Iran Dismisses ‘Ridiculous’ Allegations of Planned Attacks on Israelis in Turkey
Al-Manar – June 24, 2022
Iran dismissed Israeli accusations that it is allegedly plotting to target Israelis in Turkey as “ridiculous” on Friday.
In a tweet from Iran’s Foreign Ministry, spokesperson Saeed Khatibzadeh said that Lapid’s “baseless accusations” about such Iranian activity are “ridiculous” and part of a “pre-designed scenario to destroy relations between the two Muslim countries.”
“It is expected from Turkey not to remain silent in the face of these divisive allegations,” he said.
Khatibzadeh also stressed that Iran would respond forcefully to “assassinations and acts of sabotage by the Zionist regime” but “without threatening the security of civilians and the security of other countries.”
Russian forces encircle thousands as Ukrainian troops begin surrender
Samizdat – June 24, 2022
Up to 2,000 Ukrainian troops, nationalists and foreign fighters have been surrounded by the Russian forces and the Donbass militias, Moscow revealed on Friday. The forces were encircled in two neighboring towns in the Lugansk People’s Republic.
Four Ukrainian battalions. as well as an artillery unit are among those trapped, Russia’s Defense Ministry announced. The encircled forces also include around 120 fighters from the notorious Ukrainian ‘Right Sector,’ a neo-Nazi group of up to 80 foreign fighters, according to the ministry.
The troops have been surrounded in the towns of Gorskoye and Zolotoye, located south of the major cities of Severodonetsk and Lisichansk, which have recently become one of the major targets for both sides amid the continued fighting for the territory of the Donetsk and Lugansk People’s Republics.
The Russian military has also claimed that the surrounded units have lost over 60% of their strength. According to the defense ministry, 41 Ukrainian soldiers encircled in the area have surrendered. The Defense Ministry has also published a video supposedly showing the surrendered soldiers.
The head of the Ukrainian Gorskoye military administration, Aleksey Babchenko, confirmed to the Ukrainian media on Friday that the town has been fully seized by the Russian forces and the Donbass militias.
Sergey Gaidai, who Ukraine calls the head of the “Lugansk Oblast,” has also said on Telegram that the Ukrainian forces might soon retreat from Lisichansk since their defensive positions had been destroyed by the Russian forces and there is “little sense” in staying.
The Russian Air Force has also successfully hit a Ukrainian artillery battery equipped with the US-made M777 howitzers in the Kharkov region. Earlier, Washington vowed to supply 90 such artillery pieces to Kiev, according to a May report by the New York Times.
The news comes just days after the Russian military claimed to have killed hundreds of Ukrainian troops in a strike on a shipbuilding plant in the Ukrainian port of Nikolaev. Last week, the defense ministry also claimed to have killed scores of Ukrainian officers after striking a compound where a meeting of commanders of several Ukrainian units was taking place.
The UK is Doing Its Best to Stir a Food Crisis While Pinning the Blame on Russia
By Ekaterina Blunova – Samizdat – 24.06.2022
Russia’s special operation in Ukraine may cause a two-year global food crisis even if the standoff ends tomorrow, The Telegraph claims, citing Western officials. They insist that exporting grain “trapped” in Ukraine is the remedy, while remaining mute about West’s sanctions paralyzing larger food exports from Russia to third-world countries.
“We are very clear that this grain crisis is urgent, that it needs to be solved within the next month otherwise we could see devastating consequences,” UK Foreign Secretary Liz Truss told the press on June 23.
The ongoing conflict has disrupted production, “causing global food prices to soar to record levels,” claims The Telegraph. In particular, wheat prices increased to an average of 56.2% in May, 2022 above their value last year, according to the UN Food and Agriculture Organization (FAO).
The newspaper’s source says that the British officials see current efforts to move Ukrainian grain over land and road as “far below” what is needed. They insist that the commodity needs to be exported by sea, accusing Russia of blocking Ukraine’s food supplies from leaving Ukraine’s Black Sea ports. According to UK Prime Minister Boris Johnson, Moscow was trying to hold the world “ransom.”
The newspaper also cites “newly declassified US intelligence” claiming that the Russian navy “has been given orders to lay mines” in Odessa and Ochakov and “mined” the Dnieper River “as part of its blockade of Ukrainian grain exports.” According to BoJo, the UK is helping Ukraine “at a technical level to help demine Odessa.”
Western Press Remain Mute About Russia’s Black Sea Corridors
Russia denounced the US and the UK claims, stressing that the Ukrainian military mined their own ports during the retreat. Furthermore, Ukraine continues to stampede Russo-Turkish efforts to demine the area and ensure the safe passage of ships from the country’s territorial waters.
On June 2, Russia’s Permanent Representative to the UN Vasily Nebenzya made it clear that Russia is ready to provide safe corridors for Ukrainian ships carrying 20 million tons of grain if Kiev demines the water area surrounding its ports.
In late May, the Russian Ministry of Defense announced that the Russian Navy had created safe zones in the Black and Azov Seas for ships leaving Ukraine along humanitarian corridors. The corridors with a length of 139 miles and 3 miles wide are operating daily from 8:00 am to 7:00 pm (GMT+3) in the Black Sea for vessels stationed in the ports of Kherson, Nikolaev, Chernomorsk, Ochakov, Odessa and Yuzhny.
Nevertheless, the Kiev authorities “continue to do everything possible to evade interaction with representatives of foreign states and ship-owning companies in resolving the issue of ensuring the safe exit of blocked ships,” according to the MoD.
Turkey, which has worked with Russia in demining the Black Sea and providing safe passage to vessels, echoes Moscow’s concerns. Turkish Foreign Minister Cavusoglu told Anadolu Agency last month that the two major obstacles hindering grain exports are mines placed by the Ukrainian military in the Odessa water area as well as Western sanctions slapped on Russian ships in terms of insurance and the provision of services at international ports.
Ukraine’s Role in Food Crisis Largely Overestimated
The Western press is shying away from discussing how anti-Russian sanctions, imposed on the country’s trade, finance, transportation and crucial agricultural commodities have backfired on the global food market sending prices high.
Senegalese President and African Union chief Macky Sall raised the alarm earlier this month over Western restrictions preventing Russia’s grain and fertilizers exports to Africa.
“Sanctions against Russia have aggravated the situation with the supply of grains and fertilizers to African countries. We no longer have access to them, and this poses a serious threat to food security on the continent,” Sall warned on 3 June during an official visit to Russia.
Together Ukraine and Russia produce about a third of the wheat traded in global markets, according to the Washington-based International Food Policy Research Institute (IFPRI). Still, Russia is the world’s largest exporter of wheat, providing more than 17% of all wheat sold in the global market while Ukraine’s share amounts to roughly 10%.
For comparison’s sake, Russia exported 44.64 million tons of wheat in 2018, while Ukraine provided the global market with 16.91 tons of the commodity the same year, according to FAO.
Ukraine’s role as a food commodity exporter is deliberately overestimated by the West, Russian President Vladimir Putin said in a June interview with Rossiya-1.
“The world produces about 800 million tons of grain and wheat per year. Now we are told that Ukraine is ready to export 20 million tons. 20 million tons compared to the 800 million tons the world makes is 2.5% of that figure. But if we proceed from the fact that wheat makes up only 20% of the total food supply (and this is the reality, these are not our figures but those of the UN) this means that these 20 million tons of Ukrainian wheat make up 0.5 percent,” the Russian president told the broadcaster.
Putin dismissed claims that Russia was supposedly trying to block the export of Ukrainian grain, calling the allegations a “bluff.” The Russian president stressed there were no obstacles to the export of grain from Ukraine. He stressed that ships carrying wheat could enter the Black Sea any time if Kiev clears ports of mines. World wheat prices have fallen by 10% after Putin signaled Russia’s readiness to ensure the transport of grain from Ukrainian ports.
G7 & NATO to Double Down on Further Isolating Russia
While the British government continues to castigate Russia’s special operation for the unfolding global food crisis, the British prime minister is calling for Europe to step up military aid to Ukraine.
In particular, BoJo came up with a new plan offering Ukraine a training campaign for its military personnel and urging Western leaders to provide “constant funding and technical help” to Ukraine to ensure Kiev’s longstanding resistance to Russia.
BoJo is expected to push France and Germany to strengthen their support for Ukraine during the G7 summit next week, “as he fears that [Ukrainian President] Volodymyr Zelensky could be bounced into agreeing a ‘s***y’ peace deal [with Russia],” according to the Telegraph.
For its part, Reuters projects that next week G7 and NATO leaders will work to “increase pressure” on Russia over its special operation in Ukraine, while seeking to further isolate the country from the global economy.
Argentina Requests BRICS Membership
Samizdat – 24.06.2022
Argentina’s President Alberto Fernández requested BRICS membership for his country during the 14th summit of the international organization, which the Argentinian leader attended among other high-ranking guests.
“We aspire to be a full member of this group of nations that already represents 42% of the world’s population and 24% of the global gross product”, the president said.
Fernández noted that his country could supplement the union of five countries as a reliable supplier of food, as well as a recognized player in the field of biotechnology and logistics. He further stressed Argentina’s ability to train specialists in various fields, as well as provide various services on the international scale.
The president expressed an eagerness for his country to join the BRICS group (Brazil, Russia, India, China and South Africa) during its 14th summit, which is taking place in a videoconference format this year. It formally kicked off on June 22 and has continued through June 24.
Its members meet to discuss acute political and economic trends and mildly coordinate their own political and economic policies. They also discussed how to jointly navigate the currents of global trade and exercise their considerable influence (24% of global GDP) to change them.
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?
Israel Murders Iranians While Biden Kills the Iran Deal
By Connor Freeman | The Libertarian Institute | June 23, 2022
In a clear message to Tehran, an American B-52 flew over the Persian Gulf as soon as Joe Biden entered the White House. Biden promised to return the U.S. to the Iran nuclear deal. But indirect talks to revive the Joint Comprehensive Plan of Action (JCPOA), which began last April, have stalled for three months without a resolution in sight. Counting on the reliable support of Biden and bipartisan Iran hawks in Congress, the nuclear-armed Israeli apartheid regime intends to kill the deal entirely.
Tehran, a decades-long signatory of the Non-Proliferation Treaty, is neither seeking nor has ever sought nuclear weapons. But the Islamic Republic, once Tel Aviv’s “best friend,” serves as Israel’s favorite boogeyman, superficially justifying billions of dollars in American military aid each year. The JCPOA threatens the racket.
Formally known for years as “Israel’s man in Washington,” President Biden is essentially pursuing ultra-Zionist Donald Trump’s foreign policy regarding Iran and supporting, tacitly or otherwise, Tel Aviv’s relentless attacks against Iran and its allies. Biden is continuously imposing yet more sanctions, increasing the “Maximum Pressure” on the economically crippled Iranian people.
The rial has hit all-time lows. With a population of 82 million, almost half of all Iranians live below the poverty line, and inflation is somewhere between 40-50%.
America’s self-styled sanctions artists delight in seeing the results of their economic war on Iran: excess deaths, severe medical shortages, prohibitively high prices for staple goods, plummeting incomes, and social unrest over food costs.
This year, Tel Aviv has been bombing Syria, Tehran’s ally, at the usual weekly rate. A recent strike, coming from the illegally occupied Golan Heights, attacked Damascus International Airport. The airstrike targeted the facility’s only working runway Israel had not yet destroyed, rendering the airport temporarily inoperable.
Shortly afterwards, The Wall Street Journal put out a story confirming that Tel Aviv coordinates with the Pentagon on many of its strikes in Syria.
The Israelis just wrapped up month-long war drills, the largest held in decades, aimed squarely at Tehran. Exercises over the Mediterranean Sea, with over 100 aircraft and navy submarines, spanned 10,000 kilometers and were designed to simulate repeated airstrikes on Iran and their civilian nuclear facilities.
Early reports were that the U.S. Air Force would participate, providing refueling planes, but this reportedly did not come to pass. Although General Michael Kurilla, the new head of U.S. Central Command (CENTCOM), observed some of these Chariots of Fire exercises.
On May 22, 2022, the Israelis carried out a high profile assassination of a senior colonel in the Iranian Revolutionary Guard Corps (IRGC), Col. Hassan Sayyad Khodaei. Shortly afterwards, citing an unnamed intelligence official, The New York Times reported Tel Aviv had informed Washington that it was responsible. Israel’s attacks seem to be primarily focused on the Iranians’ drone program, namely killing people who work on drone technology and attacking related sites.
As Dave DeCamp, Antiwar.com news editor, reported,
Israel was immediately suspected of the assassination since it has a history of carrying out targeted killings and other attacks inside Iran. Israel rarely officially acknowledges such operations, and it’s typical that its responsibility is revealed by leaks to the media, often by Israeli officials.
Israeli officials claimed to the Times that Khodaei was in charge of a secret covert IRGC group known as Unit 840, which Iran denies exists. The Israelis claim Khodaei was involved in plots to kill and kidnap Israeli civilians and officials around the world, but there’s no evidence Tehran was planning to target Israelis abroad.
Two people affiliated with the IRGC told the Times that Khodaei was a logistics officer who played a key role in transporting drone and missile technology to Syria and Hezbollah in Lebanon and advised militias in Syria. Iran has said Khodaei was involved in the fight against ISIS in Iraq and Syria.
Israel is suspected to have subsequently poisoned and murdered two Iranian scientists including Ayoub Entezari, an aerospace engineer, who reportedly worked on missile and drone projects, and Kamran Aghamolaei, a geologist.
Last month, a few dozen miles south of Tehran, quadcopter suicide drones attacked the Parchin military complex. The drones hit a building being used for drone development and killed a young engineer. In February, Israel used six quadcopter drones in a strike targeting another Iranian drone facility in Kermanshah which did significant damage. In Tabriz, there were reports of another Israeli attack on a drone factory, as many as three people may have been killed. This month, two additional IRGC members also working in the aerospace industry died during mysterious accidents in Iran. Both deaths were declared “martyrdoms.”
In the midst of these soaring tensions, Robert Malley, Biden’s Iran envoy, is telling Congress “all options are on the table.”
The U.S. Senate overwhelmingly voted to pass a non-binding resolution which insists they would never support a restoration of the JCPOA if the IRGC were removed from the Foreign Terrorist Organization (FTO) blacklist. The FTO designation is ostensibly one of the final sticking points preventing the deal’s straightforward revival. Congress has been sending messages, loud and clear, to Tehran and Biden that the deal has virtually no support.
Meanwhile, Secretary of State Antony Blinken is peddling baseless stories about Tehran attempting to assassinate his predecessor Mike Pompeo. Pompeo enthusiastically supported Trump’s Maximum Pressure campaign as well as the drone strike murder of top Iranian General Qasem Soleimani, leader of the IRGC Quds Force. Though these claims of Pompeo’s life being endangered remain unproven, U.S. taxpayers pay millions per month for a security detail to put his and Blinken’s mind at ease.
Much like Tel Aviv’s unproven accusations that the IRGC is out to kidnap and murder Israelis, especially in Istanbul for some reason, this obviously plays well with the overall anti-JCPOA campaign.
The IRGC is the only state military organization on the terrorism blacklist. Considering the myriad preexisting sanctions on the unit, it is a superfluous insult. In 2019, Trump implemented this policy at the behest of Israeli-partisan hawks like Mark Dubowitz at the Foundation For Defense of Democracies, a notoriously anti-Iran think tank. This is one of the largest bricks in the so called “sanctions wall” precluding any of Trump’s successors from ever returning to the deal for fear of the built-in political toxicity. It is enough to keep Biden and the cowardly Democrats from backing what is ultimately Barack Obama’s deal in favor of a neoconservative-style Iran policy.
As May began, Israel started making these claims about a global Iranian plot to kill Israelis. At that time, the JCPOA negotiations were seemingly stalled irrevocably because of the IRGC-FTO issue. But then the Vienna talks’ broker, European Union nuclear negotiator Enrique Mora, traveled to Tehran. He took meetings with Iran’s lead negotiator Ali Bagheri Kani as a last ditch effort to break the deadlock. Mora was sent by EU foreign policy chief Josep Borrell. As a result of the American led sanctions blitz on Russia, Europeans are in desperate need of another crude supplier as Borrell has noted. The same week, the emir of Qatar, Sheikh Tamim bin Hamad Al Thani, also made a trip to Tehran and pushed for progress during meetings with President Ebrahim Raisi as well as Ayatollah Ali Khamenei. On May 13th, Borrell announced Mora’s mission went “better than expected,” Vienna talks had been unblocked, and a final deal was within reach.
Days later, coinciding with Israeli Defense Minister Benny Gantz’s visit to Washington, and his meetings with National Security Adviser Jake Sullivan and Pentagon chief Lloyd Austin, Khodaei was murdered in the drive-by shooting. Israel’s assassination campaign had commenced.
Two days after the Khodaei killing, Politico reported that the final decision to keep the IRGC on the FTO list was made. On Twitter, Israeli Prime Minister Naftali Bennett thanked Biden for the “principled decision and for being a true friend of the State of Israel.”
Following Trump, Biden’s administration is also continuing to seize tankers, stealing Iranian oil and pirating it for profit. Ironically, after Russian President Vladimir Putin invaded Ukraine, there was some talk from Biden officials about making a deal with the Islamic Republic to put Iran’s abundant oil back on the market to reduce global energy prices. But this was apparently never taken seriously.
Biden instead prefers to kowtow to the genocidal Saudi regime which along with Abu Dhabi and Washington have starved to death and bombed over 400,000 Yemenis, including more than 263,000 children.
Those deaths mean little to the Abraham Accords caucus. This bipartisan coalition in Congress is working to ensure Washington arms these tyrants further while the Pentagon assists them in joining forces, as well as integrating missile defenses with Tel Aviv eyeing Tehran. As Biden heads to the Middle East, there is even talk of the U.S. offering security guarantees to the United Arab Emirates.
For almost a year, the Israelis have been pushing an anti-Iran, NATO-style, U.S. led alliance in the Middle East. In recent weeks, Gantz has openly promoted this strategy which Bennett is said to have suggested to Biden during a White House meeting last year.
As Iran is encircled militarily and strangled economically, the American Empire is refusing to allow them any breathing room. Each day the U.S. forgoes lifting sanctions and restoring the deal the likelihood of a hot war increases.
Given the size of Iran, its population, its geostrategic location, substantial ballistic missile deterrent, its Axis of Resistance partners, and the wide variety of U.S. military targets in the region, a war with Tehran would likely dwarf the catastrophic damage, scope, and deaths of America’s other Middle East wars.
If the JCPOA fails, the hawks armed to the teeth surrounding Iran may try to goad Tehran into leaving the NPT. Whether this happens ultimately or not, Israel may use the coming breakdown in diplomacy to justify instigating its long desired war. Rightfully, the Iranians will see such an Israeli attack as an American declaration of war.
This week, Tehran has formally dropped their demand for removing the IRGC from the FTO list. Washington has not yet responded. Contrary to the corporate press narrative, the ball is now firmly in Washington’s court.
Iran called Biden’s bluff. It is imperative that the American people now assert our support for terminating the unjustified and brutal Maximum Pressure campaign as well as denounce Israel’s murderous aggressions.
The Iranian people deserve to live and trade in peace.
The UK Online Safety Bill has laughable free speech and privacy “protections”
By Tom Parker | Reclaim The Net | June 21, 2022
The UK government’s latest push to censor online speech, the 225 page Online Safety Bill, has been roundly criticized by rights groups and proponents who have branded it a “censor’s charter” and “an attack on free speech.”
UK Digital, Culture, Media, and Sport (DCMS) Secretary of State Nadine Dorries, one of the main proponents of the bill, has pushed back against this criticism by pointing to the bill’s “duties to protect free speech.”
However, these duties and the duties for platforms to protect user privacy are so weak that they have no impact when platforms comply with the bill’s obligations to tackle “harmful” content.
The bill pays lip-service to the idea that platforms should “have regard” to the importance of “protecting users’ right to freedom of expression within the law” and that they should be “protecting users from a breach of any statutory provision or rule of law concerning privacy.”
But if platforms comply with these over-reaching obligations to tackle this so-called “harmful but legal” speech as outlined in the bill, they will, by default, be at odds with the idea of protecting speech rights and privacy.
The bill itself is the biggest threat to free speech and privacy in living memory and Big Tech platforms have no history of protecting either.
Provisions for privacy should not mean social media monopolists acting as a guardian of user privacy; they should be in place to protect citizens’ data from the platforms themselves.
Not only does the bill have weak free speech protections but it also disproportionately impacts small, independent media outlets, harms privacy, and creates a dystopian censorship alliance between Big Tech companies and the UK government.
You can get a full overview of all the free speech and privacy threats posed by the Online Safety Bill here.
You can see a full copy of the full Online Safety Bill here.
The bill is currently making its way through Parliament and you can track its progress here.
BRICS Leaders Vow to Enhance & Expand New Development Bank
Samizdat – 23.06.2022
The leaders of Brazil, Russia, India, China, and South Africa held their 14th annual summit on Thursday virtually. This year, the summit was chaired by China.
BRICS members vowed to widen the Shanghai-based New Development Bank (NDB) on Thursday, following the successful admission of Bangladesh, Egypt, the United Arab Emirates (UAE) and Uruguay in September 2021.
“We look forward to further membership expansion in a gradual and balanced manner in terms of geographic representation and comprising of both developed and developing countries, to enhance the NDB’s international influence as well as the representation and voice of Emerging Market and Developing Countries (EMDCs) in global governance,” the 75-point joint declaration released after the summit read.
BRICS has supported the NDB’s goals of attaining the highest possible credit rating and institutional development. The BRICS member nations have also stressed that they have a similar approach to the global economic governance, and their mutual cooperation can make a valuable contribution to the post-Covid economic recovery.
Geopolitical Concerns
Leaders also discussed the ongoing crisis in Eastern Europe, recalling their national positions at different global forums, including the United Nations’ Security Council and General Assembly.
“We support talks between Russia and Ukraine. We have also discussed our concerns over the humanitarian situation in and around Ukraine,” the joint declaration said.
Amid border tensions between India and China, the leaders committed to “respect the sovereignty and territorial integrity of all States,” stressing the peaceful resolution of differences and disputes through dialogue and consultation.
The BRICS countries – which represent 24 percent of the global GDP and 16 percent of worldwide trade – further reiterated the need to resolve the Iranian nuclear issue through peaceful and diplomatic means as per international law. They stressed the importance of preserving the Joint Comprehensive Plan of Action, a deal reached between Iran and the five permanent members of the UN Security Council in 2015. The stand-off between Iran and western nations continues following the US’ withdrawal from the JCPOA in May 2018.

