Category: Vaccine

Texas Biomedical Researchers study potential Bird Flu treatments and vaccines

by SBG San Antonio Staff Reports

Texas Biomed has broadened the scope of its vaccine research to include Avian Influenza amid recent concerns. (Getty Images){p}{/p}

SAN ANTONIO - Texas Biomedical Research Institute (Texas Biomed) has announced its researching potential vaccines and antivirals that could combat Avian Influenza, also known as H5N1 or Bird Flu.

These will be intended to combat strains that mirror those found in cows and chickens, and now one person in Texas.

This is only the second case of Bird Flu found in Humans in the United States, which officials say was contracted through contact with Dairy Cows.

Thankfully, the risk of the current H5N1 case becoming widespread among people remains low, says Larry Schlesinger, M.D., Texas Biomed President and CEO. But viruses adapt and evolve especially influenza viruses which is why it is so critical to be studying them and developing vaccines and treatments well before they are needed.

Researchers at Texas Biomed are using techniques learned from years of vaccine development for both Seasonal Influenza as well as the recent developments made as a result of the COVID-19 pandemic.

The new initiative, hosted by Professor Luis Martinez-Sobrido, Ph.D.s laboratory, will see the scope of research increased to include Avian Influenza, testing if current vaccines and antivirals would have any effect on stopping the spread or mitigating the virus impact.

The genetic sequencing analysis from the CDC indicates that the H5N1 strain found in the patient does not have any mutations associated with resistance to current antiviral drugs, says Prof. Martinez-Sobrido. However, it is important to continue developing an array of countermeasures in case existing ones lose effectiveness.

Fewer than 900 cases of bird flu infecting humans have been reported globally since 1996, however, infection has a fatality rate of about 50%.

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Texas Biomedical Researchers study potential Bird Flu treatments and vaccines - WOAI

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The same class of artificial intelligence that made headlines coding software and passing the bar exam has learned to read a different kind of textthe genetic code.

That code contains instructions for all of life's functions and follows rules not unlike those that govern human languages. Each sequence in a genome adheres to an intricate grammar and syntax, the structures that give rise to meaning. Just as changing a few words can radically alter the impact of a sentence, small variations in a biological sequence can make a huge difference in the forms that sequence encodes.

Now Princeton University researchers led by machine learning expert Mengdi Wang are using language models to home in on partial genome sequences and optimize those sequences to study biology and improve medicine. And they are already underway.

In a paper published April 5 in the journal Nature Machine Intelligence, the authors detail a language model that used its powers of semantic representation to design a more effective mRNA vaccine such as those used to protect against COVID-19.

Scientists have a simple way to summarize the flow of genetic information. They call it the central dogma of biology. Information moves from DNA to RNA to proteins. Proteins create the structures and functions of living cells.

Messenger RNA, or mRNA, converts the information into proteins in that final step, called translation. But mRNA is interesting. Only part of it holds the code for the protein. The rest is not translated but controls vital aspects of the translation process.

Governing the efficiency of protein production is a key mechanism by which mRNA vaccines work. The researchers focused their language model there, on the untranslated region, to see how they could optimize efficiency and improve vaccines.

After training the model on a small variety of species, the researchers generated hundreds of new optimized sequences and validated those results through lab experiments. The best sequences outperformed several leading benchmarks for vaccine development, including a 33% increase in the overall efficiency of protein production.

Increasing protein production efficiency by even a small amount provides a major boost for emerging therapeutics, according to the researchers. Beyond COVID-19, mRNA vaccines promise to protect against many infectious diseases and cancers.

Wang, a professor of electrical and computer engineering and the principal investigator in this study, said the model's success also pointed to a more fundamental possibility. Trained on mRNA from a handful of species, it was able to decode nucleotide sequences and reveal something new about gene regulation. Scientists believe gene regulation, one of life's most basic functions, holds the key to unlocking the origins of disease and disorder. Language models like this one could provide a new way to probe.

Wang's collaborators include researchers from the biotech firm RVAC Medicines as well as the Stanford University School of Medicine.

The new model differs in degree, not kind, from the large language models that power today's AI chat bots. Instead of being trained on billions of pages of text from the internet, their model was trained on a few hundred thousand sequences. The model also was trained to incorporate additional knowledge about the production of proteins, including structural and energy-related information.

The research team used the trained model to create a library of 211 new sequences. Each was optimized for a desired function, primarily an increase in the efficiency of translation. Those proteins, like the spike protein targeted by COVID-19 vaccines, drive the immune response to infectious disease.

Previous studies have created language models to decode various biological sequences, including proteins and DNA, but this was the first language model to focus on the untranslated region of mRNA. In addition to a boost in overall efficiency, it was also able to predict how well a sequence would perform at a variety of related tasks.

Wang said the real challenge in creating this language model was in understanding the full context of the available data. Training a model requires not only the raw data with all its features but also the downstream consequences of those features. If a program is designed to filter spam from email, each email it trains on would be labeled "spam" or "not spam." Along the way, the model develops semantic representations that allow it to determine what sequences of words indicate a "spam" label. Therein lies the meaning.

Wang said looking at one narrow dataset and developing a model around it was not enough to be useful for life scientists. She needed to do something new. Because this model was working at the leading edge of biological understanding, the data she found was all over the place.

"Part of my dataset comes from a study where there are measures for efficiency," Wang said. "Another part of my dataset comes from another study [that] measured expression levels. We also collected unannotated data from multiple resources." Organizing those parts into one coherent and robust wholea multifaceted dataset that she could use to train a sophisticated language modelwas a massive challenge.

"Training a model is not only about putting together all those sequences, but also putting together sequences with the labels that have been collected so far. This had never been done before."

The paper, "A 5' UTR Language Model for Decoding Untranslated Regions of mRNA and Function Predictions," was published in Nature Machine Intelligence. Additional authors include Dan Yu, Yupeng Li, Yue Shen and Jason Zhang, from RVAC Medicines; Le Cong from Stanford; and Yanyi Chu and Kaixuan Huang from Princeton.

More information: Yanyi Chu et al, A 5 UTR language model for decoding untranslated regions of mRNA and function predictions, Nature Machine Intelligence (2024). DOI: 10.1038/s42256-024-00823-9

Journal information: Nature Machine Intelligence

Excerpt from:

Can language models read the genome? This one decoded mRNA to make better vaccines - Phys.org

New research examining the characteristics of physicians with the largest share of patients unvaccinated against SARS-CoV-2 may help increase vaccination rates going forward. The study, published in CMAJ (Canadian Medical Association Journal) https://www.cmaj.ca/lookup/doi/10.1503/cmaj.230816, found that family physicians in Ontario with the largest percentage of unvaccinated patients generally served patients living in marginalized neighbourhoods and had less support in their practices.

Researchers analyzed linked data on 9060 family physicians with more than 10 million enrolled patients and calculated the percentage of patients unvaccinated against SARS-CoV-2 per physician. They compared family physicians (n = 906) caring for the largest proportion of unvaccinated patients (top 10%) with the rest of the comprehensive-care family physicians in Ontario. They found the group with the largest proportion of unvaccinated patients were more likely to be male, to have trained outside Canada, to be older (mean age of 56 v. 49 years), and to work in a fee-for-service model than the remaining 90% of physicians.

"The family physicians with the most unvaccinated patients were also more likely to be solo practitioners and less likely to practise in team-based models, meaning they may have fewer support staff in their clinics," says Dr. Jennifer Shuldiner, lead author and scientist, Women's College Hospital, Toronto, Ontario. "This illustrates the ongoing inverse relationship between the need for care, and its accessibility and utilization. In other words, the practices with the highest need receive the fewest resources."

As many of the physicians with the largest percentage of unvaccinated patients served people living in marginalized neighbourhoods, awareness of cultural differences in perspectives on vaccination should be considered.

"Many marginalized communities have a history of neglect from government (municipal, provincial, federal) and health care, and this may lead to mistrust in public health initiatives," the study authors write. "Interventions to support these communities should include meaningful community engagement and consideration for age-, language-, and culturally appropriate communication tools to assist primary care in boosting vaccine uptake."

Although the majority of SARS-CoV-2 vaccines were not administered by family physicians, clinicians have an important role to play in educating patients about the benefits of vaccination.

"We know that relationships with trusted family physicians can positively influence patients' decisions," explains Dr. Noah Ivers, senior author and clinician scientist, Women's College Hospital. "Our study highlights the need to create equitable systems and processes that create opportunities for primary care teams to play a crucial role in influencing both general and SARS-CoV-2-specific vaccine-related decision-making."

Expanding primary care teams in marginalized neighbourhoods and using hotspot strategies to focus public health resources in under-vaccinated communities could help support public health initiatives like vaccination.

The rest is here:

Link Uncovered Between Physician Traits and COVID-19 Vaccine Gaps - Mirage News

Patients suffering from Urinary Tract Infections (UTI) often struggle due to pain. However, a new oral spray vaccine can prevent recurring infections for up to years.

Known as MV140, the pineapple-flavoured oral spray can even be an alternative to antibiotics which are conventionally-used to treat the infection. According to the researchers, the antibiotics that often prescribed to treat UTIs have become less effective over time.

The study was conducted by the Royal Berkshire NHS Foundation Trust among 89 participants with recurrent UTIs and they were given MV140. The findings of the study were presented at the European Association of Urology Congress in Paris and it revealed that 54 percent of participants have not had a UTI since they took the vaccine.

The researchers also revealed that those volunteers who developed a UTI suffered from only minor symptoms.

According to report by Daily Mail, the vaccine contains four types of inactivated bacteria including E. Coli, the most common cause of a UTI.

Many of those who did get a UTI told us that simply drinking plenty of water was enough to treat it. [The vaccine] could be a game-changer for UTI prevention if it is offered widely, reducing the need for antibiotic treatments, Bob Yang, a consultant urologist at the Trust, said, as quoted by Daily Mail.

An infection in any part of the urinary system is called Urinary Tract Infection (UTI). According to Mayo Clinic, most infections involve the lower urinary tract the bladder and the urethra.

It is noteworthy that women are at more risk of developing a UTI than men. When a UTI occurs in the bladder, it leads to extreme pain and discomfort. However, if the infection spreads to the kidney, it can lead to serious health issues.

According to Mayo Clinic, UTIs dont always cause symptoms. When they do, they may include:

Usually, UTIs occur when bacteria enter the urinary tract through the urethra and begin to spread in the bladder. The most common UTIs occur mainly in women and affect the bladder and urethra.

These measures can help in lowering the risk of UTIs:

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THIS oral UTI vaccine can stop infections for up to nine yearsHeres what you need to know - The Financial Express

Pharmaceutical medicine has its place, but no single safety study can assess the cumulative impact of one prescription on top of another prescription, and one shot on top of another shot on top of another shot, throughout the course of childhood. We just dont do that study right now and we ought to. We can and we will. Conditions like autism used to be one in 10,000. Now here in the state of California it is one in 22.

Independent vice-presidential candidate Nicole Shanahan, remarks in Oakland, March 26

Shanahan, a technology lawyer tapped by Robert F. Kennedy Jr. to be his running mate in his independent bid for president, has a child who she says was diagnosed with autism. She has said the discovery prompted her to delve deep into research on autism. In her first news conference as a candidate, she devoted a lengthy passage to describing what she had learned, including suggesting that vaccines play a role.

Autism spectrum disorder (ASD) is an umbrella diagnosis covering a range of neurological and developmental disorders that include autism and Aspergers syndrome. Symptoms and severity vary dramatically from one person to another, but they typically impair a persons ability to communicate and interact with others or result in restricted, repetitive behaviors.

We checked with five autism experts about her full comments, repeated below, and they said much of what she claimed is misguided, wrong or lacks context. Kennedy himself is a longtime purveyor of falsehoods about vaccines, spreading misinformation. He has repeatedly claimed that vaccines cause autism, despite study after study showing there is no link. (Our colleagues at FactCheck.org last year published a three-part series that closely examined his vaccine claims.)

In recent interviews, Shanahan has expressed skepticism about vaccines but said she and Kennedy are not anti-vaxxers. In an interview with Newsweek after being named his running mate, she said Kennedy is not an anti-vaxxer; hes just someone who takes vaccine injuries seriously. In February, she told the New York Times I do wonder about vaccine injuries, adding, I think there needs to be a space to have these conversations.

The Kennedy-Shanahan campaign did not respond to a request for comment.

Here are Shanahans full comments about autism from her news conference:

Because it has been so personal for me and my daughter, I got deep into the research and consulted some of the best scientists and doctors. Let me tell you what I found. There are three main causes.

One, is the toxic substances in our environment, like endocrine disrupting chemicals in our food, water, and soil, like the pesticide residues, the industrial pollutants, the microplastics, the PFAs, the food additives, and the forever chemicals that have contaminated nearly every human cell. Yes, and it makes you angry to hear this. It makes me angry to say it because we shouldnt be here right now.

Second is electromagnetic pollution. You dont hear politicians talking much about that either, but it is something we need to look at. As Bobby says, we need to investigate every possible cause of the chronic disease epidemic that is devouring our nation from the inside.

Third, Im sorry to say, is our own medications. Pharmaceutical medicine has its place, but no single safety study can assess the cumulative impact of one prescription on top of another prescription, and one shot on top of another shot on top of another shot, throughout the course of childhood. We just dont do that study right now and we ought to. We can and we will. Conditions like autism used to be one in 10,000. Now here in the state of California it is one in 22. One in 22 children affected.

Lets address these claims in order.

Toxic substances and electromagnetic pollution

This is speculative and so far without evidence. First of all, genetic factors are estimated to contribute a significant portion of risk from ASD, with more than 100 genes identified.

Paul A. Offit, director of the Vaccine Education Center, an attending physician at Childrens Hospital of Philadelphia and author of the 2008 book Autisms False Prophets, said in a telephone interview that there is no evidence that post-birth events, like the environment, result in a diagnosis of ASD, whereas there is increasing evidence of pre-birth factors.

For instance, a significant increase in risk has been found depending on the age of a father, especially if he is in his 40s or older. Moreover, Valproate, a drug used to treat epilepsy and other neuropsychological disorders, has been found to significantly increase the risk if used during pregnancy.

Every piece of legitimate evidence we have suggests that the causes of autism are present in utero, said David Mandell, director of the Penn Center for Mental Health at the University of Pennsylvania, in an email. To the extent that environmental factors are causative, they likely interact with genetic risk factors in the womb.

Abnormalities in brain function and organization are likely present during fetal development, even though the behavioral ramifications may not be seen for years in some children, Catherine Lord of the Center for Autism Research and Treatment at the University of California-Los Angeles said in an email.

Of course, even if a link to air pollution is not yet proved, that does not mean it can be ruled out. Its hard to disagree with the opinion that exposure to neurotoxins and air pollution is bad for our health and that we should be doing more to protect our environment and prevent these exposures, Maureen Durkin, chair of the Department of Population Health Sciences at the University of Wisconsin-Madison, said in an email. Credible research into the causal links of these exposures to autism specifically is difficult to do but should be done and critically evaluated to inform environmental policies.

Shanahan told Newsweek that she wholeheartedly attributes her daughters autism to environmental toxins.

Our own medications

Pharmaceutical medicine sounds like code for vaccines, given that she links it in the same sentence with one shot on top of another shot on top of another shot during childhood and its hard to imagine what that might refer to other than multiple vaccines, a mainstay of childhood medicine. But a link to autism has been debunked in study after study.

Fears about a link between autism and vaccines started in 1998 after the publication of a genuine hoax the Wakefield study, in the journal Lancet. Based on a supposedly random sample of 12 children, now-discredited anti-vaccine activist and former physician Andrew Wakefield suggested that the measles, mumps and rubella (MMR) vaccine led to gastrointestinal symptoms, which in turn put harmful proteins in the bloodstream that resulted in autism.

Dozens of studies followed, including one that studied 1.8 million children over 14 years, all of which showed there was no link. Eventually, it was revealed that Wakefield had received secret payments from a lawyer seeking to sue MMR manufacturers and who supplied some of the patients, had filed a patent application for his own measles vaccine, and had misrepresented or altered medical histories of the 12 patients. In 2010, the article was retracted and Wakefield lost his medical license.

But the damage has never been erased, as fears about a link between vaccines and autism persist among parents. There are dozens of studies looking at autism and vaccines, and they dont show a link, said Alison Singer, president of the Autism Science Foundation, which has posted dozens of studies on its website. It is not even a case of needing to do more research.

No single safety study can assess the cumulative impact

This is a false construct, asking for a study that experts say would be unethical as a randomized study would require a group that took no vaccines, exposing them to potentially dangerous risks and would not be informative. It is an untestable hypothesis, Offit said.

In 2002, Offit co-wrote a report for the American Academy of Pediatrics that reviewed existing studies and concluded that children respond to multiple vaccines given at the same time in a manner similar to individual vaccines. Current studies do not support the hypothesis that multiple vaccines overwhelm, weaken, or use up the immune system, the study said. On the contrary, young infants have an enormous capacity to respond to multiple vaccines, as well as to the many other challenges present in the environment.

No single study can assess the cumulative effects of everything (all medicines and vaccines) on autism risk over the life course, Durkin said in her email. Neither a randomized controlled trial nor an observational study design would be feasible for this. Most pharmaceutical safety studies focus on one or a few medications or vaccines at a time and invariably find some adverse effects, but if the benefits dont outweigh the adverse effects, the medication should not be approved.

Offit and Mandell said the call for a study is an example of Kennedy and other vaccine skeptics often changing the goal posts.

This is fearmongering, Mandell said, noting that Wakefield first said autism was the result of the MMR vaccine and no link was found. Then RFK Jr. said that the thimerosal in vaccines caused autism. Then thimerosal was removed from vaccines, with no change in increasing rates of diagnosis. Then they said that it was the number of vaccines or the timing of the vaccines.

Autism used to be one in 10,000. Now it is one in 22 [in California].

These numbers are in the ballpark but lack context. The percentage of people diagnosed with ASD has gone up mainly because of expanded definitions and better detection. There is no blood test for autism, so a diagnosis is based on observations of a persons behavior.

Much of the rise in autism prevalence in recent years is likely due to expansion of the concept of autism from a narrowly defined condition to a spectrum, and to more screening, better tools and training for diagnostic assessments, and more access to therapies and services, Durkin said. Mandell agreed, adding that there may be effects of increased parental age and our increased ability to keep compromised infants alive.

Infantile autism was first coined in 1943, But not until 1980 did autism receive its own diagnosis in the Diagnostic and Statistical Manual of Mental Disorders; the category was broadened in 1987 and then again in 1994. Finally, in 2013, for the DSM-5, autism, Asperger syndrome and pervasive developmental disorder-not otherwise specified (PDD-NOS) were folded into a single diagnosis.

Thats why the earliest studies of autism in the 1960s and 1970s estimated that autism was in 2 to 4 people per 10,000, which led to the impression that autism was a rare childhood disorder, according to a 2015 book published by the the National Academies of Sciences, Engineering, and Medicine. The 1 in 22 estimate for California is based on a survey by the Centers for Disease Control and Prevention in one county in the state. Nationally, the 2023 CDC estimate of autism prevalence at age 8 years is 1 in 36 children, compared with 1 in 150 children in 2000, when CDC began monitoring the prevalence of autism in the United States.

Indeed, while diagnosis of autism has increased, those of intellectual disability have decreased, indicating that previously children may have been misdiagnosed with other conditions.

Shanahan does not quite say that vaccines cause autism, but she implies it, demanding a study that is not feasible because it would be unethical. She cites numbers that claim that autism has spiked, without acknowledging the main reason is because the definition of autism has been greatly expanded. This is textbook anti-vaccine rhetoric. The overall effect is to cast doubt on the safety of vaccines. She earns Four Pinocchios.

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Analysis | Robert F. Kennedy Jr.'s running mate and the vaccine wars - The Washington Post

Photo-Illustration: Intelligencer; Photo Getty Images

This article was featured in One Great Story, New Yorks reading recommendation newsletter. Sign up here to get it nightly.

Early one morning this January, a school nurse in Suffolk County received an email with a distressing subject line: STATEWIDE ALERT False Immunization Records Baldwin Midwifery. New Yorks Department of Health was notifying schools across the state that a Long Island midwife named Jeanette Breen had falsified 12,499 records related to 1,452 students at 300 schools. Rather than administer shots to protect kids against hepatitis B, chicken pox, and other diseases, Breen had given nearly all of her patients homeopathic pellets.

Follow-up emails alerted the Suffolk nurse that a student at her school was among those who had seen Breen. I called the mom and I said, Do you have any other health records from any other doctors other than Breen? the nurse said. Her answer was no and, once she got an inkling where this was going, she decided to pull her child out of school that day. She hasnt been back. They decided to homeschool her.

From a public-health standpoint, the nurse (who asked that I not use her name) wasnt concerned. Her school had more than 500 students, and just one was unlikely to start an outbreak. Still, she was irked. First of all, what Breen did is just wrong and illegal, she said. Beyond the lying and deceit, I was worried about the one or two students here who cant be vaccinated because they have cancer and are going through chemo. I was shocked she wasnt arrested.

Rather than bring criminal charges, in November, the state reached a settlement with Breen. The midwife agreed to pay a $300,000 fine and admitted to fraud in a detailed stipulation. Still, questions lingered. Had Breen, who is 77, tricked parents who thought their kids were getting genuine inoculations? Or had anti-vaxxers sought her out? Was Breen motivated by money or ideology?

Recently, I went to visit Breen at her office in Baldwin, a hamlet in Long Islands South Shore. Her midwifery is one in a quaint row of storefronts, next to a travel agency and two doors down from a pediatrician. Her assistant said she was too busy to speak with me, and later Breen sent me a text: The NYS is watching me like a hawk and I am sure they would have a field day with anything you would report. So sorry to say no comment .

Public records, news reports, and interviews fill in some of the story. Over decades, Breen built a dedicated following among her obstetrics and gynecological patients, though she often sparred with hospitals and the medical Establishment. Then, in the middle of 2019, her practice changed conspicuously.

That year saw the largest measles outbreak in New York State in 27 years, with more than 1,000 cases, largely in Orthodox communities. Lawmakers responded by tightening vaccination requirements, doing away with exemptions for those with religious, philosophical, and personal reasons. The shift meant that going into the 201920 school year, some 26,000 students across the state whod used those exemptions to skip vaccinations would need to show proof theyd gotten their shots or intended to. Three months after the vote, in September 2019, Breen started seeing adolescents.

The Department of Health hasnt said what the parents and guardians of Breens pediatric patients knew about the midwifes history or what kind of care they expected their children to receive. But while some of her clientele along the South Shore could have conceivably chosen her thinking she would provide care similar to a standard pediatric provider, others were enrolled in schools as far away as Erie County. Those parents would need a powerful incentive to make a seven-hour drive for medical care.

My understanding is people sought her out. They knew what they were doing, says Kathleen Shortis, an obstetrics patient of Breens. Although Shortis took her kids to a pediatrician for health care, she says she has empathy for anyone who may have used Breen to skirt the law. People dont want to feel pressured about something theyre putting into their childrens bodies. That scares people. And it became very politicized.

Shortis insists that Breen, like her patients, does not easily fit into a political or ideological stereotype. I think people probably have the idea that she is one thing and she is not flat-earthy. Shes also not a Birkenstock hippie. COVID made strange bedfellows on this issue.

Whether they knew it or not, the parents who went to Breen enlisted a health-care provider who seemed to have a deep-seated distrust of traditional medicine and its practitioners. At least some of her animus was personal. My three boys were all born in hospitals, she told Newsday in 1978, while attending a conference on alternative childbirth. I had three different obstetricians, none of whom Id recommend to anyone. And I would never have another hospital birth. (I also saw some evidence suggesting that the father of Breens children, who is now deceased, was a hospital executive.)

Breen became a certified midwife in New York in 1984. In March 1988, she was granted privileges to practice at Winthrop-University Hospital in Nassau County. A year later, Breen clashed with a doctor there over a newborn shed delivered in a home birth. Dr. Bernard Leonard was concerned about the results of a jaundice test and wanted a follow-up done immediately; Breen advised the parents it could wait until the next morning. Leonard filed a complaint with Breens sponsor at the hospital saying she had interposed her limited knowledge and her considerable rapport with the patient and undercut the fragile patient-doctor relationship. The hospital immediately revoked Breens privileges. Breen filed a lawsuit against the hospital and a defamation suit against Leonard, both of which were unsuccessful. (The baby turned out fine.)

Breens practice thrived, and according to court records, she delivered hundreds of babies in the early 1990s, including dozens of home births every year. One significant dispute came in 2002, when a new mother and father sued Breen for medical malpractice, claiming, among other things, that shed failed to recognize a medical/surgical emergency and should have contacted a hospital. Breen settled with the parents for $315,000.

In 2005, Breens privileges at another hospital, the Nassau University Medical Center, were suspended for disregarding infection-control protocol: Shed walked out of the hospital with a placenta in Tupperware. Its a common belief among midwives, and those who enlist midwives, that the organs shouldnt be discarded as medical waste. In this case, a new mother told Breen she didnt have a place to bury her own placenta, and Breen offered to inter it for her. At the time, Breen indicated she had 50 to 60 placentas buried in her garden. I have two or three in my freezer right now, ready to go, she told the New York Post. Again, Breen sued the hospital to have her privileges restored. She forced the hospital, and eventually the state, to consider more deeply the rules and regulations of medical-waste disposal, but her lawsuit was unsuccessful.

Breen continued to run afoul of common medical practices. In 2014, the board for midwifery suspended her from practicing in New York for two years after she failed to document informed consent for vaginal births in patients who have had prior Cesarean sections, self-reporting of blood sugar levels, and some of her actual patient care for three patients. The suspension was stayed while she adhered to a two-year probationary period.

Soon after that period ended, Breen wrote a flu-vaccine exemption letter for a pregnant woman who worked at NYU Winthrop Hospital, which mandated all employees receive the shot. When the hospital refused to accept Breens exemption letter, Breens patient sued under the Pregnancy Discrimination Act. In a deposition for the case, Breen said she believed the Centers for Disease Control was a political organization not necessarily representing factual information. When asked why she thought the American College of Obstetricians and Gynecologists wasnt a reputable organization, she responded, Well, a doctor doesnt always know best. (Her patient lost the case.)

Over the years, Breen had taken courses in homeopathy the pseudoscientific theory that people can ward off disease by administering very small doses of substances that trigger immune responses. (According to the National Institutes of Health, theres little evidence that homeopathy is effective at treating any known condition.) After the 2019 change in vaccine regulation, Breen treated her patients with something called the Real Immunity Homeoprophylaxis Program, a series of oral pellets advertised as a safe, effective, non-toxic approach to disease prevention. Also known as nosodes, homeoprophylaxis has long been marketed to people experiencing vaccine hesitancy. Study after study shows nosodes are no substitute for vaccination.

The Real Immunity program was developed, marketed, and sold by Dr. Cilla Whatcott, who held a Ph.D. in homeopathy from Kingdom College of Natural Medicine. (As to whether that school is accredited, its website says, Yes, but not nationally or regionally accredited, which means that KCNH is not listed with the U.S. Department of Education, nor does it wish to be.) Earlier this year, Whatcott took to Instagram to warn customers that the pellets could be deactivated by the 5G network. A subsequent post on her Instagram account said that Whatcott died in February from cancer.

In April 2020, Breen began logging records into a database, the New York State Immunization Information System, that made it look as if her pediatric patients had been immunized. This was, of course, the same time that COVID-19 was spreading rapidly worldwide and expectations were building of a vaccine that might become required for billions. Conspiracy theories about microchips and sinister plots by pharmaceutical companies proliferated, and more people began to talk about refusing vaccines of all kinds as a political statement, rather than as a personal or public-health decision.

In January 2021, the Department of Health established a Vaccination Complaint Investigation Team tasked with looking into complaints of COVID-vaccine fraud. In 2022, the team helped police take down Julie DeVuono, a Long Island nurse practitioner who turned a $1.5 million profit by falsifying vaccine cards. DeVuono eventually pleaded guilty to forgery and money laundering. According to Joseph Giovannetti, the departments director of investigations, the team began looking into frauds involving all sorts of vaccines, not just for COVID, and at the end of 2022, a tip came in about Breen. After a six-month inquiry, the Department of Health confronted her and eventually reached a settlement.

Giovannetti says his department has a number of open investigations, but he doesnt think the state will be engaged in a never-ending war on vaccine fraud. This isnt an intractable situation. Its not something thats just going to be cat-and-mouse or anything like that, he says. Were going to be able to nip it in the bud.

Still, real dangers are posed by vaccine resistance. The percentage of kindergarteners vaccinated against measles, which the CDC declared eliminated in 2020, has dipped nationwide since 2019, from 95 to 93 percent. A recent Pew survey found that only 57 percent of Republicans believed measles, mumps, and rubella vaccines should be required for children to attend public schools down from 79 percent before the pandemic.

When Breens fraud made headlines in January, it stoked furor from both people concerned about anti-vaxx vigilantes and those who heralded the midwife as a kind of civil-rights hero. By then, Breen had reportedly paid half of her $300,000 fine. Shortis created a fundraiser on GiveSendGo, a Christian crowdfunding platform popular among right-wing causes, to help pay the rest. Coffee & Covid, a conservative newsletter written by a Florida attorney, which claims to have more than 138,000 subscribers, promoted the fundraiser, and within days the effort raised more than $172,000. Bravo for those like Jeanette who put principle above propaganda and personal safety! wrote one donor. Another wrote, Thank you for saving all those children from the poison of Dr Fauci and Bill Gates eugenics shots! [sic]

Meanwhile, the school nurses tasked with keeping track of Breens unvaccinated patients are upset. Its an insult to the nursing profession, said Sylvia Kallich, president of the Nassau County Association of School Nurses. Over the past few months, the Department of Health has been circulating a tip sheet to schools about identifying vaccine fraud. Red flags include records from health-care practitioners who are not located within a reasonable distance from the student or school and records from an office that doesnt typically administer childhood immunizations including homeopathic practices and midwiferies.

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What Led a New York Midwife to Fake 12,499 Vaccine Records? - New York Magazine

Key takeaways:

Participants at HJF Medical Research International in Abuja, Nigeria, have been vaccinated in the first Phase 2 clinical trial of a Lassa fever virus (LASV) vaccine candidate to date, according to IAVI, a nonprofit scientific research organization and the trial sponsor. The study (IAVI C105/PREVAIL15) is funded by CEPI, an innovative global partnership working to accelerate the development of vaccines against epidemic and pandemic threats.

The trial in Nigeria has been designed in consultation with in-country partners, including the Nigeria Centre for Disease Control and Prevention and the Nigeria Lassa Vaccine Taskforce. HJF Medical Research International, Ltd/Gte (HJFMRI) has been conducting infectious diseases research in collaboration with HJF and the Walter Reed Army Institute of Research in Nigeria since 2014. In addition to Nigeria, and pending regulatory approval, IAVI expects to enroll additional participants at the Noguchi Memorial Institute for Medical Research (NMIMR), College of Health Sciences, University of Ghana, and the Partnership for Research on Vaccines and Infectious Diseases in Liberia (PREVAIL)[1].

Nigerian clinicians, scientists andcommunity membersare key leaders in this international collaboration, which will ensure that vaccine development incorporates local context, experience and perspectives while fostering sustainable in-country research capacity and partnerships, said Dr. Abdulwasiu Bolaji Tiamiyu, clinical research center director, HJFMRI, and principal investigator of IAVI C105 in Nigeria.

No approved vaccine currently exists for LASV, which causes an acute viral hemorrhagic illness called Lassa fever. Given its potential to cause a public health emergency of international concern, LASV is included in the World Health Organization R&D Blueprint of priority pathogens for which there is an urgent need for accelerated research and development (R&D) and countermeasures[2]. IAVI and members of the global Viral Hemorrhagic Fever Consortium have been collaborating since 2018 to accelerate clinical development of IAVIs single-dose LASV vaccine candidate in studies supported and funded by CEPI and the European & Developing Countries Clinical Trials Partnership (EDCTP). Read more.

An estimated 5,000 people die each year from LASV, and about 300,000 people fall ill across West Africa annually though the true disease burden is thought to be much higher. Nigeria, Liberia, Sierra Leone, and Guinea are most affected, but increasingly, neighboring countries are experiencing their own emerging outbreaks, with travelers occasionally carrying infections to other regions. Although most people who develop LASV have mild or no symptoms, approximately 20% will develop more serious symptoms including widespread bleeding and major organ failure. Approximately a third of those infected with LASV experience associated deafness, sometimes resulting in lifelong disability. Children under 10 years old, pregnant people, and health care workers are especially vulnerable to LASV infection.

Continued outbreaks of Lassa fever and the emergence of Ebola Sudan in Uganda both underscore the need to have vaccines for known disease threats available for evaluation and use during outbreak situations the overarching goal of IAVIs emerging infectious disease program. said Swati Gupta, DrPH, MPH, vice president and head of emerging infectious diseases and epidemiology, IAVI. IAVI C105 is an important step toward attaining eventual licensure of a Lassa fever vaccine, should IAVIs vaccine candidate prove to have an acceptable safety profile and be efficacious. We are grateful to our funders, our clinical partners, and our consortium collaborators for their continued support of IAVI and commitment to a more secure world.

Lassa fever has long been a threat to much of West Africa, and factors like climate change and population growth could exacerbate its transmission in coming decades, explainsDr. Richard Hatchett, CEO of CEPI. The world urgently needs a Lassa vaccine for routine immunization. The initiation of IAVIs new Phase 2 trial the most advanced Lassa vaccine trial to date is an important milestone in public health and signals that better tools to manage and prevent outbreaks are coming. We look forward to continuing to collaborate with IAVI and regional partners to advance this promising vaccine as quickly as possible.

IAVIs LASV vaccine candidate was well-tolerated and immunogenic among participants in both the U.S. and Liberian cohorts of IAVIs Phase I LASV vaccine trial (IAVI C102). Robust immune responses appear to be sustained for up to one year after vaccination[3]. In the Phase 2 study, researchers will evaluate the vaccine candidates safety, tolerability, and immunogenicity at two different dosage levels in adults, including people living with HIV, as well as in adolescents and in children two years of age and older. Approximately 612 participants will be enrolled and followed for six months after vaccination to monitor their safety and immune responses. A subset of participants will be followed for an additional two years for extended safety and immunogenicity.

CEPI and IAVI are united in their commitment to global equitable access. Should the candidate be found to be safe and efficacious in clinical testing, IAVI is committed to making its Lassa vaccine affordable and accessible to all populations in need.

Harnessing a proven platform technology for global preparedness

IAVIs LASV vaccine candidate uses the same recombinant vesicular stomatitis virus (rVSV) vector platform as ERVEBO, Mercks single-dose Zaire ebolavirus (ZEBOV) vaccine, which is licensed in North America, Europe, and 10 African countries. The rVSV platform has been used extensively in adults and children[4].

IAVIs goal is to develop and test rVSV-based vaccines against emerging infectious disease pathogens that pose epidemic threats as part of an overall preventive strategy which includes routine immunization as appropriate as well as stockpiles which can be rapidly deployed for larger outbreaks as needed. IAVIs EID portfolio includes a Sudan ebolavirus vaccine candidate supported by BARDA; a Lassa fever vaccine candidate supported by CEPI and EDCTP; a Marburg virus vaccine candidate supported by BARDA and the Defense Threat Reduction Agency (DTRA) of the U.S. Department of Defense (DOD); and an intranasal SARS-CoV-2 vaccine candidate supported by DOD DTRA and the Japan Ministry of Finance.

Much of the R&D on IAVIs rVSV platform is performed at the IAVIVaccine Design and Development Lab(DDL) in Brooklyn, New York. The DDL is one of the worlds leading viral vector vaccine R&D labs, known for innovation and generation of novel vaccine design concepts. Scientists with IAVIsHuman Immunology Laboratory(HIL) in London, U.K., are involved in processing participant samples and developing the analytical assays needed to evaluate IAVI C105 participants immune responses. They are also facilitating technology transfer of the assays to West African partner institutions.

IAVIs LASV vaccine candidate was manufactured byBatavia Biosciencesin Leiden, The Netherlands, a contract-development and manufacturing organization focused on delivering sustainable, low-cost manufacturing solutions in the field of infectious disease and cancer. Through itspartnershipwith Batavia, IAVI intends to develop an end-to-end platform for flexible, low-cost production of epidemic preparedness vaccines.

Results from IAVI C105 are expected in 2025 and will be made available through open-access publications and via scientific meetings to ensure all can benefit from the research.

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IAVI Media Contact Rose Catlos Rcatlos@iavi.org 212-847-1049

CEPI Media Contact press@cepi.net +44 7387 055214

HJFMRI Media Contact Lisa Reilly lreilly@Global-ID.org 301-339-3566

About IAVI

IAVI is a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges including HIV, tuberculosis, and emerging infectious diseases. Its mission is to translate scientific discoveries into affordable, globally accessible public health solutions. Read more atiavi.org.

Follow IAVI on Facebook, LinkedIn, Instagram, and YouTube, and subscribe to our news updates.

About CEPI

CEPI was launched in 2017 as an innovative partnership between public, private, philanthropic and civil organisations. Its mission is to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic threats so they can be accessible to all people in need. CEPI has supported the development of more than 50 vaccine candidates or platform technologies against multiple known high-risk pathogens or a future Disease X. Central to CEPIs pandemic-beating five-year plan for 2022-2026 is the 100 Days Mission to compress the time taken to develop safe, effective, globally accessible vaccines against new threats to just 100 days.

About IAVIs rVSV vaccine candidates

IAVI holds a nonexclusive license to the rVSV vaccine candidates from the Public Health Agency of Canada (PHAC). The vector was developed by scientists at PHACs National Microbiology Laboratory.

IAVI initially developed its rVSV vector for HIV vaccine candidates and has since expanded its use to the development of vaccines addressing emerging infectious diseases (Lassa Fever, Marburg, Sudan ebolavirus, and COVID-19).

Funders who have made the development of IAVIs rVSV-vectored vaccine candidates possible include the Bill & Melinda Gates Foundation; the Government of Canada; the Danish Ministry of Foreign Affairs; the Government of Japan; the Irish Department of Foreign Affairs and Trade; the Netherlands Ministry of Foreign Affairs; the Norwegian Agency for Development Cooperation; the U.K. Foreign, Commonwealth & Development Office; the U.S. National Institutes of Health; and through the generous support of the American people from the United States Agency for International Development. This project is funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority under contract number 75A50121C00077.

[1] PREVAIL is aLiberia-U.S. clinical research collaboration established in 2014 by the U.S. National Institute of Allergy and Infectious Diseases (NIAID) and the Ministry of Health in Liberia. In 2015, PREVAIL participated in a clinical trial (PREVAIL 1) of Mercks now-licensed Ebola Zaire vaccine ERVEBO, which uses the same recombinant vesicular stomatitis virus (rVSV) vector backbone as the candidates in IAVIsemerging infectious diseases(EIDs) vaccine development portfolio, including the IAVI LASV vaccine candidate being evaluated ina Phase I clinical trial.

[2] Blueprint (who.int)

[3] https://www.iavi.org/wp-content/uploads/2023/11/C102_ASTMH_Poster_Chicago2023.pdf

[4] https://cdn.who.int/media/docs/default-source/blue-print/who-vaccine-prioritization-report-uganda-ebola-trial-nov-16-2022.pdf

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Participants in Nigeria vaccinated in first-ever Phase 2 Lassa fever vaccine clinical trial, sponsored by IAVI - IAVI

An inverse vaccine developed by Nykode Therapeutics to boost immune system tolerance to a specific protein target was able to prevent the development of multiple sclerosis (MS) in a mouse model of the disease.

The vaccine, known as a Vaccibody, is designed to teach the immune system to recognize certain proteins as self without impacting other immune cell functions, as is often seen with current MS therapies.

The data, which were presented in a poster at the 2024 Antigen-Specific Immune Tolerance Drug Development Summit, provide additional motivation for us to pursue a completely new approach to treating autoimmune diseases, Agnete Fredriksen, chief business officer and co-founder of Nykode, said in a company press release.

The immune system usually protects the body against potential threats by attacking what it doesnt recognize as self. In autoimmune diseases, however, the ability to distinguish what is self from what isnt becomes impaired, and the immune system starts to attack the bodys own tissues, driving a lasting inflammatory response.

In MS, for example, the immune system attacks the myelin sheath, a fatty coating that wraps around nerve fibers to help them send electrical signals faster, and the resulting damage causes a range of symptoms.

The idea behind an inverse vaccine is to induce immune tolerance. In contrast with a regular vaccine, which teaches the immune system how to fight a threat, it instead tells the immune system that certain targets (antigens) should not be seen as a threat and should be left unharmed.

Nykodes inverse vaccine technology is designed to deliver small circular DNA molecules to muscle cells that provide the instructions for making the Vaccibody proteins. These proteins are then secreted by the cells and, once in circulation, they target antigen-presenting cells (APCs).

APCs are immune cells capable of processing and presenting certain targets to immune T-cells, promoting an immune response against those targets. However, Vaccibody vaccines are instead developed to recruit APCs that present targets to regulatory T-cells, which limit the activity of other immune cells.

The company has now presented data from a Vaccibody called TV004, which was designed to induce tolerance against myelin oligodendrocyte glycoprotein (MOG), a myelin protein.

In a mouse model of experimental autoimmune encephalitis, which is commonly used to mimic MS in mice, TV004 infections before MS induction effectively protected the animals from disease, with very mild or no symptoms at all over 28 days.

The treatment also showed a dose-dependent reduction in the amount of pro-inflammatory molecules found at the peak of disease symptoms.

The effect was specifically related to immune tolerance to the MOG protein, as treatment with a Vaccibody designed to induce tolerance against ovalbumin (the major protein found in egg white) resulted in symptoms as severe as those on a placebo.

In addition to stopping the disease development, the data show that the disease protection is antigen-specific, Fredriksen said.

This supports our technologys potential to offer future treatments that precisely target specific autoimmune disorders without negatively affecting a fully functional immune system, a common side effect associated with todays available treatments, Fredriksen added.

The researchers have plans to carry out an in-depth analysis aimed at further dissecting the immunological and molecular mechanisms behind the disease control mediated by Vaccibody vaccine, they wrote.

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Nykode's 'inverse vaccine' found to prevent MS in mouse model - Multiple Sclerosis News Today

As a recent study in Scotland made clear, girls who were vaccinated before age 12 and 13 had zero cervical cancer, Robert Bednarczyk, an epidemiologist at Emory University and member of the HPV Vaccination Roundtable of the Southeast, told the Atlanta Journal-Constitution. The fact that the vaccine prevents six types of cancer that tens of thousands of Americans get each year should be our message.

According to the CDC, the vast majority of cancers caused by HPV are cervical cancer in women, and throat cancer in men. The good news is vaccinations prevent at least 90% of these cancers. The more mixed news is that vaccination rates dipped during the pandemic, and experts in Georgia and California say they are still playing catch up.

We were on such a good trajectory in the U.S. and in California, and then came COVID, Catherine Flores Martin, executive director for the California Immunization Coalition (CIC), told The Atlanta Journal-Constitution. We lost ground, but we are working with parents and providers to build confidence in vaccines again.

Though 63% of children in the U.S. are fully vaccinated against HPV, California and Georgia both are lagging the national average, with about 61% of adolescents ages 13-17 in each state vaccinated.

During the pandemic, HPV vaccination rates in the U.S. slid 13.6%, according to the CDC, compared to a 5.7% fall for measles vaccinations.

While measles vaccination rates in Georgia have returned to pre-pandemic labels, the states HPV vaccination rate remains 18% lower than before the pandemic, CDC data show.

As cervical cancer rates in younger, vaccinated women have fallen, rates have increased among middle-age women who may not have had the chance to be vaccinated. Moreover, about 70% to 90% of head and neck cancers in the U.S. are now linked to HPV. Survival rates are high if the cancer is found early. HPV testing alone detects more abnormalities than Pap tests alone, especially in young women thats why the American Cancer Society recommends co-testing with a Pap test and an HPV test every five years, or a Pap test every three years.

About 37,000 annual cancer cases in the U.S. are attributable to human papillomavirus, 34,400 of which may have been prevented through vaccination. Preventing and treating HPV-associated diseases costs the U.S. at least $9 billion annually, according to the CDC.

Flores Martin says Californias strategy is to normalize vaccine uptake so parents see it as a standard vaccine, like those against measles, tetanus, flu.

Last year, California passed legislation to inform parents that HPV vaccination can prevent cancers, and that the state strongly recommends children be immunized by the 8th grade, or age 13-14. Letters to that effect will be sent out this spring.

It might just seem like a letter, but we see it as another opportunity to get information to parents who might have been unaware or on the fence about it, Flores Martin said.

The approach was seen as a compromise. Although U.S. states like Rhode Island or countries like Portugal were able to achieve HPV vaccination rates of over 80% by requiring it for school matriculation, Flores Martin said the political climate in the U.S. right now made a mandate unlikely, even in California. Moreover, Texas subsequent reversal of its 2011 HPV vaccine mandate has led California to favor an approach that emphasizes parent-doctor cooperation in HPV vaccination planning.

A parental consent process like the one adopted in California has been a success in Australia, said Karen Canfell, a researcher at the The Daffodil Centre, a partnership between the Cancer Council New South Wales and The University of Sydney.

Its a parental-consent process in Australia, Canfell told the AJC. And from the beginning, there has been clear messaging to parents of young girls and boys that this has been a lifesaving vaccine.

Australia adopted a WHO recommendation that one dose of the vaccine in children would provide lasting protection, after initially giving children two doses.

Australia wants to increase coverage rates to meet and exceed 90% coverage, and the one-dose regime will be an enabler of that, she said.

Walter Orenstein, formerly Director of the United States Immunization Program and currently of Emory Vaccine Center, said the U.S. needs to do a better job in explaining to parents the seriousness of HPV. One way to accomplish this, he said, could be to compensate physicians for family vaccine counseling.

Even if physicians do not give the vaccine that day, this will give them an incentive to invest the time in talking to families, Orenstein told the AJC. If nothing else, we should do research to see whether or not this would enhance vaccine uptake.

Efforts to increase outreach should also include adults, who also can benefit from HPV vaccinations until at least age 45, said Joshua ONeal, Director of Sexual Health, Medical and Preventive Services at the Fulton County Board of Health.

And he says Georgia needs to overcome a taboo around talking about HPV.

HPV is the leading cause of throat cancer among men, but we dont talk about it enough, ONeal told the AJC. We talk about cervical cancer, but I hardly ever hear people talk about how they are connected.

Who should get the HPV vaccine? CDC recommends HPV vaccination for:

How do I know if I have HPV?

Most people with HPV do not know they have the infection or have developed cancer. The American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines recommend HPV testing for women aged 30 to 65 years as part of a cervical cancer screening. The HPV test is used in conjunction with a Pap test every 5 years. Some women over 65 might require more frequent testing. The tests may also be beneficial to gay men. HPV tests are not recommended to adolescents, or women under the age of 30 years.

Source: Centers for Disease Control and Prevention and ASCCP

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Promoting a vaccine that prevents some cancers is a new focus in Georgia - The Atlanta Journal Constitution

After press reports flagged the possibility of an inactivated polio vaccine (IPV) shortage in India, Sanofi says it's ready to supply the nation with a newly approved shot.

Thursday, after the company gained an approval for a new polio vaccine, IMOVAX-Polio, Sanofi issued an assurance that it will be able to keep providing sufficient supplies. The developments come quickly on the heels of an Economic Times report alleging that a shortage crisis was looming following Sanofis decision to shut down certain vaccine manufacturing operations in the country.

Last September, Sanofi revealed plans todiscontinue its previous polio shot in India.

Still, to hear Sanofi tell it, India shouldnt be concerned.

The companys local branch remains dedicated to supporting Indias public health program for polio, a Sanofi India spokesperson told Fierce Pharma on Thursday. To ensure that there is no interruption to the availability of IPV vaccines, we have already obtained approvals for our product IMOVAX-Polio, she added.

Regarding the companys decision to discontinue its previous polio shot, Sanofi Indias spokesperson pointed to the rapidly shifting healthcare environment in the country following the COVID-19 pandemic.

Amid rising demand for production capacity in India, Sanofi last year opted to discontinue its older polio shot. The company's spokesperson noted that the shot was only filled and packaged at the companys factory in Hyderabad, while the antigens themselves were manufactured in France.

Sanofi and its Indian affiliate Shantha Biotechnics pledged to supply polio vaccines for Indias universal immunization program through UNICEF back in 2015.

Sanofi got its hands on Shantha in 2009 when the French drugmakers vaccine division agreed to pay 550 million euros ($784 million) for the Merieux Alliances controlling stake in the Indian shot maker.

Elsewhere in India, Sanofi last week called on local drugmakers Cipla and Dr. Reddys Laboratories to help sell its central nervous system (CNS) drugs and vaccines in country.

Cipla is slated to market six Sanofi CNS medicines, including the leading epilepsy therapy Frisium, which Sanofi will continue to own, import and manufacture.

Dr. Reddys, for its part, is on deck to sell five Sanofi vaccines in the country.

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Sanofi pledges to keep polio vaccine supplies afloat in India after new approval - FiercePharma