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Path to a better TB vaccine runs through Montana

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Path to a better TB vaccine runs through Montana


Jim Robbins

(KFF) A team of Montana researchers is playing a key role in the development of a more effective vaccine against tuberculosis, an infectious disease that has killed more people than any other.

The BCG (Bacille Calmette-Guérin) vaccine, created in 1921, remains the sole TB vaccine. While it is 40% to 80% effective in young children, its efficacy is very low in adolescents and adults, leading to a worldwide push to create a more powerful vaccine.

One effort is underway at the University of Montana Center for Translational Medicine. The center specializes in improving and creating vaccines by adding what are called novel adjuvants. An adjuvant is a substance included in the vaccine, such as fat molecules or aluminum salts, that enhances the immune response, and novel adjuvants are those that have not yet been used in humans. Scientists are finding that adjuvants make for stronger, more precise, and more durable immunity than antigens, which create antibodies, would alone.

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Eliciting specific responses from the immune system and deepening and broadening the response with adjuvants is known as precision vaccination. “It’s not one-size-fits-all,” said Ofer Levy, a professor of pediatrics at Harvard University and the head of the Precision Vaccines Program at Boston Children’s Hospital. “A vaccine might work differently in a newborn versus an older adult and a middle-aged person.”

The ultimate precision vaccine, said Levy, would be lifelong protection from a disease with one jab. “A single-shot protection against influenza or a single-shot protection against covid, that would be the holy grail,” Levy said.

Jay Evans, the director of the University of Montana center and the chief scientific and strategy officer and a co-founder of Inimmune, a privately held biotechnology company in Missoula, said his team has been working on a TB vaccine for 15 years. The private-public partnership is developing vaccines and trying to improve existing vaccines, and he said it’s still five years off before the TB vaccine might be distributed widely.

It has not gone unnoticed at the center that this state-of-the-art vaccine research and production is located in a state that passed one of the nation’s most extreme anti-vaccination laws during the pandemic in 2021. The law prohibits businesses and governments from discriminating against people who aren’t vaccinated against covid-19 or other diseases, effectively banning both public and private employers from requiring workers to get vaccinated against covid or any other disease. A federal judge later ruled that the law cannot be enforced in health care settings, such as hospitals and doctors’ offices.

In mid-March, the Bill & Melinda Gates Medical Research Institute announced it had begun the third and final phase of clinical trials for the new vaccine in seven countries. The trials should take about five years to complete. Research and production are being done in several places, including at a manufacturing facility in Hamilton owned by GSK, a giant pharmaceutical company.

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Known as the forgotten pandemic, TB kills up to 1.6 million people a year, mostly in impoverished areas in Asia and Africa, despite its being both preventable and treatable. The U.S. has seen an increase in tuberculosis over the past decade, especially with the influx of migrants, and the number of cases rose by 16% from 2022 to 2023. Tuberculosis is the leading cause of death among people living with HIV, whose risk of contracting a TB infection is 20 times as great as people without HIV.

“TB is a complex pathogen that has been with human beings for ages,” said Alemnew Dagnew, who heads the program for the new vaccine for the Gates Medical Research Institute. “Because it has been with human beings for many years, it has evolved and has a mechanism to escape the immune system. And the immunology of TB is not fully understood.”

The University of Montana Center for Translational Medicine and Inimmune together have 80 employees who specialize in researching a range of adjuvants to understand the specifics of immune responses to different substances. “You have to tailor it like tools in a toolbox towards the pathogen you are vaccinating against,” Evans said. “We have a whole library of adjuvant molecules and formulations.”

Vaccines are made more precise largely by using adjuvants. There are three basic types of natural adjuvants: aluminum salts; squalene, which is made from shark liver; and some kinds of saponins, which are fat molecules. It’s not fully understood how they stimulate the immune system. The center in Missoula has also created and patented a synthetic adjuvant, UM-1098, that drives a specific type of immune response and will be added to new vaccines.

One of the most promising molecules being used to juice up the immune system response to vaccines is a saponin molecule from the bark of the quillay tree, gathered in Chile from trees at least 10 years old. Such molecules were used by Novavax in its covid vaccine and by GSK in its widely used shingles vaccine, Shingrix. These molecules are also a key component in the new tuberculosis vaccine, known as the M72 vaccine.

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But there is room for improvement.

“The vaccine shows 50% efficacy, which doesn’t sound like much, but basically there is no effective vaccine currently, so 50% is better than what’s out there,” Evans said. “We’re looking to take what we learned from that vaccine development with additional adjuvants to try and make it even better and move 50% to 80% or more.”

By contrast, measles vaccines are 95% effective.

According to Medscape, around 15 vaccine candidates are being developed to replace the BCG vaccine, and three of them are in phase 3 clinical trials.

One approach Evans’ center is researching to improve the new vaccine’s efficacy is taking a piece of the bacterium that causes TB, synthesizing it, and combining it with the adjuvant QS-21, made from the quillay tree. “It stimulates the immune system in a way that is specific to TB and it drives an immune response that is even closer to what we get from natural infections,” Evans said.

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The University of Montana center is researching the treatment of several problems not commonly thought of as treatable with vaccines. They are entering the first phase of clinical trials for a vaccine for allergies, for instance, and first-phase trials for a cancer vaccine. And later this year, clinical trials will begin for vaccines to block the effects of opioids like heroin and fentanyl. The University of Montana received the largest grant in its history, $33 million, for anti-opioid vaccine research. It works by creating an antibody that binds with the drug in the bloodstream, which keeps it from entering the brain and creating the high.

For now, though, the eyes of health care experts around the world are on the trials for the new TB vaccines, which, if they are successful, could help save countless lives in the world’s poorest places.





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Montana Supreme Court upholds landmark youth climate ruling

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Montana Supreme Court upholds landmark youth climate ruling


Montana’s Supreme Court has upheld a lower court’s decision that had sided with 16 young activists who argued that the state violated their right to a clean environment.

The lawsuit was brought by students arguing that a state law banning the consideration of climate when choosing energy policy was unconstitutional.

In a 6-to-1 ruling, the top court found that the plaintiffs, between ages five and 22, had a “fundamental constitutional right to a clean and healthful environment”.

Wednesday’s ruling came after a district court’s decision last year was appealed by the state. Similar climate lawsuits are ongoing across the US but this is first of its kind a from a state supreme court.

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The lawsuit targeted a 2011 state law that made it illegal for environmental reviews to consider climate impacts when deciding on new projects, like building new power plants.

It cited a 50-year-old constitutional clause that guaranteed the “state and each person shall maintain and improve a clean and healthful environment in Montana for present and future generations”.

The ruling on Wednesday stated that the “plaintiffs showed at trial – without dispute – that climate change is harming Montana’s environmental life support system now and with increasing severity for the foreseeable future” .

Rikki Held, the lead plaintiff in the lawsuit, said in a statement that “this ruling is a victory not just for us, but for every young person whose future is threatened by climate change”.

Montana state officials expressed disappointment with the court’s decision.

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Governor Greg Gianforte said his office was still assessing the ruling, but predicted the impact would be “perpetual lawsuits that will waste taxpayer dollars and drive up energy bills for hardworking Montanans”.

Western Environmental Law Center, which represented the young plaintiffs, said in a statement that the decision marks “a turning point in Montana’s energy policy”.

It said plaintiffs and their legal team “are committed to ensuring the full implementation of the ruling”.

Similar cases are scheduled to be heard in several other states, including Hawaii, Utah and Alaska, as well as in countries like Australia, New Zealand, Pakistan, Colombia and Uganda.



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Montana Supreme Court affirms decision in landmark youth climate case

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Montana Supreme Court affirms decision in landmark youth climate case


What’s New

The Montana Supreme Court on Wednesday affirmed a landmark climate decision that declared the state was violating residents’ constitutional right to a clean environment by allowing oil, gas and coal projects without regard for global warming.

Why It Matters

The decision reinforces an August 2023 ruling by District Court Judge Kathy Seeley, who found that Montana’s practices violated its residents’ constitutional right to a “clean and healthful environment.”

This pivotal case, spearheaded by a group of young plaintiffs aged 6 to 23, represented a milestone for climate advocates seeking judicial intervention to compel governmental action on climate change.

What To Know

On Wednesday in a 6-1 ruling, the Montana Supreme Court upheld the August 2023 decision.

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The court’s decision strikes down a state policy that prohibited the consideration of greenhouse gas emissions in granting permits for fossil fuel development.

The state had previously appealed the ruling by Seeley, and arguments were heard in July, in which the state argued that greenhouse gases released from Montana fossil fuel projects are minuscule on a global scale and reducing them would have no effect on climate change.

Dale Schowengerdt, representing Montana Governor Greg Gianforte and state environmental agencies, argues before the Montana Supreme Court on July 10, 2024, in Helena, Montana, in the youth climate lawsuit Held v. Montana. The Montana Supreme…


Thom Bridge/Independent Record/ AP

Chief Justice Mike McGrath dismissed the state’s argument that Montana’s emissions are insignificant on a global scale, likening the defense to an “everyone else is doing it” excuse.

McGrath wrote, “The right to a clean and healthful environment is meaningless if the State abdicates its responsibility to protect it.”

What Are People Saying

Melissa Hornbein, an attorney with the Western Environmental Law Center and attorney for the plaintiffs said, “With the ruling now in place, the Montana Supreme Court’s decision compels the state to carefully assess the greenhouse gas emissions and climate impacts of all future fossil fuel permits.”

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Chief Justice Mike McGrath wrote for the majority: “Plaintiffs may enforce their constitutional right to a clean and healthful environment against the State, which owes them that affirmative duty, without requiring everyone else to stop jumping off bridges or adding fuel to the fire. Otherwise the right to a clean and healthful environment is meaningless.”

Republican Governor Greg Gianforte said in a statement that the state was still reviewing the decision, but said it will lead to “perpetual lawsuits that will waste taxpayer dollars and drive up energy bills for hardworking Montanans.

Pushback From State Leadership

The ruling has sparked a backlash from Gianforte, who criticized the court for what he described as judicial overreach. He warned the decision could invite an onslaught of lawsuits, increase energy costs for Montanans and hinder the state’s “all-of-the-above” energy strategy.

“This Court continues to step outside of its lane to tread on the right of the Legislature, the elected representatives of the people, to make policy,” he said in a statement. “This decision does nothing more than declare open season on Montana’s all-of-the-above approach to energy, which is key to providing affordable and reliable energy to homes, schools, and businesses across our state.”

Gianforte also convened energy stakeholders earlier this week to discuss boosting production to meet rising demand, emphasizing the need for “unleashing American energy” to maintain grid stability.

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The Plaintiffs’ Perspective

For the 16 young plaintiffs, the court’s decision validates their personal struggles with the tangible effects of climate change. In a Wednesday statement, lead plaintiff Rikki Held called the ruling “a victory not just for us, but for every young person whose future is threatened by climate change.”

During the trial, the plaintiffs described how worsening wildfires, droughts and diminishing snowpack have disrupted their lives, polluted the air and depleted vital natural resources. They argued that the state’s failure to address these challenges imperils their future and violates their constitutional rights.

What Happens Next

The ruling has positioned Montana as a flashpoint in the national debate over climate accountability, potentially inspiring similar legal challenges across the United States.

This article includes reporting from The Associated Press.

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Pregnant woman claims Montana Highway Patrol wrongfully arrested her for DUI

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Pregnant woman claims Montana Highway Patrol wrongfully arrested her for DUI


BOZEMAN — A pregnant woman from Sheridan is claiming she was wrongfully arrested by the Montana Highway Patrol (MHP) for allegedly driving under the influence during a traffic stop near Bozeman.

“I was just pretty shocked. And I constantly told him I’m pregnant, and I haven’t drunk in probably eight months,” says Alyssa Johnson.

Alyssa is a photographer from Sheridan who, at 22 weeks pregnant, was pulled over by an MHP trooper on Dec. 1, 2024 for an alleged traffic violation.

“I have a stutter, and he thought I was slurring so he pretty much said can you step out of the car. Made me do all these kinds of tests,” says Alyssa.

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Alyssa explains that she has severe dyslexia, which makes understanding directions, and completing any sort of test, difficult.

“I mean, Alyssa, when she was in school, she used to have extra time to take an exam and she’d have questions read to her,” explains Alyssa’s husband, Tim Johnson.

Alyssa says in addition to her mental handicap, she was in a state of panic during the traffic stop—affecting her ability to give a proper breathalyzer result.

“They were saying that since I couldn’t breathe through the breathalyzer and the testing wasn’t doing good, they arrested me and pretty much took me to the hospital for more blood work,” she says.

A written statement by her therapist confirms Alyssa’s dyslexia diagnosis.

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And after the incident, the couple got a third-party blood test—because the one conducted by law enforcement could take up to eight weeks to return.

The blood test, provided by the Johnsons, shows negative for any type of drug.

Alyssa says, “I take a prenatal, an aspirin for my blood pressure, and stuff for my heartburn, like Tums. Just like simple stuff.”

Tim explains that in addition to expecting their second child, they’re currently building a home—making the cost of bail and towing a hard hit on finances.

He says, “We have a budget to stick to and the budget doesn’t include any unexpected costs like this.”

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Tim says this is an opportunity for police to receive better training on mental impairments and hopes that charges will be dropped from Alyssa’s record.

“And I understand they have to do their job too. I mean, support police. But this wasn’t right to do,” she says.

The couple says they have filed a formal complaint with MHP.

I reached out to MHP for comment but did not receive a response regarding the incident. We will update this story if we hear back.





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