Pandemic News Links / Current News Updates

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University Of Miami doctors conducted clinical trials for new drug that treats Alzheimer’s

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UM doctors conducted clinical trials for new drug that treats Alzheimer’s

https://www.yahoo.com/news/um-doctors-c ... 09242.html

The new drug approved by federal officials to treat Alzheimer’s disease has a Miami connection.

A group of medical experts from the University of Miami Miller School of Medicine, including memory disorders specialist Dr. Bernard Baumel, were part of a consortium of worldwide clinical trials to test the pioneering drug marketed as Aduhelm (aducanumab), manufactured by Biogen.

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Ana Claudia Chacin
Thu, June 10, 2021, 2:52 PM
The new drug approved by federal officials to treat Alzheimer’s disease has a Miami connection.

A group of medical experts from the University of Miami Miller School of Medicine, including memory disorders specialist Dr. Bernard Baumel, were part of a consortium of worldwide clinical trials to test the pioneering drug marketed as Aduhelm (aducanumab), manufactured by Biogen.

Dr. Bernard Baumel, a neurologist at the Miller School of Medicine at the University of Miami.
Dr. Bernard Baumel, a neurologist at the Miller School of Medicine at the University of Miami.
Baumel, a neurologist and UM researcher, told el Nuevo Herald the clinical trial, which has lasted more than three years, will continue to measure how people progress and whether there will be any long-term effects from the drug.

The Food & Drug Administration approved Aduhelm on Monday, despite sharp criticism from the agency’s own scientific advisers, who contend there isn’t sufficient evidence that the drug works.

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It is the first drug of its kind to be approved since 2003. The FDA fast-tracked the process, known as “accelerated approval,” which the agency will do for a drug of a serious or life-threatening disease that it says provides a significant therapeutic advantage over existing treatments, bringing it to patients faster. The FDA noted Aduhelm is the first drug that treats the cause rather than the symptoms of Alzheimer’s, which affects more than 6 million Americans.

“As we have learned from the fight against cancer, the accelerated approval pathway can bring therapies to patients faster while spurring more research and innovation,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.

The drug is an infusion to be ingested every four weeks. It is a disease-modifying drug, which means that the affected person, with the appropriate dose, would not get worse as quickly as they might if the drug were not taken, Baumel said.

Not all experts agree with the FDA’s decision, as the federal agency approved Biogen’s treatment based on clinical trial results that show “a reasonable probability” of efficacy.

Dr. Caleb Alexander, a medical researcher at John Hopkins University and an adviser to the FDA who recommended against approving the drug, told the Associated Press that he was “surprised and disappointed” by the decision.

“The FDA gets the respect that it does because it has regulatory standards that are based on firm evidence. In this case, I think they gave the product a pass,” Alexander told the AP.

In compliance with the accelerated approval process, the FDA is requiring Biogen to conduct a follow-up randomized clinical trial to verify clinical benefits of the drug.

For those who have criticism, Baumel, who has patients participating in the trial, said while Alzheimer’s is a terrible disease, “if there is any indication that we could help people, we should see that happens. ... Let them take the medicine.”
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Biogen says FDA didn't push for trial before Alzheimer's approval

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Biogen says FDA didn't push for trial before Alzheimer's approval

Two Biogen executives said in an interview the company's newly approved Alzheimer's drug is priced fairly, and that it didn't conduct another clinical trial before approval because the FDA didn't push them to do so.

Why it matters: The scientific consensus is the drug, Aduhelm, has not been proven to work. But Biogen and the FDA are content with "hopefully" validating the $56,000 drug's efficacy at some unknown point in the future.

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This interview was with Maha Radhakrishnan, Biogen’s chief medical officer, and Chirfi Guindo, Biogen's head of global product strategy and pricing, and has been edited for brevity and clarity.

Axios: The FDA approved Aduhelm under the condition that Biogen run a confirmatory trial. When will the company start that?

Maha Radhakrishnan: We're in the process of discussions of what the study should look like. As things become more clear to us, we'll be sure to share that publicly.

A: The FDA said they were going to give up to nine years to submit trial data. Do you plan on taking that long?

MR: Our plan is to be able to finalize a study design, the patient population, the site, the countries, et cetera. What we do not have in our control ... we do have milestones on recruitment and enrollment. Whether it will pan out in the real world as we expect is the question, which is why we usually give ourselves time, but with the hope that we can can expedite and accelerate the study readout.

Q: Why didn't Biogen do this trial in 2019, when you were parsing through the data again?

MR: That's a good question. But I do want to go back a minute to the amount of information, the substantial volume of evidence that we submitted to the FDA as part of our filing package. We submitted data on eight clinical programs ... so based on the negotiations we've had with the regulators, we are about to embark on a path where we will actually look to validate and verify the data that we have seen in our clinical program.

Q: But going back to my question, why didn't Biogen conduct another trial before submitting an application to the FDA?

Chirfi Guindo: I think we were informed by our engagement with the regulator, and we were prepared to do what was necessary in order to get Aduhelm to the finish line. We're pleased to be in a situation now where we can provide access to these patients and their families, while we continue to generate data going forward.

A: But why not start the trial when you were looking at the data in 2019? One of the phase 3 trials failed outright, and then the other showed some signs of amyloid reduction. Didn't you feel you at the least needed a tiebreaker?

MR: When we decided to go back into discussions with the FDA, after really looking at the data, we were essentially respecting the guidance from the FDA in terms of what was needed to submit the [drug application]. All companies follow the pathway given by the regulators.

A: So, in 2019, did the FDA say you didn't have to run another trial — just submit an application?

MR: Anytime a company gets into a regulatory dialogue, we usually listen to the advice and feedback that we get.

A: Why does Biogen believe Aduhelm's $56,000 list price is fair, especially considering this hasn't been proven to work? This could potentially balloon Medicare spending.

CG: We've consulted with experts, health economists, clinicians, as well as payers and policy leaders, because we take this responsibility very seriously. We were guided by the value that Aduhelm has and will have going forward. The second principle is the commitment that we have to continue to research and develop innovative medicines in, not only Alzheimer's but also other areas of neuroscience. These are all areas that are very risky. And then lastly, we are committed to working with the payers, working with public policymakers, to ensure that Aduhelm is affordable for patients. That is really what is most important to patients: affordability, and then the sustainability of the whole system.

A: But doing just a little math on how Medicare pays for these drugs results in tens of billions of dollars in added spending. So it's going to raise out-of-pocket costs significantly, but also Medicare premiums.

CG: We anticipate that there will be probably around 10% of Medicare patients who would be really exposed to a high copay. We have been talking with [the Centers for Medicare & Medicaid Services] to see if there's something that can be done for those patients. On the total budget impact, we do not anticipate a very rapid uptake. This is not a treatment that is one pill, once a day that your average family physician can prescribe.

A: Even if you get only 200,000-300,000 Alzheimer's patients, we're talking upwards of $17 billion. That'd make it the drug Medicare spends most on by a long shot, no?

CG: I don't believe we will get into those tens of billions of dollars, at least not in the initial few years. But if you look at the bigger picture, the system collectively spends $600 billion a year on Alzheimer's care. Just imagine you have a treatment that over time can mitigate some of that cost.

A: But those analyses assume the drug works. How can you make those types of assumptions of saved costs if Aduhelm hasn't been proven yet?

MR: You keep saying it has not worked. The data from our studies actually talk to the evidence seen in the study, which is what we're looking to verify by the next study. And again, in the last 20-plus years ... there has been really no treatment, no hope for patients. What Aduhelm offers, hopefully, is a hope to really be able to integrate these patients back into society, give them back a quality of life.

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curncman
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Texas man who declined COVID-19 vaccine speaks out after undergoing double lung transplant

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Texas man who declined COVID-19 vaccine speaks out after undergoing double lung transplant

https://www.yahoo.com/gma/texas-man-dec ... 26073.html

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curncman
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Midatech Pharma Soars on 'Breakthrough' Drug Delivery Technology Shares of Midatech Ph

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Midatech Pharma Soars on 'Breakthrough' Drug Delivery Technology
Shares of Midatech Pharma soar after the company announces a 'breakthrough' in the development of its injectable drug-therapy delivery technology.

Midatech Pharma (MTP) - Get Report shares soared Thursday after the U.K.-based biotechnology company announced a "breakthrough" in the development of its specialized technology that can form proteins into long-lasting injectable drug therapies.

Midatech Pharma's American depositary receipts were up 52.46% at $3.11 on the Nasdaq after the company said that in-vitro data show the potential of its Q-Sphera technology to formulate proteins into long-acting injectable products.

Q-Sphera is a technology that employs proprietary 3D printing techniques to encapsulate drugs in microspheres which may be injected to form depots in the body that release the drug over predictable, sustained periods from one week to several months.

“A significant number of latest generation medicines are protein based and reformulation as long-acting injectables could provide significant benefits to patients, physicians and payors," the company said in a statement, adding that the results are a “breakthrough” that to date no other commercial or academic organization has been able to successfully replicate.


“The company believes no other commercial or academic organization has been able to successfully deliver therapeutic proteins over extended periods using methods capable of commercial scaling,” Midatech said, noting that sales of monoclonal antibody formulations, or mAbs,were $154 billion globally in 2020.

The U.K. biotechnology company, which also is listed on London's AIM market, said its next steps will be to further optimize the drug loading and dissolution profile for encapsulated monoclonal antibodies.

Among other developments, the company also has begun discussions with potential licensing partners for MTD211, a treatment for schizophrenia marketed under the brand name Rexulti.

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Applied Therapeutics Gets Fast Track Designation from FDA Applied Therapeutics says drug candidate to treat rare disorde

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Applied Therapeutics Gets Fast Track Designation from FDA
Applied Therapeutics says drug candidate to treat rare disorder affecting sugar processing gets fast track designation from the FDA.

https://www.thestreet.com/investing/app ... _ven=YAHOO

Applied Therapeutics (APLT) - Get Report said Thursday that the U.S. Food and Drug Administration granted the biopharma fast track designation to its drug candidate for the treatment of a rare disorder that inhibits the body’s ability to process a simple sugar.

Shares of the New York company were up 1.50% to $23.29 at last check.

Stocks Waver but Nasdaq Rises 1% as Wall Street Turns to Growth Shares

Applied Therapeutics said its candidate, AT-007, is intended for the treatment of galactosemia.

AT-007 is the company’s central nervous system-penetrant Aldose Reductase inhibitor in development for multiple rare metabolic disorders.

The company said AT-007 significantly reduced plasma galactitol levels compared with a placebo in adults with Galactosemia in a Phase 2 registrational trial. The long-term extension in adults remains ongoing.

AT-007 is currently being studied in a registrational trial in children ages 2-17 with galactosemia.

Applied Therapeutics said it plans to submit a new drug application for accelerated approval of AT-007 for the treatment of galactosemia in the third quarter.

The Orphan Drug Designation Program provides orphan status to drugs and biologics that are intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people.

The fast track designation is granted to drugs being developed for the treatment of serious or life-threatening diseases or conditions where there is an unmet medical need.

"There are currently no drugs approved for galactosemia, and we believe AT-007 has the potential to be the first drug approved for patients urgently in need of treatment," Shoshana Shendelman, founder and CEO, said in a statement.
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Re: Pandemic NewsBiotech Century Therapeutics Inc. IPSC, set terms for its initial public offer Links / Current News Upd

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Biotech Century Therapeutics Inc. IPSC, set terms for its initial public offering on Monday, with plans to offer 10.6 million shares priced at $18 to $20 each. The company has applied to list on Nasdaq, under the ticker symbol "IPSC." JP Morgan, BofA Securities, SVB Leerink and Piper Sandler are underwriting the deal. Proceeds will be used to fund pre-clinical activity and research and development, as well as working capital and general corporate purposes. "We are an innovative biotechnology company developing transformative allogeneic cell therapies to create products for the treatment of both solid tumor and hematological malignancies with significant unmet medical need," the company says in its prospectus.
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Hedge Funds Still Buying Mirati Therapeutics, Inc. (MRTX)

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Hedge Funds Still Buying Mirati Therapeutics, Inc. (MRTX)

he latest 13F reporting period has come and gone, and Insider Monkey is again at the forefront when it comes to making use of this gold mine of data. Insider Monkey finished processing 866 13F filings submitted by hedge funds and prominent investors. These filings show these funds' portfolio positions as of March 31st, 2020. In this article we are going to take a look at smart money sentiment towards Mirati Therapeutics, Inc. (NASDAQ:MRTX).

Mirati Therapeutics, Inc. (NASDAQ:MRTX) investors should be aware of an increase in support from the world's most elite money managers lately. Mirati Therapeutics, Inc. (NASDAQ:MRTX) was in 57 hedge funds' portfolios at the end of March. The all time high for this statistic was previously 56. This means the bullish number of hedge fund positions in this stock currently sits at its all time high. There were 56 hedge funds in our database with MRTX holdings at the end of December. Our calculations also showed that MRTX isn't among the 30 most popular stocks among hedge funds (click for Q1 rankings).

If you'd ask most stock holders, hedge funds are seen as slow, outdated investment tools of the past. While there are greater than 8000 funds trading at present, We hone in on the upper echelon of this club, approximately 850 funds. These hedge fund managers preside over bulk of all hedge funds' total capital, and by watching their matchless picks, Insider Monkey has determined a number of investment strategies that have historically outstripped the S&P 500 index. Insider Monkey's flagship short hedge fund strategy defeated the S&P 500 short ETFs by around 20 percentage points a year since its inception in March 2017. Also, our monthly newsletter's portfolio of long stock picks returned 206.8% since March 2017 (through May 2021) and beat the S&P 500 Index by more than 115 percentage points. You can download a sample issue of this newsletter on our website .

Joseph Edelman of Perceptive Advisors

At Insider Monkey, we scour multiple sources to uncover the next great investment idea. For example, an activist hedge fund wants to buy this $29 biotech stock for $50. So, we recommended a long position to our monthly premium newsletter subscribers. We go through lists like the 10 best battery stocks to pick the next Tesla that will deliver a 10x return. Even though we recommend positions in only a tiny fraction of the companies we analyze, we check out as many stocks as we can. We read hedge fund investor letters and listen to stock pitches at hedge fund conferences. You can subscribe to our free daily newsletter on our homepage. Keeping this in mind we're going to analyze the fresh hedge fund action encompassing Mirati Therapeutics, Inc. (NASDAQ:MRTX).

Do Hedge Funds Think MRTX Is A Good Stock To Buy Now?
At the end of the first quarter, a total of 57 of the hedge funds tracked by Insider Monkey were bullish on this stock, a change of 2% from the previous quarter. By comparison, 33 hedge funds held shares or bullish call options in MRTX a year ago. So, let's review which hedge funds were among the top holders of the stock and which hedge funds were making big moves.

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trader32176
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Re: Pandemic News Links / Current News Updates

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The hard realities of a ‘no jab, no job’ mandate for health care workers

6/18/21


https://www.news-medical.net/news/20210 ... rkers.aspx


Christopher Richmond keeps a running tab on how many workers at the ManorCare skilled nursing facility he manages in western Pennsylvania have rolled up their sleeves for a covid-19 vaccine.

Although residents were eager for the shots this year, he's counted only about 3 in 4 workers vaccinated at any one time. The excuses, among its staff of roughly 100, had a familiar ring: Because covid vaccines were authorized only for emergency use, some staffers worried about safety. Convenience mattered. In winter, shots were administered at work through a federal rollout. By spring, though, workers had to sign up online through a state program — a time-sucking task.

ManorCare urges every worker to be immunized against covid but turnover has vexed that effort. Managers at ProMedica, a nonprofit health system that operates ManorCare and senior care facilities in 26 states, faced a workforce conundrum familiar to all manner of providers during the pandemic: how to persuade essential workers to get vaccinated — and in a way that didn't drive them away. Raises and bonuses, costing millions of dollars, did not move the needle to 100%.

Animus toward the vaccine created turmoil for some providers. Dr. Eric Berger, a pediatrician in Philadelphia who opened his practice more than a dozen years ago, enforced mandatory shots in May and saw six of his 47 staff members walk out. Berger said he worked for months to educate resistant workers. In April, he learned that several, women in their 20s and 30s, had attended a private karaoke party. Within days, four staffers were infected with covid.

Berger, who had seen in-office costs for protective equipment soar, then set a deadline for shots. He looks back with steely resolve over the last-minute "I quit" texts he received — and the hassle of finding a new receptionist and billing and medical assistants.

"We expected hesitancy to vary by group, but how much they varied was surprising," King said. "These were not people who were anti-vaccine, but they were worried about the effect of the vaccine."

Still, King said the percentage who didn't trust the government was alarming. "If somebody doesn't understand the vaccine, that's one thing. If you don't trust that government, that is a much more difficult issue to address."

That may change as two prominent vaccine makers approach full approval by the Food and Drug Administration. Pfizer and BioNTech applied for approval in May; Moderna applied in early June. A recent KFF poll found nearly a third of unvaccinated adults said they would be more likely to get a vaccine once it was fully approved by the FDA.

At ProMedica, Pile described a multipronged approach in such states as Florida and Pennsylvania, home to large elderly populations. On-site counseling in groups, with familiar doctors and staff, helped persuade some who were reluctant, he said. Short videos on why and how the vaccine worked were readied. ProMedica senior medical staff flew to Florida to advise as the National Guard arrived at its facility in Pinellas County, the health system's first to receive the vaccine.

Falon Blessing, a nurse, manages other practitioners at ManorCare Health Services Center throughout the Tampa region. She recounted how employees had wondered aloud how such newly created vaccines could be safe.

"I think people at first just wanted to know: I'm not going to grow a tail in five years," she said. "But then there was a momentum. It wasn't so much 'Are you going to get vaccinated?' but rather 'Of course, I'm going to get vaccinated.'"

During three vaccinations sessions ended in January, though, the facility reached about the same rate as Pennsylvania overall — about 76% of its workers were vaccinated. That rate has fallen to 62% this month because of attrition. An education effort continues, a ProMedica spokesperson said.

"My takeaway was it mattered to have one-on-one discussions," Pile said. "If you talk to 10 people, why they wouldn't get the vaccine, you'd get 10 different reasons."

"And there were political opinions — what they heard on Facebook — and then they'd say: I want to see how it goes," he said.

The questions and qualms about vaccines came at the end of a deeply distressing pandemic year for health care workers, and facilities are now finding fewer applicants for essential care.

By spring, ProMedica had 1,500 job postings in Pennsylvania alone, compared with a typical 400 openings. Pile said ProMedica raised wages in dozens of locations, though he declined to provide wage ranges or rates. It spent $4.5 million in Pennsylvania from March through last week — and still supplemented its workforce across the U.S. by hiring through staffing agencies.

"In 2020, we spent over $32 million on staffing agencies," he said. Through this spring, ProMedica was on course to spend $66 million on staffing agencies for 2021, said Pile, who has worked in the care sector for 18 years.

"I have less employees than ever before," he said. "I have never seen anything like it."

The Pennsylvania Health Care Association, an advocacy group, surveyed members in April to better understand vaccine reluctance. Zachary Shamberg, the group's president, said it found that defining "hesitancy is not that simple."

Shamberg said PHCA focused on why people had yet to be immunized and the characteristics of the workforce were telling: About 92% of all its workers are women; 65% are between ages 16 and 44. Among them, some worried early on about possible infertility from the new vaccine, he said, and some wanted to wait for the single-shot Johnson & Johnson vaccine. Others were sick with covid and were advised, once recovered, not to get a vaccine for 90 days.

Shamberg was also critical of the state data. Those surveys, taken in March and released in April, reflected a time when the vaccine was new to many people.

Pennsylvania, a battleground state in recent presidential elections, remains politically charged, and Shamberg noted that politics likely plays a role among holdouts. In recent months, PHCA enlisted churches and doctors' consortiums to change minds. Keeping residents and workers safe should be a priority in a state that, in a few years, will face a "silver tsunami" of residents in their 80s, Shamberg said.

In recent weeks, there has been clear momentum among the general population for shots in Pennsylvania. The state now ranks among the top 10 states in the nation to administer first doses of vaccines, according to data from the Centers for Disease Control and Prevention.

"Pennsylvania is a big and diverse state," Shamberg said. "And it's interesting why some of our staff in western Pennsylvania were hesitant versus workers in the city of Philadelphia."

"The vast majority of workers in Philadelphia are female and, among them, minority populations that have some inherent distrust based on historical experience. Then you go out west and you have a more conservative viewpoint — and a distrust of government today and a distrust of government vaccine."

"Fortunately, we had some wonderful people who put in extra time," he said. "It's been stressful, but I think we did the right thing."

Brittany Kissling, 33 and a mother of four, was one of the hesitant workers at Berger's practice who decided — largely for financial reasons — to get vaccinated. The clinic manager couldn't afford to lose her job. But she said she was nervous and that most of the workers who left recoiled at being told vaccinations were not negotiable. "I was a no-show my first time," Kissling said about her first vaccine appointment. "I was scared. There were a lot of unknowns."

But Kissling said Berger's practice has spent "thousands and thousands and thousands of dollars" on masks and even paid workers for five days a week when they worked only two during the pandemic's worst months. She said she understood how and why the karaoke episode prompted a mandate. "I get it from the business side," said Kissling, about the requirement. "I do think it's fair. I do think it is tough."

Berger saw no other choice. "Vaccines are fundamental to our practices. That's what we do," he said. "Some got it in their heads that it could cause infertility; some had other reasons. It's frustrating … [and] I don't think it was political. If anything, most of these people are apolitical."

At ManorCare, managers decided money could make a difference. Bonuses — up to $200 per employee — were added as an incentive, which in Pennsylvania alone cost ProMedica $3 million, said Luke Pile, vice president and general manager for ProMedica Senior Care skilled nursing centers.

Richmond, at ManorCare, said the resident council has been pivotal in keeping the focus on the risks of covid to the elderly — and no one there needs a reminder about the stress of the past year. According to Medicare records, the facility had 107 cases of covid among staffers and residents — and 14 deaths among residents beginning in March 2020.

"I constantly wear a mask. Not out of fear, but I don't want to spread it by being asymptomatic," Richmond said. "I tell people here: Whatever is happening in the community, that is what is happening in the community. But we are a health care institution and caring for the elderly. We need to be constantly vigilant."

Richmond and other administrators admit it can be a struggle to understand why some health workers are unmoved by the science.

"Everything has been so polarized this past year. I don't know that there is a single reason that individuals don't get the vaccine," Pile said. "In trying to educate people, personally and professionally, we talk about the history and science. Unfortunately, individual opinions don't always align with that."

Mandating vaccines is a step that ProMedica has yet to take, even as more businesses, universities and health care providers do so. A few long-term care operators, such as Atria Senior Living, operating in the United and Canada, and Juniper Communities, announced mandates. Some have been met with lawsuits from workers aligned with conservative groups. In May, more than 100 staffers at Houston Methodist Hospital filed suit to dispute and derail the hospital system's compulsory vaccination. A judge dismissed the challenge this month on the grounds that the hospital's requirement did not violate state or federal law or public policy.

Last week, the U.S. Labor Department issued a temporary emergency standard for health care workers, saying they face "grave danger" in the workplace when "less than 100 percent of the workforce is fully vaccinated."

In Pennsylvania, whose population ranks among the oldest according to 2019 census data, statistical snapshots published in April underscored the need for vigilance. Two state agencies overseeing skilled nursing care and personal care homes reported that only half of their workers were vaccinated. Covid was notably devastating to long-term care facilities nationwide in 2020; some of Pennsylvania's deadliest outbreaks were reported by local media in places shown later to have low staff vaccination rates.

A survey by the Delphi Group, begun in March 2020 with over 700,000 Facebook respondents ages 18 to 64, recently was analyzed by researchers from Carnegie Mellon and the University of Pittsburgh, who found that health care workers were largely leading the vaccine uptake. But there were notable differences over the winter among people working, side by side, in health care settings.

Pharmacists, physicians and registered nurses were the least hesitant to get vaccinated. Home health care aides, EMTs and nursing assistants showed the highest hesitancy among front-line health workers. Overall hesitancy across professions decreased from January to March 2021, as much as 5 percentage points, as vaccinations expanded, according to the analysis by the university researchers.

University of Pittsburgh researcher Wendy King said people indicated they were receptive to the vaccine if they were familiar with its science. Educators, overall, displayed the least hesitancy; workers in construction, mining and oil/gas extraction showed the greatest. Half of those who were hesitant cited possible side effects — a fear that could be eased by education, King said. A third among the hesitant gave other reasons: They didn't believe they needed the vaccine. They didn't trust the government. Or they didn't trust the covid-19 vaccines.
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Re: Pandemic News Links / Current News Updates

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Convalescent plasma associated with better survival in blood cancer patients with COVID-19

6/18/21


https://www.news-medical.net/news/20210 ... ID-19.aspx


Convalescent plasma therapy was associated with better survival in blood cancer patients hospitalized with COVID-19, especially in sicker patients. The findings by the COVID-19 and Cancer Consortium (CCC19) are newly published in the peer-reviewed journal JAMA Oncology.

The Mays Cancer Center, home to UT Health San Antonio MD Anderson, is part of the CCC19. The international consortium is composed of 124 medical centers and institutions in North and South America that conduct research to learn how COVID-19 affects cancer patients.

Dimpy Shah, MD, PhD, is an epidemiologist and assistant professor of population health sciences at The University of Texas Health Science Center at San Antonio, and a member of its Mays Cancer Center. She serves on the CCC19 steering committee, leads the consortium's Epidemiology Core Committee and is a co-senior author on the study.

" Early case reports suggested that cancer patients with COVID-19 benefitted from convalescent plasma, but this is the first analysis that associated convalescent plasma with improved survival using this large, real-world data set."

- Dr. Dimpy Shah, MD, PhD, epidemiologist and assistant professor of population health sciences, UT Health San Antonio

The analysis compared the 30-day death rates of hospitalized adults with both blood cancer and COVID-19 from patient data supplied by the CCC19 consortium institutions. The analysis compared treatment data from 143 patients who received convalescent plasma and 823 who did not.

"Our study showed a 48% reduced risk of death for COVID patients who had blood cancer and had received convalescent plasma compared to similar patients who did not receive this treatment," she said. "This survival benefit with convalescent plasma was even greater in patients who were admitted to the intensive care unit (60% reduced risk of death) and those who needed mechanical ventilation (68% reduced mortality)," she said.

Blood cancers are associated with defects in the immune system. They begin either in the bone marrow, where blood is made, or in cells of the immune system. These types of cancer include leukemia, lymphoma and multiple myeloma.

Plasma is the largest component of human blood. Red blood cells, white blood cells and platelets are other major blood components. Convalescent plasma is plasma donated by patients who have recovered from an infection, such as COVID 19, and has been used to treat other patients suffering from the disease. Convalescent plasma was used to treat patients during the 1916 poliomyelitis outbreak in New York and during the 1918 Spanish flu epidemic, as well as later for viral infections.

"While acknowledging the limitations of non-randomized observational data, this study provides an important signal regarding the benefits of convalescent plasma. We recommend that researchers conduct randomized clinical trials to prospectively evaluate the benefits of convalescent plasma in patients with blood cancer and severe COVID-19," added Pankil Shah, MD, PhD, MSPH, assistant professor of urology at UT Health San Antonio. As the lead data scientist, Dr. Pankil Shah performed the analysis for this CCC19 study.

Ruben Mesa, MD, FACP, executive director of the Mays Cancer Center, added, "Membership in the CCC19 is just one example of our cancer center's commitment to provide the best possible care for patients throughout South Texas. In addition to providing evidence-based treatments, we also offer our patients participation in hundreds of cancer clinical trials led nationally and at our cancer center that evaluate the newest possible treatments."

He continued: "Throughout the pandemic we have safely cared for our patients and encourage the public to continue getting cancer screenings to avoid the possible progression of undiagnosed cancer to stages where it is more difficult to treat. We are open and ready to safely provide cancer screenings, research opportunities and treatment to the people of South Texas."

Other authors on the study include corresponding author Jeremy Warner, MD, MS, FASCO, associate professor medicine at Vanderbilt University Medical Center (VUMC); lead author Michael Thompson, MD, PhD, oncologist and hematologist with Advocate Aurora Health and Advocate Aurora Research Institute; and additional lead author Jeffrey Henderson, MD, PhD, associate professor of medicine and molecular microbiology at Washington University.

The CCC19 was formed in early 2020 to rapidly collect data as part of an effort to understand the unique effects the coronavirus has on cancer patients.

Source:


University of Texas Health Science Center at San Antonio

Journal reference:


Thompson, M.A., et al. (2021) Association of Convalescent Plasma Therapy With Survival in Patients With Hematologic Cancers and COVID-19. JAMA Oncology. doi.org/10.1001/jamaoncol.2021.1799.
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Re: Pandemic News Links / Current News Updates

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COVID-19 virus can infect the testes, hamster study shows

6/18/21


https://www.news-medical.net/news/20210 ... shows.aspx


Researchers at the University of Texas Medical Branch have observed that SARS-CoV-2, the virus that causes COVID-19, can infect the testes of infected hamsters. The findings, published in the journal Microorganisms, could help explain symptoms some men with COVID-19 have reported and have important implications for men's health.

As the pandemic goes on, clinicians continue to report their findings that COVID-19 affects more than just the lungs. Some patients have reported testicular pain and some reports have shown decreases in testosterone, a key hormone produced in the testes. Autopsies have also shown significant disruption of the testes at the cellular level, including the presence of immune cells.

"Given the magnitude of the COVID-19 pandemic, it is critical to investigate how this disease can impact the testes, and the potential consequences for disease severity, reproductive health, and sexual transmission," said Dr. Rafael Kroon Campos, the study's lead author and postdoctoral fellow in the laboratory of Dr. Shannan Rossi at UTMB.

The Rossi lab has been studying Zika virus infection in the testes for years and wondered if SARS-CoV-2 could cause a similar disease. Hamsters are commonly used to model COVID-19 in humans since they develop similar signs of disease. Virus was detected in the testes of all infected hamsters during the first week but tapered off. The authors think this may represent what could occur in men with mild to moderate COVID-19 disease.

" These findings are the first step in understanding how COVID-19 impacts the male genital tract and potentially men's reproductive health. We have much more to do before we have the full picture. Moving forward, we will investigate ways to blunt this impact, including using antivirals, antibody therapies and vaccines."

- Dr. Shannan Rossi, Associate Professor, Departments of Pathology and Microbiology & Immunology, UTMB

Future studies also include modeling conditions associated with severe COVID-19, such as pre-existing conditions like obesity and diabetes and SARS-CoV-2 variants of concern, the study authors said.

Source:


University of Texas Medical Branch at Galveston

Journal reference:


Campos, R.K., et al. (2021) SARS-CoV-2 Infects Hamster Testes. Microorganisms. doi.org/10.3390/microorganisms9061318.
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