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Novavax Launches Covid-19 Vaccine Efficacy Trial In South Africa

Novavax Launches Covid-19 Vaccine Efficacy Trial In South Africa



Late-stage biotech Novavax (NVAX) has announced the beginning of a Phase 2b clinical trial in South Africa to evaluate the efficacy of NVX-CoV2373, Novavax’ COVID-19 vaccine candidate.

NVX‑CoV2373 is a stable, prefusion protein made using the company’s nanoparticle technology and Matrix‑M adjuvant, which is designed to enhance the immune response and stimulate high levels of neutralizing antibodies.

Dr. Shabir Madhi, Professor of Vaccinology at Wits University, will lead the clinical trial, which is supported in part by a $15 million grant from the Bill & Melinda Gates Foundation.

“Because South Africa is experiencing a winter surge of COVID-19 disease, this important Phase 2b clinical trial has the potential to provide an early indication of efficacy, along with additional safety and immunogenicity data for NVX-CoV2373,” said Gregory M. Glenn of Novavax.

The randomized, observer-blinded, placebo-controlled Phase 2b clinical trial of NVX-CoV2373 will include two cohorts. One cohort will evaluate efficacy, safety and immunogenicity in approximately 2,665 healthy adults.

Meanwhile the second cohort will evaluate safety and immunogenicity in approximately 240 medically stable, HIV-positive adults. This allows for evaluation of the vaccine across a diverse, representative study population, the company says.

Novavax expects that, if approved in South Africa, its COVID-19 vaccine would ultimately be supplied to South Africa through Novavax’ recently announced collaboration with the Serum Institute of India.

“The major motivation for the COVID-19 vaccines being evaluated at an early stage in South Africa is to generate evidence in the African context on how well these vaccines work in settings such as our own,” said Shabir Madhi.

In the Phase 1 portion of the Phase 1/2 clinical trial, conducted in Australia, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera.

Phase 2 clinical trials will begin in August. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

In the run-up to developing a coronavirus vaccine candidate, the stock has exploded by over 3,580%. B.Riley FBR analyst Mayank Mamtani recently reiterated a Buy rating on the stock with a $257 price target (75% upside potential).

“We anticipate NVAX continuing to secure supply agreements to secure region specific demand, totaling in ~2-3 billion ‘2373 doses delivered in 2021-22 timeframe,” Mamtani told investors.

“Management noted for this distribution roadmap to become clearer in coming weeks, which we anticipate to then transition over to purchase agreement contracts with possibly disclosed terms on economics flowing to NVAX and ‘2373 pricing” he added. (See Novavax stock analysis on TipRanks).

The rest of the Street has a cautiously optimistic outlook on the stock. The Moderate Buy analyst consensus shows 4 Buy ratings versus 1 Sell rating. Despite the elevated prices, the $227.60 average analyst price target indicates that shares can rise a further 55%.

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The post Novavax Launches Covid-19 Vaccine Efficacy Trial In South Africa appeared first on TipRanks Financial Blog.

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Amish culture prizes peace − but you wouldn’t necessarily know it from a stop in Amish Country tourist towns

Much of the tourism industry that’s sprung up around Amish areas says more about Americans’ own identity than Amish values, a scholar writes.



Gift items for sale in Walnut Creek, Ohio, in May 2023. Susan Trollinger

Ohio’s Amish Country, located in the northeastern part of the state, draws over 4 million visitors every year – second only to Cedar Point amusement park as the Buckeye State’s most popular tourist attraction.

October, with its cooler temperatures and spectacular colors, is the region’s peak month for tourist traffic. Hundreds of thousands of tourists descend on the area in the fall to shop for Amish-made furniture, enjoy buggy rides and visit small towns that many Americans romanticize as bucolic escapes from the world.

And what will they find in the shops that line the main streets of towns like Berlin, Sugarcreek and Walnut Creek? Among other things, a plethora of items that feature Christian nationalist motifs, intense patriotism and ominous suggestions of violence – all antithetical to the core values of the Amish.

The reality is that Amish Country tourism has long been at odds with the plain and simple life of the Amish – a discrepancy at the heart of my 2012 book “Selling the Amish: The Tourism of Nostalgia.”

A life apart

Descended from Anabaptist immigrants who fled religious persecution in Europe, the Amish typically live in rural areas where they seek to live a different sort of life, resisting aspects of contemporary American culture that undermine their commitments to church, family and community.

A simple, open-top horse-drawn carriage with a man and woman inside, going down a paved road.
An Old Order Amish couple drive their buggy through an intersection in Berlin, Ohio. Susan Trollinger

To live at a slower pace, they drive horse-drawn buggies instead of cars. To pursue their calling to follow Jesus rather than chase personal ambitions, they stop school after eighth grade. To avoid the distractions of consumer culture, they prohibit TVs and internet connections in their homes. And to keep themselves humble, they yield to communal rules about dressing plainly, living in modest homes and keeping their businesses small.

Seeking to follow Jesus, they embrace nonviolence and find inspiration in the story of a 16th-century Anabaptist, Dirk Willems, who was imprisoned for his faith. He escaped, but because of his commitments to love his enemy, he turned back when he saw that his captor had fallen through the ice. His captor survived to witness Willems being burned at the stake.

Out of their deep commitment to separation between church and state, the Amish refuse to swear oaths, receive Social Security benefits or join the military. That’s why you won’t see an American flag in an Amish school or hear Amish students recite the Pledge of Allegiance.

The ‘Amish brand’

Yet tourist towns capitalizing on what has become the “Amish brand” are full of gift shops selling merchandise you would not expect to find in an Amish home – Uncle Sam cutouts, Mickey Mouse yard flags, ornate lace curtains and Elvis Presley figurines.

As a scholar of rhetoric and religion, I’ve long been curious about Amish Country tourism, since it seemed – at least on the face of it – to have so little to do with the Amish themselves. “Selling the Amish” was my attempt to explain why many Americans found Amish Country so compelling.

My answer was that Amish Country tourism afforded visitors a nostalgic experience of a “simpler time” when Americans could imagine that they were in control of technology; that men were “men” and women were “women”; and that families sat down to Mom’s home-cooked meal every evening.

The region’s tourist towns play into this nostalgic desire that visitors have for a future that resembles an imagined past. In that imagined future, they would, like the Amish, escape cultural forces that they think have compromised America’s ability to be the Christian nation it supposedly once was.

A glimpse of real life

Since 2008, I’ve taken students from the University of Dayton to the Amish settlement located in Holmes and Wayne counties in northeastern Ohio.

A simple sign advertising homemade goods and candy outside a white farmhouse.
A Swartzentruber Amish farm in Wayne County, Ohio, where tourists can purchase homemade treats and handwoven baskets. Susan Trollinger

In the course of the day, we visit a two-room school run by New Order Amish, whose rules for daily life are among the least strict among the Amish. Then we’re off to a candle shop owned and operated by five Old Order Amish sisters, followed by a visit to a Swartzentruber Amish farm. The Swartzentruber are among the strictest Amish groups. In the small shop located between the house and a woodworking shop, a young woman sells woven baskets, homemade preserves and wood furnishings crafted by her father. We also enjoy meals and conversation at two Amish homes.

Of course, the stops we make are part of the tourism industry. And many Amish make their living from that industry, whether they are crafting solid wood furniture, serving diners in Amish-style restaurants or preparing hotel rooms for guests.

Importantly, the Amish don’t own the big Amish-style restaurants or gift shops or hotels. And because I want my students to have conversations with the people they have been studying, we spend very little time in these tourist towns.

When I was invited to present a paper last summer on Amish Country tourism – an update of “Selling the Amish,” as it were – I was obliged to spend some time in those tourist towns.

Guns and crosses

What I saw blew me away. There I was in the heart of the biggest Amish settlement in the world, when measured by the number of congregations. This area is home to nearly 40,000 Amish people deeply committed to pacifism: people who would rather suffer solitary confinement and reduced rations – as some did during World War I – than participate in “the war machine,” and who would never sing the national anthem.

Store shelves show pointy, bullet-shaped silver and gold items next to novelty mugs.
Beverage containers and coffee mugs for sale in Berlin, Ohio, on May 30, 2023. Susan Trollinger

Yet, I saw the Stars and Stripes everywhere: on T-shirts, ball caps, decorative wreaths, candles and, perhaps most strikingly, wooden crosses. There were concrete statues of soldiers kneeling at crosses, patriotic bunting and images of the Founding Fathers, with facsimiles of the Declaration of Independence, the Ten Commandments and the Pledge of Allegiance nearby.

A large display in one Berlin shop featured merchandise from “Hold Fast,” a company whose website says its merchandise is designed “for freedom loving Americans who want to see Biblical values preserved and are taking a stand and letting their voices be heard.” Flags figure prominently across the merchandise, along with messages like: “One nation under God. Psalm 33:12. Hold Fast.”

I was even more taken aback by home decor items announcing that the “2nd Amendment is my gun permit,” along with thermoses challenging government authorities to “come and take it” – “it” being a gun – and coffee mugs that listed gun calibers (.22, .380, 9 mm, .40, .45) and proclaiming, “All faster than dialing 911.”

Amish Country tourism has never simply been about the plain and simple life of the Amish. But these days, sites that fuse Christian symbols and sacred texts with a brand of nationalism that celebrates masculine bravado, guns and the military marks a further and dramatic remove from the character of Amish life.

Still, if one ventures down a back road and ends up behind a slow-moving buggy, or ducks into an Amish-owned shop selling bulk foods, handmade brooms or half-moon pies, they can still encounter a people whose life is wildly at odds with so much that characterizes mainstream America today.

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

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COVID-19 vaccine mandates have come and mostly gone in the US – an ethicist explains why their messy rollout matters for trust in public health

Vaccine policies fall on a spectrum, from mandates to recommendations. Deciding what to use and when is not so much a science but a balancing act between…




Proof of COVID-19 vaccination was once required to access many venues during the pandemic. skaman306/Moment via Getty Images

Ending pandemics is a social decision, not scientific. Governments and organizations rely on social, cultural and political considerations to decide when to officially declare the end of a pandemic. Ideally, leaders try to minimize the social, economic and public health burden of removing emergency restrictions while maximizing potential benefits.

Vaccine policy is a particularly complicated part of pandemic decision-making, involving a variety of other complex and often contradicting interests and considerations. Although COVID-19 vaccines have saved millions of lives in the U.S., vaccine policymaking throughout the pandemic was often reactive and politicized.

A late November 2022 Kaiser Family Foundation poll found that one-third of U.S. parents believed they should be able to decide not to vaccinate their children at all. The World Health Organization and the United Nations Children’s Fund reported that between 2019 and 2021, global childhood vaccination experienced its largest drop in the past 30 years.

The Biden administration formally removed federal COVID-19 vaccination requirements for federal employees and international travelers in May 2023. Soon after, the U.S. government officially ended the COVID-19 public health emergency. But COVID-19’s burden on health systems continues globally.

I am a public health ethicist who has spent most of my academic career thinking about the ethics of vaccine policies. For as long as they’ve been around, vaccines have been a classic case study in public health and bioethics. Vaccines highlight the tensions between personal autonomy and public good, and they show how the decision of an individual can have populationwide consequences.

COVID-19 is here to stay. Reflecting on the ethical considerations surrounding the rise – and unfolding fall – of COVID-19 vaccine mandates can help society better prepare for future disease outbreaks and pandemics.

Ethics of vaccine mandates

Vaccine mandates are the most restrictive form of vaccine policy in terms of personal autonomy. Vaccine policies can be conceptualized as a spectrum, ranging from least restrictive, such as passive recommendations like informational advertisements, to most restrictive, such as a vaccine mandate that fines those who refuse to comply.

Each sort of vaccine policy also has different forms. Some recommendations offer incentives, perhaps in the form of a monetary benefit, while others are only a verbal recommendation. Some vaccine mandates are mandatory in name only, with no practical consequences, while others may trigger termination of employment upon noncompliance.

COVID-19 vaccine mandates took many forms throughout the pandemic, including but not limited to employer mandates, school mandates and vaccination certificates – often referred to as vaccine passports or immunity passports – required for travel and participation in public life.

Sign on window reading 'New York City requires you to be vaccinated against COVID-19 to enter this business,' with a person sitting at a desk inside the room
COVID-19 vaccine requirements were intended to protect the health and safety of the public. Seth Wenig/AP Photo

Because of ethical considerations, vaccine mandates are typically not the first option policymakers use to maximize vaccine uptake. Vaccine mandates are paternalistic by nature because they limit freedom of choice and bodily autonomy. Additionally, because some people may see vaccine mandates as invasive, they could potentially create challenges in maintaining and garnering trust in public health. This is why mandates are usually the last resort.

However, vaccine mandates can be justified from a public health perspective on multiple grounds. They’re a powerful and effective public health intervention.

Mandates can provide lasting protection against infectious diseases in various communities, including schools and health care settings. They can provide a public good by ensuring widespread vaccination to reduce the chance of outbreaks and disease transmission overall. Subsequently, an increase in community vaccine uptake due to mandates can protect immunocompromised and vulnerable people who are at higher risk of infection.

COVID-19 vaccine mandates

Early in the pandemic, arguments in favor of mandating COVID-19 vaccines for adults rested primarily on evidence that COVID-19 vaccination prevented disease transmission. In 2020 and 2021, COVID-19 vaccines seemed to have a strong effect on reducing transmission, therefore justifying vaccine mandates.

COVID-19 also posed a disproportionate threat to vulnerable people, including the immunocompromised, older adults, people with chronic conditions and poorer communities. As a result, these groups would have significantly benefited from a reduction in COVID-19 outbreaks and hospitalization.

Many researchers found personal liberty and religious objections insufficient to prevent mandating COVID-19 vaccines. Additionally, decision-makers in favor of mandates appealed to the COVID-19 vaccine’s ability to reduce disease severity and therefore hospitalization rates, alleviating the pressure on overwhelmed health care facilities.

However, the emergence of even more transmissible variants of the virus dramatically changed the decision-making landscape surrounding COVID-19 vaccine mandates.

The public health intention (and ethicality) of original COVID-19 vaccine mandates became less relevant as the scientific community understood that achieving herd immunity against COVID-19 was probably impossible because of uneven vaccine uptake, and breakthrough infections among the vaccinated became more common. Many countries like England and various states in the U.S. started to roll back COVID-19 vaccine mandates.

With the rollback and removal of vaccine mandates, decision-makers are still left with important policy questions: Should vaccine mandates be dismissed, or is there still sufficient ethical and scientific justification to keep them in place?

Vaccines are lifesaving medicines that can help everyone eligible to receive them. But vaccine mandates are context-dependent tools that require considering the time, place and population they are deployed in.

Though COVID-19 vaccine mandates are less of a publicly pressing issue today, many other vaccine mandates, particularly in schools, are currently being challenged. I believe this is a reflection of decreased trust in public health authorities, institutions and researchers – resulting in part from tumultuous decision-making during the COVID-19 pandemic.

Engaging in transparent and honest conversations surrounding vaccine mandates and other health policies can help rebuild and foster trust in public health institutions and interventions.

Rachel Gur-Arie does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

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AI identifies antimalarial drug as possible osteoporosis treatment

Correction (Oct. 17, 2023): The paper’s title has been corrected to “Deep Learning-Predicted Dihydroartemisinin Rescues Osteoporosis by Maintaining…



Correction (Oct. 17, 2023): The paper’s title has been corrected to “Deep Learning-Predicted Dihydroartemisinin Rescues Osteoporosis by Maintaining Mesenchymal Stem Cell Stemness through Activating Histone 3 Lys 9 Acetylation

Credit: Adapted from ACS Central Science, 2023, DOI: 10.1021/acscentsci.3c00794

Correction (Oct. 17, 2023): The paper’s title has been corrected to “Deep Learning-Predicted Dihydroartemisinin Rescues Osteoporosis by Maintaining Mesenchymal Stem Cell Stemness through Activating Histone 3 Lys 9 Acetylation

Artificial intelligence has exploded in popularity and is being harnessed by some scientists to predict which molecules could treat illnesses, or to quickly screen existing medicines for new applications. Researchers reporting in ACS Central Science have used one such deep learning algorithm, and found that dihydroartemisinin (DHA), an antimalarial drug and derivative of a traditional Chinese medicine, could treat osteoporosis as well. The team showed that in mice, DHA effectively reversed osteoporosis-related bone loss.

In healthy people, there is a balance between the osteoblasts that build new bone and osteoclasts that break it down. But when the “demolition crew” becomes overactive, it can result in bone loss and a disease called osteoporosis, which typically affects older adults. Current treatments for osteoporosis primarily focus on slowing the activity of osteoclasts. But osteoblasts — or more specifically, their precursors known as bone marrow mesenchymal stem cells (BMMSCs) — could be the basis for a different approach. During osteoporosis, these multipotent cells tend to turn into fat-creating cells instead, but they could be reprogrammed to help treat the disease. Previously, Zhengwei Xie and colleagues developed a deep learning algorithm that could predict how effectively certain small-molecule drugs reversed changes to gene expression associated with the disease. This time, joined by Yan Liu and Weiran Li, they wanted to use the algorithm to find a new treatment strategy for osteoporosis that focused on BMMSCs.

The team ran the program on a profile of differently expressed genes in newborn and adult mice. One of the top-ranked compounds identified was DHA, a derivative of artemisinin and a key component of malaria treatments. Administering DHA extract for six weeks to mice with induced osteoporosis significantly reduced bone loss in their femurs and nearly completely preserved bone structure. To improve delivery, the team designed a more robust system using injected, DHA-loaded nanoparticles. Bones of mice with osteoporosis that received the treatment were similar to those of the control group, and the treatment showed no evidence of toxicity. In further tests, the team determined that DHA interacted with BMMSCs to maintain their stemness and ultimately produce more osteoblasts. The researchers say that this work demonstrates that DHA is a promising therapeutic agent for osteoporosis.

The authors acknowledge funding from the National Natural Science Foundations of China, the Beijing International Science and Technology Cooperation, the Beijing Natural Science Foundation, Peking University Clinical Medicine Plus X – Young Scholars Project, the Ten-Thousand Talents Program, the Key R & D Plan of Ningxia Hui Autonomous Region, the Innovative Research Team of High-Level Local Universities in Shanghai, the Beijing Nova Program, the China National Postdoctoral Program for Innovative Talents, the China Postdoctoral Science Foundation, and the Peking University Medicine Sailing Program for Young Scholars’ Scientific & Technological Innovation.

The paper’s abstract will be available on Oct. 18 at 8 a.m. Eastern time here:

The American Chemical Society (ACS) is a nonprofit organization chartered by the U.S. Congress. ACS’ mission is to advance the broader chemistry enterprise and its practitioners for the benefit of Earth and all its people. The Society is a global leader in promoting excellence in science education and providing access to chemistry-related information and research through its multiple research solutions, peer-reviewed journals, scientific conferences, eBooks and weekly news periodical Chemical & Engineering News. ACS journals are among the most cited, most trusted and most read within the scientific literature; however, ACS itself does not conduct chemical research. As a leader in scientific information solutions, its CAS division partners with global innovators to accelerate breakthroughs by curating, connecting and analyzing the world’s scientific knowledge. ACS’ main offices are in Washington, D.C., and Columbus, Ohio.

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