Moderna, Inc. (MRNA) revealed that it has submitted data to the European Medicines Agency (EMA) for conditional marketing approval (CMA) for the evaluation of its COVID-19 vaccine booster at the 50 µg dose level.
The 50 µg dose of the company's booster taken six months after the second vaccine is said to induce strong antibody responses of more than 40 times against the deadly delta variant. Shares of the vaccine maker closed up 4.8% at $416.70 on September 3. (See Moderna stock charts on TipRanks)
Commenting on the efficacy of the booster dose, Stephane Bancel, CEO of the company, said, “The amended Phase 2 study and additional analyses shows that a 50 µg booster dose of our COVID-19 vaccine induces robust antibody responses against the Delta variant…We remain committed to staying ahead of the virus and following the evolving epidemiology of SARS-CoV-2.”
The company conducted an amended Phase 2 study in which it offered a 50 µg booster dose of mRNA-1273 to participants. According to the company, the efficacy of the neutralizing titers had diminished significantly approximately six months after the second dose. However, the booster dose elevated the neutralizing titers well above the Phase 3 benchmark across all age groups, especially in adults above 65 years of age.
The safety profile following dose 3 was similar to that observed before dose 2 of the vaccine. Markedly, Moderna will submit this data to a peer-reviewed publication.
Furthermore, along with inducing strong antibody responses, the additional 50 µg dose of the booster meaningfully increased the geometric mean titers (GMT) by 42.3-fold for all variants, including Beta (B.1.351) by 32- fold, Gamma (P.1) by 43.6-fold, and Delta (B.1.617.2).
Moderna has been granted emergency use by the U.S. FDA for its COVID-19 vaccine Spikevax in adults 18 years and above. It has also received emergency authorization for its vaccine use from health agencies in more than 50 countries, as well as an Emergency Use Listing (EUL) from the World Health Organization (WHO).
Recently, Jefferies analyst Michael Yee maintained a Hold rating on the stock with a price target of $425, implying 2% upside potential to current levels.
The analyst noted, "the ACIP still appears to be hesitant on whether add'l doses are needed despite waning antibodies and increasing infections...ACIP cited continued protection from severe disease, lack of correlates of protection and global "inequity" as reasons why a third dose should not be administered yet."
Yee added, "We think the ACIP could be leaning toward just a narrow 3rd dose recommendation for high-risk people (healthcare workers, elderly) vs. the more blanket recommendation the White House favors."
Overall, the stock has a Hold consensus rating based on 4 Buys, 7 Holds, and 2 Sells. The average Moderna price target of $285.30 implies 31.5% downside potential to current levels. Shares have exploded 666.8% over the past year.
The post Moderna Submits Data for COVID Vaccine Booster to EMA appeared first on TipRanks Financial Blog.white house covid-19 vaccine fda antibodies european world health organization
Guerilla gardening: how you can make your local area greener without getting into trouble
Many people are gardening on land that is not theirs – here are some things to consider to avoid getting into trouble.
When Richard Reynolds first started gardening around London’s streets, he was so worried he might be arrested that he worked under the cover of darkness. Reynolds was one of the UK’s first modern guerrilla gardeners, a movement that encourages people to nurture and revive land they do not have the legal rights to cultivate.
This issue is particularly pronounced among city dwellers, ethnic minorities and young people. A 2021 survey conducted in England revealed that those aged 16-24 were more than twice as likely to lack access to a garden or allotment compared to those aged over 65.
This article is part of Quarter Life, a series about issues affecting those of us in our twenties and thirties. From the challenges of beginning a career and taking care of our mental health, to the excitement of starting a family, adopting a pet or just making friends as an adult. The articles in this series explore the questions and bring answers as we navigate this turbulent period of life.
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Guerrilla gardening is a particularly good option for these groups of people. It can involve planting herbs or vegetables for a whole community to enjoy, spreading seeds or plants, tidying weeds, or even something as simple as picking up litter.
But if you’re considering becoming a guerilla gardener, it’s important to understand your rights. Could you be arrested for it? And should you wait until after dark?
Can you be prosecuted?
It’s important to remember that much of the unused or abandoned land that is potentially suitable for guerilla gardening in towns and cities throughout the UK is owned by local councils. Common examples of such locations include broken pavements with missing slabs, wasteland and the central areas of roundabouts.
Although much of this land is already open for the public to walk over, actively gardening on it would become an act of trespass.
The law of trespass sounds scary. However, gardening on this land would be a breach of civil law rather than a crime. This means that most guerrilla gardeners are unlikely to receive a fine or a criminal record.
Landowners do have the legal right to use “reasonable force” to remove trespassers from their land. But, fortunately, it seems most councils have ignored guerrilla gardeners, having neither the time, money or inclination to bring legal action against them.
Colchester Council, for example, were unable to track down the identity of the “human shrub”, a mysterious eco-activist who restored the flowers in the city’s abandoned plant containers in 2009. The shrub returned again in 2015 and sent a gift of seeds to a local councillor.
In other areas of the UK, the work of guerilla gardeners has been cautiously welcomed by local councils. In Salford, a city in Greater Manchester, there is a formal requirement to submit an application and obtain permission to grow on vacant spots in the city. But the local authority tends not to interfere with illegal grow sites.
There seems to be an unwritten acceptance that people can garden wherever they want, given the abundance of available space and the lack of active maintenance. This also offers the additional advantage of saving both time and money for the local council.
You should still be careful about where you trespass though. In some areas, guerrilla gardening can lead to unwelcome attention. During the May Day riots of 2000, for example, guerrilla gardeners were accused of planting cannabis seeds in central London’s Parliament Square.
Gardening at night may draw the wrong attention too, particularly if you are carrying gardening tools that might be misunderstood by the police as threatening weapons.
How can you start?
There are many different types of guerrilla gardening that you could get involved in, from planting native plant species that benefit pollinators and other wildlife to tidying derelict land to create safer places for the local community.
One of the simplest forms of guerilla gardening is planting seeds. Some environmental projects circulate “seed bombs” and others use biodegradable “seed balloons” that are filled with helium and deflate after a day, distributing seeds by air.
Whatever you try, as a guerrilla gardener you shouldn’t harm the environment or spoil other people’s enjoyment of the space around you. Remember that weeds and wilderness have an environmental value too. And think carefully about the species you are going to plant so that you can protect local plants and wildlife.
The most attractive species to humans might not provide the best home or food for wildlife. Some can even outcompete native plants and drive them towards extinction. Planting certain harmful, invasive or poisonous species like ragwort, knotweed or Himalayan balsam is even prohibited by law.
That said, some guerrilla gardeners have used social media to organise “balsam bashing” events, where people come together to pull up this harmful invasive plant.
Guerrilla gardening takes many forms and can bring great benefits for people and the environment. You’re unlikely to be arrested for planting and growing trees and other greenery in public spaces. But remember that these spaces should be shared with everyone, including your local wildlife.
Ben Mayfield does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.uk
Fractyl Health’s GLP-1 gene therapy spurs 25% weight loss in obese mice, clinical trials slated for 2024
One of the biggest problems facing the burgeoning class of weight loss drugs is that people must take them day after day, week after week. When the injections…
One of the biggest problems facing the burgeoning class of weight loss drugs is that people must take them day after day, week after week. When the injections of semaglutide — the ingredient in Ozempic and Wegovy — stop coming, so do the benefits. Lost weight is regained.
But researchers at Fractyl Health, a Lexington, MA-based biotech, believe they have a solution to that problem: a one-time gene therapy injected into the pancreas that lets the body make its own GLP-1 agonists in perpetuity.
New data slated to be presented today at a diabetes conference in Germany suggest that obese mice injected with the therapy lost nearly 25% of their body weight after just two weeks, according to a copy of the company’s presentation obtained by Endpoints News.
The results leave many questions unanswered, including how safe and effective the approach will be beyond the first two weeks, although the presentation indicated that such studies are ongoing. Fractyl declined requests for an interview.
The company previously announced plans to begin testing the treatment in people with diabetes and obesity in 2024. It’s a bold step towards moving gene therapy beyond the rare diseases typically pursued by biotech companies.
“It’s hard to get people to take injections once a week, and if we can figure out how to do something closer to one and done, that would be a big step for patients,” Randy Seeley, who directs an obesity research center at the University of Michigan School of Medicine, told Endpoints in an interview.
“But how permanent this will be can’t really be answered in a mouse,” he added. Seeley is a consultant to Fractyl, and the company supports research in his lab.
Fractyl was originally just developing the GLP-1 gene therapy for type 2 diabetes. In a diabetic mouse model, human pancreatic islets and human beta cell lines, the treatment significantly enhanced glucose-stimulated insulin secretion, improving blood sugar levels.
GLP-1 needs to act on receptors in the brain for its weight loss effects, and since the therapy is injected directly into the pancreas, the company didn’t expect the diabetic mice would lose weight, Seeley said. But surprisingly, they did, shedding 23% of their mass after four weeks compared to a control group.
Those results spurred the company to test its gene therapy in a diet-induced obesity mouse model. Twenty mice were fed a high fat diet for 25 weeks before half of them got a single injection of the gene therapy while the other half received daily injections of semaglutide.
Both groups of mice began losing weight a day after the injections. Within five days, the mice who got the gene therapy were losing weight faster and shed 24.8% of their body weight after just two weeks, even as they maintained their high fat diet. The mice on semaglutide lost 18.4% of their weight, according to the data presented at the European Association for the Study of Diabetes Scientific Congress.
“The most surprising part of the data is how much weight these animals lose,” Seeley said. “it’s better than semaglutide, and it’s not exactly clear how that occurs.”
Given the uncertain long-term effects of taking GLP-1 drugs for weight loss, a potentially permanent gene therapy approach is sure to raise many questions.
“If you’re taking your once-a-week version, if something goes wrong, we can turn it off and we just take it away,” Seeley said. “But with gene therapy, there’s no way to turn it off. It’s unknown what happens, and so it is going to take both some careful thought.”fed congress treatment testing clinical trials therapy european germany
Trans To Be Banned From Female Hospital Wards In UK
Trans To Be Banned From Female Hospital Wards In UK
Authored by Steve Watson via Summit News,
The UK Health Secretary is to issue a proposal…
The UK Health Secretary is to issue a proposal to ban trans patients from female hospital wards in the UK, as well as reinstating ‘sex specific’ language in National Health Service materials, according to reports.
The Daily Mail reports that “Steve Barclay will unveil the plans to push back against ‘wokery’ in the health service amid concerns that women’s rights are being sidelined.”
Daily Mail: "Trans women patients 'to be banned from female wards' under plans to be announced by Health Secretary Steve Barclay today"https://t.co/dPU9wbKEZL— Emily Wilding Davison (@Wommando) October 3, 2023
The proposal would see only people of the same biological sex sharing wards, with care coming from doctors and nurses of the same sex, when it comes to intimate health matters.
“We need a common-sense approach to sex and equality issues in the NHS. That is why I am announcing proposals for clearer rights for patients,” Barlcay stated, adding “It is vital that women’s voices are heard in the NHS and the privacy, dignity and safety of all patients are protected.”
He added “And I can confirm that sex-specific language has now been fully restored to online health advice pages about cervical and ovarian cancer and the menopause.”
As we previously highlighted, the word ‘women’ was removed from such materials and replaced with non-gendered terms to be “more inclusive”:
A source close to the Health Secretary told the Telegraph that “The Secretary of State is fed up with this agenda and the damage it’s causing, language like “chestfeeding”, talking about pregnant “people” rather than women. It exasperates the majority of people, and he is determined to take action.”
“He is concerned that women’s voices should be heard on healthcare and that too often wokery and ideological dogma is getting in the way of this,” the source added.
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