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Reinforcing the Body’s Defenses against Cancer

New immunotherapy developments include the use of tumor-infiltrating lymphocytes, allogeneic T cells, co-stimulatory signals, and engineered cytokines.
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Cancer continues to claim a staggering number of lives. It is the leading cause of death worldwide and in the United States. Yet the statistics are not entirely grim. In the United States, the death rate peaked in 1991 and has steadily decreased since.

This encouraging trend may be strengthened now that immunotherapies are being deployed more widely. Immunotherapies are already revolutionizing the treatment of cancer—not just blood cancers, but solid cancers, too.

Despite the pandemic, immunotherapy continues to inspire hope and excitement, attitudes that serve to sustain the field and drive it forward. Hope and excitement are certainly evident among the scientists scheduled to speak at the 17th Annual PEGS Boston—The Essential Protein Engineering & Cell Therapy Summit. This event, which will be held virtually May 2021, will highlight the newest approaches in the field.

Next-generation targets and strategies include investigating the power of a patient’s own tumor-infiltrating lymphocytes (TILs); developing an allogeneic T-cell therapy using a dimeric antigen receptor to target an overexpressed tumor protein; enhancing innate immunity to remodulate the tumor microenvironment; and generating an engineered interleukin-15 (IL-15) for expanding killer cell responses.

“Stealth” lymphocyte attack

In the early stages of a tumor’s development, host TILs attack the foreign mass by penetrating its stroma. This natural defense does not always work. “If there are genetic or environmental factors affecting tumor growth, the tumor cells may prevail,” explains Maria Fardis, PhD, president and CEO of Iovance Biotherapeutics. “Cancer cells may also suppress the natural antitumor response of the body by expressing cell surface proteins such as PD-L1 or CTLA-4.”

Iovance’s platform utilizes a patient’s own TILs as a stealth-like technology for immune defense against solid tumors. “Instead of targeting one preselected antigen, as with many other types of therapy, we isolate and expand a patient’s TILs, which target a diverse array of cancer antigens,” Fardis elaborates. “We infuse the TILS back into the patient to attack the cancer.”

The process first entails removing a section of the tumor (~1.5 cm) with surgical resection. TILs from the sample are expanded to billions of cells via Iovance’s streamlined proprietary 22-day process in the company’s GMP-compliant manufacturing facility. Fardis asserts, “Removing cells from the immunosuppressive tumor environment and growing the cells ex vivo activates and expands the patient’s polyclonal TILs.”

nonmyeloablative lymphodepletion (NMA-LD) and then receives TIL and interleukin-2 (IL-2) infusions diagram
Iovance Biotherapeutics utilizes a patient’s own tumor-infiltrating lymphocytes (TILs) as a one-dose cancer-fighting therapeutic strategy. A patient’s TILs are isolated from a small section of tumor and expanded into billions of polyclonal TILs in a 22-day GMP-compliant process. Prior to infusion, the patient undergoes nonmyeloablative lymphodepletion (NMA-LD) and then receives TIL and interleukin-2 (IL-2) infusions. ©2021 Iovance biotherapeutics, Inc.

Prior to TIL infusion, the patient is preconditioned to remove suppressive factors. “We have achieved a 90% success rate in TIL manufacturing and have dosed greater than 400 patients,” Fardis notes. “What’s remarkable is that the TIL approach enables a one-dose treatment and requires no follow-up treatment. In our melanoma clinical trial, for example, after a single infusion of TILs, 36% of late-stage patients demonstrated a response. Even after 28 months, these patients have not yet reached the median duration of response. This could mean the TILs are still active and working!”

In addition to melanoma, Iovance is pursuing a number of ongoing Phase II trials including those for cervical cancer, head and neck cancer, and non-small cell lung cancer.

The company continues to refine and expand its TIL technology platform, and it hopes to see TILs become part of cancer adjuvant therapy in the future. “To prevent metastasis of a newly diagnosed cancer, TILs could be given after tumor removal as part of treatment,” Fardis explains. “Another potential application is to genetically modify TILs to remove the ‘brakes’ on the natural immune response, such as the well-known PD-1 and CTLA-4 pathways. TIL therapy could represent the utmost in personalized medicine as well as a revolutionary, accessible, and mainline cancer therapy.”

“DAR T-ing” for a cure

Autologous chimeric antigen receptor (CAR) T-cell therapy has shown great promise, especially for the treatment of hematological malignancies. However, several CAR T-cell therapy challenges continue to vex the field. For example, therapies typically rely on patient cells, and manufacturing remains difficult.

To help overcome these challenges, Sorrento Therapeutics has developed an allogeneic T-cell therapy based on genetic engineering of donor-derived T cells to express a dimeric antigen receptor (DAR). One of the company’s DAR T-cell programs focuses on targeting GD2, a disialoganglioside that has limited expression in normal tissues but is overexpressed across a wide range of tumors.

“GD2 is a well-characterized tumor antigen in neuroblastoma, which is also expressed on osteosarcomas and some other sarcomas,” comments Wenzhong Guo, PhD, CTO, Cell Therapy, Sorrento. “The prognosis for advanced neuroblastoma remains poor with a high risk of recurrence even after multiple therapies. Therapies based on monoclonal antibodies that specifically target GD2 on tumor cells are improving treatment results for high-risk neuroblastoma.”

Sorrento Fab
Instead of using an scFv, a molecule characteristic of traditional chimeric antigen receptor (CAR) T cells, Sorrento Therapeutics uses a Fab. Left: The current CAR T-cell technology. It uses viral vectors to deliver transgenes, which are randomly integrated into the genome of the target cells. It results in the formation of an scFv linked with a signaling domain. Right: Sorrento’s next-generation dimeric antigen receptor (DAR) technology. Notice that the transgenes integrate into the T-cell receptor (TCR) locus and that an antibody Fab may be linked with one or more intracellular signaling domains (X: second signal; Y: first signal).

Sorrento is developing second-generation anti-GD2 allogeneic DAR T cells to target GD2 for improving the efficacy of CAR T-cell therapy. Guo explains, “In the DAR structure, a Fab antibody is used to replace the scFv antibody of the CAR structure. Preclinical studies show this modification can improve specificity and antitumor activity.

“Further, a proprietary one-step ‘knock out/knock in’ (KOKI) approach is used to integrate the DAR construct into the T-cell receptor locus, which eliminates viral vector transduction, saving product development time and reducing manufacturing costs. This approach can be used to produce both autologous and allogeneic DAR T-cell products.”

Guo believes the approaches are not mutually exclusive: “Although allogeneic CAR T cells can resolve some current challenges of autologous CAR T cells, allogeneic approaches are associated with two major issues. First, the administered allogeneic T cells may cause life-threatening graft-versus-host disease. Second, these allogeneic T cells may be rapidly eliminated by the host immune system, limiting their antitumor activity.

“Multiple approaches have been used to resolve these issues; however, the persistence of autologous CAR T cells is typically better than that of allogeneic CAR T cells. Allogeneic and autologous CAR T-cell therapies may each have therapeutic benefits, depending on the desirability of CAR T-cell persistence for a given indication.”

Sorrento’s preclinical studies are targeting neuroblastoma, osteosarcoma, and other cancers. The company have filed an IND application for its allogeneic anti-CD38 DAR T-cell program.

Enhancing immunotherapy response

Although immune checkpoint inhibitors such as CTLA-4 and PD-1 blockers can achieve significant survival benefits against metastatic melanoma, poorly immunogenic tumors require additional modalities such as strong co-stimulatory signals to amplify T-cell signaling for maximal antitumor response.

A number of strategies are being employed to manipulate co-stimulatory signals to enhance T cell–mediated tumor attack. For example, activation of NKG2D, an activating immune surveillance receptor, assists in the elimination of abnormal cells. NKG2D is expressed primarily on the cytotoxic arm of the immune system: natural killer (NK) cells, CD8+ T cells, natural killer T cells (NKTs), and subsets of γδ T cells.

In humans, NKG2D is activated via binding to the family of ligands for the major histocompatibility complex (MHC) class I chain–related molecules referred to as MICs. Usually, MICs are expressed only on cells under oncogenic or environmental challenge, and not on healthy cells. Further, a tumor-derived soluble version of an MIC (sMIC) serves as a decoy ligand that impairs NKG2D-mediatedNK cell tumor-killing ability and co-stimulation of tumor-killing CD8+ T cells.

Jennifer Wu, PhD, professor of urology and immunology, Feinberg School of Medicine, Northwestern University, investigated the NKG2D-MIC axis in association the immunosuppressive effects of sMIC during PD-1/PD-L1 blockade and CTLA-4 blockade therapy. She and colleagues tested the hypothesis that antibody targeting of sMIC could enhance the therapeutic efficacy of PD-1/PD-L1 blockade and CTLA-4 blockade.

They assessed a single-agent therapy of a PD-1/PD-L1 or CTLA-4 blockade antibody or a nonblocking antibody that targeted sMIC, or a combination therapy of PD-1/PD-L1 or CTLA-4 blockade antibody and the sMIC-targeting antibody. The therapies were administered to well-characterized preclinical MIC/sMIC+ tumor models that closely resembled the NKG2D-medated oncoimmune dynamics of MIC+ cancer patients.

The team found that antibody co-targeting of sMIC enhanced responses of sMIC+ tumors to the PD-1/PD-L1 blockade and the CTLA-4 blockade. Further, using combination therapy enhanced antigen-specific CD8+ T-cell enrichment and antitumor function in tumors. Wu and colleagues proposed that the study provides proof of concept that targeting sMIC with a nonblocking monoclonal antibody can enhance responses to PD-1/PD-L1 therapy or CTLA-4 therapy on sMIC+ tumors.

IL-15 agonist

The primary curative option for patients with advanced hematological malignancies is allogeneic hematopoietic cell transplantation. Despite this treatment, patients often have a poor prognosis and relapse rates of nearly 50%. Nektar Therapeutics is pursuing the strategy of enhancing antitumor immunity by utilizing an engineered version of IL-15 to stimulate natural immunity.

Willem Overwijk, PhD
Willem Overwijk, PhD
Nektar Therapeutics

“Activation of the IL-15 pathway can promote antitumor responses as it enables the expansion, survival, and function of NK cells and memory CD8+ T cells without inducing suppressive regulatory T cells,” says Willem Overwijk, PhD, vice president of oncology research at Nektar. “However, native IL-15 has some important drawbacks that have limited its application in cancer therapy. For example, it has a very short half-life in the circulation, necessitating frequent administration of high doses that can lead to toxic side effects as well as desensitization over time.”

The company’s drug candidate under development, NKTR-255, is an engineered version of native IL-15. It employs advanced polymer chemistry and is designed to capture the full IL-15 pathway activity and increase cytotoxic function against cancer cells, while also providing a highly improved pharmacokinetic profile. According to Overwijk, the polymer chemistry “lets NKTR-255 remain active in the bloodstream longer, improving tolerability and allowing for administration once every 2 to 4 weeks.”

Overwijk notes that NKTR-255 is advantageous in two respects: “By targeting the natural IL-15 pathway, NKTR-255 increases the number and activity of NK cells and CD8+ T cells, which mediate direct antitumor activity in preclinical models of cancer. In addition, NK cells activated by NKTR-255 can efficiently recognize specific antibody therapeutics that bind to cancer cells, which could further increase their efficacy and thus lead to better patient outcomes.”

engineered version of interleukin-15 (IL-15)
To stimulate adaptive and innate antitumor immunity, Nektar Therapeutics utilizes an engineered version of interleukin-15 (IL-15). The molecule can activate the native IL-15 pathway, inducing both the proliferation and activation of both natural killer (NK) cells and of cytotoxic T cells to enhance NK cell–mediated antibody-dependent cellular cytotoxicity against tumor cells; boost cytotoxic T cell–mediated killing of tumor cells; and promote the maintenance of memory T cells that can cause tumor cell death.

NKTR-255 is currently being evaluated in a Phase I study in adults with relapsed/refractory non-Hodgkin lymphoma or relapsed/refractory multiple myeloma (NCT04136756) and in a Phase Ib/II study in combination with cetuximab as a salvage regimen for solid tumors (NCT04616196).

Nektar has a number of investigational medicines in different stages of clinical development. Overwijk reports, “Nektar continues to build upon its deep understanding of immunology to discover and develop novel immunomodulatory therapies for the treatment of cancer, autoimmune disorders, and chronic inflammatory conditions.”

The post Reinforcing the Body’s Defenses against Cancer 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…

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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),

President…

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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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Spread & Containment

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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