StemCell Therapy

Economic uncertainty and instability are real cost of Israels elections

Elections cost money. And Israels upcoming election, the fourth in two years, will cost much more than previous ones.

The financial burden of the election on state coffers is compounded by the fact that the government has not passed national budgets for 2020 and 2021.

The cost of holding Israels upcoming election, scheduled for March 23, 2021, is estimated at close to 500 million NIS ($155.4 million). This is at least 20% higher than the last elections in March 2020 and higher by as much as 40% than the first election in the last two years that took place in April 2019.

There is a price for everything, and a democracy requires spending money, Giora Pordes, spokesman for Israels Central Election Commission, told The Media Line.

One reason for this cost increase is arrangements needed to hold elections during the coronavirus pandemic. Adding extra voting sites and poll workers, taking precautionary measures and dealing with the unknown are major factors driving up those costs.

The Knesset, Israels parliament, disbanded itself in late-night votes on Monday that stretched into early Tuesday morning, once again sending the country to the polls

But economic uncertainty and instability are the real cost to Israels economy of holding new elections.

Israel is suffering from a lack of governing decisions, with not passing national budgets for 2020 and 2021 among the most major. The economic situation has been made even more difficult during the past year for the country, and the entire world, due to the coronavirus pandemic.

Clearly, under normal conditions, Israel as an advanced economy with 14% unemployment and in a recession due to the pandemic should have a well-functioning government with a well-defined budget and a set of reforms. Unfortunately, we are not there, Leo Leiderman, professor of comparative economics at Tel Aviv University, told The Media Line.

I think clearly that going to the fourth elections in two years is not something to be applauded by anyone. On the other hand, we have to realize that the existing government has not been performing. It is in paralysis in its decision-making processes, said Leiderman, who is the chief economic advisor to Bank Hapoalim, Israels largest commercial bank, and formerly served at the Bank of Israel as head of the research department and a senior director.

There is a price for everything, and a democracy requires spending money

Not having an annual national budget is a major factor in the uncertainty that Israel currently is facing.

On the cusp of the new year, the government is still running itself based on the 2019 budget, alongside certain emergency pandemic- and defense-related allocations. Because of this, government ministries cannot prepare for 2021.

We dont know what to do. We dont know whether to prepare cuts in our budget or not. We are in a period of uncertainty, said a source in one ministry who asked not to be named.

The finance ministry told The Media Line on Wednesday that it will provide instructions to the ministries in the coming days.

Only after the election and the formation of a new government can a budget be planned, passed and implemented.

In perspective, 2021 seems like it will be a very challenging year for the political system and we need to have a budget as early as possible, by mid-year or later, Gil Bufman, chief economist for Bank Leumi, Israels oldest banking corporation, told The Media Line.

Government policies have longer-term impact, especially regarding structural changes in the economy, for instance with tax breaks or with policies directly connected to the countrys social fabric, Bufman said.

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Health care, mental health, social services and education are some of what Bufman termed, soft infrastructure. These are areas that are suffering greatly from a lack of investment by the state, he said.

A budget framework with multi-year elements of planning gives more time for longer projects like hard infrastructure projects, for instance, energy, water and transportation. We already see a lot of these in much deeper progress, such as the Tel Aviv subway system, Bufman explained.

For Bufman, the lack of a budget, and even more so during another election period, is a big challenge. We need structural change. Putting things off from year to year is not healthy, he said.

There is a large degree of inequality of what is in the pipeline. I have a feeling that the soft infrastructure projects will suffer, he said.

If and when we get the coronavirus pandemic under control and the economy starts to recover next year, our economic pace will be much lower than our potential. We could be doing much better with a stable government, infrastructure projects and reform. It is not a catastrophe, but it is a pity, it is too bad

The Alyn Hospital Pediatric & Adolescent Rehabilitation Center says its projects will suffer, too.

There is no preventative medicine. We [the healthcare sector] are dealing with emergencies because of the lack of strategic planning and policies. The government is not looking at long-term health processes, said Dr. Maurit Beeri, Alyn Hospitals director-general.

There is a lack of policy building. The HMOs are looking at things quarterly, short-term instead of long-term. Frankly, they should be investing in these young people, rather than paying far more for services when these children grow older, Beeri told The Media Line.

Yet, even with the pandemic hanging over a new governments policies, Israel is in a comparatively good position relative to other developed economies.

This is a result of the country starting the pandemic in a better position due to the growing high-technology sector and steady population growth, which much of the developed world lacks, Bufman said.

Israel has a good economy, Bufman said. We are in better shape than Spain, France and the UK. We are doing much better, he said.

Leiderman said that Israels good economy could be better if the country was in a good political situation.

If and when we get the coronavirus pandemic under control and the economy starts to recover next year, our economic pace will be much lower than our potential. We could be doing much better with a stable government, infrastructure projects and reform. It is not a catastrophe, but it is a pity, it is too bad, he said.

Still, Leiderman noted, the sooner elections occur, the sooner the political situation can become clarified which can lead to better times.

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Israel Paying Economic Price for 4th Election in 2 Years - The Media Line

Editors note:The nurses interviewed in this feature are former recipients of the Mpls.St.Paul Magazine Outstanding Nurses Award. We are grateful for their time and input for this feature.We are in the process of outlining our approach to this annual editorial initiative. Please send an email tooutstandingnurses@mspmag.comto let us know you would like to receive details once we are ready to move forward.

Time is of the essence when you find yourself in an emergency situation.

Just ask Kathleen Koivisto, an in-flight emergency medicine nurse with Life Link III. She doesnt waste any time when the helicopter carrying her and her team lands at the scene of an accident.

She quickly gathers all the needed suppliessuch as airway bags, a ventilator, sometimes an ultrasound, and protective gear to help keep patients safeto prepare or intubate a patient before putting them in the helicopter for the ride of their life to a level-one trauma center. But now with COVID-19, theres an extra, critical step. Before Koivisto can interface with first responders for the handoff of the patient, she must also put on all the necessary high-level personal protective equipment (PPE) to ensure she keeps herself and those around her healthy and safe. We wear masks, gloves, and eye protection with all patients. With suspicion for COVID or COVID-positive patients, we add Tiger masks or N95 and gowns. It all depends on what symptoms the patient presents.

Taking the time to put on the added PPE can be tense when a patient needs immediate attention. If youre watching a monitor and their vital signs are junky . . . it feels long, Koivisto says. A couple minutes is a long time in an emergency. Nobody has suffered because of this vital extra step, except maybe Koivistos nerves.

Not all of her patients are accident victims. Some need transport from rural hospitals to major medical centers for specialized neuro, cardiology, and trauma care. Still, COVID protocols are essential. Patients who dont require a breathing tube but are COVID positive can be transported with a Sea-Long Helmet. This allows us to give them oxygen and support their breathing without exposing the transport staff and others to the virus.

Our pandemic-filled world is testing nursesfrom administrators and educators to those on the frontlines in ways they never could have imagined when this year started. And thats saying a lot, since some of them have been doing their jobs for decades.

We talked to seven nurses who shed light on their lives and their profession during these unprecedented times.

Kristin Lau, a public health nurse in Ramsey County, works with first-time mothers, and an important part of her care strategy is visiting them in their homes. She makes house calls from the time theyre pregnant until their child is 2 years old to ensure everyone stays healthy and progresses as they should. However, since March, shes needed to turn these visits into virtual ones.

Now, instead of hopping into her car and listening to some relaxing music to clear her head between home vis- its, Lau engages with her mamas, as she affectionately refers to them, on Zoom, Microsoft Teams, and Google platforms. A day of several back-to-back virtual visits can leave her feeling extra tired. Theres a study that says it takes a lot more energy to engage over Zoom for one hour than it does in person, Lau says. I think its something like it takes three times the energy.

However, shes thankful to have the technology so she can stay engaged with the women she cares for and get a chance to still see them moving about their lives at home. Lau is always on the lookoutmonitoring her pregnant mamas for any visible signs of distress. For example, one client who was 37 weeks pregnant showed signs of preeclampsia, a life-threatening condition for both mother and baby. As soon as she popped up on my screen I could see her face was quite puffy, Lau recalls. After asking her client a series of questionsAre your hands swollen or tight? Do you have a headache? Hows your visionblurry, seeing spots? Any dizziness?she had the expectant mother check her blood pressure using the cuff thats provided by Ramsey County. Lau

knew this woman had to get medical help right away. She delivered the baby about six hours after she went to the hospital, Lau says.

As a nurse who does home visits, Lau has always had a unique portal into the personal lives of her new mothers, which helps her advise and care for them. And now, with Lau working from home, these new mothers are getting a glimpse into hers. Lau has five childrenages 9 to 20three of whom are doing distance learning at home. Plus, her husband, who has a preexisting health condition, also works from home. So thats five people, plus a couple of pet dogs, jammed into their home. Lau has set up a private room for her meetings, but that doesnt stop her clients from hearing her kids loudly engage with their siblings in another room and her dogs barking at the Amazon truck. I think its almost relatable to them to see me in the mother role, Lau says. It brings them joy.

We think about this cohort of students now in the academic programs. Theyll be the first nurses to be educated about this type of pandemic worldwide. Theyve studied and learned about pandemics in other countries, but its at a distance. Its not us. But now its here, and were living it, and were not doing so well either. Susan OConner-Von, associate professor, University of Minnesota School of Nursing

College campuses, such as St. Catherine University, have also taken to making virtual house callsbut in this instance on students. One evening back in March, Jocelyn Bessette Gorlin, an associate professor of pediatrics in the school of nursing, was teaching an advanced nursing health assessment class. That same night, the school announced it was closing the next day due to COVID-19. In the week or so leading up to the announcement, Gorlin had gotten a jump-start and had connected with the schools IT department to learn how to record Panopto videos, a kind used in the field of education, just in case the school transitioned to e-learning. We asked ourselves: How can we teach hands-on assessment skills remotely? she says.

After class that March evening, Gorlin, along with other faculty members and teaching assistants, formed an assembly line and filled Ziploc bags with the tools that the graduate students would need to practice their skills at home (tongue depressors, reflex hammers, pen lights, and more). When a ship is having trouble, you get on this raft and you do what you have to do, Gorlin says.

As it turns out, they learned they could do quite a lot. Within one week, students recorded their first video demonstrating health assessment skills on people with whom they were quarantined, such as their children, parents, and roommates. (One student who lived alone formed a mannequin out of old clothes that she beautifully assessed, Gorlin says.) Gorlin witnessed her students listening to their childrens heartbeats and gently assessing parents abdomens. The recorded videos gave us a glimpse into their home lives, she says.

Gorlin also used Google Meet and Sammy, a 140-pound medical mannequin from the school of nursing that wound up lying on her dining room table, to interface with students and offer feedback on how they could improve their assessment of a patient. Google Meet also came in handy when she held virtual lab sessions three times a week from her home. Gorlin enjoyed demonstrating how to do cranial nerve and musculoskeletal assessments on her roommateher husband, a hematologistwhod sometimes provide comic relief by swing dancing instead of sitting quietly for his checkup.

In the fall, Gorlins students returned to campus for classes on a part-time basis. While Panopto videos and Google Meet were part of the syllabus, so were small face-to-face lab classes that alternated with synchronous virtual sessions connected via technology and teamwork. At the start of class, students get their temperature taken and don gloves, masks, and face shields before meet- ing up with their assigned partner, whos wearing a plastic three-by-four-inch name tag with their picture on itas all of the PPE makes the faculty and students unrecognizable.

The teamwork Gorlin witnesses, along with the use of technology, seems a little NASA-like to her, as students depend on each other to maintain health and safety while also promoting new state-of-the-art technology that will benefit people and health care. Were in different spaces, we have high-tech technology, and were connecting remotely. Even though its estimated that this sort of hybrid teaching model takes educators about one and a half times longer to prepare and to teach, its worth it. Were preparing them to be on the frontlines, Gorlin says. So were on the frontlines to put them on the frontlines.

As of press time, in Minnesota alone, 157,096 people have tested positive for COVID-19, and 15,022 have been health care workers.* Given the state of the world, some educators thought that enrollment in nursing programs would decrease. However, enrollment in the nursing program at the University of Minnesota School of Nursing has remained steady and increased in some cases. Ive always been impressed with students, but especially now with their deep desire to become nurses in the midst of a pandemic, says Susan OConner-Von, a full-time faculty member at the University of Minnesota School of Nursing, whos been in the profession for more than 40 years. I think we were nervous. Will anyone come back, you know? Who would want to become a nurse during this time? Im just so impressed with their motivation, with their dedication, with their desire to help others.

OConner-Von and her colleagues have discussed the unanticipated experience nursing students are having right now. We think about this cohort of students now in the academic programs. Theyll be the first nurses to be educated about this type of pandemic worldwide, she says. Theyve studied and learned about pandemics in other countries, but its at a distance. Its not us. But now its here, and were living it, and were not doing so well either. This cohort of students are going to be so uniquely prepared because they have the lived experience.

During the early months of the pandemic and the social unrest that soon followed, when many of Gorlins students expressed their concerns about what was happening all around them, she set aside time when they could connect with her one-on-one. Id say 80 percent of our conversation focused on them questioning what was right in their career going forward and how they were going to do it, she recalls. Her advice? What I kept saying to the students was, This is not the journey you expected. But youre still marching forward. Youregoing to have a different step, and youre going to have a different pace to the march, but youre still moving forward, and youre going to be more resilient because of it.

My hope is that people will recognize how devastating underlying conditions can be. A silver lining to this pandemic would be if this changed peoples perspectives on health and they made lifestyle choices that improved quality of life and improved resistance to disease. Kathleen Koivisto, in-flight emergency medicine nurse with Life Link III

Michelle Curley is the director of nursing for home health agency and infusion nursing at Pediatric Home Service, and she sees this kind of resilience and desire to help firsthand. In her area of speciality, nurses travel to families homes to administer IV therapy to children. However, because these patients are especially susceptible to illness, nurses need to be extremely careful. So when a nurse has even one symptom from the CDCs long list of potential COVID-19 symptoms and has to be quarantined until tested, another nurse will readily step in to avoid having to send the vulnerable child to an infusion center. So far, eight nurses (out of 14 nurses on the team) have had to quarantinethankfully, none of them have tested positive for the virus. Two have gone on maternity leaves during this time. This can make things extra challenging. People have hardly taken PTO because everybody is trying to cover for everybody, Curley says.

There are some treatments, such as intravenous nutrition, that nurses can teach parents to administer to their children without having to leave the safety of their homes to learn how to do it. Pre-pandemic, parents and caregivers would travel to the hospital for up to three days of instruction. After hospitals went on lockdown, nurses traveled to clients homes to teach families. Now one nurse is fully dedicated to doing this training for some treatments virtually.

Of course, young patients love to see their nurses familiar faceespecially in the comfort of their home. However, these days, it can be hard to see that friendly face when its covered in PPE. To put their young patients at ease, and to get some giggles, nurses get creative and will draw eyelashes and lips on their protective goggles and face shields.

Due to a shortage of face shields during the first month of the pandemic, Curley and her crew made some from plastic, foam, and Velcro. Today theres enough PPE for all her nursing staff, and Curley wants it to stay that way. To help manage its supply, Curleys office puts it on lockdown, allowing nurses to grab only what they think theyll need over a set amount of days.

During these past nine months, the nursing profession has proven it can pivot with how nurses deliver care to patients. And they do so remarkably well. Mari Holt, vice president of clinical operations at Allina Health Mercy Hospital-Unity Campus, says one of the biggest challenges nurses continue to face is the vital yet complex layering on of head-to-toe PPE protection when engaging with COVID-positive patients or patientswhose COVID-19 status is under investigation.

This isnt Holts first experience with a health crisis that required such a high level of protection for staff, however. Back in 2014, when the Ebola crisis hit, she was part of a front-line team that not only helped Unity pre- pare for patients but also worked with three patients who may have been impacted by the virus. But Coronavirus is far different, she says. As a facility that received patients under investigation for Ebolathat was on one unit, she says. The PPE was similar but it was one person on one unit, not 18 patients on the same unit requiring multiple staff to care and be gowned up each and every day throughout the entire shift.

The Unity Campus has different wings and depending on patient volumes, it can have patients under investigation in one wing and COVID-positive patients in another clearly delineated zone. While working in a COVID zone allows nurses to go from room to room and conserve PPE, as all of the patients on that unit are positive, Holt notes, the challenge for the nursing staff is being in the equipment all of their shift. With Ebola, staff would come out of the room and be able to remove their PPE.

When asked how her teams are managing the stress, Holt notes the emotional challenges that accompany being a frontline care worker are very real. Nurses man- aging patients in isolation help anxious families juggle care strategies and telehealth-type visits. Even at a time when patients can have compassionate care visitors, she says, many family members do not want to come and visit their loved one if they have COVID. At times, she notes, nurses are the only person holding the patients hand and spending time with the patient as they take their last breath.

Nurses as a whole also experience an insiders perspective of the health disparities among underserved populations. This fact takes a toll on nurses emotionally. Lisa Sundberg, a nurse care manager who cares for home- less vets at the VA Community Resource and Referral Center in downtown Minneapolis, sees firsthand how the pandemic has affected the homeless population. According to Sundberg, some veterans deal with feelings of isolation alreadyfeelings of being cut off from other people, a loss of relationships, employment, and financial security. Homelessness increases the stress.

When the pandemic reached Minneapolis, many of these vets, some of whom have mental health illnesses, feared for their lives. The veterans were scared to death, Sundberg says. My heart went out to them. They have nothing. Theyre like, At least people have a home to go to and isolate.

Thankfully, the center is a safe haven for those in the community offering medical triage daily for trauma and medical illness, vaccines, COVID tests, and primary care for nearly 300 veterans. Its also a place for thosein need of a warm shower, a place to do their laundry, or a bagged lunch. The staff preaches the importance of handwashing and social distancing. They provide masks for their clients, but many are already wearing one when they enter the building. Also, the center helps these folks connect to other social services nearby, such as homeless shelters like Exodus, Salvation Army Harbor Lights, and House of Charities. Recently, a homeless vet who spent time with an asymptomatic friend who tested positive for coronavirus isolated himself for 14 days in his own room at one of the shelters.

Nurses are so dedicated to their patients, OConner-Von says. They have this strong sense of duty. Back when I worked in ICUs, we would have times where wed be really busy for a week or two. Wed be working double shifts, working all weekend, picking up extra time. But then after several weeks or a month wed get a reprieve. And you could maybe take that day off. This has been going nonstop since March. And so that feeling of exhaustion must be overwhelming. Not only for the patients and families but for the health care professionals.

I think about those administrators trying to support their staff and somehow do self-care and provide emotional support in whatever way they can.

Being the natural caregivers that they are, nurses often want to extend their hand to everyoneincluding their loved oneswho may be struggling. But it can be difficult to do so when theyre stretched so thin. Oftentimes this results in feelings of guilt and putting themselves on the backburner. OConner-Von uses these insights and examples to teach her nursing students that caring for themselves is also part of the job. She gives extra credit to those who take the dog for a run, read a book they dont have to underline, or call a close family member or friend just to catch up so self care becomes a habit. You cant go in burned out and provide compassionate care, she says.

Nurses try to remain hopeful and optimistic about the future. However, many are wondering how people will fare this winter, when the flu is added to the mix. Were all a little on edge, Sundberg says.

In addition, the sheer magnitude of trying to drive home the seriousness of this disease can feel overwhelming at times. Lau educates her families about the signsand symptoms of Coronavirus and where they can get a free test. Im in public health so were trying to keep our public healthy, Lau says. So it feels like a big responsibility.

She tries not to allow the heaviness she feels at times to overwhelm her. Though she admits its easy at times to get tied up in ... your own chest and in your own stress. Thats when she reminds herself that things are going to be OK and puts something on the calendar that she can look forward to, even if its just a Friday night date at Costco with her husband.

Lau says the number-one lesson they taught in nursing school was the importance of being adaptable and flexible. Never has that proven more true than it has in 2020, a year that we will never forget. Lau likens her role to being a wartime nurse. The battlefield has changed, she says. Our battlefield is our community, our grocery store, our hospitals, our schools. Were all trying to combat this [disease] and were all in this together.

As with any warfare, tactics evolve to ensure peoples safety and care. We are all adapting to be flexible, Holt says. Communication is key as things have changed, and continue to change, as we learn more about the disease. It is challenging to keep up with the changes, which is imperative for our bedside staff.

The CDC reports those with certain underlying medical conditions have a greater chance of becoming severely ill from COVID-19. Of course, not all underlying medical conditions are manageable. However, Koivisto believes that if people become more cognizant in caring for their overall health it would give them a better chance of combatting health setbacks. My hope is that people will recognize how devastating underly- ing conditions can be, she says. Many of these can be lessened with lifestyle changes like clean eating and exercise. A silver lining to this pandemic would be if this changed peoples perspectives on health and they made lifestyle choices that improved quality of life and improved resistance to disease. It would be amazing to see more Americans use food and exercise as preventative medicine to help decrease the impact of diseases like COVID and others.

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Nurses Reflect on Being at the Frontline of the Coronavirus Pandemic - Mpls.St.Paul Magazine

A well attended online Campus course staged by the SIG Reproductive Genetics heard that the expansion of sequencing analysis is poised to push forward the development of cost-effective preconception tests able to identify several underlying genetic causes of infertility

The everyday implications of preconceptional medicine have so far been largely evident in lifestyle advice conducive to successful pregnancy, but a well attended online Campus meeting staged in December suggests that genomic medicine has an increasingly important role to play. Sessions at the meeting not only covered the much debated subject of genetic risk assessment by expanded carrier screening, but explored the application of genome-wide sequencing in recurrent miscarriage, in predicting ART outcomes from parental genome analysis, and even in explaining the different responses to ovarian stimulation with gonadotrophins. Such subjects, especially expanded carrier screening, are not without their ethical problems, notably in the disclosure (or not) of secondary findings, so it was also appropriate at this meeting to hear a preview of ESHREs forthcoming recommendations on expanded carrier screening in ART.

In his opening lecture Stphane Viville, a former coordinator of ESHREs SIG Reproductive Genetics, said that known genetic and chromosomal factors account for around 20% of all infertility cases, with three additional (and relatively unknown) phenotypes now moving into active research: POI, oocyte maturation defect, and preimplantation embryonic lethality, all of which were covered at this meeting. Viville added that so far at least 21 genes have been implicated in POI and advised that genetics is now getting more and more into IVF labs and no longer confined to chromosomal aberrations or microdeletions on the Y chromosome.

Much of the content of this Campus course has been explored in detail in a recent Human Reproduction Update review, whose first author, Antonio Capalbo, is deputy of ESHREs SIG Reproductive Genetics and an organiser of this course.(1) In the review, as was repeatedly implied at this meeting, Capalbo et al note that the expansion of sequencing analysis may enable the development of cost-effective preconception tests capable of identifying underlying genetic causes of infertility, which until now have largely been defined as idiopathic.

One such step in this move towards a more positive and personalised approach to preconceptional medicine is in genetic risk assessment by expanded carrier screening, which occupied a large section of this meeting. James Goldberg, prominent in the development of ECS, said its availability now steps beyond the disparities and restrictions of ethnicity-specific screening and aims to inform couples about their risk of having children with autosomal recessive and X-linked recessive disorders and thereby to support informed decision making. Nevertheless, two of the current guidance statements on ECS cited by Goldberg both from the USA are largely based on ethnicity screening with an emphasis on cystic fibrosis and spinal muscular dystrophy. ECS, said Goldberg, represents a more equitable approach to identifying risk. Such risk assessment in both the general population and IVF couples - will allow identification of those who carry recessive mutations, and thereby provide increased reproductive autonomy to couples deemed at risk and where PGT is available for embryo selection.

However, when a publicly provided ECS programme was set up in Amsterdam offering a test panel of 50 genes (at a cost of 650 euro per test) and following the guidance of the European Society of Human Genetics, there was a relatively quiet response (20%) from the general risk population, and higher (80%) from the high risk population.(2) Nevertheless, assessment of the programme, began in 2016, appeared to raise more questions than answers, and no clear resolution of how such a programme might be best provided. Capalbo and his fellow Update reviewers concluded that ECS represents one of the most effective and advanced applications of preconception genomic medicine worldwide today and is expected to grow in application in coming years.

The preview of recommendations from ESHREs Ethics Committee was specifically about ECS ahead of ART (and not just involving gamete donors). Thus, asked Dutch bioethicist Guido de Wert, would the offer of ECS to all such applicants be proportionate, and if so, for what kinds of disorders and under what conditions? Applying the three ethicists principles of proportionality, respect for autonomy and justice, De Wert firstly noted that any possible benefits should clearly outweigh any possible harms, that ECS should still be embedded in a research framework, and that a couples access to ECS should only be on condition that they take preventive measures and apply for PGT, donor gametes, or, maybe, prenatal diagnosis.

Even the outcome of fertility treatments may well be affected by genetic mutations, and such extreme outcomes as oocyte maturation failure and embryonic developmental arrest are now investigated as a genetic cause of infertility. Indeed, Semra Kahraman from theIstanbul Memorial Hospital reported that variants in more than 2000 genes are now predicted to be involved in various infertility pathways. She described her own study in which 22 IVF patients whose repeated failure was attributed to oocyte maturation failure and embryo development arrest and who were investigated using whole exome sequencing panels. Family history analysis had also identified infertility and early menopause in the family of nine of the subjects. The analysis identified genomic variants in eight of the 22 subjects, including four genes known to be lethal at the embryonic stage.

With ovarian ageing identified as one of todays most frequent causes of infertility, John Berry, an MRC investigator from Cambridge, reported in a keynote lecture that ten years ago population studies had identified four common genetic variants associated with menopause. Today, he added, there are now more than 300 loci identified, which explain around 10% of the heritable component. Too few to be clinically useful? he asked. Again, there appeared more questions than answers, notably if POI can be explained solely by monogenic alleles and if menopausal age can indeed be predicted by genetics.

The conclusions from this meeting, as well as the increasing number of genes and variants identified, suggest that genomic assessment ahead of conception may have real clinical benefits at both the individual (in identifying genetic risks in the male and female partner) and the couple level (in allowing a specific reproductive prognosis). Information at this early stage may thus lay the basis for personalised interventions, and certainly make at-risk couples better informed of their reproductive choices.

1. Capalbo A, Poli M, Riera-Escamilla A, et al. Preconception genome medicine: current state and future perspectives to improve infertility diagnosis and reproductive and health outcomes based on individual genomic data, Hum Reprod Update 2020; doi:10.1093/humupd/dmaa044

2. Henneman L, Borry P, Chokoshvili D, et al. Responsible implementation of expanded carrier screening. Eur J Hum Genet 2016; 24: e1-e12. doi:10.1038/ejhg.2015.27

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The expanding role of genomics in preconceptional 'personalised' medicine - ESHRE

This clinical pilot will evaluate the effectiveness of Digbi Health's obesity management digital program personalized to each bariatric surgery patient, one-year post sleeve gastrectomy, based on their lifestyle, genetic and gut microbiome risks, in further reducing weight and maintaining weight loss. Obesity is a complex metabolic disease and an ongoing epidemic, with associated inflammatory, digestive, musculoskeletal, skin morbidities, as well as a risk factor for diabetes, cardiovascular disease, COVID-19, and reduced life expectancy, which currently affects 42 percent of the adult population in the United States. Bariatric surgery is the most effective long term intervention for morbid obesity, and successful bariatric surgery outcomes depend on lifelong changes in eating patterns and social support.

Research indicates individuals' genetic and gut microbiome makeups are intrinsically linked to their metabolism and following personalized nutrition recommendations and meal plans curated to an individual's genetic and gut microbiome markers may assist with further weight loss and ongoing weight maintenance post sleeve gastrectomy.

"WVU Bariatrics is excited to partner with Digbi Health to better understand how genomic, gut microbiome and metabolomic factors can contribute to successful weight loss following bariatric surgery," said Nova Szoka MD, FACS, FASMBS, Assistant Professor at J.W. Ruby Memorial Hospital, WVU Bariatrics Surgical Weight-Loss Center and principal investigator of the study.

"Digbi Health is the first company to operationalize a genetic and gut microbiome-based prescription-grade platform for doctors and payers to deliver weight loss, digestive health, and diabetes care programs at scale," said Ranjan Sinha, CEO, and founder of Digbi Health.

"Digbi is committed to empowering people suffering from obesity and chronic inflammatory lifestyle illnesses, struggling with ineffective one-size-fits-all diets, with personalized nutrition and lifestyle support that works for them. Through this collaboration with WVU Medical, we aim to deeper explore the critical importance of personalized nutrition and its direct impact on people suffering from obesity and associated illnesses," said Sinha.

More information about J.W. Ruby Memorial Hospital, WVU Medical, and Surgical Weight-Loss Center can be found here.

About Digbi HealthDigbi Healthis a first-of-its-kind precision digital therapeutics company that offers a prescription-grade digitally enabled personalized obesity and obesity-related gut, skin disorders, hypertension, and other cardiometabolic health management programs based on an individual's gut biome, genetic risks, blood markers, and lifestyle factors. Digbi Health and members of its physician network are committed to empowering people to take control of their own health and wellness. Digbi Health is prescribed by doctors, healthcare providers, and insurance companies.

SOURCE Digbi Health

digbihealth.com

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Digbi Health partners with West Virginia University Medicine and WVU Bariatrics Surgical Weight-Loss Program to improve postoperative weight loss...

Dec. 24, 2020 23:30 UTC

SAN FRANCISCO--(BUSINESS WIRE)-- Audentes Therapeutics, an Astellas genetic medicines company, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold for the ASPIRO clinical trial evaluating AT132 in patients with X-linked myotubular myopathy (XLMTM). XLMTM is a serious, life-threatening neuromuscular disease characterized by extreme muscle weakness, respiratory failure, and early death.

We are grateful for the efforts of our team and investigators who have worked tirelessly to answer the FDAs questions and we now look forward to resuming this study, said Natalie Holles, President and Chief Executive Officer of Audentes. We want to again extend our deepest sympathies to patients families impacted by the events earlier this year. We are deeply committed to the continued safe development of AT132 for the families and patients living with XLMTM, a disease with no existing treatments.

The company is now working to complete all clinical and regulatory activities necessary to resume dosing and plans to have discussions at a future date with the regulators on the path forward toward global registration filings for AT132.

About X-linked Myotubular Myopathy XLMTM is a serious, life-threatening, rare neuromuscular disease that is characterized by extreme muscle weakness, respiratory failure and early death. Mortality rates are estimated to be 50 percent in the first 18 months of life. For those patients who survive past infancy, there is an estimated additional 25 percent mortality by the age of 10. XLMTM is caused by mutations in the MTM1 gene that lead to a lack or dysfunction of myotubularin, a protein that is needed for normal development, maturation and function of skeletal muscle cells. The disease affects approximately 1 in 40,000 to 50,000 newborn males.

XLMTM places a substantial burden of care on patients, families and the healthcare system, including high rates of healthcare utilization, hospitalization and surgical intervention. More than 80 percent of XLMTM patients require ventilator support, and the majority of patients require a gastrostomy tube for nutritional support. In most patients, normal developmental motor milestones are delayed or never achieved. Currently, only supportive treatment options, such as ventilator use or a feeding tube, are available.

About the ASPIRO Study ASPIRO is a two-part, multinational, randomized, open-label ascending dose trial to evaluate the safety and preliminary efficacy of AT132 in XLMTM patients less than five years of age. Primary endpoints include safety (adverse events and certain laboratory measures) and efficacy (assessments of neuromuscular and respiratory function). Secondary endpoints include the burden of disease and health-related quality-of-life, and muscle tissue histology and biomarkers.

About AT132 for the treatment of X-linked Myotubular Myopathy Audentes is developing AT132, an AAV8 vector containing a functional copy of the MTM1 gene, for the treatment of XLMTM. AT132 may provide patients with significantly improved outcomes based on the ability of AAV8 to target skeletal muscle and increase myotubularin expression in targeted tissues following a single intravenous administration. The preclinical development of AT132 was conducted in collaboration with Genethon (www.genethon.fr).

AT132 has been granted Regenerative Medicine and Advanced Therapy (RMAT), Rare Pediatric Disease, Fast Track, and Orphan Drug designations by the U.S. Food and Drug Administration (FDA), and Priority Medicines (PRIME) and Orphan Drug designations by the European Medicines Agency (EMA).

About Audentes Therapeutics, Inc. Audentes Therapeutics, an Astellas company, is developing genetic medicines with the potential to deliver transformative value for patients. Based on our innovative scientific approach and industry leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for the newly created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina.

About Astellas Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+ healthcare solutions combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at https://www.astellas.com/en

Cautionary Notes In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on managements current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas intellectual property rights by third parties.

Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.

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Audentes Therapeutics Announces FDA Lifts Hold on ASPIRO Clinical Trial of AT132 for Treatment of X-Linked Myotubular Myopathy (XLMTM) - BioSpace

Even the most promising drugs can hit a pothole in the road to U.S. Food and Drug Administration (FDA) approval, particularly when working in the complicated, evolving world of gene therapies.

After touting positive Phase III resultsat ASH (American Society of Hematologys annual meeting),uniQuregot slapped with anFDA clinical holdfor their hemophilia B treatment due to a patient developing liver cancer.

Theresearch team alerted the FDA of the development after a lesion was found during a routine one-yearfollow-up.A hepatocellular carcinoma (HCC) isexpectedto be confirmed with a full surgical resection.

However, the cancer may not be related to the gene therapy, as this particular patient was high risk for liver cancerwith a long history of hepatitis C, hepatitis B virus, findings of non-alcoholic fatty liver disease and advanced age.UniQurepointed out thatchronicinfections with hep B and C are associated with 80% of HCC cases.

Patient safety will always be our top priority, and we are working closely with the FDA and our advisors to conduct a thorough investigation into the cause of this event which we expect to be completed in early 2021, said RicardoDolmetsch, Ph.D., president of R&D atuniQure. We will investigate whether there is a relationship to treatment. At this time, we do not have adequate data to determine a possible causal relationship, especially in the context of the other known risk factors.

The hold is not expected to affect the pivotal trial results as the dosing of the patients is completed.

While several treatments areavailable for hemophilia B, doctors and patients are holding out hope for a cure that will stop the disease at its source. Thats thepotential that genetic medicine has held for this area.

UniQuresdrug, AMT-061, substantially increased production of the blood-clotting protein factor IX, thefactor missing forhemophiliaBpatients,innearly all trial participants with moderate to severe disease.

Drug developers have run into a challenge with gene therapies in patients with high levels of neutralizing antibodies. Those antibodies can disarma gene therapyby attacking its viral vector delivery systembefore it ever has the chance to help thepatient.Many gene therapy trials wont enroll patients who test positive for neutralizing antibodies.

UniQuresgene therapy is delivered by an AAV5 vehicle, whichis believed to be harder to impair than other vectors.The company enrolled 23 patients with neutralizing antibodiespresent.Only one patient did not respondto the therapy. That was one who had a large amount of theantibodies- encouraging results that at least some with neutralizing antibodies could go on the therapy.

All patients in our hemophilia B gene therapy program, including the 54 patients in HOPE-B, will continue to be monitored by their care teams while we gather additional information as rapidly as possible, noted CEO Matt Kapusta. We do not anticipate any impact to our regulatory submission timeline for the hemophilia B program as a result of this clinical hold.

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Hope on Hold: Promising Hemophilia B Therapy Paused by FDA - BioSpace

MORGANTOWN, W.Va. (WV News) Dr. Mary Louise Russell is a member of the team of experts at the WVU Medicine Childrens that specializes in pediatric physical medicine and rehabilitation.

She and her colleagues treat children who have movement issues due to a wide range of causes, Russell said.

Sometimes the children only have movement problems, and sometimes the movement problems are part of a more complex picture, she said. For example, children with Down syndrome can have movement problems, and they might be behind on learning to walk. But, they might have other problems, too, like developmental delay and even some other medical difficulties, like heart defects or GI problems.

She sees children of all ages, from just nine days old to beyond age 18, Russell said.

For new patients, well go all the way to 18 years. Although, for some who have had pediatric onset of chronic conditions, well see them into at least young adulthood, say mid-20s, she said. That would usually be a person with cerebral palsy.

Cerebral palsy is among the most common diagnosis she sees, Russell said.

Cerebral palsy is a problem with how the brain works that effects how somebody moves. It can be confined to the movement control part of the brain, or there may be other problems, like seizures or developmental delay, she said.

There are a variety of treatments for patients with cerebral palsy, Russell said.

The first treatment to be used is physical and occupational therapy, she said. In the United States, there is a service called Birth to Three or Early Intervention that is a federal government-supported service administered by states for kids to get in-home therapy services.

Other treatments for cerebral palsy include braces, walkers, crutches, or wheelchairs, Russell said.

Medications can be administered to reduce tone spasticity, and orthopaedic or neurosurgery can help to reduce muscle spasticity, she said. There is a variety of possible treatments that cover a range of issues.

The COVID-19 pandemic has forced her to rely on remote visits with some patients, which isnt quite the same as seeing them in person, Russell said.

I think its better than nothing, but for what I do say for a patient with cerebral palsy I really like to be able to feel how much resistance they give me when trying to stretch their arms or their legs, she said. Thats kind of a hard thing to do from a screen.

She looks forward to being able to see all of her patients in-person again in the near future, Russell said.

A lot of families right now are reluctant to bring their children for in-person visits, and I can understand. Many of these kids are medically fragile or chronically ill, she said. We just need to wait a little while longer for their in-person visits.

Russell, who has more than 30 years of medical experience, said she has seen significant leaps in what genetics can reveal about a patients condition.

What has been the biggest help to us has been advances in genetics, she said. I can remember when we would just diagnose them and say They have low muscle tone. Now, were able to identify genetic syndromes and where parts of a chromosome may be missing or duplicated.

When she was first starting out information was much more limited, Russell said.

Having genetic information helps you with set reasonable goals, she said. You may not be able to fix the underlying problem, but you know what to expect and to plan for.

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WVU Medicine Children's Dr. Mary Louise Russell brings 30-plus years experience in the treatment of children with movement issues - WV News

Dozens of countries have banned travel from the UK in an effort to contain a new Covid-19 variant first reported in England.

The new mutation is being called VUI-202012/01 the first "Variant Under Investigation" in the UK in December 2020. While scientists hunt for more information about the variant, its impact is already being felt, with dozens of countriesimposing restrictions on travelers from the UK.

Here's what we know so far about the Covid-19 variant:

What is a variant and why are officials concerned about this one?A variant occurs when the genetic structure of a virus changes. All viruses mutate over time and new variants are common, including for the novel coronavirus.

Like other variants, this one carries agenetic fingerprint that makes it easy to track, and it happens to be one that is now widespread in southeast England. That alone does not necessarily mean a variant is more contagious or dangerous.

But scientists advising the UK government have estimated that this variant could be up to 70% more effective at spreading than others. Peter Horby, chair of theNew and Emerging Respiratory Virus Threats Advisory Group(NERVTAG), said Monday that experts "now have high confidence that this variant does have a transmission advantage" over other variants.

The World Health Organization said Tuesday that the changes to the variant include 14 key mutations, and that some of them "may influence the transmissibility of the virus in humans," though it added that further laboratory investigations were needed.

Where did the variant originate and how has it taken hold?The new variant is believed to have originated in southeast England, according to the WHO. Public Health England (PHE) says backwards tracing, using genetic evidence, suggests the variant first emerged in England in September. It then circulated in very low levels until mid-November.

Chris Whitty, England's chief medical officer, said Saturday the variant was responsible for 60% of new infections in London, which have nearly doubled in the last week alone.

Multiple experts have also suggested that this new variant could have been amplified because of a superspreader event, meaning the current spike in cases could also have been caused by human behavior.

Is the new variant more deadly? There is no evidence as of now to suggest that the new variant is more deadly, according to Whitty and the WHO, though it is too early to tell.

Several experts have noted that in some cases, virus mutations that increase transmissibility are accompanied by a drop in virulence and mortality rates.

"As viruses are transmitted, those that allow for increased virological 'success' can be selected for, which changes the properties of the virus over time. This typically leads to more transmission and less virulence," Martin Hibberd, professor of emerging infectious disease at the London School of Hygiene & Tropical Medicine, told the SMC.

Learn more about the UK coronavirus varianthere.

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The latest on the coronavirus pandemic and vaccines: Live updates - CNN

As the COVID-19 vaccine starts rolling out across the country, pregnant or breastfeeding women may be wondering if they should get it too.

First, the unknowns: Because clinical trials didnt include pregnant patients, there is no conclusive evidence related to vaccine safety and efficacy during pregnancy.

What experts do know: Pregnant patients are at higher risk of severe disease and worse outcomes from COVID-19 than non-pregnant peers and therefore would benefit from protection from the virus.

We have been following the research and federal guidance closely about pregnancy and the COVID-19 vaccine, says Molly Stout, M.D., MSCI, maternal fetal medicine director at Michigan Medicine Von Voigtlander Womens Hospital.

Based on the current information available and known risks of COVID-19 severity in pregnancy, we strongly recommend that pregnant and nursing people have access to the vaccine. We advise patients to discuss potential benefits and unknown risks specific to their individual situation with their healthcare provider.

Stout responds to some of the top questions about the COVID-19 vaccine and pregnancy:

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Stout: No, the vaccines have not been studied in pregnancy specifically. A few unexpected pregnancies occurred during the vaccine trials in participants, but we dont have further data on those cases at this time. There are ongoing efforts to include pregnant women in current COVID-19 vaccine trials.

Stout: Because pregnant women were not included in the early studies, we cannot be certain of how well the vaccine will work in pregnancy. The vaccine appears to be 95% effective in reducing COVID-19 disease in non-pregnant individuals. We also do not have specific safety information in pregnancy. However, the consensus of scientists, doctors, and professional organizations in the U.S. is to support pregnant women receiving the vaccine because the health risks of COVID-19 in pregnancy can be severe.

This recommendation is based on the known risk of COVID-19 in pregnancy and the biology of mRNA vaccines which are made with a string of the virus genetic material (a message of RNA that generates protein) and not the virus itself.

The technology of mRNA vaccines has been available for a long time and in general the risks from this form of vaccine are low. Also, the safety profile of the vaccine from the randomized control trials in non-pregnant individuals suggested no significant safety concerns.

Stout: Its important to understand that there is no way to get COVID-19 from the vaccine. While some vaccines are called live because they contain the virus, the COVID-19 vaccine is not one of them. However, when your immune system is doing its job reacting to the vaccine, you may experience some flu-like symptoms.

Eighty-four percent of people in the studies experienced redness or soreness at the site of the injection, over half felt fatigue and a headache, 1/3 had muscle pain and chills and 15-20% had joint pain or a fever.

Scientists think these symptoms are related to the vaccine activating your immune system to make the cells and proteins against COVID-19. There havent been any dangerous safety events that occurred more commonly in people who got the vaccine.

Stout: Vaccination is recommended for nursing mothers because benefits of the vaccine outweigh the theoretical risks regarding the safety of vaccinating.

Vaccine trials excluded lactating individuals, so we dont have any clinical data on the safety of the vaccine during lactation. However, because of the biology of the vaccine, (which doesnt involve a live virus) there should be no transfer into breastmilk.

In fact, antibodies from the lactating mother that transfer into the breastmilk may actually protect the breastfeeding child. The Academy of Breastfeeding Medicine does not recommend stopping breastfeeding for people who get the COVID-19 vaccine.

Stout: We have seen some misinformation about this topic. It is too early to know whether the vaccine has any impact on fertility, but we dont suspect it does.

The mRNA vaccines do not incorporate into the genetic material of the individual. The mRNA is the code or message to make a protein that helps the body react more quickly if exposed to COVID-19. Thus, there is no genetic reason an egg or a sperm would be affected by the vaccine.

A pregnancy test prior to vaccination isnt recommended or required.

Stout: Because of their higher risk of exposure, certain groups have been prioritized for initial vaccine distribution, including healthcare workers, first responders and workers in long-term healthcare facilities.

The general guidance is that pregnant patients who are in these frontline categories should be able to receive the vaccine as soon as they meet the criteria and its available to them.

Stout: Right now there havent been any recommendations to change dosing or schedules for the COVID-19 vaccine for people with allergies who experience anaphylaxis.

Stout: Recent studies have suggested that pregnant people who contract COVID-19 have a higher risk of severe illness and outcomes, such as being admitted to intensive care, being put on a ventilator and dying than non-pregnant women with the virus. These risks are higher for women of color, including African-American and Hispanic populations.

Adverse pregnancy outcomes such as preterm birth for COVID-positive patients have also been reported, but data in this area are still evolving.

Given these risks, pregnant patients should consider getting vaccinated against the virus and also take all other precautions to protect themselves from exposure by socially distancing, wearing masks and following safety guidelines.

Stout: Studies are limited in this area as well. There have been cases of newborns testing positive for COVID-19 shortly after birth. Whats unclear is whether they were infected with the virus before, during, or after birth from close contact with someone who had the virus.

Most newborns who tested positive for COVID-19 had mild or no symptoms.

Stout: The vaccine has been shown to decrease your chance of having COVID-19 symptoms and severe disease. What is unknown is whether vaccinated people can still carry and transmit the virus. For this reason, the recommendation is to continue to wear masks, socially distance and maintain other recommended safety measures even for people who have been vaccinated.

Stout: There have been efforts to collect outcomes data on pregnant women who have received the vaccine and our hope is that vaccine manufacturers report this information as it becomes available.

Development of the COVID-19 vaccine is a major scientific feat and marks the fastest vaccine development and distribution to date. Doctors and scientists agree COVID-19 vaccines will be a critical measure in slowing the spread and mortality associated with COVID-19. The downside of this remarkable scientific success is we have to be able to continue to collect longer term data as we follow pregnant and non-pregnant patients forward in time and continue to track vaccine success.

Stout: Based on what we know about how COVID-19 may negatively impact a pregnant patients health, we see great benefits to patients being protected from the virus through all measures available, including the vaccine.

We expect recommendations to continue to evolve as more data are collected about these vaccines and their use in specific populations, including pregnant patients. We will be following this evolving data closely and keeping all obstetric care providers at Michigan up to date.

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Should Pregnant and Breastfeeding Patients Get the COVID-19 Vaccine? - University of Michigan Health System News

As the world grapples with the pandemic amid the origin of newer and potentially lethal strains, BioNTech CEO Ugur Sahin has said that the deadly virus is going to stay with us for the next decade at least.

In a virtual press conference this week, Sahin spoke about the potential virus deadline when asked when life could return to normal.

"We need a new definition of normal. The virus will stay with us for the next 10 years," he told mediapersons.

Sahin also said that the vaccine can be adjusted for the new UK variant in about six weeks.

"In principle, the beauty of the messenger technology is that we can directly start to engineer a vaccine which completely mimics this new mutation - we could be able to provide a new vaccine technically within six weeks," he was quoted as saying in media reports.

Sahin said he was confident that the new variant of the Covid-19 strain in the UK would not impact the efficacy of the vaccine.

The new strain of Covid is causing worry all around the world including in India, and it remains to be seen what effect it could have.

After the discovery of a second new variant of the novel coronavirus in Britain, the UK has reported the highest number of Covid-19 fatalities this week, since late April.

Health Secretary Matt Hancock said that the second new variant was reportedly related to travellers from South Africa, and two cases have been reported so far.

"This new variant is highly concerning because it is yet more transmissible and it appears to have mutated further than the new variant that has been discovered in the UK," he said this week.

As a result, Johnson imposed Tier Four restrictions om London and other parts of England.

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Covid virus will stay with us for next 10 years: BioNTech CEO - ETHealthworld.com

Immunai, a company specializing in comprehensive mapping of the human immune system, is joining forces with 10x Genomics. The latter will leverage its single-cell technologies to map hundreds of cell types and states. By applying its artificial intelligence (AI) and machine learning (ML) algorithms, Immunai supports biomarker discovery and insight generation to help power new therapeutic discoveries and accelerate drug development.

Outsourcing-Pharma (OSP) discussed the partnership with Luis Voloch (LV), CTO and co-founder of Immunai, and how the map generated through the collaborative effort stands to benefit drug developers.

OSP: Please tell us a bit about Immunai.

LV: Immunai is comprehensively mapping the immune system to power new therapeutic discoveries, accelerate drug development, and improve patient outcomes. Leveraging single-cell technologies to profile cells and machine learning to map incoming data to hundreds of cell types and states, Immunai supports biomarker discovery and insight generation to better detect, diagnose, and treat disease.

The immune system is an incredibly complex, distributed system that researchers have been trying to understand with limited success for years. Immunai is the first company to fully map the immune system, generating the largest proprietary database for immunology.

Were disrupting legacy companies by analyzing 10,000 times more data from each cell than they are. No one is doing exactly what were doing.

OSP: How did you come to partner with 10x Genomics?

LV: There is an undeniable fit between the goals and capabilities of our two companies. At Immunai, we want to use AI to identify and understand novel elements within hundreds of different cell types to inform drug development, and we have been leveraging 10xs products to do that at a granular level from the start.

Through our initial work together, we identified even more mutually beneficial applications of our technologies for pharma companies and academic institutions alike. So we most recently applied to 10xs Certified Service Provider Program to give 10xs customers access to our advanced immune profiling solutions.

OSP: What does each of you bring to the table in this partnership, and how will the collaboration work?

LV: With this collaboration, we will pair our immune cell atlas with the phenotypic clinical data that hospitals, biopharma, and biotech companies derive from 10xs technology. With Immunais end-to-end computational AI pipeline customized for single-cell methods, researchers at pharmaceutical and cell therapy companies can better understand how immune cells operate with both granularity and scale. In turn, we will help 10xs customers answer clinical and translational questions related to the immune response to therapies.

OSP: Could you please talk a bit about the evolution of AI and how drug discovery professionals have made use of it to date?

LV: An analysis published earlier this year in the Journal of the American Medical Association found that the median cost of R&D for a new drug in the years between 2009 and 2018 was $985 million. This ever-increasing cost forces pharma companies to search for innovative means to create efficiencies in drug development.

Pharma companies are catching on to what Immunai already knows: AI can maximize our ability to layer data points, uncover deep insights, and advance research.

We envision AIin conjunction with human intelligenceas the major component to understanding and curing cancer. AI will increasingly have a tremendous impact on pharma. Pharma has traditionally had to experiment by testing out different compounds in a dish or in animals.

With more biological data available, AI provides a partial alternative to this that allows us to predict (without actual experiments) the impact of compounds in different biological systems. This ability has increased the speed in which we can profile and improve compounds.

OSP: What is particularly novel and noteworthy about this projectwhat do you hope to accomplish that hasnt been accomplished before?

LV: Until now, no one has been able to uncover the complexities of the immune system in the way that Immunai has. Current single-cell approaches generally operate at the scale of small academic studies because they suffer from the problem of batch effects, where noise from variation in biological samples quickly washes out any real biological signal as scale grows.

Immunais end-to-end platform is designed to manage batch effects through both proprietary lab methods and advanced AI, allowing us to build a large multi-omic single-cell database that we pair with clinical context. We train our proprietary neural network models on this data to surface insights about immune responses and facilitate the development of better therapies.

This lack of understanding of the immune system contributes to inefficiencies in drug R&D. Developing immunotherapies based on information provided by only two cells doesnt give researchers a view of the entire picture.

We believe that this collaboration will help to drastically improve the development of therapies and answer some of the biggest questions about cancer.

OSP: Is there anything youd like to add that we didnt touch upon?

LV: Our work with 10x is the second official collaboration weve announced over the past few months. In November, we announced a collaboration with Baylor College of Medicine to drive forward the development of novel NKT cell therapies. As our database continues to grow with these partnerships, we can apply learnings around immune response across different diseases from cancer to autoimmune disorders to cardiovascular diseases as well.

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Collaboration to chart AI-generated map of the immune system - OutSourcing-Pharma.com

Representative Image

As a majority of the world collectively holds its breath waiting for COVID-19 vaccinations, indirect protective measures such as social distancing and wearing of masks have been keeping people out of the coronavirus' grasp. Furthermore, the development of antibodies in individuals that have successfully beaten the virus has also served as an 'antivirus' protection for themselves and those around them.

But with that said, there has been constant speculation on just how long these antibodies and the overall immunity against COVID-19 lasts in the human system. The clouds of mystery pertaining to this particular question continue to govern scientists, virologists, and researchers. Thus far, several studies have suggested that the antibodies against the infection may wane in just a few months after recovery, thereby raising concerns of contracting the infection more than once.

Now, a team of scientists from the Monash University in Australia has given the world a Christmas gift through their new study, which has indicated that immunity against COVID-19 can last for at least eight months. The research is all the more significant at the moment, when vaccines are still in their rollout phases.

"This has been a black cloud hanging over the potential protection that could be provided by any COVID-19 vaccine, and gives real hope that once a vaccine or vaccines are developed, they will provide long-term protection," said immunologist Menno van Zelm from Monash University.

The new study specifically took into account a type of cells in our immune system known as the memory B cells or MBC. These cells function to remember any infection that the human body contracts after being invaded by a pathogen, say virus. Therefore, if an individual contracts the virus again, MBC functions to trigger a protective immune response through its memory, and thus shields an individual from re-infection.

To understand the presence of memory cells, the team chased two main components of the SARS-CoV-2 virusthe spike and the nucleocapsid proteins. The study noted that the memory B cells were rapidly generated in all the patients following the infection, and remained detectable after 240 days. This very extended presence of the memory cells showcases a long-term immune response to COVID-19. It also highlights the fact that a patients immune system has the ability to fight when re-exposed to the pathogen by the rapid production of antibodies.

"These results are important because they show, definitively, that patients infected with the COVID-19 virus do in fact retain immunity against the virus and the disease," said Dr van Zelm.

Representative Image

Interestingly, the study also ascertained that even after months of virus spread, during which millions of positive infections have been found, there have not been many reported cases of re-infections among the population across the globe.

A similar study was recently published in the journal Emerging Infectious Diseases, which also confirmed the presence of antibodies against SARS-CoV-2 after 8 months of infection in most asymptomatic or mildly symptomatic patients. The study was conducted using the immunoassays test on 58 positive patients.

When attacked by a pathogen, our immune system produces proteins called antibodies in order to fight the infection. If the infected person can produce sufficient antibodies, he can recover from the disease caused by that pathogen.

To examine how long these antibodies last in case of COVID-19, researchers monitored about 25 people diagnosed with different severities of the disease, and then collected post-infection blood samples from themstarting from day 4 to day 242 after recovery. On the other hand, they also obtained data from 36 healthy control patients between March to September, so as to compare each patient's antibody presence and levels of virus-specific immune cells.

After examining this long period data, the researchers noted that the antibodies against COVID-19especially immunoglobulin (IgG), which is the most common antibody in the human bodystarted to fade in just 20 days post-infection, just like the previous studies had suggested.

Earlier, a similar research conducted by the Chongqing Medical University in China had also suggested that people who have recovered from COVID-19 showcased a sharp decline of up to 90% in their Immunoglobulin (IgG) antibodies within the time frame of 2-3 months.

The new research is a collaborative work between Monash University, The Alfred Hospital, and the Burnet Institute in Melbourne. The study was published in the journal Science Immunology on December 22, and can be accessed here.

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With the roll out of COVID-19 vaccines, many people may have questions about side effects.

During the clinical trials, people who were administered the Moderna or Pfizer vaccine experienced fever, joint pain and redness around the injection site.

These symptoms are said to last one to two days after receiving the dosage.

We spoke with a North Dakota Department of Health consultant who says the side effects are normal and a sign that your immune system is reacting to the vaccine.

Its more common to see these side effects after you receive the second dose of the vaccine. So dont be surprised if after the first dose you may have minimal or very few side effects, but after the second dose if that fever or those body aches are slightly more prominent again thats a sign your immune system is working, said Kylie Hall.

Hall says during the clinical trial side effects were more common in the Moderna vaccine than the Pfizer.

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Thats a sign your immune system is working: Side effects are normal with COVID-19 vaccines - KX NEWS

Immune system activity is enhanced after a viral infection such as COVID-19

Although the immune system is always working to prevent pathogens from invading the body, as well as eliminating those pathogens and generating an immunological memory, the metabolic activity of immune cell types is enhanced following a viral infection such as COVID-19. That heightened activity is accompanied by a higher demand of energy and nutrients, which come from diet, to meet the immune cells requirements.

In a new comprehensive review, Prof. Philip Calder from the University of Southampton provides an update on the role of nutrition in supporting the immune system as part of the current fight against COVID-19.

Different levels of evidence have shown the following as key nutrients involved in reducing infection risk by supporting antibacterial and antiviral defense:

The mechanisms by which each of the nutrients named above support the immune system include the strengthening of innate immune responses and antioxidant systems. Likewise, the gut microbiome also plays a role through its involvement in training the immune system and avoiding excessive inflammatory responses to pathogenic organisms. Furthermore, it has been shown to be altered in patients with COVID-19.

Although zinc and selenium have been shown to be particularly relevant for supporting antiviral defense, there is no single nutrient or diet that will prevent people getting infected with SARS-CoV-2 or have an impact on mortality in COVID-19. The immune system plays a central role in protecting against infection, but due to its complexity and the multiple ways in which it deals with viruses, the best advice is to consume a healthy, diverse and well-balanced diet that will provide the nutrients required to achieve a healthy gut microbiome, which can also benefit the immune system.

Considering that some patients with COVID-19 have been shown to have an altered gut microbiome, coupled with gastrointestinal symptoms, probiotics could be used as means of reducing bacterial translocation and secondary infection. However, even though probiotics containing Lactobacillus and Bifidobacterium have been shown to improve immune function and enhance the response to some vaccinations, it is still early to conclude whether the gut microbiome plays a therapeutic role in preventing or treating COVID-19.

In some COVID-19 patients, an excessive inflammatory reaction (called a cytokine storm) can occur as a compensatory reaction by immune cells for dealing with lung damage. In that regard, Philip Calder acknowledges in the review that the polyunsaturated omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) seem to be relevant in resolving ongoing inflammatory processes in patients with an outbreak of severe acute respiratory distress syndrome.

Although there is no specific evidence that nutrients alone can help protect against or lessen the effects of COVID-19, eating well and keeping a healthy weight will help the immune system cope better with the demands placed on the body before, during and after COVID-19 infection.

The World Health Organization has stressed the importance of a balanced diet to maintain a strong immune system and to avoid or minimize infections during the COVID-19 outbreak. For instance, the WHO has recommended consuming 9 servings of fruit and vegetables per day, which is more than in the usual dietary recommendations.

Although micronutrients, nutraceuticals and probiotics could be of interest for enhancing immunity during the COVID-19 pandemic, it is too early to make specific recommendations due to the small number of intervention studies that have been published.

In particular, patients with malnutrition, diabetes, obesity, cardiovascular disease and respiratory diseaseand especially older peopleare at a higher risk of complications from COVID-19 and will require personalized nutrition advice. In an attempt to provide specific nutritional advice for supporting the proper functioning of the immune system, the International Society for Immunonutrition has suggested increasing the intake of vitamin E, zinc and vitamin C in older people, along with vitamin D if they have a low serum vitamin D status.

So far, the most effective way of limiting the spread of COVID-19 is by preventing contact between people. Although several vaccines have been developed for prevention of SARS CoV-2, mass vaccination roll-out will take months. Meanwhile, nutrition should be considered in any approach to ensure that individuals immune systems are well supported, even though no nutrition studies have been published yet in the context of COVID-19.

References:

Calder PC. Nutrition, immunity and COVID-19. BMJ Nutr Prev Health. 2020; 3(1):74-92. doi: 10.1136/bmjnph-2020-000085.

World Health Organization. Nutrition advice for adults during the COVID-19 outbreak [cited 3 December 2020]. Available from: http://www.emro.who.int/nutrition/nutrition-infocus/nutrition-advice-for-adults-during-the-covid-19-outbreak.html.

Jayawardena R, Sooriyaarachchi P, Chourdakis M, et al. Enhancing immunity in viral infections, with special emphasis on COVID-19: a review. Diabetes Metab Syndr. 2020; 14(4):367-382. doi: 10.1016/j.dsx.2020.04.015.

Derbyshire E, Delange J. COVID-19: is there a role for immunonutrition, particularly in the over 65s? BMJ Nutr Prev Health. 2020; 3(1):100-105. doi: 10.1136/bmjnph-2020-000071.

International Society for Immunonutrition. ISIN Position Statement on Nutrition, Immunity and COVID-19. 2020 March [cited 2 December 2020]. In: ISIN [Internet]. Available from: https://www.immunonutrition-isin.org/docs/isinComunicadoCovid19.pdf.

Original post:
What is the role of nutrition in immunity and host susceptibility to COVID-19? - Gut Microbiota for Health

Dr. Dirk Sostman, chief academic officer at Houston Methodist, addressed questions and claims about how the shot and the immune system.

HOUSTON The VERIFY team is working hard to make sure you have the facts before you get vaccinated. Dr. Dirk Sostman, chief academic officer at Houston Methodist, addressed questions and claims about how the shot and the immune system.

CLAIM: I won't need to wear a mask after I get vaccinated for COVID-19.

FALSE. Dr. Sostman said, One of the things we don't know about this vaccine is whether it can prevent you from transmitting the virus to other people. We know itll protect you from getting sick, but you may have an asymptomatic infection and be able to pass on the virus to others. So, you must continue to wear a mask.

CLAIM: Vaccines can overload your immune system.

FALSE. Dr. Sostman said, There is nothing to indicate that vaccines will overload your immune system.

CLAIM: Natural immunity is healthier and more effective than vaccine-induced immunity.

Partly true. Dr. Sostman said, Natural immunity may give you a reaction to a wider range of parts of the virus, which potentially could be good. But, in general, what we found with these vaccines is that they actually produce a stronger immune response than natural immunity.

CLAIM. If everyone around me is immune, then I don't need to be vaccinated.

FALSE. Dr Sostman said, If everyone around you is vaccinated and immune, how do you think they got that way? We all have to be vaccinated and become immune in order for the whole population of the United States to be immune and safe from this virus.

CLAIM: Once you receive the coronavirus vaccine, you are immune for life.

UNKNOWN. Dr. Sostman said, There are reasons to believe you could be immune for a long time, but we have no real data to indicate how long the immunity is going to last.

CLAIM: You don't need both doses of the two-dose vaccine.

FALSE. Dr. Sostman said, You really do need both doses. There is some protection after the first does, but the protection is much better after the second dose. The second dose is probably what is going to give you a longer lasting immune response.

Read more here:
VERIFY: Yes, you will need to wear a mask after you get COVID-19 vaccine - KHOU.com

Supplements, vitamins and other botanicals have been a part of the health and wellness industry for years, and public interest shows no signs of slowing. According to a market research report by Fortune Business Insights, the immune health supplements market is expected to grow $13 billion over the next seven years.

And while health stores have always sold various capsules, powders and tinctures, theres another wave of immune-boosting remedies called adaptogens that are becoming increasingly popular.

Not sure which adaptogenic mushroom is right for you? Keep reading to determine which you should put in your morning potion.

Chaga. This immune-boosting mushroom is packed with antioxidants and is believed to fight inflammation.

Shiitake. According to webmd.com, shiitake mushrooms are high in natural copper, which might support healthy blood vessels, bones and overall immune system health.

Maitake. Known as the dancing mushroom, maitake is believed to promote mental and physical well-being. Popular for its immune-boosting properties, it is also used to aid in hormonal balance.

Reishi. Similar to chaga, reishi is full of antioxidants but can also help relieve depression. Reishi is also believed to help lower cholesterol and maintain heart health.

Heather Harmon and Jimmy Aston founded local apothecary the Shasta Shop, which opened last year and exists both online and in pop-up form at the Downtown Summerlin Farmers Market every Saturday, as a way to offer the community affordable access to herbs and adaptogens.

Shasta really came out of a love of health and wellnessmental health, physical health, Harmon says. To be healthy and to be thoughtful doesnt necessarily have to be that expensive.

Harmon had suffered a stress-related injury and was taking more than 20 pills and capsules to keep herself feeling healthy. But the price of those supplements started to add up.

I have always lived a really high-stress lifestyle, Harmon says. I was trying to process how [to] deal with the pressure and stress of everyday life and still be healthy and get all the nutrients you need.

I was doing things a bit backward, she continues, taking all these vitamins and running in circles. Thats when I started looking at reishi and chaga [mushrooms] and solutions that have been available to people for centuries.

Harmon and Aston say that instead of taking a daily concoction of vitamins and supplements, you can get similar or better effects from a teaspoon of adaptogens and superfoods in your coffee, tea or morning smoothie.

All adaptogens have a similar foundation of benefits, Aston explains. All of them are loaded with vitamins and nutrients and antioxidants, [but] each one has a special something that stands out more than anything else.

Aston recommends a shiitake or maitake mushroom powder to start. Thats a good all-around adaptogen that helps you in every situation and every part of your life. Its great for mental and physical health, and it has all these vitamins and nutrients. The couple also suggests lions mane, which Aston says has received quite a lot of press during the past few years for its alleged ability to produce new neural pathwayssomething that could potentially help prevent Alzheimers or dementia.

Root and mushroom powders arent all that Shasta has in store. The son of Taiwanese restaurateurs, Aston created his signature eggplant crisps after tweaking a family recipe thats been passed down through generations.

I veganized this recipe from my great-great-great-grandmother and then used it as a marinade for the eggplant, Aston says. Theres only four ingredients. We marinate it for over 24 hours, put it in a dehydrator for another 24 hours and then have these incredible snacks.

We work seasonally, Harmon adds, explaining that Shasta uses fresh fruits and vegetables when theyre available. When persimmons are gone, theyre gone. We dont fight to have something that isnt in line with the natural cycle or order of things.

As Harmon and Aston gear up for winter, theyre excited to offer shungite powder, a rare provision found only in a specific region of Russia. According to healthline.com, shungite is a black stone from Shunga, a village in Karelia, Russia. The stone is composed of fullerenes, a type of carbon nanostructure that is believed to fight pathogens, bacteria and viruses, as well as shield against electromagnetic frequencies.

Like all adaptogens, however, the benefits of each mushroom, powder or root takes time. It should be noted that theres little long-term research about adaptogens effects on the body over time. As with all other supplements, you should talk to your doctor before adding adaptogens to your diet or routine.

Adaptogens are not something you take once, Harmon says. Theyre about dedication. They definitely gain traction and are a slow build.

Instead of us taking 19 different capsules and supplements, Aston says, we have some coffee or matcha, put in a measured scoop of our lions mane and pine pollen and call it a day.

This story appeared in Las VegasWeekly.

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Vitamin alternative: Adaptogens offer a new way of boosting the immune system - Las Vegas Sun

Shoppers wear face masks on Regent Street in London on 19 December, the day the U.K. government imposed new restrictions to curb a rapidly spreading new SARS-CoV-2 variant.

By Kai KupferschmidtDec. 23, 2020 , 2:30 PM

Sciences COVID-19 reporting is supported by the Pulitzer Center and the Heising-Simons Foundation.

In June, Ravindra Gupta, a virologist at the University of Cambridge, heard about a cancer patient who had come into a local hospital the month before with COVID-19 and was still shedding virus. The patient was being treated for a lymphoma that had relapsed and had been given rituximab, a drug that depletes antibody-producing B cells. That made it hard for him to shake the infection with SARS-CoV-2.

Gupta, who studies how resistance to HIV drugs arises, became interested in the case and helped treat the patient, who died in August, 101 days after his COVID-19 diagnosis, despite being given the antiviral drug remdesivir and two rounds of plasma from recovered patients, which containedantibodies against the virus. When Gupta studied genome sequences from the coronavirus that infected the patient, he discovered that SARS-CoV-2 had acquired several mutations that might have allowed it to elude the antibodies.

Now, his analysis, reported in a preprint on medRxiv earlier this month, has become a crucial puzzle piece for researchers trying to understand the importance of B.1.1.7, the new SARS-CoV-2 variant first found in the United Kingdom. That strain, which appears to spread faster than others, contains one of the mutations that Gupta found, and researchers believe B.1.1.7, too, may have originated in an immunocompromised patient who had a long-running infection. Its a perfectly logical and rational hypothesis, says infectious disease scientist Jeremy Farrar, director of the Wellcome Trust.

Scientists are still trying to figure out the effects of the mutations in B.1.1.7, whose emergence led the U.K. government to tighten coronavirus control measures and other countries in Europe to impose U.K. travel bans. But the new variant, along with research by Gupta and others, has also drawn attention to the potential role in COVID-19 of people with weakened immune systems. If they provide the virus with an opportunity to evolve lineages that spread faster, are more pathogenic, or elude vaccines, these chronic infections are not just dangerous for the patients, but might have the potential to alter the course of the pandemic.

Its still very unclear whether that is the case, but Farrar believes its important to ensure doctors take extra precautions when caring for such people: Until we know for sure, I think, treating those patients under pretty controlled conditions, as we would somebody who has drug resistant tuberculosis, actually makes sense.

Researchers concern mostly focuses on cancer patients being treated for chemotherapy and similar situations. We dont yet know about people who are immunocompromised because of HIV, for instance, Farrar says.

B.1.1.7 attracted scientists attention because it was linked to an outbreak in Englands Kent county that was growing faster than usual. Sequences showed that virus had accumulated a slew of mutations that together caused 17 amino acid changes in the virus proteins, eight of them in the crucial spike protein. Among them are at least three particularly concerning ones.

One is 69-70del, a deletion that Gupta also found in his Cambridge, U.K., patient whose virus seemed to evade the immune system. It leads to the loss of two amino acids in the spike protein. In lab experiments, Gupta found that lentivirus engineered to carry the SARS-CoV-2 spike protein with this deletion was twice as infectious.

The second is N501Y, a mutation that evolutionary biologist Jesse Bloom of the Fred Hutchinson Cancer Research Center has shown to increase how tightly the protein binds to the angiotensin-converting enzyme 2 (ACE2) receptor, its entry point into human cells. The mutation is also present in 501Y.V2, a variant discovered by researchers in South Africa who investigated rapidly growing outbreaks in three coastal provinces. We found that this lineage seems to be spreading much faster, says Tulio de Oliveira, a virologist at the University of KwaZulu-Natal whose work first alerted U.K. scientists to the importance of N501Y. Anytime you see the same mutation being independently selected multiple times, it increases the weight of evidence that that mutation is probably beneficial in some way for the virus, Bloom says.

The third worrisome change is P681H, which alters the site where the spike protein has to be cleaved to enter human cells. It is one of the sites on spike where SARS-CoV-2 differs from SARS-CoV-1, the virus that caused the worldwide outbreak of severe acute respiratory syndrome in 2003, and the change there may allow it to spread more easily. This one is probably as important as N501Y, says Christian Drosten, a virologist at Charit University Hospital in Berlin.

So far, SARS-CoV-2 typically acquires only one to two mutations per month. And B.1.1.7 is back to this pace now, suggesting it doesnt mutate faster normally than other lineages. Thats why scientists believe it may have gone through a lengthy bout of evolution in a chronically infected patient who then transmitted the virus late in their infection. We know this is rare but it can happen, says World Health Organization epidemiologist Maria Van Kerkhove. Stephen Goldstein, a virologist at the University of Utah, agrees. Its simply too many mutations to have accumulated under normal evolutionary circumstances. It suggests an extended period of within-host evolution, he says.

People with a weakened immune system may give the virus this opportunity, as Guptas data show. More evidence comes from a paper published in The New England Journal of Medicine on 3 December that described an immunocompromised patient in Boston infected with SARS-CoV-2 for 154 days before he died. Again, the researchers found several mutations, including N501Y. It suggests that you can get relatively large numbers of mutations happening over a relatively short period of time within an individual patient, says William Hanage of the Harvard T.H. Chan School of Public Health, one of the authors. (In patients who are infected for a few days and then clear the virus, there simply is not enough time for this, he says.) When such patients are given antibody treatments for COVID-19 late in their disease course, there may already be so many variants present that one of them is resistant, Goldstein says.

Its simply too many mutations to have accumulated under normal evolutionary circumstances. It suggests an extended period of within-host evolution.

The question is whether the mutations arising in such patients could also help the virus spread more rapidly. In research published a few years ago, Bloom showed some of the mutations that arose in influenza viruses in immunocompromised patients later spread globally. Its totally possible that whats happening in immunocompromised patients could foreshadow what happens in the future with the pandemic, Bloom says. But adaptations that help a virus outperform other viruses in a patient can also be very different from what a virus needs to better transmit from patient to patient, he says.

U.K. scientists and others were initially cautious about concluding that B.1.1.7s mutations made the virus better at spreading from person to person. But the new variant is rapidly replacing others, says Mge evik, an infectious disease specialist at the University of St.Andrews. We cant really rule out the possibility that seasonality and human behavior explain some of the increase, she says. But it certainly seems like there is something to do with this variant. Drosten says he was initially skeptical, but has become more convinced as well.

But exactly what impact each mutation has is much more difficult to assess than spotting them or showing theyre on the rise, says Seema Lakdawala, a biologist at the University of Pittsburgh. Animal experiments can help show an effect, but they have limitations. Hamsters already transmit SARS-CoV-2 virus rapidly, for instance, which could obscure any effect of the new variant. Ferrets transmit it less efficiently, so a difference may be more easily detectable, Lakdawala says. But does that really translate to humans? I doubt it. A definitive answer may be months off, she predicts.

One hypothesis that scientists are discussing is that the virus has increased how strongly it binds to the ACE2 receptor on human cells, and that this allows it to better infect children than before, expanding its playing field. But the evidence for that is very thin so far, evik says. Even if children turn out to make up a higher proportion of people infected with the new variant, that could be because the variant spread at a time when there was a lockdown but schools were open. Another hypothesis is that P681H helps the virus better infect cells higher up in the respiratory tract, from where it can spread more easily than from deep in the lungs, Drosten says.

One important question is whether the South African or U.K. lineage might lead to more severe disease or even evade vaccine-induced immunity. So far there is little reason to think so. Although some mutations have been shown to let the virus evade monoclonal antibodies, vaccines and natural infections both appear to lead to a broad immune response that targets many parts of the virus, says Shane Crotty of the La Jolla Institute for Immunology. It would be a real challenge for a virus to escape from that. The measles and polio viruses have never learned to escape the vaccines targeting them, he notes: Those are historical examples suggesting not to freak out.

At a press conference yesterday, BioNTech CEO Uur ahin pointed out that the U.K. variant differed in only nine out of more than 1270 amino acids of the spike protein encoded by the messenger RNA in the very effective COVID-19 vaccine his company developed together with Pfizer. Scientifically it is highly likely that the immune response by this vaccine also can deal with the new virus, he said. Experiments are underway that should confirm that in the first week of 2021, ahin added.

Sbastien Calvignac-Spencer, an evolutionary virologist at the Robert Koch Institute, says this marks the first time countries have taken such drastic actions as the U.K. lockdown and the travel bans based on genomic surveillance in combination with epidemiological data. Its pretty unprecedented at this scale, he says. But the question of how to react to disconcerting mutations in pathogens will crop up more often as genomic surveillance expands, he predicts. People are happy they prepared for a category 4 hurricane even if predictions turn out to be wrong and the storm is less severe, Calvignac-Spencer says. This is a bit the same, except that we have much less experience with genomic surveillance than we have with the weather forecast.

Although the rise of B.1.1.7 in the United Kingdom is troubling, Farrar says he is equally concerned about the other variant spreading quickly in South Africa and that has now been detected in two travelers in the United Kingdom as well. It includes two further mutations in the part of the spike protein that binds to its receptor on human cells, K417N and E484K. These could impact the binding of the virus to human cells and also its recognition by the immune system, Farrar says. These South African mutations I think are more worrying than the constellation of the British variant. South African hospitals are already struggling, he adds. Weve always asked, Why has sub-Saharan Africa escaped the pandemic to date? Answers have focused on the relative youth of the population and the climate. Maybe if you just increase transmission a bit, that is enough to get over these factors, Farrar says.

To Van Kerkhove, the arrival of B.1.1.7 shows how important it is to follow viral evolution closely. The United Kingdom has one of the most elaborate monitoring systems in the world, she says. My worry is: How much of this is happening globally, where we dont have sequencing capacity? Other countries should beef up their efforts, she says. And all countries should do what they can to minimize transmission of SARS-CoV-2 in the months ahead, Van Kerkhove says. The more of this virus circulates, the more opportunity it will have to change, she says. Were playing a very dangerous game here.

Excerpt from:
U.K. variant puts spotlight on immunocompromised patients' role in the COVID-19 pandemic - Science Magazine

Share This Article:A nurse treats a coronavirus patient in an ICU. Image from Scripps video

Patients with severe COVID-19 disease who develop respiratory failure have malfunctions in their immune systems that distinguish them from other such patients, according to a new study.

Support Times of San Diego's growthwith a small monthly contribution

The findings could help doctors develop new ways to prevent and treat this life-threatening complication researchers said.

The Cedars-Sinai study, published Dec. 16 in the journal Cell Reports, focused on acute respiratory distress syndrome known as ARDS. The sudden-onset respiratory failure can occur when the lungs lining is damaged by illness or injury.

ARDS causes fluid to accumulate in the lungs and also causes air sacs in the lungs to collapse, impeding breathing and lowering the oxygen level in the blood.

Although most COVID-19 patients have mild respiratory illness, about 20% become seriously ill and require hospitalization due to pneumonia. That can progress to ARDS and systemic inflammation, according to recent research.

ARDS is associated with poorer outcomes, including death or lasting lung damage.

Because ARDS has such serious consequences for coronavirus patients, it is critical that we understand why it happens and what we can do to treat it, said Peter Chen, MD, professor of Medicine and director of the Division of Pulmonary and Critical Care Medicine at Cedars-Sinai. That is why we did this research.

The research team analyzed the immune systems of 17 COVID-19 patients five with moderate coronavirus disease, six with ARDS and six who were recovering from ARDS and compared these patients against three people without COVID-19.

They looked at the transcription process, which is how genes transfer their instructions to proteins that construct a cells chemical processes, in so-called peripheral blood mononuclear cells.

This category includes various types of highly specialized immune cells that fight infections.

The investigators uncovered a range of distinctive defects in the transcription processes of peripheral blood mononuclear cells in the ARDS patients, as compared with the other subjects in the study.

These defects appeared in cells in both of the bodys immune systems: the innate immune system, which initially responds to viruses and bacteria; and the adaptive immune system, which kicks in later.

The defects also affected how the body switched between innate and adaptive immunity.

Our study supports the concept that COVID-19, and especially severe cases that have progressed to ARDS, is characterized by multifaceted impairment of the bodys regulation of immune responses, said Helen Goodridge, Ph.D, associate professor of Biomedical Sciences and Medicine at Cedars-Sinai.

Future research using larger sample sizes is needed to further delineate the transcriptional landscape of immune cells in different ARDS populations, according to the study team.

In the meantime, Goodridge said, the implications of the findings are clinically relevant. They indicate that treatment of patients with ARDS arising from COVID-19 infections may require a targeted approach instead of broad, immunosuppressive therapy.

City News Service

Study Finds Immune Issues in COVID-19 Patients With Acute Respiratory Failure was last modified: December 25th, 2020 by Editor

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Study Finds Immune Issues in COVID-19 Patients With Acute Respiratory Failure - Times of San Diego

Bacteria image. Credit: The Wistar Institute

Dual-acting immuno-antibiotics block an essential pathway in bacteria and activate the adaptive immune response.

Wistar Institute scientists have discovered a new class of compounds that uniquely combine direct antibiotic killing of pan drug-resistant bacterial pathogens with a simultaneous rapid immune response for combatting antimicrobial resistance (AMR). These findings were published on December 23, 2020, in Nature.

The World Health Organization (WHO) has declared AMR as one of the top 10 global public health threats against humanity. It is estimated that by 2050, antibiotic-resistant infections could claim 10 million lives each year and impose a cumulative $100 trillion burden on the global economy. The list of bacteria that are becoming resistant to treatment with all available antibiotic options is growing and few new drugs are in the pipeline, creating a pressing need for new classes of antibiotics to prevent public health crises.

We took a creative, double-pronged strategy to develop new molecules that can kill difficult-to-treat infections while enhancing the natural host immune response, said Farokh Dotiwala, M.B.B.S., Ph.D., assistant professor in the Vaccine & Immunotherapy Center and lead author of the effort to identify a new generation of antimicrobials named dual-acting immuno-antibiotics (DAIAs).

Existing antibiotics target essential bacterial functions, including nucleic acid and protein synthesis, building of the cell membrane, and metabolic pathways. However, bacteria can acquire drug resistance by mutating the bacterial target the antibiotic is directed against, inactivating the drugs or pumping them out.

We reasoned that harnessing the immune system to simultaneously attack bacteria on two different fronts makes it hard for them to develop resistance, said Dotiwala.

Fluorescence microscopy staining showing the effects of DAIA treatment on bacteria viability. Credit: The Wistar Institute

He and colleagues focused on a metabolic pathway that is essential for most bacteria but absent in humans, making it an ideal target for antibiotic development. This pathway, called methyl-D-erythritol phosphate (MEP) or non-mevalonate pathway, is responsible for biosynthesis of isoprenoids molecules required for cell survival in most pathogenic bacteria. The lab targeted the IspH enzyme, an essential enzyme in isoprenoid biosynthesis, as a way to block this pathway and kill the microbes. Given the broad presence of IspH in the bacterial world, this approach may target a wide range of bacteria.

Researchers used computer modeling to screen several million commercially available compounds for their ability to bind with the enzyme, and selected the most potent ones that inhibited IspH function as starting points for drug discovery.

Since previously available IspH inhibitors could not penetrate the bacterial cell wall, Dotiwala collaborated with Wistars medicinal chemist Joseph Salvino, Ph.D., professor in The Wistar Institute Cancer Center and a co-senior author on the study, to identify and synthesize novel IspH inhibitor molecules that were able to get inside the bacteria.

The team demonstrated that the IspH inhibitors stimulated the immune system with more potent bacterial killing activity and specificity than current best-in-class antibiotics when tested in vitro on clinical isolates of antibiotic-resistant bacteria, including a wide range of pathogenic gram negative and gram positive bacteria. In preclinical models of gram negative bacterial infection, the bactericidal effects of the IspH inhibitors outperformed traditional pan antibiotics. All compounds tested were shown to be nontoxic to human cells.

Immune activation represents the second line of attack of the DAIA strategy, said Kumar Singh, Ph.D., Dotiwala lab postdoctoral fellow and first author of the study.

We believe this innovative DAIA strategy may represent a potential landmark in the worlds fight against AMR, creating a synergy between the direct killing ability of antibiotics and the natural power of the immune system, echoed Dotiwala.

Reference:IspH inhibitors kill Gram-negative bacteria and mobilize immune clearance by Kumar Sachin Singh, Rishabh Sharma, Poli Adi Narayana Reddy, Prashanthi Vonteddu, Madeline Good, Anjana Sundarrajan, Hyeree Choi, Kar Muthumani, Andrew Kossenkov, Aaron R. Goldman, Hsin-Yao Tang, Maxim Totrov, Joel Cassel, Maureen E. Murphy, Rajasekharan Somasundaram, Meenhard Herlyn, Joseph M. Salvino and Farokh Dotiwala, 23 December 2020, Nature.DOI: 10.1038/s41586-020-03074-x

Publication information: IspH inhibitors kill Gram-negative bacteria and mobilize immune clearance, Nature (2020). Online publication.

Co-authors: Rishabh Sharma, Poli Adi Narayana Reddy, Prashanthi Vonteddu, Madeline Good, Anjana Sundarrajan, Hyeree Choi, Kar Muthumani, Andrew Kossenkov, Aaron R. Goldman, Hsin-Yao Tang, Joel Cassel, Maureen E. Murphy, Rajasekharan Somasundaram, and Meenhard Herlyn from Wistar; and Maxim Totrov from Molsoft LLC.

Work supported by: The G. Harold and Leila Y. Mathers Foundation, funds from the Commonwealth Universal Research Enhancement (CURE) Program and the Wistar Science Discovery Fund; The Pew Charitable Trusts supported Farokh Dotiwala with a Wistar Institute recruitment grant; Additional support was provided by the Adelson Medical Research Foundation and the Department of Defense. Support for The Wistar Institute facilities was provided by Cancer Center Support Grant P30 CA010815 and National Institutes of Health instrument grant S10 OD023586.

The Wistar Institute is an international leader in biomedical research with special expertise in cancer research and vaccine development. Founded in 1892 as the first independent nonprofit biomedical research institute in the United States, Wistar has held the prestigious Cancer Center designation from the National Cancer Institute since 1972. The Institute works actively to ensure that research advances move from the laboratory to the clinic as quickly as possible.

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New Class of Dual-Acting Antibiotics Active Against a Wide Range of Bacteria - SciTechDaily

First of all let's get one thing clear: Nothing you eat or drink can keep you from getting the COVID-19 virus, but there are things you can drink or eat to stay healthy, boost your immune system, and try to lower your chances of having severe symptoms if you do contract it or any virus or cold for that matter this winter.

Here's your best bet on how to make an at-home tonic that will strengthen your immune system and protect your body from suffering the most severe symptoms if you do happen to catch something.

Like any virus, such as the flu or a cold, taking care of yourself is the best way to give your body the strength it needs to fight the invaders. In the case of COVID-19, wear a mask, wash your hands, and if you get it, quarantine, rest anddrink plenty of fluids.

The term "fire cider" has been popular since the late 70s or early 80s, created by an herbalist and recently the subject of a bigger court case about whether a company could trademark the name, which previously referred broadly to an at-home natural remedy tonic full of onions, garlic, spices, vinegar and more (The herbalists lost, leading fans of natural remedies feeling that this was a miscarriage of justice because to them it would be like branding the words ice tea).

The case was covered widely, since home remedies have been around for eons, and are often used when modern medicine comes up short, leaving every individual to fend for themselves. This is the case with new diseases such as the coronavirus since while we wait for the vaccine to become widely available, people are turning to health tonics, elixirs, and teas to try to boost their immunity.

"Yes, this type of elixir has been around for a long time. In herbal medicine, we call it an oxymel," explains Dr. Chad Larson, NMD, DC, CCN, CSCS, advisor and consultant for Cyrex Laboratories. "With the dominanceof the pharmaceuticalindustry, many of these very therapeutic remedies are becoming a lost art. Hippocrateswrote about using oxymels over two thousand years ago, to help release sputum and soothe the upper respiratory tract."

Dr. Larson sharedaninterestingblog post on oxymels, from Mountain Rose Herbs, which clarifies that not all elixirs are oxymels since the term refers to one that mixes acidic ingredients like apple cider vinegar with honey. Meanwhile,the term "fire cider"was made popular by anherbalist Rosemary Gladstar, and her fellow plant-medicine colleagues, and they recently tried without success to fight the trademarking of the name "fire cider" by a company that sells a version of it in bottled form. The casewas well watched by those interested inthe right to keep traditional remedies free of trademark restrictions, to no avail, the blog reports.

'Oxymel' describes a combination of known immune-boosting ingredients mixed into hot water that when ingested daily can add powerful antioxidants, vitamin C, zinc, and other compounds that are known to arm your cellular defenses against viral invaders. Since long before modern medicine, healers have used ginger, turmeric, horseradish, garlic, and lemon to treat ailments from congestion to indigestion. These may not kill the dreaded coronavirus, but if you are taking every other preventative measure, (mask-wearing, hand-washing, social -isolating) what could be the harm?

We have done stories at The Beet on the anti-inflammatory properties of ginger and the vitamin C benefits of lemon in hot water (which many people drink in the morning to aid digestion rather than coffee to start the day) and the immunity-boosting compounds in garlic and the anti-inflammatory properties abs multi-benefits of turmeric. So it makes sense that combining these roots and fruits into an elixiralongsidethe benefits of apple cider vinegar and spices can supercharge your immune system.

What to drink to boost immunity and the benefits of creating your own hot tea or elixirs with a combination of:

A Note about honey: If you want toadd honey to sweeten it, but if someone is vegan they choose not to eat honey since it is an animal bi-product.

Most recipes call for you to chop up all of thefruits, vegetables, and roots, add to an airtight glass jar, cover with your herbs and then fill with apple cider vinegar an inch or two past the herbs, and let sit in a warm place for a couple of weeks, shaking the jar daily. After a few weeks, strain out the liquid, and add a sweetener like honey (or agave if you're vegan) and it's ready to drink.

There are many different ways to ingest this folk remedy: You can takea couple of tablespoons in the morning like an immunity shot, add it to tea or hot water to dilute the strong taste, or incorporate it into your recipes as a marinade or salad dressing. You can even soak a cloth in your tonic and rub it on your chest to ease congestion.

Toomuch to keep on hand? Assuming you have all these ingredients or are pressed for time or don't want tocreate your own tonic, to buy it premade, try this Fire Ciderto drink instantly.

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Drink This "Fire Cider" Elixir to Boost Immunity and Stay Heathy - The Beet