By Michael Nevradakis, Ph.D. | The Defender | April 123, 2023
The U.S. government will spend $5 billion on a program to accelerate the development of new coronavirus vaccines and therapeutics, White House officials announced this week in an interview with The Washington Post.
Dubbed “Project NextGen,” the new initiative will serve as the successor to the Trump administration’s “Operation Warp Speed,” launched in March 2020 to expedite the development of COVID-19 vaccines.
Similar to Operation Warp Speed, Project NextGen — with funding from the Bill & Melinda Gates Foundation and the Rockefeller Foundation — will encourage public-private partnerships.
According to Reuters, the project will be managed out of the U.S. Department of Health and Human Services (HHS), which will coordinate across various government agencies and private-sector actors, covering “all phases of development from lab research and clinical trials to delivery.”
“Scientists, public heath [sic] experts and politicians have called for the initiative, warning that existing therapies have steadily lost their effectiveness and that new ones are needed,” the Post reported.
The new initiative is based on a “roadmap” for the development of new coronavirus vaccines, formulated by the University of Minnesota and led by a former Biden administration official.
A ‘roadmap’ for ‘better’ coronavirus vaccines
Operation Warp Speed invested approximately $30 billion in the development, manufacturing and distribution of COVID-19 vaccines, according to USA Today, with six drugmakers each receiving more than $1 billion, along with a promise of a “guaranteed market” if they successfully developed a vaccine.
Project NextGen was originally to be named “Project COVID Shield,” after some Republican lawmakers called for the launch of an “Operation Warp Speed 2.0” to build on the Trump administration’s legacy.
However, “White House officials wanted some distance from the Trump effort as well as from COVID-focused branding, when much of the country had moved on from the pandemic,” the Post reported, quoting two anonymous Biden administration officials.
The new initiative also will be “more modest,” and have a “more open-ended mission,” unlike Operation Warp Speed, which focused exclusively on COVID-19.
According to USA Today, the initial $5 billion in funding “will be financed through money saved from contracts costing less than originally estimated.”
Ashish Jha, White House coronavirus coordinator, said the new initiative has three primary goals: creating longer-lasting vaccines, accelerating the development of nasal vaccines and bolstering efforts to create “broader” pan-coronavirus vaccines.
The project also includes funding for more durable monoclonal antibodies.
The name “Project NextGen,” made more sense, Jha said, as it is “a different time” with “a different set of goals.” The new name “much more accurately captures what it is that we are trying to do,” he said.
Michael Osterholm, Ph.D., M.P.H., director of the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, is helping lead the effort.
In February, CIDRAP developed a “roadmap” for the development of “better” coronavirus vaccines. This “roadmap” serves as the basis for Project NextGen.
Osterholm was a member of the COVID-19 advisory board convened by then-president-elect Joe Biden’s transition team. The board was dissolved when Biden took office in January 2021.
Jha told the Post, “It’s been very clear to us that the market on this is moving very slowly. There’s a lot that government can do, the administration can do, to speed up those tools … for the American people.”
Previously, during a July 2022 White House coronavirus vaccine summit, Jha said:
“We need vaccines that are more durable. Vaccines that offer broader and longer-lasting protection. Vaccines that can stand up to multiple variants. Vaccines that can handle whatever Mother Nature throws at us.”
Osterholm characterized existing COVID-19 vaccines as “really good” but “not great.”
“There is a substantial amount of work [to be done] to take these good vaccines and hopefully achieve better vaccines,” Osterholm said.
Osterholm noted that SARS-CoV-2 is the third new coronavirus to appear in the past two decades — Middle Eastern respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS) were the other two. According to Osterholm, it would be “great” to be prepared for a fourth new coronavirus when and if it appears.
Reuters quoted an unnamed HHS spokesperson, who stated:
“While our vaccines are still very effective at preventing serious illness and death, they are less capable of reducing infections and transmission over time. New variants and loss of immunity over time could continue to challenge our healthcare systems in the coming years.
“Project NextGen will accelerate and streamline the rapid development of the next generation of vaccines and treatments through public-private collaborations. The infusion of a $5 billion investment, at minimum, will help catalyze scientific advancement in areas that have large public health benefits for the American people, with the goal of developing safe and effective tools for the American people.”
The Post noted, however, that while the outbreak of new coronaviruses in recent decades has “spurred worries about the potential for future health crises,” it might take years to develop a universal coronavirus vaccine, noting that such efforts have been unsuccessful for influenza despite decades of efforts.
Speaking to USA Today, Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, expressed skepticism about Project NextGen’s goals, noting that similar efforts to develop flu and HIV vaccines have been in progress for more than 40 years, without result.
Offit said that the effectiveness of nasal vaccines remains unclear, as they remain in the clinical trial stage at this time. Dr. John Moore, an immunologist at Weill Cornell Medical College in New York, expressed a similar view, saying “it’s seriously naïve to believe that it will be easy to make [a nasal vaccine].”
He added that the emphasis on improving existing COVID-19 vaccines, which he described as “amazing,” would likely undermine public trust in those vaccines.
Moore told USA Today that “an initiative like this is much needed and should have been put in place much sooner,” adding that “Anyone familiar with vaccine development knows that translation into a practical product is a much harder and more expensive process” than the creation of a basic vaccine.
“A lot of designs that look good in the early stages fizzle out because they cannot be manufactured efficiently under the conditions required for human trials,” Moore said.
According to Jha though, the new project and its investment in a new generation of coronavirus vaccines “will have very large benefits for other respiratory pathogens we deal with all the time, like flu and RSV.”
Gates, Rockefeller Foundations behind Project NextGen
On Feb. 21, CIDRAP published its “roadmap for advancing better coronavirus vaccines” — with $1 million in support from the Gates and Rockefeller Foundations, “To help jump-start the search for better vaccines [and] develop broadly protective vaccines.”
According to the project description, the funding was used to assemble “an international collaboration of 50 scientists who mapped out a strategy to make the new vaccines a reality.”
Osterholm stated at the time, “If we wait for the next event to happen before we act, it will be too late.”
Bruce Gellin, M.D., M.P.H., chief of Global Public Health Strategy at The Rockefeller Foundation, said that there is an “urgency” to take the next steps, calling for an “equivalent” to Operation Warp Speed.
According to CIDRAP, Gellin “has led several federal vaccine initiatives and has been a technical advisor for groups including Gavi, the Vaccine Alliance, COVAX, and the World Health Organization.”
The Gates Foundation is a partner of Gavi, The Vaccine Alliance, which, in turn, closely collaborates with the ID2020 Alliance, which promoted the development of digital ID. Microsoft is a founding member of the ID2020 Alliance, as well as Gavi, the BMGF, the World Bank, Accenture and the Rockefeller Foundation.
CIDRAP received the $1 million grant in April 2022, and by October 2022, had developed a draft version of its “roadmap.” According to Osterholm, it draws on a similar “roadmap strategy” employed by CIDRAP for previous projects, including the improvement of seasonal flu vaccines and the development of a universal flu vaccine.
For the new “roadmap,” these efforts culminated in a 92-page report, and accompanying summary, published in Vaccine journal. The project is divided into five core areas: virology, immunology, vaccinology, animal and human models for vaccine research, and policy and funding.
In an accompanying commentary published in the same issue of Vaccine, Dr. Margaret Hamburg, a former FDA commissioner who is co-president of the InterAcademy Partnership, and Dr. Greg Poland, director of the Mayo Clinic’s Vaccine Research Group, said that COVID-19 vaccines have been effective in preventing serious disease.
Hamburg was a participant in the Nuclear Threat Initiative’s (NTI) monkeypox pandemic simulation in March 2021, based on a remarkably prescient “fictional” monkeypox outbreak in May 2022. She is a board member of the Nature Conservancy and vice president of NTI’s Global Biological Policy and Programs and is on the board of Gavi.
However, according to Hamburg and Poland, there are some problems with the current vaccines, including “notable reactogenicity” in certain individuals, a short duration of protection, and technical requirements that make them difficult to store and administer in remote locations and areas with low resources.
They said the next-generation vaccines may offer additional benefits such as “new methods of delivery — transdermal patches, oral or intranasal vaccines — which are easy to distribute and apply, stimulate mucosal immunity, and potentially block transmission,” adding that this is superior to the current strategy of “chasing” new variants and developing boosters.
Hamburg and Poland said that a universal coronavirus would be easy to stockpile, but the road to the development of such a vaccine could take a “tiered approach,” starting with the creation of a “variant-proof” COVID-19 vaccine, followed by developing vaccines that offer broader protection against various coronavirus families.
Members of CIDRAP said in February that funding would be a challenge for the initiatives set forth in their “roadmap,” due to “shrinking support for large-scale vaccine investments, now that the emergency phase of the COVID-19 pandemic has mainly passed.”
The federal funding earmarked for Project NextGen would, however, appear to address this issue.
Other challenges the CIDRAP team identified included the “lack of corporate incentives, uncertainty around public demand for a broadly protective vaccine, and the feasibility of expanding vaccine production capacity.”
Gellin, however, said in a Feb. 21 University of Minnesota press release that: “Time and time again, we have seen that investment in science brings solutions. The COVID-19 pandemic galvanized the research community and advanced vaccine R&D efficiently and through broad collaborations,” essentially previewing Project NextGen.
On April 20, CIDRAP will hold a one-hour “scientific webinar,” open to the public, presenting their “roadmap.”
Republican lawmakers, Fauci pressed for ‘Warp Speed 2.0’
Political wrangling delayed the funding of Project NextGen, according to the Post, which reported that Republicans insisted that funds were left over from prior COVID-19 aid packages.
Ultimately, HHS “shifted funds intended for coronavirus testing and other priorities” into the new initiative.
Dr. Anthony Fauci was one of the voices who “spent months pressing Congress for billions of dollars that could be used to develop next-generation vaccines and treatments,” the Post reported, adding that these arguments “largely fell flat” in the face of Republican opposition.
However, according to the Post, “Even some of the Republicans who blocked the White House’s coronavirus funding requests last year said they wanted a ‘Warp Speed 2.0’ to rush updated vaccines and treatments that would better fight the virus.”
In August 2022, former Sens. Richard Burr (R-N.C.) and James Inhofe (R-Okla.) wrote to President Biden, stating “Operation Warp Speed was the most successful public health program since small pox. It saved millions of lives, and it should be resurrected as soon as possible.”
Dawn O’Connell, assistant secretary for Preparedness and Response at HHS, told the Post that the Biden administration learned lessons from Operation Warp Speed, including how to speed up vaccine development, and that these lessons would be applied to Project NextGen.
“We’ve learned a lot in these three years,” O’Connell said. She added that some of the lab work related to Project NextGen has begun, and that the government has launched efforts to identify potential partners in the private sector.
“We’ve begun surveying the landscape out there — assessing what vaccine candidates are available, [and] moving through what exciting technologies are there,” she said.
According to the Post, O’Connell and her team informed companies working on the development of monoclonal antibodies that the government may soon make new investments in the technology.
Jha, however, refused to set a timetable for when new products developed under the aegis of Project NextGen would be available to the public, the Post reported.
“The timelines are really going to be predicated on how quickly the scientific advancements continue, and how quickly we can study and measure the efficacy and safety of these products,” Jha said.
Project NextGen is also still without a leader, with the White House “still considering candidates,” according to the Post, which noted that the process is slowed down by “Democrats’ desire to avoid questions of conflicts of interest that dogged Operation Warp Speed, after Trump officials selected Moncef Slaoui, a pharmaceutical industry executive with significant stock holdings, to lead that program.”
Michael Nevradakis, Ph.D., based in Athens, Greece, is a senior reporter for The Defender and part of the rotation of hosts for CHD.TV’s “Good Morning CHD.”
This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
RT | April 12, 2023
Florida State University criminology professor Eric Stewart has quietly resigned after a month-long absence amid an inquiry into whether he faked data in multiple studies to inflate the prevalence of racism in the US, the Florida Standard reported last week.
A fellow of the American Society of Criminology, Stewart was first publicly accused of falsifying data in 2019 by the co-author of one of his studies, University of Albany criminology professor Justin Pickett, who claimed Stewart had made several misleading changes to the numbers in their 2011 paper ‘Ethnic threat and social control: Examining public support for judicial use of ethnicity in punishment’ immediately before publication.
The published study claimed that public desire for harsher sentences for black and Hispanic offenders increased in proportion with the size of the minority populations in a community. However, the study data showed no such relationship existed, and that the opposite might even be true. Pickett revealed that his colleague had doubled the sample size while leaving out nearly three quarters of the counties polled, mangling the data to the point of incoherence, and said Stewart refused to turn over the raw data so that Pickett could re-run the calculations himself.
That study and four more were subsequently retracted, but when Pickett tried to bring the matter to the university’s attention, he claims he was met with four months of stonewalling. When the school did eventually mount an inquiry, the three-person panel in charge included two people who had co-authored studies with Stewart, violating Florida State’s conflict of interest policy. Perhaps unsurprisingly, that inquiry claimed it had not found enough evidence for fraud and advised against continuing the investigation.
Pickett told the Florida Standard that coverups by colleagues are common in the field, explaining “there’s a huge monetary incentive to falsify data and there’s no accountability. If you do this, the probability you’ll get caught is so, so low.”
Stewart, who is black, complained to the university that Pickett – who is white – had “essentially lynched [him] and [his] academic career.”
In 2020, a sixth paper authored by Stewart was retracted – though not before being cited by 186 other papers. Another investigation found enough merit in the fraud claims to pursue them, apparently imperiling Stewart’s $190,000 per year position. Florida State declined to discuss the matter with the Florida Standard, and Stewart’s profile is still live on the university’s website.
By Madhava Setty, M.D. | The Defender | April 11, 2023
Last week I attended the 23rd World Vaccine Congress in Washington, D.C. — which bills itself as “The Most Important Vaccine Event of the Year”:
“Our event format allows for whole-sector topics, giving an opportunity for people to find out more about their specific area of research and their job-function. By running parallel niche conference channels over the 3 days, it increases the relevance of the whole event for everyone who attends.
“During the sessions you will learn how cutting-edge research efforts can be integrated with
“to produce more and better vaccines to the market.”
More than 3,100 people, largely from the pharma and biotech industries and regulatory affairs, attended the event.
Keynote speakers included prominent figures from public health agencies, including Peter Marks, M.D., Ph.D., director of the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA); various directors of research at BioNTech and Moderna; and academic bigwigs like Peter Hotez, M.D., Ph.D., dean of the National School of Tropical Medicine and co-director of Texas Children’s Hospital Center for Vaccine Development at Baylor College of Medicine (my own alma mater).
During the three full days of the conference, neither I nor Dr. Elizabeth Mumper encountered another physician presently in clinical practice.
The event was open to anyone willing to pay the entry fee, which started at $495 for students and went up to $1,000+. But from what I could tell, this was largely a gathering of big and small pharma, biotech and leaders in regulatory affairs.
General impressions
I was able to attend only a fraction of the hundreds of presentations and panel discussions during the conference. Below I summarize the most important points from the sessions I attended and key conversations I had with the presenters.
Note: Throughout this article I have quoted myself and others. I do not have access to any audio or video recordings from the sessions, if there are any. Quotations are paraphrased from my own recollection and are not to be taken verbatim.
Introduction to the conference: Anti-vaxxers are dangerous, expect annual COVID vaccinations
Dr. Gregory Poland, director of vaccine research at the Mayo Clinic, delivered the opening remarks. He then moderated a panel discussion with Marks; Paul Burton, chief medical officer at Moderna; Isabel Oliver, chief scientific advisor transition lead at UKHSA; and Dr. Penny Heaton, vaccines global therapeutic area head, Johnson & Johnson.
This first session was possibly the most fascinating 90 minutes of the entire week. Poland, I learned in a brief conversation with him after the conference, is also a pastor. His oratory skills were on full display during his opening and closing remarks. He also is vaccine-injured.
In February 2022, Poland reported suffering from significant tinnitus after receiving the second dose of “an mRNA vaccine.” At the time, Poland described his symptoms as “extraordinarily bothersome.” Nevertheless, he chose to receive a third dose (monovalent booster).
Poland’s commentary on the COVID-19 mRNA vaccines was extremely positive. He said the rapid deployment of the new therapy saved millions of lives and would have saved millions more if it weren’t for the disturbing trend of growing vaccine hesitancy.
I assumed that his vaccine-induced tinnitus had resolved over the last year. It was only at the end of the conference, several days later, when he told me personally that his symptoms were still debilitating, making his unmitigated support of these products even more astonishing.
Poland set the tone for the four-day conference in the first 10 minutes. In his mind, the COVID-19 pandemic was halted through the hard work of our regulatory agencies and the remarkable products borne of the mRNA platform.
The only failure came in the form of “inexplicable” vaccine hesitancy, a phenomenon driven by anti-vax pseudoscientists who are profiting from spreading baseless, fear-driven propaganda.
Combatting vaccine hesitancy is as big a challenge as protecting the world from the next deadly pathogen. Indeed, a significant portion of the events focused on strategies to dismantle the troubling “anti-vaxxers.”
Marks supported Poland’s position that the vaccine-hesitant are irrational, “It’s crazy that they don’t get how great vaccines are,” he said. “I am past trying to argue with people who think that vaccines are not safe.”
I found this remark to be particularly disquieting. What is it going to take for the director of the FDA’s CBER to reassess the safety profile of the mRNA shots?
The panelists expressed shock that some states (Idaho and North Dakota) are considering bills making the administration of COVID-19 mRNA vaccines illegal.
“How can we get the public to understand that science is iterative?” Heaton asked. “COVID vaccines save lives!”
Poland responded: “Can we get an amen?!!”
Marks, flanked by his partners — I mean counterparts — in industry let the audience know what the future would look like. “I am not going to hold my breath waiting for a sterilizing vaccine, protecting against severe disease is enough,” he said.
Marks predicted COVID-19 vaccines would be administered annually or even biannually.
He noted that the challenge will be to identify the strain of interest in June so that we can have a vaccine by September. A 100-day turnaround is possible as long as we have manufacturing ready to go, he said. Heaton (J&J) and Burton (Moderna) nodded in response.
To summarize, leaders of the vaccine industry and the regulatory agencies are, in my impression, convinced that they have offered the world an amazing product and are frustrated that it is not being readily and universally accepted.
They cited the fact that although 70% of Americans received the primary series, only 15% have chosen to receive the bivalent booster that became available in September 2022.
The reluctance of the public to accept the shot, they think, is due to the perceived reduction of threat of the disease, which can be overcome by “proper messaging.”
Of course, the public is correct. The pathogenicity of the strains now circulating is less than the original ancestral strain from 2020. The possibility that reduced uptake could be linked to a poor safety profile was never mentioned.
In their minds, vaccine injuries and serious adverse events are extremely rare. Their incidence has been exaggerated by anti-vax rumor mills. Poland joked that “maybe we should start a rumor that microchips are in ivermectin!”
His rejoinder was met with only sparse, nervous laughter.
Roundtable discussion: ‘Insights and tools to counter vaccine hesitancy’
Though the speakers at the introductory session were clearly entrenched in the “safe and effective” position, they acknowledged that there was a strong and growing swath of the population that was vaccine-hesitant.
More importantly, they were interested in dismantling this movement and not ignoring it. It was an opportunity to engage with them, perhaps in smaller groups or individually. I made my first attempt at a roundtable discussion where people could offer ways to convince the “anti-vaxxers” that they were wrong.
I found myself sitting next to Dame Jennifer Margaret Harries, a British public health physician and chief executive of the UKHSA. The UKHSA has been publishing U.K. health surveillance data with more granularity and frequency than our own Centers for Disease Control and Prevention (CDC).
I let her know that I appreciated the data coming from her agency and that I began following the agency’s regular surveillance reports two years ago. She was grateful for the acknowledgment and appreciated my interest in her work.
It was the UKHSA that offered the first glimpse of negative efficacy of the COVID-19 vaccines in a public dataset in September 2021.
I asked Harries about that and her tone immediately shifted. She said she was aware of no such thing and that she would have to look into it before commenting.
I was surprised by her response. The report from September 2021 wasn’t an aberration. Subsequent reports from the agency over which she presides indicated there was a large and growing incidence of COVID-19 among the vaccinated compared to the unvaccinated.
The UKHSA stopped making that data available several months later. I wanted to know why, but she was unwilling to answer.
I changed tactics and asked her about Tess Lawrie, Ph.D., of the Evidence-Based Medicine Consultancy who notably saw safety signals in the U.K.’s Yellow Card system and, in an open letter in June 2021, urged the director of the Medicines and Healthcare products Regulatory Agency to halt the British vaccination campaign.
Harries looked at me sternly and said, “There are a number of prominent physicians in my country who are gaining fame for their unfounded positions around vaccine dangers, most recently a cardiologist.”
“Do you mean Dr. Aseem Malhotra?”
“Yes. He has gotten a lot of attention of late.”
Harries didn’t think Malhotra or Lawrie held credible opinions, or at least that’s what she told me. It wasn’t easy for me to accept this. We didn’t have a chance to speak about this further. I had another brief interaction with Harries later in the week (see below).
An American pediatrician chaired the roundtable. He opened the discussion with a request for ideas on how to counter vaccine hesitancy.
I had one:
“It’s obvious that the Krispy Kreme doughnuts and travel restrictions are carrots and sticks that have only partially worked. Those that remain hesitant are steadfast in their position because they have looked harder than most.
“They aren’t believing rumors. They are listening to credentialed physicians and scientists who have authored numerous peer-reviewed papers and who happen to be COVID-19 vaccine critics. Why don’t we engage them openly and see what they have to say?”
Katie Attwell, Ph.D., a professor from the University of Western Australia whose interest is in vaccine policy and uptake, shot down that idea. I didn’t know who she was at the time. I did manage to speak with her personally later in the week. Her rebuke was curt and to the point, “We cannot give any voice to the critic,” she told me. “Once the public sees them on equal footing with us they may believe what they are saying.”
Implicit in her strategy is the idea that the public cannot separate information from misinformation. Truth, in her mind, cannot stand on its own. It needs to be identified by those who know better.
Of course, there is another possibility. Perhaps she knows what the truth is and wants to hide it. My initial impressions were that she was earnestly doing her duty to protect the public through whatever means necessary. It would all come down to assessing her breadth of knowledge on the topic.
Chris Graves, the founder of Ogilvy Center for Behavioral Science, supported Attwell’s position. He was a smiling, gregarious fellow, who, I found out later, was hired by Merck to analyze different personality types and value/belief systems among the “anti-vax” camp.
Once a person is properly categorized, “personalized messaging” can be used to bring them back to “reality.” According to the abstract of his study:
“Just as precision medicine treats individuals, this study of 3000 parents (inclusive of all demographics) in the USA sought to identify the most effective personalized messaging to address vaccine hesitancy among parents. First, it sought correlations between: demographics; stated specific reasons for vaccine hesitancy; cognitive biases; cognitive styles; identity-linked worldviews; and personality traits.
“Second, it tested 16 messages in the form of mini-narratives, each embodied with a behavioral science principle, to find if certain messages resonated better than others depending on the many factors above.”
I later asked him how he would respond to someone who looked at the trial and observational data and found that it told a different story about the vaccines’ safety. He smiled, “Oh, those are the ones that have a higher need for cognitive closure. Yes. They are stuck because they cannot move forward if there is any uncertainty.”
Graves couldn’t describe what the “personalized messaging” would look like for this group specifically, only that it existed and had been proven to be more effective than the other types of messaging
I asked him if he was aware of how many reports of adverse events had been registered in the Vaccine Adverse Event Reporting System. “No,” he said, still smiling.
Panel discussion: ‘What vaccines and COVID have taught us about the science of immunology’
The panel included Ofer Levy, M.D., Ph.D., director of the Precision Vaccines Program at Boston Children’s Hospital and VRBPAC member.
This discussion centered around the lack of good biological markers for vaccine efficacy. According to the consensus position of the VRBPAC, antibody levels are not a surrogate for protection.
In other words, an immune response to the vaccine in the form of antibodies should not be used to judge whether the vaccine will do anything useful. Nevertheless, pediatric trials of the original formulation used them as proof of efficacy.
One of the expert panel members was Sharon Benzeno, Ph.D., chief commercial officer of Immune Medicine at Adaptive Biotechnologies, who offered encouraging information. She felt that our approach was too centered on antibody responses and that it would be possible to identify biochemical markers of vaccine-induced cellular immunity in the future.
Levy agreed that this would be an important addition to our fund of knowledge moving forward.
When it came time for questions, I asked the panel:
“As we all know, uptake of the bivalent booster is very low. People are unwilling to subject themselves to another shot because there are no trials that look at outcomes, only immunogenicity, which you yourself are saying is insufficient. Why not insist on trials that can prove an outcome benefit?”
Levy responded that the advisory panel had no say in what kind of studies were required. His advisory committee could only vote yes, no or abstain with regard to approval/authorization.
Another panel member, Alessandro Sette, doctor of biological science, head of Sette Lab and professor at La Jolla Institute for Immunology, piped in, “It wouldn’t be practical. The signal is too small because we are no longer dealing with a non-naive population.”
Sette had taken the bait. He was saying that most people have either been vaccinated or exposed to the virus already. The booster would have little benefit, if any, on a population that was already protected.
I asked the obvious follow-up: “So why then are we insisting that everyone get boosted?”
Harries, the moderator, immediately stepped in, “Okay, we have veered off topic. Next question.”
I was beginning to understand how this conference was being managed. I don’t believe the sponsors of this meeting expected to encounter many probing questions about the quality of the COVID-19 vaccines from the audience who paid for their expensive tickets. When and if they arose, moderators were quick to intervene.
Was it possible that others in the audience saw what was happening? I believe it to be so. Every time I asked a question, people seated near me told me that they appreciated the question and wondered why it went unanswered.
Even a non-scientist from Moderna approached me several times throughout the conference to let me know she agreed that responding to these issues would be the best way to “increase uptake” and that she was planning on forwarding my questions to her scientific staff.
Panel discussion: How does vaccine law impact uptake and access?
This group was moderated by a lawyer, Brian Dean Abramson, “a leading expert on vaccine law, teaching the subject as adjunct professor of vaccine law at the Florida International University College of Law.”
His opening remarks demonstrated his contempt of the vaccine-hesitant:
“We didn’t get to herd immunity because of these anti-vaxxers.
“They are dangerous. In 2021, they received $4 million in donations. It is estimated that in 2022, more than $20 million have been funneled to their movement.”
The panel included Attwell, whose position was clear from her flat response to my suggestion earlier. Her public page indicates that she has received approximately $2 million in funding for her research into increasing vaccine access and uptake.
Attwell is not a physician or a medical scientist. However, also on this panel was a public health physician from Johns Hopkins Bloomberg School of Public Health, Chizoba Wonodi, Ph.D., who has 27 years of experience in Africa, Asia and America.
I was encouraged by the flexibility in the audience from my prior challenges and when offered the microphone, I opened with a more aggressive salvo directed at the moderator:
“‘Anti-vax’ is pejorative and reflects ignorance about who the vaccine-hesitant are and why they believe what they believe. This is further reflected when you insert terms like ‘herd immunity’ with regard to this pandemic. Without a sterilizing vaccine, or even one that can prevent infection, herd immunity is an impossibility.
“Rather than inflaming the situation, why don’t we engage with the doctors and scientists who are vaccine-cautionary and hear their arguments in a fair, open and public discussion?”
Once again, Attwell politely but sternly warned the audience that this would be too dangerous in her opinion. I expected that. And I also was again encouraged that the three people sitting around me acknowledged that my point was valid and that it was puzzling that the panelists would not address the merits of my position.
Afterward, Chizoba approached me and let me know she appreciated my question. In her work, she has found that education is the most important thing. She was kind; she believed that many of the vaccine-hesitant physicians could be reached by providing them with the proper information.
I asked her how she would address a physician who simply felt that authorizing a therapy where the double-blinded trial demonstrated a greater all-cause mortality than the placebo was not only unprecedented but illogical.
She stared at me blankly. “Is this from a new study?” she asked.
I told her that this was from the published interim results from the Pfizer/BioNTech trial, the trial that launched the worldwide vaccination campaign. She was not aware of the results.
To her credit, she admitted that she hadn’t looked at the paper but planned on doing so.
The final day
I attended a session titled “Let’s Talk Shots” where Daniel Salmon, Ph.D., presented the work being done at Johns Hopkins Institute for Vaccine Safety.
“LetsTalkShots is designed to support vaccine decision-making. It shares engaging animated content based on a person’s questions or concerns.”
Suffice it to say that there is a lot of thought, money and energy behind the campaign to vaccinate the public. The approach once again is around targeted messaging, which acknowledges that different people need to hear different types of information.
Attwell also presented to the same audience. In this forum, she pointed out that the U.S. government was more tolerant of the vaccine-hesitant than in her country. She suggested that our religious and philosophical exemptions should be eliminated entirely. Only the strictest medical exemptions should be permitted. This will lead to better outcomes.
After her talk, I approached her. She looked up as if she was expecting me to ask her some questions. I asked her if she would be willing to have a more open conversation about her research and opinions. She was.
I let her know that I thought she was smart enough to realize that I was, in fact, a vaccine skeptic. She nodded her head.
“So,” I said, “the number one disinformation spreader may be running for President of the United States. What do you think should be done?”
She smiled uncomfortably and said, “Yes, it’s going to be hard to keep him from getting oxygen.”
In other words, her proposed approach to suffocate the anti-vax spokespersons becomes much harder when they are running for the highest office in the land. I thought she might be willing to reconsider her strategy. She wasn’t.
I tried a different approach. I explained that in my investigation, I haven’t found enough evidence that the COVID-19 mRNA shots were safe or effective, however, I was open to the possibility that the mRNA platform may eventually prove to be a powerful way to create therapies that are safe and effective in the future.
What good would it be to have this technology if half of the public no longer trusts it or the people who are shoving it down their throats while denying them an opportunity to debate them?
“Yes. That’s a good point.”
I told her that in this country, doctors are unwilling to write religious or philosophical exemptions to COVID-19 vaccines for fear of backlash. Many employers won’t accept them anyway, so her position is moot.
“Yes. That’s true.”
I asked her what would be a cause for a medical exemption. She didn’t know. I explained that medical exemptions are considered valid ONLY if the person has evidence of a prior reaction to an mRNA vaccine or to one or more of the ingredients in them. Nobody but a handful of people on the planet knows what exactly is in these things.
How would a doctor (or anyone else) know whether a given person was at an increased risk for an untoward event?
“I don’t know.”
I asked her if she was aware of the evidence of medical fraud around the Pfizer vaccine trials. She said she read something about it a while ago but didn’t think it was important.
Finally, I asked her why she thought vaccinating everyone was the right thing to do.
“Vaccination rates in my country are higher than in yours and we fared better.”
But there are countries whose vaccination rates are much lower than both countries and mortality rates are even lower. How could she explain that? She couldn’t.
Observations from Dr. Elizabeth Mumper
Mumper attended “Partnering for Vaccine Equity Program,” chaired by Joe Smyser, Ph.D., CEO of The Public Good Projects.
She shared this with me:
“This lecture was about vaccine acceptance and demand, specifically social and behavioral drivers, and how to link action and policy through the use of the social sciences.
“The strategy was to empower community leaders to take public health messages to communities. The research showed that disparities in vaccine acceptance decreased in black and brown communities which had the program. Research shows that now the most vaccine-hesitant are white, rural and right-wing.
“In the program described, they worked with social media influencers (like young women who did beauty blogs) to repeat public health messages to their audiences. They identified 212,700,000 disinformation messages about vaccines, most of which came from the United States.
“In this project, they worked closely with Twitter and facilitated the removal of what they deemed misinformation. They recruited 495 influencers who would share information voluntarily with their followers. As a result, they reached 60 million people.
“They know that so-called ‘anti-vaxxers will not come after social media influencers.’ The program provided training and webinars to educate how to compose effective public health messages.
“This public health social scientist called anti-vaxxers ‘idiots and jerks.’
“During the question and answer period, I said that in my experience, many parents who were vaccine-hesitant were very smart and had advanced degrees. People like doctors and lawyers and engineers knew someone in their family who had an adverse vaccine reaction. I suggested it would be more effective to engage with the vaccine-hesitant and discover what data they are relying on rather than using vitriolic name-calling.
“I am paraphrasing the speaker’s response below. He said, ‘We work upstream. We want to know where they are getting their misinformation. I can call people idiots and jerks if they are giving out misinformation. If you even raise questions like about the HPV vaccine, you will get speaker invitation and book deals. People are getting rich from spreading misinformation. We know what the right information is.’”
Mumper summarized:
“It was profoundly disturbing for me to hear details about how social scientists and public health officials worked directly with Twitter to remove content they deemed to be misinformation. Their assertion ‘that we know what is true’ did not ring true. Their efforts were directed at increasing vaccine uptake in all age groups for which emergency use authorization had been granted.
“The speaker did not seem to take into account the First Amendment rights for free speech of those who posted data questioning the effectiveness of COVID vaccines.
“I was surprised by the vitriolic rhetoric directed at those who reported side effects from the vaccine or who questioned the risk-benefit ratio.
“It was unsettling to hear how public health officials courted social media influencers to spread messages for their followers to get vaccinated. Yet they scrubbed messages from doctors and scientists who posted inconvenient data about COVID-19 vaccines.”
The last question of the symposium
The final day wound down with another plenary session. Once again, Poland moderated a panel of vaccine researchers who discussed how to quickly manufacture more durable vaccines, i.e., ones that would have longer-lasting protection.
One of the researchers made a remarkable observation. Early in the pandemic, prior to vaccine availability, young infants who contracted COVID-19 were found to have robust and enduring immunity by every measure even three years later. Perhaps some clues lay within this interesting cohort.
Mumper saw a great opportunity to pull the rug from under their feet. She said:
“I am a pediatrician in Virginia. I have been shocked at how well my infant patients did with COVID-19. The CDC has told us that the survival rate from COVID-19 is 99.997% in these infants. Now you, too, are telling us that we know these kids have great protection two years after infection.
“I am wondering why I should be pushing these vaccines on a 6-month-old when I don’t have any long-term data on what things like lipid nanoparticles do to babies. So convince me!”
(Laughter from audience.)
Poland to the panelist: “You have 30 seconds to answer.”
(More laughter.)
Panelist: “That would require more time and a bottle of wine.”
(Laughter.)
Panelist: “I don’t think I can answer that question.”
Mumper: “OK, Anybody else?”
Panelist Andrea Carfi, Ph.D., chief scientific officer at Moderna, took a shot at it, pointing out that Mumper is under the “misconception” that long-term effects of COVID-19 are less than that of the vaccines while admitting that he didn’t know what the long-term sequelae of infection were either.
Poland accepted Carfi’s response as sufficient and closed the discussion.
Those sitting next to us once again noted the merits of Mumper’s concern. Moreover, Carfi’s response didn’t resolve the issue at all. If the long-term effects of both the vaccine and the infection are unknown, on what grounds are we pushing the jab on these children?
Final thoughts
This was a rare opportunity to engage with vaccine proponents in their own house on their own terms. In my assessment, their foundation is crumbling and their structure will eventually collapse.
The big players must see this, which is why they are quick to squelch any lines of inquiry that will expose the hypocrisy.
This wasn’t lost on the audience. As I mentioned, some of them were able to realize that simple questions were not met with clear answers.
It is clear to me that the “pro-vaccine” camp is not as monolithic as we often think. There is a spectrum of skepticism amongst them. They also recognize that the vaccine-hesitant range the full continuum from “SARS-CoV-2 virus deniers” to the “wait and seers.”
They have the means to construct sophisticated “information” campaigns that target the vaccine-cautionary with specific messaging.
I suggest we use their model to at least acknowledge that we can be more precise in how we bring them to their senses.
In my first open comment in a roundtable discussion, I summarized the situation as follows:
“There are many people who are vaccine-hesitant that do not have the capacity to read scientific papers and analyze data. They see two groups who are mirror images of each other. Both sides think the other side is incredibly gullible, that they are listening to misinformation spreaders and are endangering the rest of us for their own personal gain.
“They can also see the one big difference between the two. One side is asking for an open discussion around this important issue. The other believes that only their side should have the right to express themselves while the other needs to be silenced.
“How do you think this is going to play out? Why would the undecided ever choose to follow the group that advocates censorship over open debate?”
By refusing to engage us in any meaningful exchange they may be able to bring over a few of the vaccine-hesitant to their side by what can be best described as “conversion therapy.”
However, in the end, their tower will topple because it is not based on logic, the scientific method or the unassailable facts. It relies on censorship of the voices of those who are qualified to speak on the matter to manufacture “consensus.”
It is incumbent on us to decide what should be done to hasten the inevitable emergence of sensibility around this matter.
I am quite certain there are people who know vaccines are causing incalculable harm but advocate their widespread use anyway. A few of them were likely at the conference. They won’t be swayed by open debate, however, they represent only a tiny minority of all vaccine advocates.
I suggest that we begin by not regarding every vaccine proponent as an engineer of mass murder. Most are woefully uninformed. In attempting to achieve herd immunity they have succumbed to herd mentality. They need to be reached.
In my recent experience, I see that it is possible through open dialogue. This is precisely why the engineers of this pandemic and its response want to make sure this never happens. Despite what they say publicly, I don’t think they are worried about the vaccine skeptics remaining hesitant — they are worried about losing members of their own herd to the truth.
Madhava Setty, M.D. is senior science editor for The Defender.
This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
By Anthony Watts | American Thinker | April 7, 2023
After the recent devasting tornadoes in the Midwest and South, some media outlets scrambled to try to link the weather events to climate change, when in fact there is no hard data to support this. In fact, tornado data refute claims that tornadoes are increasing in number, range, or severity. However, Salon, Axios, and the Washington Post among others ran articles suggesting climate change is expanding the length of tornado season and area over which tornadoes commonly form, as well as adding ingredients to the atmosphere to make more and bigger tornadoes.
The Salon article, “How climate change made the Mississippi tornadoes more likely,” (actually a reprint from Grist) claimed, “That added ingredient of more heat and moisture is going to be the big thing that will influence what happens and we can expect potentially worse tornado outbreaks,” said William Gallus, a professor of meteorology at Iowa State University.
Axios piled on with “What we know about how climate change affects tornado outbreaks,” which claims, “We also have expectations that the number of severe thunderstorms (hail, wind, tornado) will probably increase in the U.S.”
The Washington Post article, “Here’s what we know about how climate change is influencing tornadoes,” asserts, “Average global temperatures have risen more than 1.1 degrees Celsius (2 degrees Fahrenheit) since the late 1800s, and the impact is clear: Warmer air provides more energy for storms to develop and intensify, and holds more moisture, which can also fuel storms. Warm, moist air is a key ingredient for developing severe tornadic storms.”
These claims of increased storms due to more heat and moisture are misleading at best and demonstrate a clear lack of understanding of how weather fronts collide to form tornadoes. As Climate at a Glance: Tornadoes points out: “Tornadoes typically form when very cold, dry air clashes with warm, humid air. Climate change warms the Arctic more than the tropics and subtropics, resulting in less of a clash between cold Arctic air masses and warm Gulf of Mexico air masses. As a result, fewer and less violent tornadoes are occurring today than in previous periods, despite media claims that tornadoes are getting more frequent, stronger, or both.”
Plus, all of these articles miss one very important and immutable fact: decades of hard data on tornado activity don’t support these claims.
Despite modest warming of the climate over the past 50 years, data show no trend in increasing tornadoes linked to climate change. Indeed, the Intergovernmental Panel on Climate Change (IPCC) said in its most recent report, “There is low confidence in observed trends in small spatial-scale phenomena such as tornadoes.”
These articles all focused on the recent severe storms that caused many deaths and widespread destruction. Yet, looking at the actual data for the trend in strong to violent tornadoes suggest no cause for alarm. Violent tornadoes, those rated EF3 to EF5 on the enhanced Fujita tornado scale, have declined in recent decades, based on actual data supplied by the National Weather Service’s Storm Prediction Center.
The hard data on tornado numbers and intensity refute any assertions that tornadoes are worsening due to climate change. The number of strong to violent tornadoes, F3 or higher, has dramatically declined for nearly half a century. Additional evidence shows attempts to tie tornadoes to climate change falls flat. For instance, 2018 was a record-low year for tornadoes in the United States. Even the Washington Post wrote that 2018 was the first year with no violent tornadoes in the United States.
Also flying in the face of climate change attribution during the so-called “hottest decade in recorded history” from 2010 to 2019, two record-low years for tornado strikes in the United States occurred, in 2014 and 2018.
Finally, it is important to note that severe tornado outbreaks are not a global (as in global warming) phenomenon, but mostly limited to the United States with its unique topography and weather patterns.
All of these omissions lead one to ask if the media are aware of hard data and previous articles on the topics of tornados and climate change, or did these outlets simply not wish to consider what those articles and data implied, because they presented inconvenient truths that are counter to their attempts to link climate change and tornado behavior?
Even the scientist quoted in the Post article would not commit to the narrative that climate change was changing tornado behavior.
Per the Post, “That suggests more tornadoes may be likely, too. But scientists aren’t ready to declare that yet.”
Also, according to the Post, “There is nothing concrete to say, ‘Yes, we’re going to see more tornadoes,’ Allen said,” as Dance reported.
The willful choice to ignore these facts is indicative of the shoddy state of what passes for journalism today. The Washington Post’s banner reads, “democracy dies in darkness.” Evidently, science dies in darkness, too.
BY CHRIS MORRISON | THE DAILY SCEPTIC | APRIL 8, 2023
Government-controlled surface datasets, the bedrock of climate thermogeddon fears promoting Net Zero, cannot possibly be accurate, and are only “an estimate with high uncertainty”. The claim comes from the noted U.S. meteorologist Anthony Watts, who has spent the last decade highlighting the numerous flaws built into global temperature monitoring systems. Data are collected by government bodies from a weather station network, “that was never intended to detect a ‘global warming signal’”, notes Watts. He goes on to call for a new independent global climate database. Given that governments are spending billions of taxpayer dollars on climate mitigation programmes, “doesn’t it make sense to get the most important thing – the actual temperature – as accurate as possible”, he asks.
To date, continues Watts, there is only one network of climate capable weather stations that is accurate enough to fully detect a climate change signal. This is the U.S. Climate Reference Network (USCRN), started in 2005 as a state-of-the-art automated system designed specifically to accurately measure climate trends at the surface. It comprises 114 stations across North America sited well away from any non-climatic effects, such as urban heat caused by humans.
The USCRN graph above shows that there has been no significant warming trend over the last two decades in the United States. “Unfortunately, the data from the USCRN network are buried by the U.S. Government, and are not publicly reported in monthly or yearly global climate reports. [The network] has also not been deployed worldwide,” observed Watts.
Watts notes that past temperature records were collected to validate weather forecasting. Temperatures were rounded by volunteers to the nearest whole degree of Fahrenheit. When comparing such “coarsely recorded” data to claims of 1.8°F global warming since the late 1800s, “obvious questions” of accuracy arise. Referring to his own recent work, Watts says that even more concerning is the widespread corruption of data by urbanisation. Many stations are compromised by being placed next to air conditioners, jet exhausts and concrete, asphalt and nearby buildings. This happens not just in the USA but in many other territories, including the U.K.
In the U.K., the state-funded Met Office has become highly politicised in recent years as it relentlessly pushes the collectivist Net Zero project. Despite writing a paper on the temperature standstill between 2000-14, it removed the pause in later retrospective adjustments to its HadCRUT global database. In under 10 years it added 30% extra warming to the recent global record, at a time when accurate satellite measurements suggested global warming started running out of steam about 25 years ago. Last summer, the Met Office confirmed and promoted a new U.K. record temperature of 40.3°C at Coningsby. In fact the record was set halfway down the runway at RAF Coningsby, home of Typhoon fighter jet squadrons, and lasted just 60 seconds. It was achieved with a sudden spike in temperature of 0.6°C followed by an almost immediate drop. To this day, the Met Office has refused to answer questions from the Daily Sceptic asking if jet aircraft movements were a contributing factor.
Watts is not the only scientist raising important concerns about the databases at the heart of the political campaign to promote panic about rising temperatures. Recent work by Dr. Roy Spencer and Professor John Christy of the University of Alabama in Huntsville found that up to a fifth of all warming reported across the planet by around 20,000 weather stations is invalid due to corruption from non-climatic data. The stations form part of the Global Historical Climate Network and are an important constituent of all global datasets. Interestingly, the two scientists noted that the U.S. weather service NOAA claims to remove urban heat distortions, but they found that on average it is “spuriously warming station temperature data trends when it should be cooling them”. The detailed reasons are given in a note published by Dr. Spencer, where he asks why NOAA adjustments are going in the wrong way. “To say the least, I find these results … curious”, he adds.
Lopping off chunks of recent warming at a time when very little ‘heating’ is occurring would be unwelcome in Net Zero extremist circles. Scientists such as Emeritus Professor Richard Lindzen point out that the warming since the ending of the Baroque mini ice age is already tiny. Evidence continues to accumulate that recent periods were much warmer than the present. In February, a group of bio scientists (Brozova et al., 2023) presented evidence showing that the Arctic around Svalbard was 6°C warmer in the early Holocene around 10,000 to 8,000 years ago. Further scientific evidence showing past warming can be found here, here and here.
Global surface temperatures recorded and compiled by government agencies are said by Watts to be a mishmash of rounded, adjusted and compromised readings, rather than being an accurate representation of Earth’s temperature. “Given the Government’s monopoly on use of corrupted temperature data, questionable accuracy, and a clear reticence to make highly accurate temperature data from the USCTN available to the public, it is time for a truly independent global temperature record to be produced,” Watts concludes.
Chris Morrison is the Daily Sceptic’s Environment Editor.
They charged Kirk Moore with a crime. Dr. Moore is allowed discovery to prove his innocence. JACKPOT!
By Steve Kirsch | April 9, 2023
Executive summary
The US Attorney in Utah issued a criminal indictment against Dr. Kirk Moore for “running a COVID-19 Vaccine Scheme to Defraud the Government and CDC.”
But what if Dr. Moore was actually saving lives instead and is a hero?
Since this is a criminal proceeding in federal court, Dr. Moore cannot be denied discovery to show that the vaccines are deadly.
This is relevant due to the opportunity for jury nullification where a jury has the right to issue a “not guilty” verdict if they believe the law is unjust.
If the judge denies Moore the discovery, he can appeal because there is no country in the world that has correlated the death-vax data and released the records for public analysis. They all keep it hidden behind closed doors and all attempts to get that data have been rebuffed.
A federal court has jurisdiction over all 50 states and can order the CDC and all states to turn over COVID vaccination records and death records. You know, the records that the states and CDC don’t want to be made public for some reason. Those records.
So Dr. Moore is now empowered to do something that nobody else in the world can do: access the secret public health records of every state in the US that will finally show to the entire world what everyone in power wants to hide from the public: the truth.
Kirk is one of my followers on Substack and I reached out to him today to suggest the records he should request to aid in his defense.
The judge can allow these records to be made public if they are in the public interest, which they will be.
Finally, it is the job of the courts to find the truth. And thanks to the US Attorney in Utah, we are finally going to find the truth!
Introduction
Not a single country, state, or even county health official anywhere in the world has correlated the vaccination data with the health data. I wonder why?
But now, courtesy of the US Attorney in Utah, Dr. Kirk Moore will have the right to do that.
And people are going to be stunned at what it will reveal. I can promise you that.
More about jury nullification
Some background on Jury Nullification, for those unfamiliar with it:
Department of Justice discussion (1993)
NY Times discussion focus on marijuana, but applies to all (2011)
Vox discussion focused on race, but applies to all (2016)
Jury nullification is a powerful check on abusive government and unjust laws. But most Americans aren’t aware of it and lawyers aren’t allowed to inform a jury of their right to nullify a law. It will take a massive public education effort to make enough Americans aware of the power they hold in jury duty to make a difference in trials. So spread the word!! Tell two friends.
You can follow Dr. Moore on Twitter
You can follow Dr. Moore on Twitter here.
You can donate to help his defense here
If you are a lawyer and want to help out on this case
Fill out the form here.
Why the court has to allow the discovery
There is a necessity defense. The discovery is crucial to showing that this defense is justified.
Also, the prosecution has to show criminal intent to harm the US government. Could it be that Dr. Moore’s intent was to save the life of his patients? Is that a crime in America today?
Summary
The bottom line is the US Attorney in Utah has given Dr. Moore the ability to end the narrative worldwide. And I have a feeling that Dr. Moore will take full advantage of the opportunity.
I leave you with this post Dr. Moore recently made on my Substack:
This is the biggest opportunity ever to end the narrative. The US government has literally opened up the secret books in every state (aka our public health data) for inspection. I could not be happier that the truth will finally be known.
British Study Reveals Alarming Risks of Suicide and Homicide
By Peter A. McCullough, MD, MPH | Courageous Discourse | April 9, 2023
Many of us have been struck by the rapid rise in clinical interest and reported studies on transgender persons. The main clinical indication for gender change medication and or surgery is gender dysphoria. This means that individuals are afflicted with a syndrome in which they are not happy with their natural gender from birth. While changing biological gender the opposite is associated with a modest improvement in gender dysphoria scores, one may wonder if there is a price to pay for such a substantial and and relatively permanent intervention for a psychiatric illness?
Jackson et al, recently reported on the outcomes of total of 1951 British transfeminine (male at birth) (mean [SE] age, 36.90 [0.34] years; 1801 White [92.3%]) and 1364 transmasculine (female at birth) (mean [SE] age, 29.20 [0.36] years. The normal control group was matched to 68,165 cisgender men (59 136 White [86.8%]) and 68,004 cisgender women (57 762 White [84.9%]). Compared with cisgender men, there was an increased risk of overall mortality for transfeminine (MRR, 1.34; 95%CI, 1.06-1.68). Compared with cisgender women, there was an increased risk of overall mortality for transmasculine (MRR, 1.75; 95%CI, 1.08-2.83) adults.
The most notable relative risks for those who changed genders was suicide and homicide as shown in the table. These data suggest that psychiatric and behavioral determinants arising from background gender dysphoria and the transgender process contribute to death at a relatively young age among those who have chosen to change from their original biological gender to the opposite.
The Highwire with Del Bigtree | April 6, 2023
Bombshell vaccine safety surveillance data out of Western Australia shows it was reactions from the Covid vaccine that were overwhelming local hospitals. Data shows Australia’s zero-Covid plan was for nothing, as cases have spiked.
The Highwire with Del Bigtree | April 6, 2023
In March 2022, Florida Surgeon General, Dr. Joseph A. Ladapo, faced significant criticism for advising against the COVID-19 vaccine for children under 17, citing reported risks outweighing the benefits. Now, W.H.O. has rolled back its own recommendation on the vaccine for healthy children and teenagers. Dr. Ladapo joins Del for a nice ‘I told you so’.
The Highwire with Del Bigtree | April 6, 2023
No matter what political affiliation, American’s are now entertaining the idea that someone in their family may have died from a Covid jab. As Robert F. Kennedy, Jr. and others now approach the 2024 elections, vaccine safety and mandated medicine have become a top issue.
BY IAN MACLEOD | THE DAILY SCEPTIC | APRIL 3, 2023
The battle of ideas around Covid has few clashes as hotly contested as Long Covid. Alarmists have hyped the frequency and severity with which infection causes long-term damage. Sceptics see no reason for panic. A new study helps to settle at least part of this debate.
The paper in the Journal of the American Medical Association’s (JAMA) Network Open looked at “post–COVID-19 condition (PCC) in young people after mild acute infection” to find how common it was and to find risk factors. Participants were aged between 12 and 25.
The authors offer this straightforward conclusion: “PCC was not associated with biological markers specific to viral infection.” That is, participants were equally likely to suffer from ‘Long Covid’, whether or not they had suffered from acute COVID-19.
The researchers concluded that Long Covid is predicted by “initial symptom severity” and, intriguingly, “psychosocial factors”.
The full article is available on JAMA Network Open.
The main results from the present study were: (1) the prevalence of PCC six months after acute COVID-19 was approximately 50%, but was equally high in a control group of comparable SARS-CoV-2-negative individuals; (2) acute COVID-19 was not an independent risk factor for PCC; (3) the severity of clinical symptoms at baseline, irrespective of SARS-CoV-2 status, was the main risk factor of persistent symptoms six months later.
Symptom prevalence data are consistent with other controlled studies of young people after acute COVID-19 reporting a high symptom load, with only subtle differences between individuals testing positive and negative for SARS-CoV-2. Correspondingly, a large population-based study found no associations between most persistent symptoms attributed to COVID-19 and serological evidence of SARS-CoV-2 infection. …
These findings suggest that persistent symptoms in this age group are related to factors other than SARS-CoV-2 infection, and therefore question the usefulness of the WHO case definition of PCC.
Worth reading in full.
By Brenda Baletti, Ph.D. | The Defender | April 7, 2023
People who receive Pfizer’s respiratory syncytial virus (RSV) vaccine should be monitored for Guillain-Barré syndrome, according to the authors of a Pfizer-funded study published this week in the New England Journal of Medicine (NEJM).
The paper — one of several published Wednesday reporting interim analyses for Pfizer’s phase 3 clinical trials for the RSV vaccine — concluded the vaccine was effective in preventing RSV in adults age 60 and over “without evident safety concerns.”
But that same article also flagged Guillain-Barré syndrome as a safety concern moving forward with the vaccine.
“If RSVpreF vaccine [Pfizer’s RSV vaccine] is approved and recommended, these adverse events warrant close monitoring in future studies and with real-world data and post-marketing surveillance,” the authors of the NEJM study said.
The U.S. Food and Drug Administration (FDA) is expected to approve Pfizer’s RSV vaccine for older adults in May.
Safe and effective?
Guillain-Barré syndrome is a rare disorder in which the body’s immune system attacks its own nerves. Symptoms can range from brief weakness to paralysis.
The FDA asked Pfizer to include the condition as an “important potential risk” of the vaccine and to develop a safety study to monitor for potential cases if the shot is approved, CNBC reported.
When the FDA vaccine advisory panel met in February to review Pfizer’s data pre-publication, there was substantial disagreement about the data on safety and effectiveness, although the majority of the committee voted to recommend the vaccine for approval.
Four of 12 committee members voted that the safety data was not adequate for approval — and one abstained — because of their concerns with the Guillain-Barré cases.
Four committee members also voted the evidence of vaccine effectiveness was not adequate for approval, while seven said it was and one member abstained.
In the NEJM study, one person developed Guillain-Barré syndrome and another developed Miller Fisher syndrome, a subset of Guillain-Barré. The symptoms appeared six and seven days post-vaccination, respectively.
The person with Miller Fisher syndrome recovered. The person diagnosed with Guillain-Barré continues to suffer from loss of motor function.
CNBC reported:
“In the New England Journal of Medicine article, the scientists said the two cases occurred in patients who were in an age group that has an increased risk of developing Guillain-Barré. Potential factors other than the vaccine also could have caused the individuals to develop the syndrome, they added.
“But the FDA said the agency views the Guillain-Barré cases as possibly related to the vaccine because the patients developed the syndrome shortly after receiving the shot, according to briefing documents published in February.
“Pfizer concluded that the cases were unrelated, and the clinical trial’s data monitoring committee did not identify any safety concerns with the vaccine.”
Dr. Hana El Sahly, the FDA committee chair and professor of molecular virology and microbiology and infectious diseases at the Baylor College of Medicine, said Guillain-Barré has an incidence of about 1 in 100,000 among people ages 60 and older. But in the vaccine trial, the rate was closer to 1 in 9,000, which is significantly higher.
“It’s significant in terms of incidence,” she said. The FDA advisors told Pfizer that safety monitoring for Guillain-Barré after FDA approval “would be crucial,” CNBC reported.
There is currently no vaccine approved to prevent RSV, a lower respiratory disease that is one of the most common causes of childhood cold-like illness and was first discovered in humans in 1956.
The illness is mild for most people.
In children under age 5, RSV causes 58,000 to 80,000 hospitalizations per year and 100 to 300 deaths.
In adults ages 65 and older, RSV causes 6,000 to 10,000 deaths and 60,000 to 160,000 hospitalizations per year, according to the Centers for Disease Control and Prevention.
Research shows the virus originated in monkeys housed in a Maryland facility where they were used to conduct polio vaccine research.
Brian Hooker, Ph.D., P.E., chief scientific officer for Children’s Health Defense (CHD), told The Defender :
“I find it ironic that Pfizer is creating a vaccine for RSV, an illness that was created due to the development of the polio vaccine. It seems like vaccine manufacturers are paid to prevent diseases that they already created.
“The incidence of Guillain-Barré is very troubling and although many patients recover, there is nerve damage associated with it leading to permanent weakness, numbness and fatigue.”
The NEJM study reported that the vaccine was 86% effective at preventing lower respiratory tract illness with three or more symptoms, and 66% effective at preventing the illness with two or more symptoms, among adults over age 60.
The study determined there were not enough cases of severe RSV-associated lower respiratory tract illness — meaning cases needing hospitalization or ventilation or extra oxygen — to determine whether the vaccine was effective for those cases, CNN reported.
RSV vaccines for pregnant women failed to meet major goal in trials
Pfizer is also seeking FDA approval for its vaccine to protect infants from RSV by vaccinating pregnant mothers.
However, in the interim data on clinical trials, also published Wednesday in the NEJM, the vaccine failed to meet one of its two main goals.
Last year, Pfizer reported that its vaccine was highly effective at protecting newborns from RSV. The drugmaker also sought rapid FDA approval for the vaccine for pregnant mothers.
The FDA is expected to decide by August.
According to the study published Wednesday, the vaccine was 82% effective in preventing severe lower respiratory tract illness — such as very low oxygen levels or need for ventilator support — in infants in the first 90 days of life, but that dropped to 69% efficacy up to 180 days after a baby is born.
But the vaccine failed to meet its second big goal: reducing non-severe RSV-associated lower respiratory illness in infants.
The study enrolled 7,128 women — half received the RSV vaccine and half received the placebo.
Severe illness occurred within three months in six infants whose mothers received the vaccine, compared with 33 infants from the placebo group who contracted serious RSV infections.
The company evaluated 3,570 infants as part of the study, Reuters reported.
Big Pharma’s race for the RSV vaccine
The RSV virus causes annual outbreaks of respiratory illnesses in all age groups, typically during the fall, winter and spring in most regions of the U.S. It has existed for decades and doesn’t usually spark alarm.
But RSV made headlines last fall as part of a “tripledemic” — COVID-19, flu and RSV — scare, just as these new RSV products were preparing to come on the market.
Robert F. Kennedy, Jr., CHD chairman-on-leave, said at the time, “fear sells,” tweeting:
As The Defender reported, pharmaceutical companies have been working on the development of a vaccine for RSV since the 1960s — at times with deadly outcomes.
After a disastrous attempt at producing a vaccine, where 80% of vaccinated children were hospitalized, RSV vaccine development was put on hold.
Over the last several years, “lured by the prospect of a large untapped global RSV vaccine market,” four manufacturers set their sights on RSV vaccine development for infants, pregnant women and the elderly.
Initially, Johnson & Johnson and Bavarian Nordic also were developing RSV vaccines, but the former dropped out of the race last month and Bavarian Nordic’s clinical trials are in progress.
That leaves Pfizer and GlaxoSmithKline (GSK), who have been in a tight race to be the first Big Pharma player to tap into the RSV vaccine market, which is estimated to be over $5 billion and could exceed $10 billion by 2030, Reuters reported last month.
Both companies have RSV vaccines under regulatory review with the FDA.
The FDA advisory committee voted unanimously in favor of GSK’s vaccine’s effectiveness in preventing lower respiratory tract disease caused by RSV in adults aged 60 and above, and voted 10 to 2 for its safety last month, based on interim data presented last October, Reuters reported.
Brenda Baletti Ph.D. is a reporter for The Defender. She wrote and taught about capitalism and politics for 10 years in the writing program at Duke University. She holds a Ph.D. in human geography from the University of North Carolina at Chapel Hill and a master’s from the University of Texas at Austin.
This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
Concerning increase in mortality in New Zealand
By Ian Miller | Unmasked | April 7, 2023
COVID has unfortunately created any number of repetitive stories.
Jurisdiction imposes mask mandates, population complies, masks prove ineffective, media claims masks didn’t work because of lack of compliance.
Another example would be when countries with extraordinary compliance, such as Singapore or South Korea, would see increases ignored entirely, or blamed on the population not wearing masks of a correct level of quality.
Yet as a general rule, the most consistently predictable repetitive storyline has been the media and expert community declaring that a country was a pandemic success, only for their results to dramatically change in a relatively short period of time.
This was the case with the Czech Republic, with Australia, with Taiwan and many other locations.
Even within the United States adjustments showed that states like California – heralded as pandemic winners – actually had significantly worse results than previously realized.
But few places on earth have been as heavily praised as New Zealand.
Their science-following leadership was repeatedly hailed, honored, and praised for their effective communication, endless lockdowns, tyrannical response to protests, and prolific commitment to mandates.
All of the above, combined with their strict border controls, should have meant that New Zealand would avoid the significant increase in negative outcomes seen in other parts of the world.
At least, that’s what the media and activist public health authorities claimed would happen.
The reality is far more complicated.
Throughout 2020 and into 2021, New Zealand saw very little COVID transmission.
Unsurprisingly, the BBC praised the country for their efforts, explaining in detail how the country had become “COVID free.”
Jacinda Arden, now former prime minister, was once so completely committed to maintaining an illusion of infallibility that she claimed that the only source of accurate information available to the public was the government.
Of course, Arden then made the provably inaccurate claim that those who were vaccinated would net get sick and would not die.
The ridiculous over-confidence in the proclamations of public health authorities led to Arden convincing New Zealanders that strict mandates and interventions could stop the spread of the virus.
As winter and new variants arrived in 2021, Arden and local leaders predictably enforced increasingly strict measures. Mask mandates, lockdowns and “red traffic light” policies include vaccine passports.
Surprise. None of it worked.
After several months of completely unchecked spread, even the country’s cumulative metrics, once seemingly so impressive, exploded in dramatic fashion.
Consistently and exceptionally high mask wearing rates were also entirely ineffective.
And yet defenders of New Zealand’s authoritarian policies still believed that the country’s strategy was warranted, for one specific reason.
They had delayed the spread of the virus until the COVID vaccines became widely available.
In theory, that was supposed to prevent a substantial increase in deaths, especially considering their extraordinary rate of uptake.
That didn’t work either.
While these rates were generally lower after adjusting for population than many other countries, they still represented an obvious, significant surge compared to previous time periods.
But COVID related deaths only tell a part of the story, often influenced by attribution methodology and testing.
In theory, New Zealand’s exceptional vaccination rate and consistently high mask compliance should have meant that all cause mortality would also remain low.
So did it?
Fortunately, thanks to the New Zealand government’s own data, we now have an answer. And just as the country’s failure to stop omicron, it presents another contradiction to the endless media praise.
Despite the exceptionally high vaccination rate, despite their exceptionally high booster rate, despite vaccine passports, strict lockdowns, “red traffic light” policies and border controls, the pandemic came for New Zealand as well.
The government’s own data shows that all cause deaths in New Zealand jumped significantly in 2022, to the highest level in recorded data.
The country universally praised for their dedication to following The Science™, whose leadership told the public that following her dictates would keep them safe, stop the spread and control outcomes, has seen a record level of all cause mortality.
Exactly the same as other countries who were criticized for their supposedly less effective response.
Even after adjusting for population, the scale of the surge in 2022 is exceptional.
In fact, it represents an over 17% increase from 2020.
Not to mention that the one year increase, over 10%, represented the largest single year increase in New Zealand since the 1918 flu.
So why didn’t their policies prevent this? Why didn’t waiting for widespread vaccination to open up prevent this?
The New Zealand government themselves blame COVID for at least a portion of the increase. So why were so many people dying of COVID given the country’s exceptional vaccination and booster uptake and masking?
After all, ~95% of the population over 12 had been fully vaccinated by the middle of 2022, with over 90% fully vaccinated by early 2022. Similarly, adult booster rates were nearly 80% by early in 2022.
Why didn’t it work?!
Some may try to claim that their results would have been worse had they not had such policies.
But countries like Sweden thoroughly debunk that theory. Sweden had one of the least restrictive responses anywhere on earth, yet their results were among the best in their region.
Even throughout 2022, excess deaths remained low.
So why did New Zealand fail?
Compared to other countries, New Zealand’s cumulative COVID mortality rate still remains low. But the all cause mortality tells a different story.
Their strict policies and delayed opening were supposed to prevent this exact situation from occurring. All because the government put their faith in experts.
The experts mistakenly believed that vaccinations would prevent virtually all deaths, as Jacinda “we are your sole source of truth” Arden explained.
Obviously that was not the case.
It’s not clear what percentage of the excess mortality rate came from vaccinated people. But even more importantly, the majority of the increase was entirely unrelated to COVID.
Nearly 6,000 more people died in 2022 than did in 2020, despite a relatively small population increase. Yet the government says just 2,400 were associated with COVID.
So what caused the other 3,600 unexpected deaths?
In raw numbers, nearly 7,500 more people died in 2022 than in 2016. Accounting for population increases, that meant virtually 100 more people per 100,000 died in 2022 than in 2016.
What happened?
Whatever it was, it’s almost certainly related to New Zealand’s mistaken assumptions. Ancillary lockdown-related causes, missed health screenings, side effects — any or all of it could have contributed to the dramatic increase.
And all of it was because the government mistakenly proclaimed that they could control COVID. Instead, they delayed the inevitable.
Governments have many lessons to learn from the pandemic, but the first should be to never, ever, put blind faith in “experts.”
All too often they’re flying blind themselves.
or go to
Aletho News Archives – Video-Images
By Malcolm Kendrick | RT | November 25, 2020
New research suggests that four billion people globally will be overweight in 2050. This trend can be traced back to the ‘low-fat, high-carb’ guidelines first issued in the 70s, and should prompt a major U-turn on dietary advice.
A recent report from the Potsdam Institute predicts that by 2050 there will be four billion overweight people in the world, with one-and-a-half billion of them obese. This is not entirely surprising. The world has been getting fatter for years, and things do not seem to be slowing down.
Why is this happening? … continue
Aletho News If Americans Knew No Tricks Zone
Aletho News 