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Gene Therapy’s Renaissance

Gene Therapy’s Renaissance



It is 21 years since the death of teenager Jesse Gelsinger nearly obliterated the field of gene therapy. In 1999, Jesse received a dose of the ornithine transcarbamylase gene, engineered into a recombinant adenovirus, at the University of Pennsylvania. The idea was for the gene to zero in on liver cells. However, soon after the treatment, he developed jaundice, inflammation, and multiple organ failure. Within four days, Jesse was dead.

Since then, genetic technology has made gigantic leaps forward. The human genome has been sequenced in its entirety, and the cost of sequencing has plummeted 100,000-fold. CRISPR-Cas9 has emerged as a precise and efficient tool to edit genes. Artificial intelligence and deep learning are being put to use in designing molecules. And gene therapy has morphed from a blacklisted experimental concept to a life-altering practical solution for a growing list of previously incurable diseases.

To date, the U.S. Food and Drug Administration (FDA) has approved five gene therapy products for a half-dozen diseases (Table). Earlier this year, the FDA announced that it “anticipates many more approvals in the coming years, as there are more than 900 investigational new drug applications for ongoing clinical studies in this area.”

Table. FDA-approved gene therapy productsThe ideal target for gene therapy is a Mendelian disease caused by defined single-gene mutations, such as hemophilia or Duchenne muscular dystrophy. That has been its initial focus, bolstered by approvals of drugs such as Luxturna (for a type of Leber’s congenital amaurosis, an inherited blindness disorder) and Zolgensma (for spinal muscular atrophy).

Now, gene therapy is taking on more complex, multigene diseases such as central nervous system diseases, neuropathic pain, sleep apnea, and cancer. Beyond correcting genes, gene therapy is revolutionizing cell-specific delivery of therapeutic proteins and synthetic drugs, as well as inspiring basic research into unanswered questions on immunogenicity. But lest anyone think gene therapy has solved all of its earlier issues, the deaths last summer of two young boys in an experimental trial for a rare muscular disorder remind us that the field still has a lot of work to do to ensure gene therapy can be safely delivered for all patients.


The first order of business is to deliver therapeutic gene products into target cells. Vehicles used to transport genes into the cell include genetically modified viruses for long-term genomic integration or lipid nanoparticles for more transient tasks such as expressing genome editing nucleases.

The reason for gene therapy’s healthier outlook in 2020 is “improvements in the technology of gene transfer,” says James M. Wilson, MD, PhD, director of the Gene Therapy Program at the University of Pennsylvania. “Our work with adeno-associated viruses and the work of a number of other investigators, including that of Luigi Naldini, MD, PhD,  in creating lentiviral vectors, were fundamental advances that paved the way for everything else.” He credits the clinical successes of his Penn colleague Jean Bennett, MD, PhD, on retinal blindness; the work of Nationwide Children’s Hospital’s Jerry R. Mendell, MD, on spinal muscular atrophy; and “the pivotal work on hemophilia out of St. Jude’s.”

The former vector favorite, adenovirus, has been largely supplanted by adeno-associated viruses (AAVs), generally used for in vivo gene therapy, and lentiviruses, used to modify cells outside the body, such as chimeric antigen receptor (CAR) T cells in the treatment of cancer. These ex vivo engineered cells are then amplified in tissue culture and returned to the patient.

AAV-based gene therapy has made great strides in recent years. Pioneering work from the lab of Terence R. Flotte, MD, dean, provost, and executive deputy chancellor of the University of Massachusetts Medical School, has propelled clinical trials for two classic Mendelian disorders, alpha-1 antitrypsin (AAT) deficiency and Tay-Sachs disease. With excellent safety and durability established in a five-year follow-up of its Phase IIa trial, the AAT gene therapy is now in its final investigational new drug–enabling toxicology study stage.

“AAT trials have shown some unusual tolerogenic properties,” says Flotte. “The study shows patients develop regulatory T cells against AAV coat proteins that prevent them from reacting negatively even without pharmaceutical immune suppression.”

Nearly 75% hemophilia patients take regular intravenous infusions of a recombinant factor VIII (F8) protein coupled with other drugs that prevent bleeding or the breakdown of clots. “Current treatment for hemophilia A is very burdensome to patients,” says Bettina M. Cockroft, MD, chief medical officer at Sangamo Therapeutics.

A new therapy being developed by Sangamo and Pfizer injects a recombinant AAV6 encoding F8, which could provide a permanent solution. “The gene therapy for F8 shows lasting activity,” Cockroft reports. “Five patients tested in Phase I/II of the clinical trial did not need F8 infusions and had no bleeding events.”

Vectors injected into blood generally don’t get across barriers. Wilson’s lab, in collaboration with Amicus Therapeutics, is focusing on developing penetrating next-generation AAVs that deliver more efficiently to cells in organs such as the muscle, heart, and brain. “With the new AAVs,” notes Wilson, “you can get more delivery with less vector. Less vector would mean less toxicity.”


Patient and public support for gene therapy is crucial for its advance. “I have a pretty good idea of how stakeholders view gene therapy,” Wilson asserts. “Because gene therapy is primarily focused on treating and potentially curing diseases of significant unmet need that are disabling or lethal, I see incredible enthusiasm for us to move forward.” Public and private ventures have invested heavily in the promise of curing genetic disease by altering or replacing faulty genes.

The change in the academic, industrial, and public outlook on gene therapy is readily appreciable in the reaction to the recent tragic deaths of two young boys in a gene therapy trial, sponsored by Audentes Therapeutics, for X-linked myotubular myopathy (XLMTM), despite impressive efficacy in preclinical studies, as discussed in a recent episode of GEN Live (“Gene Therapy: What’s Up With AAV?”). Instead of blacklisting the entire field of gene therapy as was seen decades earlier, the trial has been put on temporary hold while researchers reevaluate data so that such fatalities can be avoided in the future.

“Audentes has elaborated further on the data surrounding the deaths in a recent letter to Human Gene Therapy,” says Flotte, the journal’s editor-in-chief. The presence of comorbidities, particularly liver disease, and prior exposures to the virus in these patients might have played a role, in addition to technical challenges, such as the lack of standardized assays for measuring levels of preexisting viral antibodies. Ongoing preclinical investigations are focused on establishing safer doses and understanding immune mechanisms in response to AAV that might exacerbate existing liver dysfunctions.

“In the long term,” says Nicole Paulk, PhD, assistant adjunct professor, biochemistry and biophysics, UCSF, “we need to shift our focus from ‘How can we safely use high doses?’ to ‘How can we design the vector so we don’t have to?’” Limiting the viral dosage necessary for maximal efficacy in gene therapies is being evaluated through experimental approaches, such as engineering more penetrating capsids, introducing regulatory elements for tissue-specific viral expression, developing better manufacturing and purification processes to increase the purity of virus injected, and devising strategies to avoid immune responses.

More than correcting genes

Drug delivery:

Future applications of gene therapy technology for more common, polygenic diseases will not necessarily treat defective genetic components directly. Instead, these applications may improve the delivery of proteins that are otherwise used to treat diseases. “An example is Lucentis, an anti-antigenic protein developed at RegenXbio for age-related macular degeneration,” suggests Wilson, a company co-founder. RegenXbio investigators inject Lucentis into the retina, circumventing the need for repeated injection. “Technically this is not a genetic defect,” Wilson remarks, “but it is an application of gene therapy.” The program is currently in Phase II trials.

Modifier gene platform:

Ophthalmologist Mohamed Genead, MD, chair of Ocugen’s retina scientific advisory board, is excited about a revolutionary new approach—the modifier gene platform—that takes a “gene-independent approach” by overexpressing upstream regulatory genes for nuclear hormone receptors (NHRs) in retinal cells instead of attempting to correct mutations in individual genes.

The Ocugen modifier gene therapy platform engineers retinal cells to overexpress nuclear hormone receptors (NHRs) to cure multiple types of inherited blindness. This introduces upstream modifier genes into the cell, which can restore normal function or homeostasis, irrespective of the specific genetic cause of dysfunction.

“Overexpressing NHRs does not correct the gene mutations; instead, it corrects the disease phenotype,” says Genead. “Conventional gene therapy has several limitations. The amount of DNA you can package into the virus is restrictive. Gene therapy can work if you have identified the mutation, but most genetic diseases do not have identified mutations.”

NHR overexpression regulates endoplasmic reticulum stress to promote normal function in cells with defective genes. “Its efficacy remains to be shown in the clinical trials,” comments Genead, “but if we see in patients what we see in animal models, there will be a significant shift of the treatment paradigm in patients with retinal degeneration.”

Chemogenetic therapies:

Continuous positive airway pressure machines or surgery are the currently available treatments for obstructive sleep apnea, a condition where the tongue loses muscle tone and blocks the upper airway in sleeping patients. Consequences range from fatigue and metabolic disruptions to stroke and death.

An alternative approach is being explored by researchers at Johns Hopkins Medical School. They are evaluating whether DREADDs—designer receptors exclusively activated by designer drugs—can be used to activate the genioglossus muscle, and thereby improve breathing during sleep.

At Johns Hopkins Medical School, Alan Schwartz, MD, and Thomaz Curado, PhD, engineer mice to express DREADDs (designer receptors exclusively activated by designer drugs). Left panel: Electromyograph responses upon activation of DREADDs by a ligand that relieves sleep apnea. Magnetic resonance imaging before (middle panel) and after (right panel) treatment showing the forward movement of the tongue (lower arrow) and the opening of the airway (upper arrow).

“We are inserting designer receptors for synthetic drugs in specific brain cells to maintain patency of the airways,” says Thomaz Curado, MD, PhD, research associate at Johns Hopkins. “If translated successfully in human clinical trials, this can mean a one-time injection combined with a nightly pill will eliminate risk of death due to obstructive sleep apnea.”

Conferring resistance to infectious diseases:

Single-gene disorders and infectious diseases are being treated using the same tools and concepts. “We are in the midst of a very aggressive program in using AAV as a way to prevent infections of COVID-19,” says Wilson. Essentially, AAV vectors are, as usual, being used to engineer cells in patients to express proteins. In this program, however, the proteins confer resistance to COVID-19.

AAVCOVID, a gene-based vaccine that will deliver genetic sequences of the SARS-CoV-2 in an AAV capsid, is being developed jointly by the Gene Therapy Program at the University of Pennsylvania and the Massachusetts Eye and Ear and Massachusetts General Hospital, and it is scheduled to enter clinical trials later this year.

Safety, success, and staying on

Lacunae in the basic understanding of how the immune system responds to foreign vectors are currently at the forefront of investigations on toxicity and inflammation induced by gene therapy.

“What factors predispose complement activation and the hemolytic-uremic syndrome at high-doses of rAAV? What factors predispose to inflammation in the dorsal root ganglia and spinal cord after direct rAAV-mediated gene delivery into the central nervous system? What is the nature of liver toxicity in patients treated with high doses of rAAV gene therapy? [These] are the frontier questions,” says Flotte. “How significant are immune responses to Cas9 and other nucleases? How important is the toxicity from off-target gene editing effects? [These] are questions facing gene editing in the context of gene therapy.”

One of the limitations of the ubiquitous AAV vector has been the mounting of an antibody response against the vector itself, according to Federico Mingozzi, PhD, chief scientific officer at Spark Therapeutics. Hence the interest in imlifidase (IdeS), an endopeptidase that degrades circulating antibodies without disrupting B lymphocytes that produce antibodies. The enzyme, already in the clinics for transplantation patients, has two main benefits for gene therapy. It can be used to treat seropositive patients, and it permits the re-administration of the gene therapy product if the need arises.

Neutralizing antibodies to AAV
Neutralizing antibodies to AAV are common in humans and limit the efficacy of AAV-based gene therapy products. Imlifidase (IdeS), an endopeptidase, can degrade circulating antibodies for brief periods without affecting lymphocytes that produce antibodies. This increases effective gene transfer in mice and nonhuman primates, even upon reinjection of AAV, says Spark Therapeutics, and has proven to be safe in transplant patients.

“Once you give IdeS, you see a sharp and immediate drop in circulating antibodies. They stay low for 3–4 days and then go up again,” says Mingozzi. “Of course, it has to be tested in humans in conjunction with gene therapy, but it has a very good safety profile.”

“The reality is that we are at the beginning of a revolution,” declares Wilson. “The forward move for gene therapy is to make it safer and more effective.” Making it durable depends on the context but depends on three key factors: The genome must be stable, the cell has to persist, and therapeutic gene expression cannot be turned off. “Of these three,” says Wilson, “I think the major challenge is going to be to assure that its expression is ongoing.”

“Durability is a major consideration for rAAV gene therapy and is intertwined with immune and inflammatory toxicity,” adds Flotte. “It is less of a concern in gene editing, which involves permanent changes in the genome.”


According to Laura Hercher, director of student research, Human Genetics Program, Sarah Lawrence College, “the main roadblock is going to be price and accessibility. Unfortunately, in countries where there isn’t that kind of money to spend on a single patient, it is only going to be available to the very wealthy.”

A new nonprofit called the Institute for Life Changing Medicines aims to secure, develop, manufacture, and distribute life-changing medicines such as gene therapy at cost. “Ultimately, we want to provide access in countries where the diseases might not be rare, but the governments who are responsible for reimbursements simply won’t pay,” says Wilson. “I’m going to do everything I can to the last day I’m on my job to assure [global access]. What we are trying to do to assure global access is to be very efficient in clinical development and manufacturing to contain cost.”

Following a No Disease Left Behind strategy, the nonprofit is currently committed to providing gene therapy solutions for Lesch-Nyhan syndrome, aromatic L-amino acid decarboxylase deficiency, and Crigler-Najjar syndrome type I—diseases where gene therapy has a proven transformative effect.

The post Gene Therapy’s Renaissance appeared first on GEN - Genetic Engineering and Biotechnology News.

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Fauci Deputy Warned Him Against Vaccine Mandates: Email

Fauci Deputy Warned Him Against Vaccine Mandates: Email

Authored by Zachary Stieber via The Epoch Times (emphasis ours),

Mandating COVID-19…



Fauci Deputy Warned Him Against Vaccine Mandates: Email

Authored by Zachary Stieber via The Epoch Times (emphasis ours),

Mandating COVID-19 vaccination was a mistake due to ethical and other concerns, a top government doctor warned Dr. Anthony Fauci after Dr. Fauci promoted mass vaccination.

Coercing or forcing people to take a vaccine can have negative consequences from a biological, sociological, psychological, economical, and ethical standpoint and is not worth the cost even if the vaccine is 100% safe,” Dr. Matthew Memoli, director of the Laboratory of Infectious Diseases clinical studies unit at the U.S. National Institute of Allergy and Infectious Diseases (NIAID), told Dr. Fauci in an email.

“A more prudent approach that considers these issues would be to focus our efforts on those at high risk of severe disease and death, such as the elderly and obese, and do not push vaccination on the young and healthy any further.”

Dr. Anthony Fauci, ex-director of the National Institute of Allergy and Infectious Diseases (NIAID. in Washington on Jan. 8, 2024. (Madalina Vasiliu/The Epoch Times)

Employing that strategy would help prevent loss of public trust and political capital, Dr. Memoli said.

The email was sent on July 30, 2021, after Dr. Fauci, director of the NIAID, claimed that communities would be safer if more people received one of the COVID-19 vaccines and that mass vaccination would lead to the end of the COVID-19 pandemic.

“We’re on a really good track now to really crush this outbreak, and the more people we get vaccinated, the more assuredness that we’re going to have that we’re going to be able to do that,” Dr. Fauci said on CNN the month prior.

Dr. Memoli, who has studied influenza vaccination for years, disagreed, telling Dr. Fauci that research in the field has indicated yearly shots sometimes drive the evolution of influenza.

Vaccinating people who have not been infected with COVID-19, he said, could potentially impact the evolution of the virus that causes COVID-19 in unexpected ways.

“At best what we are doing with mandated mass vaccination does nothing and the variants emerge evading immunity anyway as they would have without the vaccine,” Dr. Memoli wrote. “At worst it drives evolution of the virus in a way that is different from nature and possibly detrimental, prolonging the pandemic or causing more morbidity and mortality than it should.”

The vaccination strategy was flawed because it relied on a single antigen, introducing immunity that only lasted for a certain period of time, Dr. Memoli said. When the immunity weakened, the virus was given an opportunity to evolve.

Some other experts, including virologist Geert Vanden Bossche, have offered similar views. Others in the scientific community, such as U.S. Centers for Disease Control and Prevention scientists, say vaccination prevents virus evolution, though the agency has acknowledged it doesn’t have records supporting its position.

Other Messages

Dr. Memoli sent the email to Dr. Fauci and two other top NIAID officials, Drs. Hugh Auchincloss and Clifford Lane. The message was first reported by the Wall Street Journal, though the publication did not publish the message. The Epoch Times obtained the email and 199 other pages of Dr. Memoli’s emails through a Freedom of Information Act request. There were no indications that Dr. Fauci ever responded to Dr. Memoli.

Later in 2021, the NIAID’s parent agency, the U.S. National Institutes of Health (NIH), and all other federal government agencies began requiring COVID-19 vaccination, under direction from President Joe Biden.

In other messages, Dr. Memoli said the mandates were unethical and that he was hopeful legal cases brought against the mandates would ultimately let people “make their own healthcare decisions.”

“I am certainly doing everything in my power to influence that,” he wrote on Nov. 2, 2021, to an unknown recipient. Dr. Memoli also disclosed that both he and his wife had applied for exemptions from the mandates imposed by the NIH and his wife’s employer. While her request had been granted, his had not as of yet, Dr. Memoli said. It’s not clear if it ever was.

According to Dr. Memoli, officials had not gone over the bioethics of the mandates. He wrote to the NIH’s Department of Bioethics, pointing out that the protection from the vaccines waned over time, that the shots can cause serious health issues such as myocarditis, or heart inflammation, and that vaccinated people were just as likely to spread COVID-19 as unvaccinated people.

He cited multiple studies in his emails, including one that found a resurgence of COVID-19 cases in a California health care system despite a high rate of vaccination and another that showed transmission rates were similar among the vaccinated and unvaccinated.

Dr. Memoli said he was “particularly interested in the bioethics of a mandate when the vaccine doesn’t have the ability to stop spread of the disease, which is the purpose of the mandate.”

The message led to Dr. Memoli speaking during an NIH event in December 2021, several weeks after he went public with his concerns about mandating vaccines.

“Vaccine mandates should be rare and considered only with a strong justification,” Dr. Memoli said in the debate. He suggested that the justification was not there for COVID-19 vaccines, given their fleeting effectiveness.

Julie Ledgerwood, another NIAID official who also spoke at the event, said that the vaccines were highly effective and that the side effects that had been detected were not significant. She did acknowledge that vaccinated people needed boosters after a period of time.

The NIH, and many other government agencies, removed their mandates in 2023 with the end of the COVID-19 public health emergency.

A request for comment from Dr. Fauci was not returned. Dr. Memoli told The Epoch Times in an email he was “happy to answer any questions you have” but that he needed clearance from the NIAID’s media office. That office then refused to give clearance.

Dr. Jay Bhattacharya, a professor of health policy at Stanford University, said that Dr. Memoli showed bravery when he warned Dr. Fauci against mandates.

“Those mandates have done more to demolish public trust in public health than any single action by public health officials in my professional career, including diminishing public trust in all vaccines.” Dr. Bhattacharya, a frequent critic of the U.S. response to COVID-19, told The Epoch Times via email. “It was risky for Dr. Memoli to speak publicly since he works at the NIH, and the culture of the NIH punishes those who cross powerful scientific bureaucrats like Dr. Fauci or his former boss, Dr. Francis Collins.”

Tyler Durden Mon, 03/11/2024 - 17:40

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Trump “Clearly Hasn’t Learned From His COVID-Era Mistakes”, RFK Jr. Says

Trump "Clearly Hasn’t Learned From His COVID-Era Mistakes", RFK Jr. Says

Authored by Jeff Louderback via The Epoch Times (emphasis ours),




Trump "Clearly Hasn't Learned From His COVID-Era Mistakes", RFK Jr. Says

Authored by Jeff Louderback via The Epoch Times (emphasis ours),

President Joe Biden claimed that COVID vaccines are now helping cancer patients during his State of the Union address on March 7, but it was a response on Truth Social from former President Donald Trump that drew the ire of independent presidential candidate Robert F. Kennedy Jr.

Robert F. Kennedy Jr. holds a voter rally in Grand Rapids, Mich., on Feb. 10, 2024. (Mitch Ranger for The Epoch Times)

During the address, President Biden said: “The pandemic no longer controls our lives. The vaccines that saved us from COVID are now being used to help beat cancer, turning setback into comeback. That’s what America does.”

President Trump wrote: “The Pandemic no longer controls our lives. The VACCINES that saved us from COVID are now being used to help beat cancer—turning setback into comeback. YOU’RE WELCOME JOE. NINE-MONTH APPROVAL TIME VS. 12 YEARS THAT IT WOULD HAVE TAKEN YOU.”

An outspoken critic of President Trump’s COVID response, and the Operation Warp Speed program that escalated the availability of COVID vaccines, Mr. Kennedy said on X, formerly known as Twitter, that “Donald Trump clearly hasn’t learned from his COVID-era mistakes.”

“He fails to recognize how ineffective his warp speed vaccine is as the ninth shot is being recommended to seniors. Even more troubling is the documented harm being caused by the shot to so many innocent children and adults who are suffering myocarditis, pericarditis, and brain inflammation,” Mr. Kennedy remarked.

“This has been confirmed by a CDC-funded study of 99 million people. Instead of bragging about its speedy approval, we should be honestly and transparently debating the abundant evidence that this vaccine may have caused more harm than good.

“I look forward to debating both Trump and Biden on Sept. 16 in San Marcos, Texas.”

Mr. Kennedy announced in April 2023 that he would challenge President Biden for the 2024 Democratic Party presidential nomination before declaring his run as an independent last October, claiming that the Democrat National Committee was “rigging the primary.”

Since the early stages of his campaign, Mr. Kennedy has generated more support than pundits expected from conservatives, moderates, and independents resulting in speculation that he could take votes away from President Trump.

Many Republicans continue to seek a reckoning over the government-imposed pandemic lockdowns and vaccine mandates.

President Trump’s defense of Operation Warp Speed, the program he rolled out in May 2020 to spur the development and distribution of COVID-19 vaccines amid the pandemic, remains a sticking point for some of his supporters.

Vice President Mike Pence (L) and President Donald Trump deliver an update on Operation Warp Speed in the Rose Garden of the White House in Washington on Nov. 13, 2020. (Mandel Ngan/AFP via Getty Images)

Operation Warp Speed featured a partnership between the government, the military, and the private sector, with the government paying for millions of vaccine doses to be produced.

President Trump released a statement in March 2021 saying: “I hope everyone remembers when they’re getting the COVID-19 Vaccine, that if I wasn’t President, you wouldn’t be getting that beautiful ‘shot’ for 5 years, at best, and probably wouldn’t be getting it at all. I hope everyone remembers!”

President Trump said about the COVID-19 vaccine in an interview on Fox News in March 2021: “It works incredibly well. Ninety-five percent, maybe even more than that. I would recommend it, and I would recommend it to a lot of people that don’t want to get it and a lot of those people voted for me, frankly.

“But again, we have our freedoms and we have to live by that and I agree with that also. But it’s a great vaccine, it’s a safe vaccine, and it’s something that works.”

On many occasions, President Trump has said that he is not in favor of vaccine mandates.

An environmental attorney, Mr. Kennedy founded Children’s Health Defense, a nonprofit that aims to end childhood health epidemics by promoting vaccine safeguards, among other initiatives.

Last year, Mr. Kennedy told podcaster Joe Rogan that ivermectin was suppressed by the FDA so that the COVID-19 vaccines could be granted emergency use authorization.

He has criticized Big Pharma, vaccine safety, and government mandates for years.

Since launching his presidential campaign, Mr. Kennedy has made his stances on the COVID-19 vaccines, and vaccines in general, a frequent talking point.

“I would argue that the science is very clear right now that they [vaccines] caused a lot more problems than they averted,” Mr. Kennedy said on Piers Morgan Uncensored last April.

“And if you look at the countries that did not vaccinate, they had the lowest death rates, they had the lowest COVID and infection rates.”

Additional data show a “direct correlation” between excess deaths and high vaccination rates in developed countries, he said.

President Trump and Mr. Kennedy have similar views on topics like protecting the U.S.-Mexico border and ending the Russia-Ukraine war.

COVID-19 is the topic where Mr. Kennedy and President Trump seem to differ the most.

Former President Donald Trump intended to “drain the swamp” when he took office in 2017, but he was “intimidated by bureaucrats” at federal agencies and did not accomplish that objective, Mr. Kennedy said on Feb. 5.

Speaking at a voter rally in Tucson, where he collected signatures to get on the Arizona ballot, the independent presidential candidate said President Trump was “earnest” when he vowed to “drain the swamp,” but it was “business as usual” during his term.

John Bolton, who President Trump appointed as a national security adviser, is “the template for a swamp creature,” Mr. Kennedy said.

Scott Gottlieb, who President Trump named to run the FDA, “was Pfizer’s business partner” and eventually returned to Pfizer, Mr. Kennedy said.

Mr. Kennedy said that President Trump had more lobbyists running federal agencies than any president in U.S. history.

“You can’t reform them when you’ve got the swamp creatures running them, and I’m not going to do that. I’m going to do something different,” Mr. Kennedy said.

During the COVID-19 pandemic, President Trump “did not ask the questions that he should have,” he believes.

President Trump “knew that lockdowns were wrong” and then “agreed to lockdowns,” Mr. Kennedy said.

He also “knew that hydroxychloroquine worked, he said it,” Mr. Kennedy explained, adding that he was eventually “rolled over” by Dr. Anthony Fauci and his advisers.

President Donald Trump greets the crowd before he leaves at the Operation Warp Speed Vaccine Summit in Washington on Dec. 8, 2020. (Tasos Katopodis/Getty Images)

MaryJo Perry, a longtime advocate for vaccine choice and a Trump supporter, thinks votes will be at a premium come Election Day, particularly because the independent and third-party field is becoming more competitive.

Ms. Perry, president of Mississippi Parents for Vaccine Rights, believes advocates for medical freedom could determine who is ultimately president.

She believes that Mr. Kennedy is “pulling votes from Trump” because of the former president’s stance on the vaccines.

“People care about medical freedom. It’s an important issue here in Mississippi, and across the country,” Ms. Perry told The Epoch Times.

“Trump should admit he was wrong about Operation Warp Speed and that COVID vaccines have been dangerous. That would make a difference among people he has offended.”

President Trump won’t lose enough votes to Mr. Kennedy about Operation Warp Speed and COVID vaccines to have a significant impact on the election, Ohio Republican strategist Wes Farno told The Epoch Times.

President Trump won in Ohio by eight percentage points in both 2016 and 2020. The Ohio Republican Party endorsed President Trump for the nomination in 2024.

“The positives of a Trump presidency far outweigh the negatives,” Mr. Farno said. “People are more concerned about their wallet and the economy.

“They are asking themselves if they were better off during President Trump’s term compared to since President Biden took office. The answer to that question is obvious because many Americans are struggling to afford groceries, gas, mortgages, and rent payments.

“America needs President Trump.”

Multiple national polls back Mr. Farno’s view.

As of March 6, the RealClearPolitics average of polls indicates that President Trump has 41.8 percent support in a five-way race that includes President Biden (38.4 percent), Mr. Kennedy (12.7 percent), independent Cornel West (2.6 percent), and Green Party nominee Jill Stein (1.7 percent).

A Pew Research Center study conducted among 10,133 U.S. adults from Feb. 7 to Feb. 11 showed that Democrats and Democrat-leaning independents (42 percent) are more likely than Republicans and GOP-leaning independents (15 percent) to say they have received an updated COVID vaccine.

The poll also reported that just 28 percent of adults say they have received the updated COVID inoculation.

The peer-reviewed multinational study of more than 99 million vaccinated people that Mr. Kennedy referenced in his X post on March 7 was published in the Vaccine journal on Feb. 12.

It aimed to evaluate the risk of 13 adverse events of special interest (AESI) following COVID-19 vaccination. The AESIs spanned three categories—neurological, hematologic (blood), and cardiovascular.

The study reviewed data collected from more than 99 million vaccinated people from eight nations—Argentina, Australia, Canada, Denmark, Finland, France, New Zealand, and Scotland—looking at risks up to 42 days after getting the shots.

Three vaccines—Pfizer and Moderna’s mRNA vaccines as well as AstraZeneca’s viral vector jab—were examined in the study.

Researchers found higher-than-expected cases that they deemed met the threshold to be potential safety signals for multiple AESIs, including for Guillain-Barre syndrome (GBS), cerebral venous sinus thrombosis (CVST), myocarditis, and pericarditis.

A safety signal refers to information that could suggest a potential risk or harm that may be associated with a medical product.

The study identified higher incidences of neurological, cardiovascular, and blood disorder complications than what the researchers expected.

President Trump’s role in Operation Warp Speed, and his continued praise of the COVID vaccine, remains a concern for some voters, including those who still support him.

Krista Cobb is a 40-year-old mother in western Ohio. She voted for President Trump in 2020 and said she would cast her vote for him this November, but she was stunned when she saw his response to President Biden about the COVID-19 vaccine during the State of the Union address.

I love President Trump and support his policies, but at this point, he has to know they [advisers and health officials] lied about the shot,” Ms. Cobb told The Epoch Times.

“If he continues to promote it, especially after all of the hearings they’ve had about it in Congress, the side effects, and cover-ups on Capitol Hill, at what point does he become the same as the people who have lied?” Ms. Cobb added.

“I think he should distance himself from talk about Operation Warp Speed and even admit that he was wrong—that the vaccines have not had the impact he was told they would have. If he did that, people would respect him even more.”

Tyler Durden Mon, 03/11/2024 - 17:00

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The next pandemic? It’s already here for Earth’s wildlife

Bird flu is decimating species already threatened by climate change and habitat loss.

I am a conservation biologist who studies emerging infectious diseases. When people ask me what I think the next pandemic will be I often say that we are in the midst of one – it’s just afflicting a great many species more than ours.

I am referring to the highly pathogenic strain of avian influenza H5N1 (HPAI H5N1), otherwise known as bird flu, which has killed millions of birds and unknown numbers of mammals, particularly during the past three years.

This is the strain that emerged in domestic geese in China in 1997 and quickly jumped to humans in south-east Asia with a mortality rate of around 40-50%. My research group encountered the virus when it killed a mammal, an endangered Owston’s palm civet, in a captive breeding programme in Cuc Phuong National Park Vietnam in 2005.

How these animals caught bird flu was never confirmed. Their diet is mainly earthworms, so they had not been infected by eating diseased poultry like many captive tigers in the region.

This discovery prompted us to collate all confirmed reports of fatal infection with bird flu to assess just how broad a threat to wildlife this virus might pose.

This is how a newly discovered virus in Chinese poultry came to threaten so much of the world’s biodiversity.

H5N1 originated on a Chinese poultry farm in 1997. ChameleonsEye/Shutterstock

The first signs

Until December 2005, most confirmed infections had been found in a few zoos and rescue centres in Thailand and Cambodia. Our analysis in 2006 showed that nearly half (48%) of all the different groups of birds (known to taxonomists as “orders”) contained a species in which a fatal infection of bird flu had been reported. These 13 orders comprised 84% of all bird species.

We reasoned 20 years ago that the strains of H5N1 circulating were probably highly pathogenic to all bird orders. We also showed that the list of confirmed infected species included those that were globally threatened and that important habitats, such as Vietnam’s Mekong delta, lay close to reported poultry outbreaks.

Mammals known to be susceptible to bird flu during the early 2000s included primates, rodents, pigs and rabbits. Large carnivores such as Bengal tigers and clouded leopards were reported to have been killed, as well as domestic cats.

Our 2006 paper showed the ease with which this virus crossed species barriers and suggested it might one day produce a pandemic-scale threat to global biodiversity.

Unfortunately, our warnings were correct.

A roving sickness

Two decades on, bird flu is killing species from the high Arctic to mainland Antarctica.

In the past couple of years, bird flu has spread rapidly across Europe and infiltrated North and South America, killing millions of poultry and a variety of bird and mammal species. A recent paper found that 26 countries have reported at least 48 mammal species that have died from the virus since 2020, when the latest increase in reported infections started.

Not even the ocean is safe. Since 2020, 13 species of aquatic mammal have succumbed, including American sea lions, porpoises and dolphins, often dying in their thousands in South America. A wide range of scavenging and predatory mammals that live on land are now also confirmed to be susceptible, including mountain lions, lynx, brown, black and polar bears.

The UK alone has lost over 75% of its great skuas and seen a 25% decline in northern gannets. Recent declines in sandwich terns (35%) and common terns (42%) were also largely driven by the virus.

Scientists haven’t managed to completely sequence the virus in all affected species. Research and continuous surveillance could tell us how adaptable it ultimately becomes, and whether it can jump to even more species. We know it can already infect humans – one or more genetic mutations may make it more infectious.

At the crossroads

Between January 1 2003 and December 21 2023, 882 cases of human infection with the H5N1 virus were reported from 23 countries, of which 461 (52%) were fatal.

Of these fatal cases, more than half were in Vietnam, China, Cambodia and Laos. Poultry-to-human infections were first recorded in Cambodia in December 2003. Intermittent cases were reported until 2014, followed by a gap until 2023, yielding 41 deaths from 64 cases. The subtype of H5N1 virus responsible has been detected in poultry in Cambodia since 2014. In the early 2000s, the H5N1 virus circulating had a high human mortality rate, so it is worrying that we are now starting to see people dying after contact with poultry again.

It’s not just H5 subtypes of bird flu that concern humans. The H10N1 virus was originally isolated from wild birds in South Korea, but has also been reported in samples from China and Mongolia.

Recent research found that these particular virus subtypes may be able to jump to humans after they were found to be pathogenic in laboratory mice and ferrets. The first person who was confirmed to be infected with H10N5 died in China on January 27 2024, but this patient was also suffering from seasonal flu (H3N2). They had been exposed to live poultry which also tested positive for H10N5.

Species already threatened with extinction are among those which have died due to bird flu in the past three years. The first deaths from the virus in mainland Antarctica have just been confirmed in skuas, highlighting a looming threat to penguin colonies whose eggs and chicks skuas prey on. Humboldt penguins have already been killed by the virus in Chile.

A colony of king penguins.
Remote penguin colonies are already threatened by climate change. AndreAnita/Shutterstock

How can we stem this tsunami of H5N1 and other avian influenzas? Completely overhaul poultry production on a global scale. Make farms self-sufficient in rearing eggs and chicks instead of exporting them internationally. The trend towards megafarms containing over a million birds must be stopped in its tracks.

To prevent the worst outcomes for this virus, we must revisit its primary source: the incubator of intensive poultry farms.

Diana Bell does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

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