The U.S. Food and Drug Administration’s (FDA) top vaccine official told a congressional committee on Friday that COVID-19 vaccines for kids under 6 will not have to meet the agency’s 50% efficacy threshold required to obtain Emergency Use Authorization (EUA).
The FDA is reviewing data from Moderna’s two-shot vaccine for infants and toddlers 6 months to 2 years old, and for children 2 to 6 years old.
The agency is awaiting data on Pfizer and BioNTech’s three-dose regimen for children under age 5 after two doses of its pediatric vaccine failed to trigger an immune response in 2-, 3- and 4-year-olds comparable to the response generated in teens and adults.
According to Endpoints News, Dr. Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA, told the House Select Subcommittee on the Coronavirus Crisis the agency would not withhold authorization of a pediatric vaccine if it fails to meet the agency’s 50% efficacy threshold for blocking symptomatic infections.
COVID-19 vaccines for adolescents, teens and adults had to meet the requirement.
“If these vaccines seem to be mirroring efficacy in adults and just seem to be less effective against Omicron like they are for adults, we will probably still authorize,” Marks said.
The FDA on June 30, 2020, issued guidance that in order for an experimental COVID-19 vaccine to obtain EUA, it must “prevent disease or decrease its severity in at least 50 percent of people who are vaccinated.”
The guidelines were issued during a briefing with the Senate Committee on Health, Education, Labor and Pensions, during which senators sought assurances from former FDA Commissioner Stephen Hahn, Dr. Anthony Fauci and other top health officials that the expedited speed of development of COVID-19 vaccines wouldn’t compromise the integrity of the final product.
All previously authorized COVID-19 vaccines and boosters for all age groups were required to meet the FDA’s 50% requirement prior to obtaining EUA.
Vinay Prasad, a hematologist-oncologist and associate professor of Epidemiology and Biostatistics at the University of California, San Francisco posted a video responding to the news the FDA would bypass its own standard to authorize pediatric COVID-19 vaccines for kids.
Prasad said:
“Peter Marks from the FDA — he’s the defacto regulator-in-chief when it comes to vaccines — is saying that kids’ vaccines don’t need to hit the target. They don’t need to hit the 50% vaccine efficacy against symptomatic SARS-CoV-2 target. That was the target that the FDA themselves came up with in the original pandemic.
“They came up with this target 50% point estimate above, and the lower bound to the 95% confidence interval has to be above 30%. That was their minimum efficacy standard for vaccination. That was the standard they themselves set and that was the standard initial vaccine trials did clear for adults.
“But the pediatric vaccine trials — both the Pfizer and Moderna — appear not to have cleared that bar, and Peter Marks is talking to congressional officials and he is saying that it’s okay, we’ll probably authorize it anyway.”
Vasad said it was “incredible” that Marks would sign off on a pediatric vaccine if it seems to be mirroring efficacy in adults but is less effective against Omicron.
“We have standards for a reason,” Vasad said. The standard chosen by the FDA was “arbitrary and if anything I’d argue it was on the low side — 50% isn’t as good as what we wanted,” Vasad said.
“Fifty percent is quite low, and if you have a very low vaccine efficacy […] you can have compensatory behavior that actually leads to a lot more viral spread,” he added.
Vasad said when it comes to kids, it’s “kind of a moot point” because estimates from the Centers for Disease Control and Prevention from a few months ago showed 75% of children had zero prevalence — and it’s “probably higher now.”
“Taking a child under the age of 5 who already had and recovered from COVID and trying to make them better off with a vaccine against the original Wuhan ancestral strain — that’s an uphill battle,” Vasad said.
“The absolute upper bound, absolute risk reduction, has got to be super super low because once kids have it and recover from it they generally do pretty well. If they get it again they do even better than the first time.”
Lowering the regulatory standards for vaccine products is not the direction FDA should go, Vasad said. “They need to be upholding the standards they’ve set and raising the standards.”
Vasad raised concerns over what the standard will be moving forward if the agency doesn’t abide by its own minimum requirement.
“At what point will vaccine efficacy arrive at something the agency doesn’t accept?” He asked.
Vasad said once the FDA does away with EUA, many preschools will immediately mandate COVID-19 vaccines, and they won’t make exceptions for natural immunity or provide any exceptions at all.
“And so what he’s talking about is authorizing a vaccine in a setting where you have 75% minimum zero prevalence and the vaccine efficacy could be less than 50%,” Vasad said. “How much less?”
Pointing to a Moderna press release stating one arm of its trial showed its pediatric vaccines were only 37% and 23% effective, Vasad asked, “How much lower can it go — 10%? How low before Peter Marks says that’s too low?”
Vasad said if the adult vaccine becomes less effective over time, “tell me why that means you should accept the less effective kids’ vaccine?”
Vasad explained:
“If a therapy loses efficacy over time, why does that mean the bar to be a therapy is lower? It should mean that we need new therapies. We need a new mRNA construct.
“You need to kind of aim at the thing that’s actually out there now and not the original thing from two years ago. Maybe you want to rejigger your process. Try something new but it doesn’t mean we keep lowering the bar. This is ridiculous.”
Moderna reports concerning efficacy data for pediatric COVID-19 vaccines
As The Defender reported, Moderna on April 28 asked the FDA to approve its COVID-19 mRNA-1273 vaccine for children 6 months to 6 years old, citing different efficacy numbers than it disclosed in March.
The company conducted separate trials for two versions of the vaccine, one for infants and toddlers aged 6 months to 2 years, and one for children 2 to 6 years, and claimed data showed “a robust neutralizing antibody response” and “a favorable safety profile.”
Yet, Moderna’s KidCOVE study showed the company’s COVID-19 vaccine failed to meet the FDA’s minimum efficacy requirements for EUA in the 2- to under-6 age group, and barely surpassed the agency’s 50% efficacy requirement in the 6-month to 2-year age group — even after the vaccine maker changed its analysis of the study to meet the threshold.
Moderna also did not follow trial participants beyond 28 days, so vaccine effectiveness after that time is unknown. Data from New York state show vaccine effectiveness for the 5-to-11 age group plummets within seven weeks to 12%.
“Here, we’re looking only at the first four weeks,” Dr. Madhava Setty told The Defender. “Although data from New York were in a different age group using a different mRNA vaccine, the effectiveness was remarkably similar after four weeks. Why wouldn’t we expect that the same thing is going to happen?”
The House Select Subcommittee on Coronavirus Crisis on April 26 asked the FDA for a status update on COVID-19 vaccines for children under 5.
The agency said it was considering holding off on reviewing Moderna’s request to authorize its COVID-19 vaccine for children under 5 until it has data from Pfizer and BioNTech on their vaccine for children, pushing the earliest possible authorization of a vaccine from May to June.
When asked on Friday whether the FDA’s vaccine advisors would slow-roll Moderna’s applications and wait to review Pfizer’s and Moderna’s applications together, Marks said the meetings set for next month could move up if necessary.
“Obviously if we get through reviews faster, then we will send them to committees sooner,” Marks said.
According to Rep. Jim Clyburn’s (D-S.C.) account of the meeting, Marks said the FDA’s vaccine advisory committee has reserved earlier dates, enabling the agency to potentially “move dates up even by a week for any of these reviews.”
“At the end of the day, we want people to have confidence in getting vaccinated,” Marks said. “We need to get more kids vaccinated, not just in the younger than 5 age range, but also older than 5.”
Megan Redshaw is a staff attorney for Children’s Health Defense and a reporter for The Defender.
I’ve mentioned previously that the roll out of a dose of vaccine has been associated with an increase in excess deaths (eg, here), and we seem to have seen the same effect in March.
At around the 21st March (week 12) England started to roll out the spring booster doses for those aged over 75 (and other vulnerable individuals). By the 7th April (week 14) the NHS had congratulated itself with the announcement that over 1 million doses had been given.
Here’s the data (from Euromomo) for excess deaths in England for those aged 75-85 since the start of the year:
I’ve highlighted the period where the million booster doses were delivered.
I note that we managed to get through the Omicron wave in the UK with normal levels of excess deaths in those aged 75-85, but as soon as the booster doses were rolled out we rapidly hit the threshold for a ‘substantial increase’.
Of course, it might be a coincidence — we have had rather a lot of coincidences over the last 15 months.
The Russian Defence Ministry has stated that Ukrainian forces are planning a false flag operation involving missile strikes at gatherings of civilians in the Lvov and Volyn regions in Ukraine’s west. The ministry said that the goal of this operation is to falsely accuse Russia of causing civilian deaths.
“The Kiev regime plans to carry out yet another sophisticated provocation involving the death of civilians in the western regions of the country on May 8 during the Day of Remembrance and Reconciliation celebrated in Ukraine instead of the Victory Day […] It will be carried out in order to accuse the Russian Armed Forces of indiscriminate missile strikes”, the ministry said.
The ministry elaborated that Ukrainian forces will be using Tochka-U missiles for this purpose. Kiev has repeatedly accused Moscow of firing these missiles at Ukrainian civilian targets, but Moscow strongly denied these accusations, noting that the Russian Armed Forces stopped using Tochka-U missiles a long time ago, unlike its Ukrainian counterpart.
Russia has repeatedly stressed that its forces are only targeting military installations in Ukraine as they carry out the special military operation. Moscow accused Kiev’s forces of hitting civilian infrastructure to delay Russian forces’ advance and later accuse them of damaging these targets.
Virologists pushed back on the possibility of tighter regulation of viruses tweaked in the lab to be more lethal at a public meeting Wednesday.
An enhanced pandemic potential pathogen is a virus or microbe that has gained increased transmissibility — capacity to spread from person to person and reverberate throughout a population — or virulence — capacity to cause serious disease.
Experiments that are reasonably anticipated to generate deadlier pathogens are supposed to receive heightened oversight from the Department of Health and Human Services under what is nicknamed the HHS “P3CO,” short for the pandemic potential pathogen committee.
Though established just a few years ago, critics say the committee’s work is hidden from public view, suffers from glaring loopholes and needs a reboot. Work that contributes to vaccine development or results from viral surveillance efforts in nature is exempted from this extra layer of review, for example.
Speculation by some in the U.S. intelligence community that SARS-CoV-2 may have seeped out of a lab at the pandemic’s epicenter may have prompted a public meeting to consider whether current policies are adequate. Reporting irregularities by a nonprofit partner of the lab involved in gain-of-function research on coronaviruses and funded by the National Institutes of Health called EcoHealth Alliance has also led many to conclude the P3CO needs to apply to more research projects and be more accountable to the public.
One million Americans have died of COVID-19. A review by the U.S. intelligence community last summer about whether the novel coronavirus spilled over from an animal or spilled out of a lab was inconclusive.
The Office of Science and Technology Policy and NIH cohosted the meeting Wednesday.
White House COVID-19 testing czar Tom Inglesby was harshly critical of the existing framework. His top recommendation: Scientists should be required to explain in detail the goals of undertaking such research in the first place, and why less perilous methods could not reach the same goal.
“There must be an extraordinary and public justification,” he said. “I do think there are experiments we shouldn’t do.”
But lobbying groups representing virologists and other life scientists pushed back.
“The systems of review should not be a solution looking for a problem,” said Felicia Goodrum, president of the American Society for Virology.
Goodrum said regulation risks “tying two hands behind our backs” when it comes to modeling pandemic risks.
Goodrum added that the inherently unpredictable nature of manipulating viruses means that it’s unwieldy to determine whether or not an experiment will make a virus more dangerous, so the regulations should be lax.
“We must be careful about dichotomizing research as simply either ‘risky’ or not because it is not possible to absolutely predict the biology of a virus with the committee,” she said.
But Gregory Koblentz, director of the biodefense graduate program at George Mason University, said that an EcoHealth Alliance grant that funded research that made coronaviruses more deadly by swapping their spike proteins is emblematic of lapses in oversight at NIH.
The research was not regulated as gain-of-function work, but NIH did add language to the grant requiring extra reporting if the viral engineering led to viruses that were 10 times more pathogenic. (The chimeric viruses proved to be much more pathogenic than even that threshold, but EcoHealth Alliance did not report it.) That language amounts to a “tacit admission” that NIH reasonably anticipated the work was gain of function, Koblentz said.
Stefano Bertuzzi, CEO of the American Society for Microbiology, conceded that labs should report more often to Congress and that scientists could do a better job allaying public concerns, but stated that the framework is otherwise sufficient.
Bertuzzi signaled he is concerned that Congress could step in.
Labs taking steps toward greater transparency “helps guard against well intended but sometimes overly prescriptive legislative approaches that could undermine the important work that needs to take place.”
Gigi Gronvall, senior scholar at the Johns Hopkins Center for Health Security, said that the “breathless hyping of risks” overshadows strong existing biosafety measures, such as U.S. efforts to train maximum containment labs abroad.
Asked which risks have been misunderstood, Gronvall said that “there is a lot of gray” and that the proper expertise is needed to interpret gain-of-function experiments, but did not go into further detail.
Indeed, some experts called for decreased transparency for controversial research. Colorado State University Biosafety Rebecca Moritz called for limiting the scope of public records requests. U.S. Right to Know has submitted a public information request for records about the university’s research on bat coronaviruses in collaboration with EcoHealth Alliance, the U.S. Department of Defense (DoD) and the Defense Advanced Research Projects Agency.
The documents raise questions about the contagion risks, for example, of shipping of bats and rats infected with dangerous pathogens.
Kanta Subbarao, director of the World Health Organization’s Collaborating Centre for Reference and Research on Influenza, disputed the idea that research that contributes to vaccine development or results from surveillance should be included in the framework.
Many representatives of the life science and biodefense fields emphasized weighing any regulation against lost opportunities for science. But members of the public who participated in the meeting were much more skeptical of the value of certain gain-of-function work.
Alina Chan, a molecular biologist at the Broad Institute, said that the public should not be surprised by controversial gain-of-function experiments for the first time in scientific papers, long after the research has been approved and completed.
Chan called for controversial experiments to be published on preprint servers and the genomes of novel viruses to be deposited into publicly available databases within a year of discovery.
She also called for greater transparency from private “virus hunting” organizations and middlemen between the NIH and labs, an apparent allusion to the EcoHealth Alliance and the Global Virome Project.
Kevin Esvelt, a biologist at the Massachusetts Institute of Technology, said creating novel viruses in the lab, combined with the ease of synthesizing viruses from a genome sequence, poses a national security threat.
“More Americans have died of COVID than would perish if a Russian Topol SS-25 thermonuclear warhead were to be detonated in the center of Washington, DC,” said Esvelt. “Pandemic viruses can be more lethal than thermonuclear weapons. That makes them a proliferation concern.”
Washington should be added to a “list of war criminals” as it is now directly participating in “hostilities” in Ukraine, Chairman of Russia’s State Duma Vyacheslav Volodin claimed on Saturday, citing media reports about alleged US intelligence-sharing with Ukraine.
US President Joe Biden has told senior intelligence officials that “counterproductive” leaks about data sharing with Ukraine should stop, NBC reported on Friday.
Though there was no official reaction to the report from the US authorities, Volodin took to Telegram to comment on it. “The United States is taking part in hostilities in Ukraine. US President Biden, demanding to stop leaks about the exchange of intelligence information with Ukraine, admitted that Washington had been exposed,” he wrote.
Volodin said that the Ukrainian government, which he described as the “Kiev Nazi regime,” not only relies on weapons from the West, but also on the “assistance of American intelligence forces.”
The Duma chairman wrote that Washington “essentially coordinates and develops military operations” in Ukraine, and is therefore directly participating in the “hostilities” against Russian forces.
“For the crimes committed in Ukraine by the Kiev Nazi regime, the US leadership should also be held accountable, adding to the list of war criminals,” Volodin concluded.
However, the Pentagon earlier dismissed some of the media reports and specifically denied that the US had provided data allowing Ukrainian forces to strike Russia’s Black Sea flagship ‘Moskva’ off the coast of Odessa last month.
“The Ukrainians have their own intelligence capabilities to track and target Russian naval vessels, as they did in this case,” said US military spokesman John Kirby.
Russia insists that its missile cruiser wasn’t attacked, but sank on April 14 after a fire that had broken out on board caused ammunition to explode.
The White House National Security Council has admitted, however, that the US is “regularly providing detailed, timely intelligence to the Ukrainians on the battlefield to help them defend their country against Russian aggression and will continue to do so.”
This statement apparently did not come as a surprise to Moscow. On May 5, Kremlin spokesman Dmitry Peskov told journalists that the Russian authorities know the US, the UK and NATO “on a permanent basis” transmit intelligence and other data to Kiev but this would not “hinder the achievement of the goals set during the special military operation.”
Russia attacked its neighboring state following Ukraine’s failure to implement the terms of the Minsk agreements, signed in 2014, and Moscow’s eventual recognition of the Donbass republics of Donetsk and Lugansk. The German- and French-brokered Minsk Protocol was designed to give the breakaway regions special status within the Ukrainian state.
The Kremlin has since demanded that Ukraine officially declare itself a neutral country that will never join NATO. Kiev insists the Russian offensive was completely unprovoked and has denied claims it was planning to retake the two republics by force.
Late last month, Russian Defence Minister Sergei Shoigu announced that Mariupol had been liberated from Ukrainian forces, and that order can now be restored in the city. Shoigu, however, stressed that the “remaining radicals” were still under siege at the Azovstal steel plant.
French independent journalist Anne-Laure Bonnel has presented eyewitness accounts of the crimes of neo-Nazis from the Azov Battalion in the Ukrainian city of Mariupol at an informal UN Security Council meeting.
Bonnel, in particular, showed a video of an interview with an unnamed male resident of Mariupol, in which he explained that he had managed to flee the city by secretly making his way along the coast of the Sea of Azov.
According to him, Azov Battalion members “occupy residential houses, beat people and don’t let them leave their homes”.
“I know for sure that people are not allowed out of their houses, they are hit with buttstocks and forced to stay at home. The Azov Battalion won’t let anyone either walk through nor leave by car. I personally know a person who was simply not allowed to leave,” he claimed.
Another resident of Mariupol named Anna said that she had not heard anything about humanitarian corridors, arguing that the Ukrainian military deployed military hardware, including armoured personnel carrier, in the courtyards of residential areas.
She was echoed by one more Mariupol resident, Ilya Klochko, who said that Azov Battalion members “deployed howitzers to residential areas and shot from there”, adding that he’d heard nothing about humanitarian corridors.
The eyewitnesses spoke as Russian troops continue to block the Azovstal steel plant in Mariupol, with humanitarian corridors operating throughout Saturday. According to Donetsk People’s Republic (DPR) officials, a total of 176 civilians had already been evacuated from the territory of the Azovstal plant, where the remaining Ukrainian forces have been hiding since the takeover of the port city by the Russian troops.
Liberation of Mariupol
In late April, Russian Defence Minister Sergei Shoigu told President Vladimir Putin that Mariupol “was liberated by the Russian armed forces and the People’s Militia of the Donetsk People’s Republic (DPR)” and that “the remnants of the nationalist formations took refuge in the industrial zone of Azovstal”.
Putin, in turn, called the assault on Azovstal pointless and ordered it to be cancelled. He explained that it is necessary to think about saving the lives of Russian soldiers and officers, ordering the Azovstal zone to be blocked.
At the time the DPR declared its independence from Kiev in 2014, Mariupol was the second-largest city of the Donbass republic after Donetsk. It was taken by Kiev’s forces back that same year. Since the beginning of Moscow’s special military operation on 24 February, the Russian troops and Donbass militias have been pushing Ukrainian forces from the city. During the liberation of Mariupol, witnesses reported numerous crimes committed by the Ukrainian militants in the city, including taking hostages and using civilians as human shields.
The Centers for Disease Control and Prevention (CDC) today released new data showing a total of 1,255,355 reports of adverse events following COVID-19 vaccines were submitted between Dec. 14, 2020, and April 29, 2022, to the Vaccine Adverse Event Reporting System (VAERS). VAERS is the primary government-funded system for reporting adverse vaccine reactions in the U.S.
Foreign reports are reports foreign subsidiaries send to U.S. vaccine manufacturers. Under U.S. Food and Drug Administration (FDA) regulations, if a manufacturer is notified of a foreign case report that describes an event that is both serious and does not appear on the product’s labeling, the manufacturer is required to submit the report to VAERS.
Of the 12,779 U.S. deaths reported as of April 29, 16% occurred within 24 hours of vaccination, 20% occurred within 48 hours of vaccination and 59% occurred in people who experienced an onset of symptoms within 48 hours of being vaccinated.
In the U.S., 575 million COVID-19 vaccine doses had been administered as of April 29, including 339 million doses of Pfizer, 217 million doses of Moderna and 19 million doses of Johnson & Johnson (J&J).
Every Friday, VAERS publishes vaccine injury reports received as of a specified date. Reports submitted to VAERS require further investigation before a causal relationship can be confirmed.
19 reports of myocarditis and pericarditis (heart inflammation).
The CDC uses a narrowed case definition of “myocarditis,” which excludes cases of cardiac arrest, ischemic strokes and deaths due to heart problems that occur before one has the chance to go to the emergency department.
The Defender has noticed over previous weeks that several reports of myocarditis and pericarditis have been removed by the CDC from the VAERS system in this age group. No explanation was provided.
U.S. VAERS data from Dec. 14, 2020, to April 29, 2022, for 12- to 17-year-olds show:
31,504 adverse events, including 1,808 rated as serious and 44 reported deaths.
The most recent reported death involves a 14-year-old girl from Tennessee (VAERS I.D. 2238618) who died after receiving her second dose of Pfizer’s COVID-19 vaccine. According to the VAERS report, the girl had a previous history of cancer but was hospitalized 29 days after receiving her second dose of Pfizer with severe COVID-19 and COVID pneumonia. She became “critically ill,” developed respiratory failure and bradycardia and later died.
65 reports of anaphylaxis among 12- to 17-year-olds where the reaction was life-threatening, required treatment or resulted in death — with 96% of cases attributed to Pfizer’s vaccine.
650 reports of myocarditis and pericarditis — two fewer than last week — with 638 cases attributed to Pfizer’s vaccine.
166 reports of blood clotting disorders — 1 fewer than last week — with all cases attributed to Pfizer.
U.S. VAERS data from Dec. 14, 2020, to April 29, 2022, for all age groups combined, show:
20% of deaths were related to cardiac disorders.
54% of those who died were male, 41% were female and the remaining death reports did not include the gender of the deceased.
Of the 3,626 cases of Bell’s Palsy reported — seven fewer cases than what was reported two weeks ago — 51% were attributed to Pfizer vaccinations, 40% to Moderna and 8% to J&J.
2,331 reports of anaphylaxis — 24 fewer reports than was what recorded two weeks ago — where the reaction was life-threatening, required treatment or resulted in death.
The question is, do they really tell us anything we don’t already know?
The big revelation doing the rounds at the minute is that the vaccines were never trialled with, and were specifically not recommended for, pregnant women.
But is this new information?
When governments started “recommending” the Covid vaccine to pregnant women in the Summer of 2021, everybody who had been paying attention knew that position was not backed up by any data at all.
In a way, the “not recommended for pregnant women” disclosure is actually good for Pfizer.
Behind a facade of being legally mandated to publish these files, it’s now become public knowledge that Pfizer (allegedly) told people not to give the vaccine to pregnant women, but many countries did it anyway.
This shifts the blame (and potential legal liability) away from Pfizer and onto the governments in question.
A good example of how “forced disclosure” can be used to reinforce and direct a narrative, through a pretence of reluctance.
Going further, shouldn’t we be asking: Can we trust anything in these documents at all?
Just because Pfizer has been (apparently) legally “forced” to release them doesn’t mean they are important, relevant or even real. Who’s verifying the documents? Who’s auditing Pfizer to make sure they release everything? The US government? Some other government or agency?
Do you trust them?
The real damning documents – if such ever existed – have likely been shredded, burned and buried in 20 feet of concrete by now…and that doesn’t matter, because we already know everything we will ever need to know about these Covid “vaccines”:
They were not subject to proper long-term testing.
One of the more pernicious and morally shocking developments surrounding the covid vaccines is hospitals forcing transplant recipients (and sometimes even their families) to be vaccinated with one of the covid vaccines.
I have heard a number of people defend this vile practice, who were genuinely convinced that there was nothing wrong with it. None of these individuals were “evil”, or anything close. Yet, they genuinely did not see a concern or dilemma that would disqualify the whole policy, or even one that would at least counsel a more thoughtful review before taking such a momentous and consequential step.
It is therefore worthwhile to present a clear explanation why, even assuming that transplant recipient vaccination is objectively beneficial as a purely scientific matter, mandating vaccination as a prerequisite for receiving a transplant is destructive to society and evil.
The following are a few of the more salient reasons why mandating recipient vaccination as a condition to remain eligible to receive a transplant, even assuming that transplant recipient vaccination are objectively beneficial as a purely scientific matter, is unjustifiable, destructive, and evil:
Breaks the Social Compact of Society:
Discriminates on the basis of a controversial political/social issue
Politicizes and undermines the trustworthiness of the medical community
Weaponizes the medical community / medical institutions in the “culture wars”
Drives the Balkanization of society
Is Intrinsically Immoral:
Such a mandate inflicts tremendous psychological torment upon people who are already suffering the stress and physical torment of a life-threatening disease
Erodes the ethics and character of medical professionals, so they regard some people as “inferior” and therefore undeserving of or not worth being treated
This is a policy that cannot be plausibly portrayed as being “in the best interests of patients”
Catch-all: Will cause considerable stress to the entire society
The Broader Context that Informs how People View Such a Mandate – The Medical Community no longer possesses the moral authority or credibility to make this sort of policy decision:
The already heavily damaged reputation and image of the medical community due to covid policies so far
A sizable minority today believes (if not outright majority) that hospitals and doctors are possibly complicit in the deaths of millions around the world and the unimaginable suffering of hundreds of millions more
Breaks the Social Compact of Society:
Discriminates on the basis of a controversial political/social issue
The reality of the current situation is that the covid vaccines are one of the preeminent issues at the forefront of the body politic in the country. This is therefore automatically a consideration when making policies on behalf of society, which any decisions regarding the prioritization scheme of transplant recipients are.
Decisions broadly affecting the whole of society that discriminate or persecute a faction/s of society break the social compact and erode or destroy the moral legitimacy of the major institutions through which political and social power and ideology are disseminated and enforced.
Specifically for this point, discriminating against a political or social minority – and surely where it is literally determining by proxy who lives and who dies – is by definition apartheid in both spirit and practice.
It goes without saying that apartheid policies are both harmful to a healthy and functioning society and evil.
Politicizes and undermines the trustworthiness of the medical community
Enacting a policy that is inextricably intertwined with a highly visible social or political controversy unavoidably conveys – regardless of whether it’s true – that the medical community is:
(A) a political actor that has
(B) vested political interests and objectives – such that it will
(C) pursue using the resources at its disposal
(D) even if/when they are in conflict with the neutral practice of medicine.
The damage from such overt political overtones and imaging (to say the least) to the practice of medicine, and the implications for the physical and mental health of the broader society, is something that does not require elaboration.
Importantly, this is true even for many of the people who agree with vaccination, because they also perceive that the medical community is “allying” with them to promote a political cause. The worse the reputation of the medical community is tarnished with political entanglements, the more difficult it becomes to rehabilitate subsequently.
Weaponizes the medical community & medical institutions in the “culture wars”
The participation of the medical community to coerce political compliance at gunpoint transforms the medical community (more than it is already) from a shared societal institution to a partisan one that one side views as a hostile force or enemy and the other views as a means to achieve political or social objectives.
The obvious (i.e. uncontroversial as factual observations regardless of whether one agrees or disagrees with the underlying position of either side here) societal harms that flow from this are manifold. Transforming the shared social institutions of science/medicine into a partisan weapon will cause the following negative consequences (among others; ‘shared’ is an increasingly tenuous proposition these days):
undermines trust in the practice of science
undermines the integrity of medical scientists by creating and incentivizing political objectives that take precedence over scientific integrity
causes a sizeable portion of society to regard doctors and medical professionals as enemies, which is harmful both to patients who will then not receive the same standards of medical care and to doctors who will suffer constant harassment and demoralizing stresses
encourages the propagation of propaganda as everyone is now incentivized to either deify or demonize medical practitioners and institutions regardless of the factual merits of any specific issue or incident
A society must have shared institutions that are not “playable characters” in the everyday social or political maelstroms that are the domain of politics in order to function and survive as a single political entity.
Drives the Balkanization of society
The most prominent consequence of the politicization and weaponization of the medical community and institutions is that it is a Balkanization of society. Regardless of the factual or scientific merits, even the perception by one faction that another faction is trying (and succeeding) in hijacking and corrupting the medical establishment is the fraying of the society as an organized political and social unit. To actually go ahead and do so is more damaging by orders of magnitude. Medical care is possibly the most foundational institution in a society – consider that the most consequential apartheid policy (besides for outright slavery) is the proscription of medical care by political or social affiliation. Thus proscribing medical care for a highly visible and prominent social faction within society – even if it wouldn’t be an outright death sentence for the patients restricted from medical treatment as is the case here – is tantamount to a declaration of [civil] war against anyone politically affiliated with the group targeted by the mandates.
It should also go without saying that you can’t have a functional society if whether your life and your human rights can be legally and socially vindicated depends upon on your political affiliation or ideological coadunation. There is no rational universe where this is an acceptable tradeoff for the conjectured benefits of restricting transplants to vaccinated patients.
Transplant Vaccine Mandates Are Intrinsically Immoral:
Such a mandate inflicts tremendous psychological torment upon people who are already suffering the stress and physical torment of a life-threatening disease
Any policy decision must consider the entire picture, not just the virtues of the preferred course of action.
Transplant vaccine mandates are dealing with a population that is exclusively comprised of people who are already under extreme suffering that is hard to contemplate or understand for someone bereft of this sort of experience. Adding distress to people already so tormented would therefore be warranted only if there was an exceptionally pressing concern. Even if the covid vaccines are somewhat beneficial as a purely scientific matter to patients awaiting an organ transplant, the marginal benefit of vaccination is hardly something that is so massive that imposing a vaccine mandate – in the context of everything else articulated in this article – can even be plausibly entertained let alone imposed. (The marginal benefit is the absolute risk reduction in all-cause morbidity/mortality gained from vaccination, not the “relative” risk reduction which is not relevant to assessing the real-world value of vaccination.)
Erodes the ethics and character of medical professionals, and influences and/or habituates them to regard some people as “inferior” and therefore undeserving of or not worth being treated
A policy of ‘either you acquiesce to vaccination or you die’ conveys to medical practitioners a clear message that people who reject the covid vaccines are not worthy of medical treatment. This is true regardless of the scientific merits of a (theoretically) objective cost/benefit analysis. Contingency of life-or-death treatment upon a political behavior or choice internalizes to medical practitioners and laypeople alike that it is appropriate to proscribe treatment to people because of political affiliation, so much so that we will even consign them to death. Medical apartheid on the basis of political or social faction characteristics is quite literally in the mold of the ideology and policies implemented in Germany in the 1930’s. Such a comparison is sufficient to retire any further consideration by itself of transplant vaccine mandates.
Such a dynamic is also corrosive to compassion and empathy — two attributes that are already in short supply in healthcare settings these days. The deprivation of treatment, especially in circumstances that are exceptionally heartwrenching, forces practitioners at minimum to suppress their sense of compassion. For many, the internal dissonance between their sense of compassion and the cruelty being inflicted on defenseless patients (& the relegation of a political class to “2nd class citizens”) that some would be complicit in will lead them to zealously embrace rationalizing that the unvaccinated are less than fully human. This is precisely how otherwise civilized people can be indoctrinated into an ideology that if unchecked ultimately enables them to commit or be complicit in the commission of atrocities.
(Requiring adherence to personal behavior standards – such as not consuming alcohol or drugs – whose medical rationale is obvious and apparent to everyone and which have already been standard requirements for decades is an entirely separate matter that has nothing to do with this discussion, and is something that requires its own lengthy dissertation to properly explore and flesh out.)
Like every other enumerated argument here, this point is true regardless of the factual merits of vaccination for transplant patients.
This is a policy that cannot be plausibly portrayed as being “in the best interests of patients”
Medical ethics is organized around the proposition that all decisions or policies must be in the best interests of patients. It is hard to imagine more blatant disregard of patients’ welfare than compromising the integrity and viability of the entire edifice of healthcare provision in the country as millions of people are less able and/or willing to seek and receive medical care as a result of all of the other points articulated above and below (and it is also not in the patients’ best interests for medical treatment to be withheld without which the patient will perish).
Contumeliously discarding the millennia-old foundational ethical principium of medicine ominously portends the possibility of medicine and healthcare unanchored to an ethical North Star.
Catch-all: This will cause considerable stress to the entire society
Polls consistently reveal that people of all social and political affiliations are suffering considerable stress. Policies that antagonize or that are erosive to the body politic spur or inflame the already burdened and fraying psyche of the populace. Even those advantaged by politically prejudicial persecution cannot escape the stresses that beset even those that have the upper hand politically, such as the worry that someday you will become a victim to the same social or political forces, or the stresses of living in a society where the social fabric is frazzled and fragmented. Especially in light of the current mental health apocalypse presently afflicting the country, it surely behooves the medical community to avoid further exacerbating the already overwrought stressors in people’s lives.
The Broader Context that Informs how People View Such a Mandate – The Medical Community no longer possesses the moral authority or credibility to make this sort of policy decision:
The reputation and image of the medical community has already been brutally savaged by the performance of the medical establishment throughout the covid crisis, especially the govt health agencies which are the backbone of the medical community’s authority and credibility. Moreover, at least a sizeable minority of the country believes that hospitals and doctors are complicit in the deaths of millions around the world and the unimaginable suffering of hundreds of millions more through draconian isolation of psychologically/emotionally vulnerable patients, denial of covid treatment, society-wide lockdowns, and vaccine carnage.
As a result, the medical community has lost the moral legitimacy and expert authority that until now was taken for granted. This is a monumental shift that is hard to overstate. The medical community previously was accorded the considerable latitude and deference by society they needed to make life-and-death policy decisions that society wouldn’t reflexively view as illegitimate or political. Without unambiguous and widely conceded moral authority to make controversial life-and-death policy decisions, the medical community ceases to be trusted and neutral stewards whose decisions can determine who lives and dies. Instead, they are no better than any other partisan and unobjective actor with their own biases and agenda. Empowering what is rationally perceived by one half of society as a conflicted and dishonest political actor to determine who lives and dies on the basis of a political characteristic is inherently evil and lacks even a semblance of moral credibility.
This last point is worth restating: This is akin to having a republican decide that democrats are not eligible for transplants unless they switch party affiliation or vice versa. The disfavored group would rightly and accurately perceive that a government that proscribes them from receiving lifesaving treatment lacks legitimacy.
Caveats:
It is important to note that there are many heroic doctors and nurses who do not agree with these policies. In a similar vein, the impact of such a policy (and the other covid policies that are similarly evil or just plainly irrational) is not uniform on all healthcare practitioners – there is a wide range of resiliency and resistance to the mental and psychological influence of this sort of policy.
It is also important to note that there is already considerable damage along the lines of everything stipulated above, so for the most part transplant mandates are aggravating already belabored destructive social pathologies as opposed to initiating or creating new ones.
However, this does not detract from the intensity or imperative of the arguments raised. The fact of the already-widespread devastation underscores how critical it is to reverse these developments – meaning that exacerbating them is that much more unconscionable.
Conclusion
Medical institutions are integral to the translation of medical and scientific knowledge into practice in a manner that will be accepted by the various major factions of society (there are always going to be fringe lunatic groups or cults that repudiate any sort of governing political bodies no matter what). A society without a shared epistemology cannot survive, as there can be no agreement on how to determine factual truth. The medical establishment institutions are fiduciaries to the entire population, granted awesome powers over society, and therefore commensurately responsible for the broader social impact of their actions (something that the medical literature en masse freely embraces, one need only look at the hundreds of papers condemning the medical community for their role in promoting “health inequities” and systemic racism).
It is not just prudent but obligatory to consider the political climate when weighing a policy choice that implicates and will resonate through the exigent political and social realities on the ground such as they are. One would think it would be common sense to go to the farthest practical extreme to avoid even the hint of appearing partisan or political, never mind actually further inflaming the divisive and increasingly weaponized political tensions. This is by no means even remotely controversial. The typical standards that society holds critical non-partisan institutions to is that they must avoid “even the appearance of” conflicts of interest, partisanship, etc. – recusals for these reasons are routine in the legal world for instance.
One would also be forgiven for thinking that the medical community would be embarrassed to be caught openly embracing the same fundamental political philosophy that animated the Nazi’s systematic denudement of the medical community back then of the ethical code synonymous with the practice of medicine.
Enacting a policy that in practice is political discrimination is irreconcilable with both basic medical ethics and the responsibility of the medical community to scrupulously avoid even the appearance of partisanship or other non-medical entanglements. There is no justification or defense for such an egregious lapse of judgement.
You may remember how from early on in the Covid vaccine roll-out the former Pfizer chief Mike Yeadon, as part of his many warnings against the new gene ‘vaccines’, strongly advised against jabbing pregnant women. Not only had there been no pre-clinical reproductive toxicology testing but research on rats showed that the vaccine accumulated in the ovaries. Needless to say the BBC was first out of the traps to dismiss fears that the vaccines could harm fertility or cause miscarriages, and to target Yeadon personally. It put out a special propaganda (News) ‘reality check’ report claiming that the study showing the vaccine accumulating in the ovaries was ‘false’.
Will there be any retraction or apology now senior obstetricians are putting their heads above the parapet to report on what they have been seeing amongst their patients?
Dr James Thorp is one such, an extensively published 68-year-old US specialist in obstetrics and gynaecology as well as maternal-foetal medicine, who has practised for more than 42 years. He told Epoch Times that he sees 6,000 to 7,000 high-risk pregnant patients a year and that many complications among them are due to the Covid vaccines.
‘I’ve seen many, many, many complications in pregnant women, in moms and in foetuses, in children, offspring, foetal death, miscarriage, death of the foetus inside the mom,’ he said, adding that what he has seen in the last two years is unprecedented.
Thorp goes on to explain that although he has seen a visible increase in foetal death and adverse pregnancy outcomes associated with the Covid-19 vaccination, attempts to quantify them ‘are hampered by the imposition of gag orders on physicians and nurses’ imposed in September 2021.
You can see the full article here – it is well worth reading.
The tragedy is, as Mike Yeadon comments in the article, that ‘adverse impacts on conception and ability to sustain a pregnancy were foreseeable’. They were, and he did his best to warn us of them, but all the BBC was interested in was discrediting him.
To remind the BBC, this is what he said then, to a Truth for Health Foundation conference, about the special dangers to women of child-bearing age from the gene-based vaccines, as reported by Neville Hodgkinson.
‘We’re being lied to . . . The authorities are not giving us full information about the risks of these products . . . The first is that we never, ever give experimental medicines to pregnant women. The thalidomide tragedy of the 1950s and 60s, in which a new product for morning sickness gave rise to at least 10,000 birth malformations, taught us that babies are not safe and protected inside the uterus, which is what we used to think. Interference by a chemical or something else at a critical stage of development could lead to irreparable damage.
‘Our government is urging pregnant women and women of childbearing age to get vaccinated, and they’re telling them they’re safe. And that’s a lie, because those studies have simply not been done. Reproductive toxicology has not been undertaken with any of these products, certainly not a full battery of tests that you would want.
‘That’s bad enough. Because it tells me there’s recklessness. No one cares. The authorities do not care what happens. But it’s much worse than that.’
Yeadon said he had seen a copy of the biodistribution report obtained from the Japanese regulator. To his horror, he said, ‘what we find is the vaccine doesn’t just distribute around the body and then wash out again, which is what you’d hope. It concentrates in the ovaries of rats, at least 20-fold over the concentration in other background tissues like muscles. And a general rule of thumb in toxicology is: if you don’t have any data to contradict what you’ve learned [from the animal studies], that’s the assumption you make for humans.
‘So my assumption at the moment is that these vaccines are concentrating in the ovaries of every female who has been given them. We don’t know what that will do, but it cannot be benign and it could be seriously harmful.’
His third concern, shared by a German doctor in a petition to the European Medicines Agency eight months ago, is that the spike protein produced by the vaccine ‘is faintly similar – not very strongly – to an essential protein in your placenta, something that’s absolutely required for both fertilisation and formation and maintenance of the placenta’.
The worry was that an immune response to the spike protein might cause antibodies to bind to the placental protein as well.
There was more. He concluded: ‘I think you can only expect that that is happening in every woman of childbearing potential. What the effect will be, we can’t be certain, but it can’t be benign.
‘So I’m here to warn you that if you are of child-bearing potential or younger, so not at menopause, I would strongly recommend you do not accept these vaccines.’
Emergency calls for cardiac arrest and acute coronary syndrome in young people in Israel were significantly associated with the vaccine rollout, both first and second doses, spiking 25% higher than in earlier years, but not with COVID-19 prevalence, a study in the Nature journal Scientific Reports has found.
Using data from the Israel National Emergency Medical Services (EMS) from 2019 to 2021, the study looked at the volume of cardiac arrest and acute coronary syndrome EMS calls in the 16-39 year-old population. It found an increase of over 25% in both call types during January-May 2021, compared with 2019-2020, but no significant increase in calls correlating with COVID-19 infection rates.
The main finding of this study concerns with increases of over 25% in both the number of CA [cardiac arrest] calls and ACS [acute coronary syndrome] calls of people in the 16-39 age group during the COVID-19 vaccination rollout in Israel (January-May, 2021), compared with the same period of time in prior years (2019 and 2020). Moreover, there is a robust and statistically significant association between the weekly CA and ACS call counts, and the rates of first and second vaccine doses administered to this age group. At the same time there is no observed statistically significant association between COVID-19 infection rates and the CA and ACS call counts. This result is aligned with previous findings which show increases in overall CA incidence were not always associated with higher COVID-19 infections rates at a population level, as well as the stability of hospitalisation rates related to myocardial infarction throughout the initial COVID-19 wave compared to pre-pandemic baselines in Israel. These results also are mirrored by a report of increased emergency department visits with cardiovascular complaints during the vaccination rollout in Germanyas well as increased EMS calls for cardiac incidents in Scotland.
While several studies have found severe myocarditis to be a rare adverse effect of the vaccines, the study authors note that myocarditis is often missed, and in fact has been found to be likely responsible for 12-20% of unexpected deaths in adults under 40 in normal times.
Myocarditis is a particularly insidious disease with multiple reported manifestations. There is vast literature that highlights asymptomatic cases of myocarditis, which are often underdiagnosed, as well as cases in which myocarditis can possibly be misdiagnosed as acute coronary syndrome (ACS). Moreover, several comprehensive studies demonstrate that myocarditis is a major cause of sudden, unexpected deaths in adults less than 40 years of age, and assess that it is responsible for 12-20% of these deaths. Thus, it is a plausible concern that increased rates of myocarditis among young people could lead to an increase in other severe cardiovascular adverse events, such as cardiac arrest (CA) and ACS. Anecdotal evidence suggests that this might not be only a theoretical concern.
The results, shown visually in the following graphs, are unmistakable, with clear corresponding spikes in vaccination numbers and emergency calls.
The study does not look at death rates in the age group, but data elsewhere show a clear spike in deaths during the period.
The Centers for Disease Control and Prevention (CDC) today released new data showing a total of 1,247,131 reports of adverse events following COVID-19 vaccines were submitted between Dec. 14, 2020, and April 22, 2022, to the Vaccine Adverse Event Reporting System (VAERS). VAERS is the primary government-funded system for reporting adverse vaccine reactions in the U.S.
The data included a total of 27,532 reports of deaths — an increase of 183 over the previous week — and 224,766 serious injuries, including deaths, during the same time period — up 1,930 compared with the previous week.
Foreign reports are reports foreign subsidiaries send to U.S. vaccine manufacturers. Under U.S. Food and Drug Administration (FDA) regulations, if a manufacturer is notified of a foreign case report that describes an event that is both serious and does not appear on the product’s labeling, the manufacturer is required to submit the report to VAERS.
Of the 12,672 U.S. deaths reported as of April 22, 16% occurred within 24 hours of vaccination, 20% occurred within 48 hours of vaccination and 59% occurred in people who experienced an onset of symptoms within 48 hours of being vaccinated.
In the U.S., 572 million COVID-19 vaccine doses had been administered as of April 23, including 338 million doses of Pfizer, 215 million doses of Moderna and 19 million doses of Johnson & Johnson (J&J).
Every Friday, VAERS publishes vaccine injury reports received as of a specified date. Reports submitted to VAERS require further investigation before a causal relationship can be confirmed.
19 reports of myocarditis and pericarditis (heart inflammation).
The CDC uses a narrowed case definition of “myocarditis,” which excludes cases of cardiac arrest, ischemic strokes and deaths due to heart problems that occur before one has the chance to go to the emergency department.The Defender has noticed over previous weeks that several reports of myocarditis and pericarditis have been removed by the CDC from the VAERS system in this age group. No explanation was provided.
U.S. VAERS data from Dec. 14, 2020, to April 22, 2022, for 12- to 17-year-olds show:
31,455 adverse events, including 1,803 rated as serious and 44 reported deaths. The most recent reported death involves a 14-year-old girl from Tennessee (VAERS I.D. 2238618) who died after receiving her second dose of Pfizer’s COVID-19 vaccine. According to the VAERS report, the girl had a previous history of cancer but was hospitalized 29 days after receiving her second dose of Pfizer with severe COVID-19 and COVID pneumonia. She became “critically ill,” developed respiratory failure and bradycardia and later died.
65 reports of anaphylaxis among 12- to 17-year-olds where the reaction was life-threatening, required treatment or resulted in death — with 96% of cases attributed to Pfizer’s vaccine.
649 reports of myocarditis and pericarditis — two fewer than last week — with 637 cases attributed to Pfizer’s vaccine.
165 reports of blood clotting disorders — 1 fewer than last week — with all cases attributed to Pfizer.
U.S. VAERS data from Dec. 14, 2020, to April 22, 2022, for all age groups combined, show:
20% of deaths were related to cardiac disorders.
54% of those who died were male, 41% were female and the remaining death reports did not include the gender of the deceased.
Our world is run by oligarchs, the holders of vast wealth from monopolies in banking, resource extraction, manufacturing, and technology. Oligarchs have such power that most of the world doesn’t even know of their influence over our lives. Their overall agenda is global power — a world government, run by them — to be achieved through planned steps of social engineering. The oligarchs remain in the background and have heads of state and entire governments acting in their service. Presidents and prime ministers are their puppets. Bureaucrats and politicians are their factotums.
Who are politicians? Politicians are people who work for the powerful while pretending to represent the people who voted for them. This double-dealing involves a lot of lying, so successful politicians must be good at it. It’s not an easy job to make the insane agenda of the powerful seem reasonable. Politicians can’t reveal this agenda because it almost always goes against the interests of their constituents, so they become adept at sophistry, mystification, and the appearance of authority. For example, wars for Israel have been part of the agenda of the powerful for years. Since 2001, wars for Israel have been sold as “the war on terror” and lots of lies had to be made up as to why the war on terror was a real thing. The visible faces promoting the war on terror were neoconservatives in the US, almost all of whom were advocates for Israel, or Zionists. Zionists are not the only members of the oligarchy, but they seem to be its lead actors. ... continue
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