagnoses classified as “serious,” including abdominal adhesions (Aug. 29, 2020), altered mental status (Aug. 29, 2020, lasting through Sept. 16, 2020), and acute hypoxic respiratory failure (Aug. 30, 2020). These diagnoses required his hospitalization.
He was also listed as having suffered from congestive heart failure on Aug. 30, 2020, but this diagnosis was listed as “not serious” and as “not related” to the vaccine, but to “prior surgery,” with no further details given. Similarly, his other serious adverse events were listed as being related to “prior” or “previous” surgery, or to “concomitant non-drug treatment.”
Other “non-serious” adverse events listed in this patient’s CRF include hypokalemia, anemia, acute renal failure, sepsis, hyponatremia, leukopenia, small bowel obstruction, aspiration pneumonia, mild concentric left ventricular hypertrophy (symptoms of which were still ongoing as of the CRF date of Mar. 29, 2021) and urinary tract infection.
The patient had a medical history encompassing ongoing hypertension, hypercholesterolemia, gastroesophageal reflux disease, constipation, hiatal hernia and previous diagnoses of small bowel resection, small bowel perforation, inguinal hernia, osteoarthritis in both knees and knee replacement (both knees).
- A male in his mid-70s (randomization number 266982) participating in the trial at Boston Medical Center suffered a series of adverse events following vaccination, including pneumonia and peripheral edema. He had received two doses of the vaccine, on Oct. 2, 2020, and Oct. 27, 2020.
The patient was hospitalized for pneumonia on Jan. 20, 2021, in an event classified as “serious” but also as “not related” to the vaccine. However, the cause of his pneumonia was listed in the CRF simply as “un-related to vaccine,” while his peripheral edema diagnosis was attributed to “existing neuropathy.”
During his hospitalization with pneumonia, his blood pressure was measured as high as 179/72, with a heart rate reaching 105 beats per minute and an oxygen saturation level that fell to 92.0. In total, he had three emergency room visits during the observation period.
The patient had a medical history that included type 2 diabetes, alcoholic cirrhosis, hypothyroidism, asthma, sleep apnea, hypertension, diabetic neuropathy, congestive heart failure, generalized anxiety disorder, depression, insomnia, excessive urination, chronic obstructive pulmonary disease and HIV-positive status.
A protocol deviation also occurred involving this patient, as his diary was not activated following administration of the first dose of the vaccine.
- A male in his early 40s (randomization number 68489) who participated in the trial at Cincinnati Children’s Hospital Medical Center sustained chronic myelogenous leukemia on Sept. 24, 2020, with the condition ongoing as of the date of the CRF on Mar. 29, 2021.
This was classified as a “serious” and “life-threatening” adverse event, albeit one that did not require hospitalization, but it was listed as “not related” to the vaccination but instead to a “genetic change in stem cells.”
The patient had been vaccinated on Aug. 26, 2020, and Sept. 17, 2020, and had a medical history of asthma and seasonal allergies. Other “non-serious” adverse events he sustained included leukocytosis and thrombocytosis.
- A female in her mid-40s (randomization number 49018) who participated in the trial at Clinical Neuroscience Solutions Inc. was diagnosed with kidney stones on Jan. 4, 2021.
This was classified as a “serious” adverse event that required hospitalization, but was listed as “not related” to the vaccine, instead being related, again, to “kidney stone” (sic). She had received the two doses of the vaccine on Aug. 17, 2020, and Sept. 8, 2020.
The patient was diagnosed with COVID-19 on Jan. 27, 2021. Her prior medical history included migraine headaches, hypercholesterolemia and a Tarlov cyst.
- A female approximately 30 years old (randomization number 53307) participating in the trial at Boston Medical Center, with nothing to report in her medical history, sustained a shoulder injury related to vaccine administration (SIRVA) on Sept. 9, 2020, with symptoms continuing until Feb. 8, 2021.
This injury was listed as being related to the second dose of the vaccine, which she received on Sept. 9, 2020 (she had previously received her first dose on Aug. 17, 2020).
- A female in her late 50s (randomization number 260125) participating in the trial at Clinical Neuroscience Solutions Inc., suffered from acute exacerbation of asthma. The symptoms appeared in mid-December 2020, following her vaccination on Sept. 16, 2020, and Oct. 5, 2020.
Her symptoms were classified as serious but not life-threatening, and she was hospitalized. However, her asthma symptoms were listed as “not related” to the vaccine, instead being related to “asthma” with no further explanation provided. On Jan. 12, 2021, her blood pressure was recorded as 183/130, with a heart rate of 98 beats per minute.
Other less serious adverse events sustained by the patient included injection site pain, body pain, chills and a low-grade fever.
Her medical history included cholecystitis (and a cholecystectomy), herniated disc, total abdominal hysterectomy, bilateral oophorectomy, bilateral salpingectomy, endometriosis, hypertension, hypercholesterolemia, rheumatoid arthritis in remission, asthma, seasonal allergies, irritable bowel syndrome and obesity.
- A male in his late 20s (randomization number 48413) who participated in the trial at Clinical Neuroscience Solutions Inc., sustained a bilateral pulmonary embolism on Dec. 14, 2020, with symptoms still ongoing as of the CRF date of Mar. 29, 2021.
This was listed as a “serious” adverse event that required hospitalization, but was attributed to the patient’s habit of vaping and his “sedentary lifestyle.” He had received the two doses of the vaccine on Aug. 13, 2020, and Sept. 2, 2020.
Other post-vaccination symptoms listed for the patient included fever, fatigue, headache, chills, vomiting, diarrhea, new/worsened muscle pain, new/worsened joint pain and swelling.
The patient had a medical history that included elevated triglycerides, genital herpes and seasonal allergies, in addition to a vaping habit.
The many serious adverse events – and several deaths – recorded during the Phase 3 trials are also apparent in a separate, massive document, exceeding 2,500 pages, cataloging such adverse events.
This document lists a wide range of adverse events suffered by trial participants classified as toxicity level 4 — the highest and most serious such level.
However, not one of the level 4 (most severe) adverse events listed in this particular document is classified as being related to the vaccination.
Level 4 adverse events listed in the document include but are not limited to the following, many of which occurred in multiple patients:
- Acute cholecystitis
- Acute respiratory failure
- Adrenal carcinoma
- Anaphylactic shock
- Aortic valve incompetence
- Appendicitis
- Arrhythmia, supraventricular
- Arteriosclerosis
- Brain abscess
- Cardiac arrest
- Chronic myeloid leukemia
- Complicated appendicitis/acute appendicitis with necrosis
- Congenital heart disease/heart anomaly
- Coronary artery occlusion
- COVID-19 illness
- Deep vein thrombosis
- Diverticulitis
- Hemiplegic migraine
- Hemorrhagic stroke
- Interstitial lung disease
- Myocardial infarction
- Orthostatic hypotension/possible postural hypotension
- Osteoarthritis
- Pericolic abscess
- Peritoneal abscess
- Renal colic
- Ruptured diverticulum
- Small bowel obstruction/small intestinal obstruction
- Spontaneous coronary artery dissection
- Subarachnoid hemorrhage
- Suicidal ideation (and suicidal ideation with attempt)
- Syncope
- Type 2 diabetes
- Worsening of abdominal pain
- An “unevaluable event/“unknown of unknown origin”
Similarly, only a small number of toxicity level 3 adverse events were indicated as having been “related” to vaccination. Such adverse events included but are not limited to the following, some of which occurred in multiple trial participants:
- Arthralgia
- Blood glucose increase/glucose spike
- Deafness/hearing loss
- Dyspepsia
- Hypotension
- Lymph node pain
- Lymphadenopathy/lymph node swelling
- Musculoskeletal chest pain (non-cardiac)
- Neutropenia
- Pain in fingers/bilateral hands
- Pruritus
- Pyrexia/febrile syndrome
- Severe headache
- Shoulder injury related to vaccine administration
- Sleep disorder/sleep disturbance
- Tachycardia
- Urticaria
- Ventricular arrhythmia
- Vertigo
Page 2,525 of the document in question also lists six trial participant deaths, with causes of death including arteriosclerosis, cardiac arrest, hemorrhagic stroke and myocardial infarction.
The small number of adverse events listed as being connected to the vaccine follows a trend noted in the previous tranche of Pfizer-BioNTech documents, released in May.
An additional document released in this month’s tranche catalogs patients who discontinued their participation in the Phase 3 trial, or whose participation was discontinued by physicians or other medical professionals.
While many patients were discontinued because they could not be located, because of a physician’s orders, because they moved to another region or for other personal reasons, numerous patients ended their participation due to adverse events, including but not limited to the following symptoms:
- Acute myocardial infarction
- Amnesia
- Anorexia
- Atrial fibrillation
- Cerebral infarction
- Congestive cardiac failure
- Coronary artery disease
- Deafness (unilateral)
- Depression
- Diabetic foot
- Diverticular perforation
- Exposure during pregnancy
- Eye pain
- Gait instability
- Gastric adenocarcinoma
- Gastrointestinal hemorrhage
- Hypertension
- Irregular heart rate
- Loss of taste and smell
- Myalgia
- Paraparesis
- Parkinsonism
- Presyncope
- Pulmonary embolism
- Pyrexia
- Swelling face
- Tachycardia
- Transient ischaemic attack
- Urticaria
- Vaccine allergy
- Vertigo
In other instances, subjects withdrew because of fears connected to safety concerns related to the vaccine, or discomfort in receiving the second dose.
Clinical review document glosses over adverse events during trials
Also included in June’s FDA document dump was a 334-page “clinical review” document, which appears to have been approved by the FDA on Apr. 30, 2021, and which presents “pivotal data” from Phase 1/2/3 Study C4591001, conducted in the U.S., along with “supporting” Phase 1/2 data from Study BNT162-01, performed in Germany.
This document refers to both Pfizer-BioNTech vaccine, which received an EUA from the FDA, and the Pfizer Comirnaty vaccine, which received full FDA approval but is reportedly almost impossible to find at vaccination locations in the U.S.
As previously reported by The Defender, a federal judge found the Pfizer-BioNTech and Pfizer Comirnaty vaccines are legally distinct.
The clinical review document states:
“BNT162b2 has received temporary authorizations for emergency supply in 28 countries and conditional marketing authorizations in 39 countries globally.
“The name of the product supplied under emergency/temporary use authorization for all applicable regions is Pfizer-BioNTech COVID-19 Vaccine.
“The name of the product supplied under conditional marketing authorization for all applicable regions is COMIRNATY [COVID-19 mRNA Vaccine (nucleoside modified)].”
The document states that trial participants were administered one of two candidate vaccines, labeled BNT162b1 and BNT162b2 (the latter of which ultimately received an EUA from the FDA), or a placebo. A variety of dosage levels were also tested, ranging from 10 μg to 100 μg for BNT162b1, and 10 μg to 30 μg for BNT162b2.
In Phase 1 of Study BNT162-01, the clinical review reports that “40% to 45% of participants who received BNT162b1 and BNT162b2 across age groups and across dose levels reported one or more AEs [adverse events] from Dose 1 through 28 days (i.e., 1 month) after Dose 2.”
In what will turn out to be a general pattern throughout the clinical review, we are told that “most AEs were considered by the investigator as not related to study intervention and mild to moderate in severity, and all AEs were reported as resolved.”
Some specific adverse events highlighted in this part of the clinical review include:
“Among BNT162b1 recipients, 1 younger participant in the 10 μg group discontinued the study due to a moderate AE of malaise (considered as not related to study intervention) after Dose 1 and 1 younger participant in the 60 μg group discontinued due to a dose-limiting toxicity of pyrexia after Dose 1.
“One older participant in the 20 μg group had an SAE of severe syncope (considered as not related to study intervention) after Dose 1 and study treatment was withdrawn.
“Among BNT162b2 recipients, 1 younger participant in the 10 μg group discontinued the study due to a moderate AE of nasopharyngitis (considered as not related to study intervention) after Dose 1.
“One older participant in the 20 μg group had an SAE of ankle fracture (considered as not related to study intervention) after receiving both doses, was listed as recovering, and remains in follow-up.”
The clinical review also states “no deaths occurred in the Phase 1 part of Study BNT162-01.”
The review adds that “from Dose 1 of BNT162b2 30 μg to the unblinding date, 6 (50.0%) participants in the younger age group and 3 (25.0%) participants in the older age group reported at least 1 AE.”
Specifically, in this portion of the study, “two (16.7%) participants in the BNT162b2 30 μg younger age group and 1 (8.3%) participant in the BNT162b2 30 μg older age group reported at least 1 severe AE,” and “in the BNT162b2 30 μg younger age group, 3 (25.0%) participants reported at least 1 related AE and 1 (8.3%) participant reported 1 severe SAE.”
These specific adverse events, according to the review, were reported in “the system organ class (SOC) of nervous system disorders (3 [25.0%] participants in the younger age group and 1 [8.3%] participant in the older age group), followed by musculoskeletal and connective tissue disorders (1 [8.3%] participant in each age group). All AEs by preferred term (PT) were reported by no more than 1 participant.”
The review adds, “from Dose 1 to the unblinding date, 1 participant in the BNT162b2 30 μg younger age group reported a severe SAE (neuritis) that was assessed by the investigator as not related to study intervention,” and “there were no Phase 1 participants randomized to BNT162b2 30 μg or corresponding placebo who died through the data cutoff date of 13 March 2021.”
Review of results from Study C4591001
While “incidences in the BNT162b2 and placebo were similar within the age groups for younger (9.1% vs 11.1%) and older (4.3% vs 8.9%) participants, among those who received BNT162b2 instead of the placebo, “two severe events of myalgia and gastric adenocarcinoma (which was also an SAE) were reported for 2 participants in the … younger age group, both assessed by the investigator as not related to study intervention.”
It is further mentioned that “the only discontinuation due to an AE during this time was the participant in the BNT162b2 younger age group who reported an SAE of gastric adenocarcinoma (discontinued from the study on Day 23 after Dose 1 of BNT162b2).”
Ultimately, from dose 1 to 1 month after dose 2 for participants during the blinded safety follow-up of study C4591001, “the numbers of overall participants who reported at least 1 AE and at least 1 related AE were higher in the BNT162b2 group (30.2% and 23.9%, respectively) as compared with the placebo group (13.9% and 6.0%, respectively).”
Specifically, “severe AEs were reported by 1.2% and 0.7% in in the BNT162b2 and placebo groups respectively, and life-threatening AEs were similar (0.1% in both groups),” and “SAEs and “AEs leading to withdrawal were reported by ≤0.6% and ≤0.2%, respectively, in both groups,” while “discontinuations due to related AEs were reported in 13 participants in the BNT162b2 group and 11 participants in the placebo group (0.1% in both groups).”
Overall, as reported for this part of the study, “in the younger age group, the number of participants who reported at least 1 AE from Dose 1 to 1 month after Dose 2 was 4233 (32.6%) and 1871 (14.4%) in the BNT162b2 and placebo groups, respectively. In the older age group, the number of participants who reported at least 1 AE from Dose 1 to 1 month after Dose 2 was 2384 (26.7%) and 1177 (13.2%) in the BNT162b2 and placebo groups, respectively.”
The review specifies that “the most frequently reported AEs in the BNT162b2 group … were injection site pain (2915 [13.3%]), pyrexia (1517 [6.9%]), fatigue (1463 [6.7%]), chills (1365 [6.2%]), headache (1339 [6.1%]), and myalgia (1239 [5.7%]),” however, some more serious adverse events that were reported during this stage of the trial included facial paralysis, cardiac disorders, hepatic cirrhosis, cholecystitis/cholecystitis acute, biliary colic, bile duct stone, biliary dyskinesia, lymphadenopathy, appendicitis, optic neuritis and hypersensitivity/anaphylaxis.
Overall, according to the review, “from Dose 1 to 1 month after Dose 2, severe AEs reported during the blinded follow-up period were low in frequency, reported in 1.2% of BNT162b2 recipients and 0.7% of placebo recipients.”
During the “open-label follow-up period,” referring to the period when the initial trial has been completed but participants are invited to continue taking the study drug for an additional period, the review states “three participants originally randomized to BNT162b2 died during open-label follow-up.”
While one of these deaths was reportedly due to a road accident, the other two were attributed to lung metastases and myocardial infarction. However, none of these deaths “were assessed by the investigator as related to study intervention.”
Furthermore, according to the report, during this period “there were 12,006 participants who had at least 6 months of follow-up. Among these, 3,454 participants (28.8%) reported at least 1 AE and 2245 participants (18.7%) reported at least 1 related AE. Severe AEs and SAEs were reported by 2.1% and 1.6%, respectively.”
The review provides data for participants from dose 3 (first dose of BNT162b2) to the data cutoff date. The severe adverse event incidence rate (IR) was 6.0 per 100 PY (patient-years), with specific conditions reported including pulmonary embolisms, thrombosis, urticaria, a cerebrovascular accident and COVID-19 pneumonia.
Here, the review adds that the IR for original placebo participants who had at least 1 life-threatening AE from Dose 3 to the data cutoff date was 0.5 per 100 PY. Only one such life-threatening event, an instance of anaphylactoid reaction, was considered to be related to the vaccination. Other life-threatening, serious adverse events included cardio-respiratory arrest, gastrointestinal necrosis, deep vein thrombosis and pulmonary embolism.
The report also notes, “There were 15 deaths in the BNT162b2 group and 14 deaths in the placebo group from Dose 1 to the unblinding date during the blinded placebo-controlled follow-up period.”
However, the report does not appear to go into detail about the causes of death for either group, other than to state, “None of these deaths were assessed by the investigator as related to study intervention.”
In the “Blinded Follow-Up Period from Dose 1 Through 1 Month After Dose 2,” in the BNT162b2 group, “SAE [serious adverse events] was similar in the BNT162b2 group (0.6%) and in the placebo group (0.5%),” with three SAEs in the non-placebo group deemed to be related to the vaccine. These included ventricular arrhythmia, lymphadenopathy and SIRVA.
During the “open-label follow-up period” for “original BNT162b2 participants,” the report states “one younger participant with no past medical history had a life-threatening SAE of myocardial infarction 71 days after Dose 2 that was assessed by the investigator as related to study intervention.”
However, despite its life-threatening nature, this condition “lasted 1 day and resolved the same day.”
Overall, “from Dose 1 to 6 months after Dose 2, during the blinded and open-label follow-up periods, 190 (1.6%) participants in the BNT162b2 group reported at least 1 SAE,” and “the number of participants who reported at least 1 SAE was 73 (1.1%) and 117 (2.2%) in the younger and older age groups, respectively.”
These SAEs were categorized as neoplasms, infections and infestations, gastrointestinal disorders, hepatobiliary disorders, respiratory/thoracic/mediastinal disorders and injury/poisoning/procedural complications.
An original placebo participant who received BNT162b2 for Dose 3 experienced a severe adverse event that “was assessed by the investigator as related to study intervention; specifically, “an anaphylactoid reaction 2 days post Dose 3” leading to the participant’s withdrawal from the study, despite a reported resolution.
A separate subsection in the report specifically addressed cases of Bell’s palsy and facial paralysis among trial participants. Specifically, “during the blinded placebo-controlled follow-up period, 6 participants developed one-sided facial paralysis (Bell’s palsy): 4 were randomized to BNT162b2 (all male) and 2 were randomized to placebo (1 male; 1 female),” according to the review.
Regarding the four vaccinated trial participants, their ages ranged from 40 to 70, with symptoms appearing three to 48 days after their last dose. Their symptoms were recorded as “mild to moderate in severity,” with duration ranging “from 3 to 68 days,” and with two of these cases “considered by the investigator to be related to study intervention.”
Moreover, “during the open-label follow-up period, 3 participants who received BNT162b2 as Dose 3 or Dose 4 (after originally being randomized to placebo) experienced facial paralysis,” according to the review. These patients were all female, with an age range between 19 and 34. Events were recorded as beginning two to eight days after administration of the third dose, and “were mild to severe.” One case had a duration of 12 days, while the other two cases were ongoing as of the cutoff date of the trial.
Notably, according to the review, “all these events of facial paralysis were considered by the investigator as related to study intervention.”
The review adds, “during the open-label follow-up period for participants originally randomized to BNT162b2, a male participant 51 years of age developed Bell’s Palsy 154 days after receiving Dose 2.” No indication is given as to whether this was deemed to be related to the vaccination or not.
From dose 1 to the unblinding date, heart-related adverse events included “6 acute myocardial infarctions, 4 myocardial infarctions group, and 1 acute coronary syndrome” in the BNT162b2 group.
According to the review, “most of these events had onset distant (ie, >30 days following) to receipt of vaccine or placebo. None of these events were assessed by the investigator as related to study intervention.”
Moreover, “there was 1 participant in the older BNT162b2 age group with pericarditis. The event had an onset of 28 days after Dose 2, was ongoing at the data cutoff date, and was assessed by the investigator as not related to the study intervention.”
Additionally, “there were 8 cases of pulmonary embolism in the BNT162b2 group,” in addition to four hemorrhagic strokes and “2 ischemic strokes, 4 cerebral vascular accidents, 2 transient ischemic attacks” in this group, plus “1 case of thrombocytopenia and 1 case of platelet count decreased.”
Furthermore, “there were 9 thrombotic events in the BNT162b2 group,” including seven instances of deep vein thrombosis, one case of coagulopathy and one case of ophthalmic vein thrombosis.
Regarding autoimmune issues in the BNT162b2 group, the review states “there were 10 autoimmune disease cases identified,” with one case each of “autoimmune thyroiditis, ulcerative colitis, Crohn’s disease, reactive arthritis, fibromyalgia, systemic lupus erythematosus, alopecia areata, psoriasis,” and two cases of psoriatic arthropathy.
Pregnancies were largely glossed over in the review, which states:
“At the time of the data cutoff date (13 March 2021), a total of 50 participants who had received BNT162b2 had reported pregnancies, including 42 participants originally randomized to the BNT162b2 group and 8 participants originally randomized to the placebo group who then received BNT162b2.”
“In total, 12 participants (n=6 each in the randomized BNT162b2 and placebo groups) withdrew from the blinded placebo-controlled vaccination period of the study due to pregnancy, and 4 participants originally randomized to placebo who then received BNT162b2 withdrew from the open-label vaccination period due to pregnancy.
“These participants continue to be followed for pregnancy outcomes. No births have been reported from individuals who have become pregnant in Study C4591001 as of the time of this submission.
“All pregnancies have a risk of birth defect, loss, or other adverse outcomes. Available data on BNT162b2 administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.”
Pfizer concludes vaccines are ‘safe and well-tolerated’
Overall, despite the incidence of severe adverse events — some of which were admitted to be related to the vaccine — and deaths, as well as an admitted lack of data regarding outcomes for pregnant women who participated in the trial, the “safety conclusions” of the review indicate the following:
“Based on Phase 1 data from the FIH Study BNT162-01, BNT162b1 and BNT162b2 were safe and well-tolerated in healthy adults 18 to 55 years of age, with no unanticipated safety findings … and the AE profile and clinical laboratory results did not suggest any safety concerns.
“Based on Phase 1 data from Study C4591001 and Study BNT162-01, BNT162b1 and BNT162b2 were safe and well-tolerated in younger healthy adults 18 to 85 years of age, with no unanticipated safety findings … and the AE profile did not suggest any safety concerns, including up to approximately 6 months after Dose 2 for BNT162b2 30 μg groups.
“Based on Phase 2/3 data from approximately 44,000 participants ≥16 years of age with up to at least 6 months of follow-up after Dose 2 in Study C4591001, BNT162b2 at 30 μg was safe and well-tolerated across age groups … and the AE profile did not suggest any serious safety concerns. The incidence of SAEs and deaths were low in the context of the number of participants enrolled and comparable in BNT162b2 and placebo. The incidence of discontinuations due to AEs was also generally low and similar between BNT162b2 and placebo groups.
“Cumulative safety follow-up to at least 6 months after Dose 2 for approximately 12,000 Phase 2/3 participants originally randomized to BNT162b2, comprising the combined blinded and open-label periods, showed no new safety signals or suggested [any] new safety concerns arising from this period of follow-up.
“Similarly, open-label follow-up of participants originally randomized to placebo from the time of unblinding to receive BNT162b2 until the data cutoff date showed no new safety signals or concerns.
“The AE profile among approximately 44,000 participants ≥16 years of age enrolled to date as of the most recent safety cutoff date (13 March 2021), was mostly reflective of reactogenicity events with low incidences of severe and/or related events. The incidence of SAEs was low and similar in the vaccine and placebo groups. Few participants withdrew from the study due to AEs. Few deaths occurred overall in both the vaccine and placebo groups with no imbalance.
“For participants randomized to placebo and then unblinded to receive BNT162b2 vaccination, open-label data from the time of unblinding to the data cutoff date (13 March 2021) showed no new safety findings or signals.
“Taken together, efficacy and immunogenicity data suggest the BNT162b2 (30 μg) 2-dose regimen induces a strong immune response and provides durable protection from COVID-19 across a spectrum of individuals representative of the population at large for individuals ≥16 years of age: those with or without prior exposure to SARS-CoV-2 and those in higher-risk categories based on age, race, ethnicity, and/or comorbidity.”
As a result, and based on the above data, the review makes a case for the approval of BNT162b2:
“A vaccine program must be implemented expediently and rapidly expanded to have a significant impact on the pandemic course. Licensure of BNT162b2 is likely to enhance vaccine uptake by facilitating supply of vaccine from Pfizer/BioNTech directly to pharmacies and healthcare providers/facilities.
“The greatest impact of BNT162b2 licensure may be direct supply to healthcare providers who serve vulnerable populations such as elderly patients and those who live in rural and underserved communities (i.e., individuals who might be unable to navigate the challenges of securing vaccine access using the systems in place for EUA).
“Expansion of vaccine via licensure would ultimately improve the prospect of achieving population herd immunity to bring the pandemic under control.
“Overall, the potential risks and benefits, as assessed by the safety profile and the efficacy and immunogenicity of BNT162b2 (30 μg), are balanced in favor of the potential benefits to prevent COVID-19 in immunized individuals.
“Likewise, the BNT162b2 30 μg benefit and risk profile support further development in pediatric, maternal, and other at-risk populations.”
Michael Nevradakis, Ph.D., is an independent journalist and researcher based in Athens, Greece.
© 2022 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.
Ivermectin Study’s Negative Conclusion is at Odds With Its Findings of Significant Clinical Benefit
BY WILL JONES | THE DAILY SCEPTIC | JUNE 21, 2022
A new study on cheap, repurposed Covid treatment ivermectin has concluded that its findings “do not support the use of ivermectin to treat mild to severe forms of COVID-19”. However, this conclusion is at odds with its findings.
The study, “Non-effectiveness of Ivermectin on Inpatients and Outpatients With COVID-19; Results of Two Randomised, Double-Blinded, Placebo-Controlled Clinical Trials”, is published in Frontiers in Medicine. It includes among its authors Dr. Andrew Hill, who last year appeared to suggest to Dr. Tess Lawrie that pressure had been applied to him not to find in support of ivermectin in an earlier paper. He told her, “I’m in a very sensitive position here”, and “I don’t really want to get into” revealing who from Gates-funded charity Unitaid, which funded the study, really wrote the conclusion of the paper downplaying the benefits of the treatment.
The new study gives a helpful introduction to the drug.
Ivermectin is a low-cost established drug with clinical benefits and minimal safety concerns, which has been shown to inhibit SARS-CoV-2 in vitro in studies. Ivermectin has rapid oral absorption, with high lipid solubility is widely circulated in the body, metabolised in the liver, and excreted in faeces. The adequate concentration of ivermectin inhibiting SARS-CoV-2 in the in vitro experiment is higher than the approved dose of ivermectin concentration in plasma and the lungs of humans. However, a meta-analysis demonstrated that the administration of a standard FDA-approved dose shows a positive clinical response in COVID-19 patients.
The study is a follow-up to an earlier, smaller study which showed promise. However, the promise has not, the authors say, been borne out.
Despite our previous more favourable results from a multicentre, randomised clinical trial in 69 COVID-19 patients at the beginning of the pandemic which noted the effectiveness of ivermectin in recovery and decreasing duration of hospital stay, the current results of this extensive study on 609 admitted patients with moderate to severe form of COVID-19 and 549 outpatients with a mild form of COVID-19, did not show adequate support for the effectiveness of this drug.
Despite this downbeat assessment, the new study did actually find a significant 32% improvement in ivermectin hospital patients achieving complete recovery, with 37% of ivermectin patients vs 28% of placebo patients achieving the outcome [95% CI, 1.04–1.66].
A number of the other key outcomes, including ICU admission and death, were also better in the ivermectin group, though the study was underpowered (not large enough) for these results to be statistically significant (i.e., we can’t be sure they weren’t coincidence). These were:
- ICU admission: 28 ivermectin vs 32 placebo patients; 9% vs 11%; 16% improvement [95% CI, 0.52–1.36].
- Invasive mechanical ventilation: 3% ivermectin vs 6% placebo; 50% improvement [95% CI, 0.24 –1.07].
- Supplemental oxygen by non-invasive ventilation: 244 ivermectin vs 252 placebo; 78% vs 85%; 7% improvement [95% CI, 0.86–1.00].
- Death: 13 ivermectin vs 18 placebo; 4% vs 6%; 33% improvement [95% CI, 0.35–1.39].
The fact that all these outcomes showed an improvement, and mechanical ventilation and death considerably so, is a signal that the benefit is unlikely to be solely due to chance. Thus the conclusion should really have been that a larger study is needed to see if the promising results can achieve statistical significance.
For outpatients, there were also some significant clinical benefits:
- Fever duration: 2.02 (± 0.11) days ivermectin vs 2.41 (± 0.13) days placebo; 16% improvement.
- On the day seventh of treatment, fever, cough and weakness were significantly higher in the placebo group compared to the ivermectin group.
A few results went the other way, though none of these were statistically significant. For inpatients:
- Length of hospital stay: 7.98 (± 4.4) days ivermectin vs 7.16 (± 3.2) days placebo; 20% worse [95% CI, 0.15–1.45]. The study claims this finding is “significant”, but the wide confidence interval going through 1.0 indicates not. The authors write that “delays in discharging patients to other facilities such as rehabilitation centres… might be the reason for more extended hospital stay other than treatment for COVID-19”.
- Mean oxygen saturation at day seven: 92.01 (Range: 72–99) ivermectin vs 93 (Range: 48–99) placebo; 1% worse [95% CI, –2.89 to 0.91].
- Relative recovery (where some symptoms persist on discharge): 53% ivermectin vs 60% placebo; 13% worse [95% CI, 0.76–1.00].
- Persistent dry cough (until seventh day): 5 ivermectin vs 10 placebo; 3% vs 9%; 36% worse [95% CI, 0.13–1.03].
For outpatients:
- Hospitalisation: 7% ivermectin vs 5% placebo; 36% worse [95% CI, 0.65–2.84].
- PCR negative on day five after treatment: 26% ivermectin vs 32% placebo; 19% worse [95% CI, 0.60–1.09].
The authors write that “no evidence was found to support the prescription of ivermectin on recovery, reduced hospitalisation and increased negative RT-PCR assay for SARS-CoV-2 five days after treatment in outpatients”. However, it’s important to note that this was for ivermectin given more than a week after symptoms began. Proponents of ivermectin often argue that treatment should be given within five days of exposure, i.e., as soon as possible.
The paper does mention this issue, though in a strange sentence with typographical errors perhaps indicative of a late addition: “Ivermectin may be going to be effective if it is given at the earliest possible time that clinical symptoms appear whiles [sic] the mean duration of symptoms before randomisation was 7.36 ± 3.43 days in the ivermectin group and 6.98 ± 3.63 days in the placebo group.” Typographical errors aside, the point is correct; an outpatient study really needs to start the treatment sooner.
There may also be a dosage issue. While the trial gave a dose of 0.4 mg per kg per day over a duration of three days, some have suggested a higher dose is required. The paper nods at this where it says: “Krolewiecki et al. assessed antiviral activity and safety of a five-day regimen of high dose ivermectin, comparing the control group in 45 patients with COVID-19. The findings support the hypothesis that ivermectin has a concentration-dependent antiviral activity against SARS-CoV-2.”
A further potential problem with the study, which was conducted in Iran where ivermectin has been popular as a Covid treatment, is the question of how many of the placebo group were also secretly taking ivermectin anyway. In the limitations the authors note that “after the allocation of ivermectin or placebo, a significant number of patients declined to be participants”, which may be because they realised they wanted to be sure they were taking the drug. Taking an antiviral medication was an exclusion criterion for outpatients – 18 admitted to it, but how many continued with the trial (for which they were presumably paid) but took such drugs anyway? Furthermore, previously taking an antiviral does not appear to have been an exclusion criterion for inpatients, so it is unknown how many placebo-arm inpatients had taken ivermectin or another medication prior to hospitalisation. Once in hospital, I imagine they would not have been able to continue taking any medication secretly, and perhaps that explains why nearly a third of the inpatient participants were lost to follow up, most due to voluntary withdrawal or “incomplete intervention” (31.6%, 282 of 891; 136 ivermectin and 146 placebo).
Overall, I find the conclusion baffling given the findings. There were statistically significant benefits of ivermectin for complete recovery, shorter duration of fever and quicker clearing up of cough and weakness. There were also large but not-statistically-significant benefits for mechanical ventilation and death. The negative findings were mostly small and none were statistically significant. This is for a study which didn’t start the treatment until over a week into symptoms, and may have been confounded by people in the placebo arm also taking the drug.
Perhaps we will never get to the bottom of exactly how effective ivermectin is against COVID-19. But since it’s a safe drug (to quote U.K. Chief Medical Officer Chris Whitty, “Ivermectin has proven to be safe. Doses up to 10 times the approved limit are well tolerated by healthy volunteers”) and this study shows once again that it gives some benefit – other studies show much greater benefit – why not be honest about that, allow medics to include it in their treatment protocol, and stop making such a fuss about stopping them?
The Lockdown Advocacy of Devi Sridhar
By Jeffrey A. Tucker | Brownstone Institute | June 20, 2022
The Covid era gave rise not only to popular mania but also to astonishing intellectual pretension. The experts were everywhere. They had all the answers. They knew for certain that a path never tried in anyone’s lifetimes was the certain way to go in order to control a virus. And this fanatical attachment to one goal caused all other considerations to be pushed aside.
The end of the story was baked in from the start. The experts were proven to have massively exaggerated their prowess and understanding of events. On point after point, their models blew up. The epidemic would end the way they always have, through acquired immunity and endemicity. Nowhere did the methods of the vaunted experts achieve the goal; at best they delayed the end point and created tremendous destruction along the way.
Now there is a problem: how to dial it all back without admitting profound error. This is a particular problem for those who wrote books before the story was complete. And by complete I am referring especially to the tremendous waves of infections that came 20 months after lockdowns were first imposed.
A paradigmatic case is Devi Sridhar, professor and chair of global public health at the University of Edinburgh, Scotland. During the pandemic, she became a ubiquitous presence on television for two years both in the UK and the US. Her main message was to advocate and defend lockdowns, masking, mandates, and the entire apparatus of compulsion that characterized the pandemic response in nearly every country in the world. Her message was always geared toward what is called eliminationism or zero Covid.
As a Rhodes scholar in a high prestige position, she was well positioned to be this messenger. She has a compelling way and presents well in the medium. Plus, the message she delivered was the one that earned an official stamp of approval from all mainstream media. She was also a pro at delivering an attitude of disdain toward anyone who dared question the zero Covid story.
Now she has a book out that further elaborates on her point of view. It has the right title: Preventable: How a Pandemic Changed the World and How to Prevent the Next One. It’s a pretentious title, presuming that she knows for certain that the pandemic was preventable and therefore she should be trusted to tell us what to do next time.
What’s striking is the contrast between the certitude of the body of the book in which she is an unapologetic defender of China-style lockdowns and the afterword, which must have been written only days before the book went to print. Here we have a very different tone, discussed toward the end of this review.
Sadly for her, the book came out just before a wave of new lockdowns came to China that wrecked the lives and liberties of hundreds of millions of people and made an enormous mess of the entire economic mission of the country. She must not have had time to revise the manuscript.
Of China, her book says:
The way China set about eliminating SARS-CoV-2 could be described as draconian. It undertook house-to-house testing and removed individuals to quarantine facilities if they tested positive (sometimes against their will); it used tracking technology to trace 99–100 per cent of those who had had contact with the infected; it locked down entire buildings so individuals could not leave their flats or have free movement; and it constructed completely new hospitals within days…
The Chinese government understood well that the virus moves when people move. So it stopped people moving internally…
The efforts to contain the spread within Wuhan were effective and focused on reducing the R number…
These measures to contain spread worked…
[China showed that] containment strategies (however draconian) could be effective at stopping this respiratory pathogen…
The evidence in February 2020 showed that containment was successful…
Within the span of three months, China had eliminated the virus fully within its borders…
This is the same message she delivered to millions day after day for two years.
We could just stop this review here, observing that none of the above turns out to be true. Currently, China faces an enormous problem. If we are to believe the data, vast swaths of China’s population still lack acquired immunity to Covid. Millions or billions need the exposure, and, as with all places in the world, the result for nearly everyone moderately healthy and not elderly will be recovery. This will happen with or without lockdowns.
President Xi Jinping, however, became convinced either by virtue of his ego or his circle of sycophants that his lockdowns two and a half years ago were his greatest achievement. He was celebrated by the World Health Organization and nearly every country in the world copied his brutal methods of virus suppression. He regarded it then as evidence that the CCP was destined to rule the future, by virtue of its masterful social, economic, and now medical management of society.
So of course the CCP cannot turn back now. He has stated repeatedly that there will be no compromise of the zero Covid stance that both he and Dr. Sridhar have long advocated. He must now either continue to threaten and enact lockdowns or figure out some clever way to back away from the position without admitting past error. He may in fact figure it out at some point.
After all, nearly every other government in the world has finally figured it out. Even under the best of assumptions that lockdowns offer some contribution to mitigate the ill-effects of a pathogen, the costs far outweigh those benefits. And those costs not only include economic, educational, and nutritional ones but also costs in terms of deaths from overdoses, despair, and self-harm from the inevitable demoralization from being treated like a prisoner or lab rat.
So I did read Dr. Sridhar’s book in search of some insight as to why she could have made such a profound error. All I found was a relentless and single-minded attachment to a zero Covid agenda, or some version of it, a genuine belief that the right deployment of human force could somehow make a virus go away. It truly boggles the mind.
The rest of the narrative is utterly predictable.
Countries that locked down are good, especially New Zealand and Australia. Countries that did not are bad, especially Sweden but also the UK and the US after reopening. Countries that kept lockdowns longer are good. Countries that opened up too soon are corrupt and rejecting “the science.” The Great Barrington Declaration is bad. Ramdesivir is good while Ivermectin is bad. And so on.
Her hard-core bias extends even to a rousing defense of Rebekah Jones, the low-level data employee in Florida who wrongly accused the Governor’s office of manipulating data in a case that was later tossed out.
The book is so partisan that she sometimes lets her politics even race ahead of her epidemiological position. For example, and this probably won’t surprise you, she comes to the defense of the George Floyd protests even in the midst of lockdowns:
In late May 2020, I was asked whether protesters were wrong to take to the streets. I replied that racism is also a pandemic, and one that Black Americans feel can’t be swept under the carpet any longer. While clearly mass gatherings during a pandemic are risky, I could understand that people were willing to take this risk in order to effect change for their children and the children of their children. This is how the civil rights movement has attempted to progress racial equality over decades.
In any case, you get the point here. She has a tribe and she wants to be its messenger. Still, I struggled through the entire text to see if I could find insight. This one jumped out at me:
While WHO was at the forefront of press briefings and leading technical and normative guidance to the pandemic, the World Bank had the financial power to help governments respond with key policies, whether through building up health systems and testing, putting in place economic packages to support lockdown measures, or in acquiring and distributing vaccines.
There we go: the World Bank subsidized lockdowns. Fascinating. That I did not know. This is a serious problem that needs to be fixed. How many millions face malnutrition as a result?
So much for the body of the book.
Probably the most telling part of the book is the afterword, written January 2022. Here our author jumps in with the latest information, namely that China had not in fact eradicated the virus and now keeps locking down, which she says is due to inferior vaccines. Within a few paragraphs, she – for the first time in the book – recognizes that even the best vaccines do not stop infection and do not stop the spread..
Whoops. Is she willing to rewrite the entire book in light of this last-minute realization that lockdown eliminationism and even mass vaccination cannot achieve the goal? No. Is she willing to rethink? Perhaps a bit but not enough.
While some say we should adapt normal social relations and mixing for the foreseeable future, I struggle with this line of thought. Humans are social: we need to hug, talk, dance, sing, kiss and be around others. We’re not bears or rhinos or other solitary creatures. We like seeing each other’s faces. And we know that a sense of community and connection are vital to wellbeing too. A holistic approach to public health is vital, and this includes not just people’s mental health but also their ability to pay rent, feed their family, stay warm through the winter and have a meaningful role in society, be that going to church or being part of a glee club. For a certain period of time, altering these made sense, so that we could avoid preventable illness and deaths; allow vaccines to be created, trialled and distributed in 2020 and into 2021; allow clinicians to better understand how to treat COVID-19; and allow a better understanding of transmission and risk.
Again, very interesting, especially because the change in tone from the rest of the book is so sharp. She doesn’t come close to repudiating her entire book – and she still believes that totalitarian measures somehow make sense for a “period of time” – but she does say that she is tired and exhausted and perhaps ready for some rethinking.
“I’ve taken a step back from media work… I’ve been testing several times a week, and, while I cautiously avoid crowded spaces, and wear masks on public transport and in shops, I continue to go to the gym and to hot yoga and to see friends outside or in small groups. I’ve found a sustainable way to live alongside COVID-19 for now… You’ve heard enough from me.
These are hopeful signs. It’s possible that even Devi Sridhar might eventually come to see the error of her ways. Or perhaps like most of the exalted experts who assisted in driving the world into the greatest calamity of the modern era, she will quietly disappear from the op-ed pages and television screens and go back to her prior life as a public health professor with degrees in anthropology. At some point, too, she will get Covid and discover with millions of others that it is part of the human experience to get sick and get well and become stronger as a result.
We will wait in vain for any sort of extended literary mea culpas. Not even the pensive afterword comes close. After all, when the next great health crisis presents itself, the WHO pushes for lockdowns again, and the major media empires need some great excuse to order people back home to be glued to the screen, the expertise of these compelling pundits – now with real media experience – will need to be called upon again.
Jeffrey A. Tucker is Founder and President of the Brownstone Institute and the author of many thousands of articles in the scholarly and popular press and ten books in 5 languages, most recently Liberty or Lockdown.
CDC Admits It Never Monitored VAERS for COVID Vaccine Safety Signals
By Josh Guetzkow, Ph.D. | The Defender | June 21, 2022
In a stunning development, the Centers for Disease Control and Prevention (CDC) last week admitted — despite assurances to the contrary — the agency never analyzed the Vaccine Adverse Event Reporting System (VAERS) for safety signals for COVID-19 vaccines.
The admission was revealed in response to a Freedom of Information Act (FOIA) request submitted by Children’s Health Defense (CHD).
In September 2021, I published an article in The Defender in which I used the CDC’s published methodology to analyze VAERS for safety signals from COVID-19 vaccines.
The signals were loud and clear, leading me to wonder “why is nobody listening?”
Instead, I should have asked, “Is anybody even looking for them?”
After that article was published, I urged CHD’s legal team to submit a FOIA request to the CDC about its VAERS monitoring activities.
Since CDC officials stated publicly that “COVID-19 vaccine safety monitoring is the most robust in U.S. history,” I had assumed that at the very least, CDC officials were monitoring VAERS using the methods they described in a briefing document posted on the CDC website in January 2021 (and updated in February 2022, with minor changes).
I was wrong.
The lynchpin of their safety monitoring was to mine VAERS data for safety signals by calculating what are known as proportional reporting ratios (PRR’s).
This is a method of comparing the proportion of different types of adverse events reported for a new vaccine to the proportion of those events reported for an older, established vaccine.
If the new vaccine shows a significantly higher reporting rate of a particular adverse event relative to the old one, it counts as a safety signal that should then trigger a more thorough investigation.
The briefing document states, “CDC will perform PRR data mining on a weekly basis or as needed.”
And yet, in the agency’s response to the FOIA request, it wrote that “no PRRs were conducted by CDC. Furthermore, data mining is outside of the agency’s purview.”
The agency suggested contacting the U.S. Food and Drug Administration (FDA), which was supposed to perform a different type of data mining, according to the briefing document.
CDC officials repeatedly claimed they have not seen safety signals in VAERS.
For example, on April 27, 2021, CDC Director Dr. Rochelle Walensky stated the CDC did not see any signals related to heart inflammation.
But a PRR calculation I did using the number of myo/pericarditis reports listed in the first table produced by the CDC obtained via the FOIA request reveals clear and unambiguous safety signals relative to the comparator vaccines mentioned in the briefing document (i.e., flu vaccines, FLUAD and Shingrix).
The table is dated April 2, 2021, almost four weeks before she made those remarks.
In fact, among the 15 adverse events for adults included in that week’s tabulations, PRRs I calculated also show loud-and-clear safety signals for acute myocardial infarction, anaphylaxis, appendicitis, Bell’s palsy, coagulopathy, multisystem inflammatory syndrome in adults (MIS-A), stroke and death.
The actual monitoring the CDC did diverges from the one promised in the briefing document in other ways.
For example, the CDC never created tables of the top 25 adverse events reported in the previous week, tables comparing different vaccine manufacturers, or tables of auto-immune diseases.
And it only began monitoring in early April 2021, even though reports from COVID-19 vaccines had been flooding VAERS since mid-December of the previous year.
To be clear, VAERS is not the only database the CDC uses to monitor COVID-19 vaccine safety.
For example, the CDC sponsored several studies of COVID-19 safety using the Vaccine Safety Datalink (VSD), which is comprised of millions of medical records from HMO’s across several states.
Those studies do not raise many safety concerns. However, they make many questionable methodological choices.
To give one example, a major safety study based on VSD data published in September 2021, in “JAMA,” compares adverse event rates that occur within 1-21 days of vaccination to the rate of occurrence from 22 to 42 days after vaccination.
It makes no comparison between vaccinated and unvaccinated individuals, or before vaccination versus after in the same individuals.
Moreover, the VSD is far from infallible, having failed initially to detect the increase in myocarditis rates.
In contrast, although calculating PRR’s is a blunt pharmacovigilance tool and far from perfect, it nevertheless has the advantage of being straightforward and difficult to manipulate with statistical sleight of hand.
PRRs are one of the oldest, most basic and most well-established tools of pharmacovigilance. The calculations are so straightforward that the CDC automated it several years ago, so it could have been done at the press of a button.
It simply beggars belief that the CDC failed to do this simple calculation. Even now, a paper published by CDC staff in March on the safety of the mRNA COVID-19 vaccines remains purely descriptive with no PRR calculation.
Meanwhile, a study published by a researcher not affiliated with the CDC in February in “Frontiers in Public Health” analyzes VAERS and EudraVigilance data using a method similar to PRRs, revealing clear and concerning safety signals.
And while it is true that VAERS is not the only database the CDC can use to monitor COVID-19 vaccine safety, it is of critical importance because it can reveal signals much faster than any other method — if anybody cares to look for them.
It remains to be seen if the FDA was properly monitoring VAERS. That will be the subject of a future FOIA request.
But even if it was, it doesn’t change the fact that the CDC completely failed in its promise to monitor VAERS for safety signals.
© 2022 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.
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Book Review
Palantir CEO Calls for Draft to Fight the Empire’s Wars
Involuntary servitude is good for business
By Kurt Nimmo | Another Day in the Empire | April 20, 2026
In 2025, Alex Karp, the CEO of government and military tech contractor Palantir, published The New York Times best-seller, The Technological Republic: Hard Power, Soft Belief, and the Future of the West. The Wall Street Journal praised the book as a cri de coeur, a passionate appeal “that takes aim at the tech industry for abandoning its history of helping America and its allies,” while Wired praised the book as a “readable polemic that skewers Silicon Valley for insufficient patriotism.”
On April 18, 2026, Palantir posted twenty-two points to social media summarizing the book. In addition to taking Silicon Valley to task for insufficient patriotism, advocating a role for AI in forever war, and denouncing the “psychologization of modern politics,” the Palantir post on X declares: “National service should be a universal duty. We should, as a society, seriously consider moving away from an all-volunteer force and only fight the next war if everyone shares in the risk and the cost.”
National conscription, a form of involuntary servitude, and the wars it portends, is good for business, especially for corporations within the orbit of the Pentagon, the CIA, and the national security state. Palantir fits comfortably within this amalgamation. … continue
Blog Roll
Aletho News- After Islamabad: How the Global South Is Reshaping Eurasian Geopolitics
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- Iran War fallout: Russia and China quietly take over natural gas markets in Asia, with Qatar gone
- Hamas dismisses US-backed disarmament plan as ‘collective suicide’
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- Supply chains breaking: The hidden bottlenecks threatening to bring the global economy to a standstill
- Israel’s Expansion Means An Unraveling of Middle East Stability
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- US strikes vessel in Caribbean killing three, death toll reaches 180
- If Americans Knew
- Israel is (still) killing aid workers in Gaza
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- Israeli soldier takes sledgehammer to Jesus statue in Lebanon – Daily Update
- Israel employs ‘Gaza tactics’ in Lebanon, destroying 1,000 homes per day – Daily Update
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- Senate again fails to block weapons to Israel
- No Tricks Zone
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- Abrupt Climate Change Also Occurred NATURALLY In The Past …25 Times During Last Ice Age
- Cave Discovery Reveals Today’s Desert Climates Were Recently Far Warmer, Wetter, Teeming With Life
- German Expert: Heat Dome Led To Record Temps In Western USA…Warmer In 1934, 1936
- New Study: No Linear Warming Or Glacier Retreat Along Northern Antarctic Peninsula Since 1980s
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