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The Health 202: Hundreds of millions of coronavirus vaccine doses will be ready in early 2021, officials say

“We are on the brink of seeing the fruits of our labor,” said Gen. Gustave Perna, chief operating officer for Operation Warp Speed, the initiative created by the administration to get a safe vaccine approved and distributed as quickly as possible.

The administration is working on two parallel tracks to get a vaccine approved and ready to distribute.

Perna said he, along with Warp Speed chief Moncef Slaoui, recently visited the Tennessee offices of McKesson, the major vaccine distributor that has contracted with the government to head up distribution of eventual coronavirus vaccines.

“At the end of the day I chose [McKesson] because they know how to do it,” Perna said.

Once the Food and Drug Administration approves a coronavirus vaccine for emergency use — expected to happen in late November or early December if trials continue going well — McKesson will partner with FedEx and UPS, along with a number of pharmacies and grocery stores including Walmart, CVS, Walgreens and Kroger, to get the doses shipped around the country, Perna said.

The Defense Department is closely involved in the effort, prompting concerns that an agency not accustomed to delivering vaccines might be charged with the critical task. Perna insisted, however, that the department is helping with logistics and program support — not distribution.

“There will not be this vision some people have of army trucks driving through the street delivering vaccine,” he told listeners on the online forum. “This is not feasible nor the proper way to do this.”

States also have a role to play. They’ve all submitted to the federal government plans for distributing a vaccine, with varying standards for who should get a vaccine first and how quickly the process should move.

New Jersey, for example, wants to administer the vaccine 70 percent of non-pregnant adults within six months. Nebraska laid out two initial phases of vaccine distribution in which the vaccine first goes to medical staff and later to the elderly and people with underlying conditions.

The vaccine news couldn’t come at a more critical time as cases of the novel coronavirus are surging across the country – and public health officials warn things could deteriorate further over the winter. Trump, however, continues to insist the country is “rounding the corner” in the disease as the election approaches next Tuesday, and his chief of staff said this weekend that the virus could only be controlled through a vaccine and therapeutics.

The process is moving with unprecedented speed, but there are plenty of challenges.

For one thing, vaccines require cold storage. Medical professionals distributing a vaccine will also need equipment including needles, syringes, alcohol, pads, bandages and masks.

And government officials say it’s critical to track who is getting the vaccine and where. Five of the six vaccines being developed as part of Warp Speed — excluding the vaccine being developed by Johnson & Johnson — require two doses. People who receive a first dose will need to be given the same vaccine in their second

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A Flu Shot Might Reduce Coronavirus Infections, Early Research Suggests

U.S. health officials are urging Americans to get their flu shots this year in the hopes of thwarting a winter “twindemic”—a situation in which both influenza and COVID-19 spread and sicken the public. But a new study suggests that there could be another key reason to get a flu jab this year: it might reduce your risk of COVID-19. The research, released as a preprint that has not yet been peer-reviewed, indicates that a flu vaccine against the influenza virus also may trigger the body to produce broad infection-fighting molecules that combat the pandemic-causing coronavirus.

The paper is in line with some other recent studies published in peer-reviewed journals that point to similar effects. But researchers caution the research is preliminary and needs to be bolstered by more rigorous experiments.

In the new study, Mihai Netea, an infectious disease immunologist at Radboud University Medical Center in the Netherlands, and his colleagues combed through their hospital’s databases to see if employees who got a flu shot during the 2019–2020 season were more or less likely to get infected by SARS-CoV-2, the virus behind COVID-19. Workers who received a flu vaccine, the researchers found, were 39 percent less likely to test positive for the coronavirus as of June 1, 2020. While 2.23 percent of nonvaccinated employees tested positive, only 1.33 percent of vaccinated ones did. Netea and his team posted their findings on the preprint server MedRxiv on October 16.

These findings do not prove that flu vaccines prevent COVID-19, however. “This is an intriguing study, but it doesn’t provide definitive evidence,” says Ellen Foxman, an immunobiologist and clinical pathologist at the Yale School of Medicine. There could be other explanations for the association the Radboud scientists and their colleagues found. For instance, people who choose to receive a flu shot may be more health-conscious and more likely to follow COVID-19 prevention guidelines than individuals who do not get vaccinated. Netea agrees, noting that overall behavior, rather than the shot, might have made people in the former group less likely to get sick in his study.

Studies such as these, which find correlations between behaviors and outcomes, cannot establish cause and effect. Determining whether flu shots actually prevent COVID-19 “requires big clinical trials at the level of the [general] population,” says Maziar Divangahi, a pulmonary immunologist at the Research Institute of the McGill University Health Center. Netea acknowledges this but points out that such a clinical trial would require a randomly chosen control group of subjects to be denied flu shots. “That’s not ethical,” he says.

Netea and his team also conducted a laboratory experiment that suggested how flu shots could prevent coronavirus infections. First, they purified blood cells taken from healthy individuals. Then they exposed some of the cells to the Vaxigrip Tetra flu vaccine, made by Sanofi Pasteur, and let the cells grow for six days. After that, the researchers exposed the cells to the Sars-CoV-2 virus and analyzed them one day later.

The cells that had first been

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Medicare and Medicaid to cover early Covid vaccine

The administration is “working to ensure that no American has to pay for the vaccine,” said one official. The administration’s planned rule also will address other Covid-19-related issues, like expanding flexibility for Medicaid patients seeking care for the coronavirus, two people familiar with the plan said.

CMS did not respond to a request for comment about the plan or how it would pay for the cost of vaccines for the roughly 120 million Americans who receive health coverage through Medicare and Medicaid.

CMS Administrator Seema Verma teased the announcement earlier this month in remarks at the HLTH virtual conference.

“I think we’ve figured out a path forward,” Verma said on Oct. 13. “It was very clear that Congress wants to make sure that Medicare beneficiaries have this vaccine and that there isn’t any cost-sharing.”

“And so, stay tuned, you’ll see more from the agency on this very shortly,” Verma added.

Congress in March sought to mandate free coronavirus vaccine coverage as part of a broader Covid-19 relief bill. But under its current rules, the Medicare program doesn’t cover the cost of drugs authorized under emergency use designations — leaving millions of Americans at risk of facing expenses tied to the vaccine.

The Trump administration later determined that it could not fix the loophole through an executive order, setting off a scramble within the health department to find alternative solutions.

Earlier this month, the administration struck a deal with CVS and Walgreens to administer an eventual vaccine with no out-of-pocket costs to seniors and health workers in long-term care facilities. Yet that arrangement only covered a narrow slice of the nation’s more than 60 million Medicare enrollees.

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Cites Link to Nonalcoholic Fatty Liver Disease and Importance of Early Detection

Echosens, a high-technology company offering the FibroScan family of products, urges increased awareness of the rise of liver cancer rates, which have more than tripled since 1980, while death rates have more than doubled during this time. About 21,000 Americans are diagnosed with primary liver cancer each year—twice as common in men than in women. Risk factors include other liver diseases, including cirrhosis, chronic hepatitis B, chronic hepatitis C and non-alcoholic fatty liver disease (NAFLD). NAFLD may be a key driver of increased cancer associated with obesity, while non-alcoholic steatohepatitis (NASH) is the fastest growing cause of liver cancer among transplant candidates.

“People with NAFLD have higher rates of several types of cancer, with the greatest increase seen for liver cancer and other gastrointestinal cancers,” says Jon Gingrich, CEO, Echosens North America. “Point-of-care examinations, monitoring and ongoing assessment of liver fat and stiffness as provided by FibroScan, a rapid, non-invasive point of care examination, can identify individuals who are asymptomatic and undiagnosed for liver damage.”

Researchers have found that liver cancer, NAFLD, hepatitis C and liver transplants are prevalent in 40-80% of people who have Type 2 diabetes and in 30-90% of people who are obese. Being overweight or obese is responsible for about 85% of fatty liver disease.

“Approximately 30,000 people die from liver cancer each year and these numbers have continued to rise in recent years,” says Lynn Gardner Seim, Executive Vice President and Chief Operating Officer, American Liver Foundation. “It is essential that patients at risk for liver cancer, including those who have previously been diagnosed with hepatitis C, NAFLD, NASH and other liver diseases, talk with their doctors and have a plan in place for getting screened.”

Traditional approaches to assessing liver health, such as liver biopsy and advanced radiological imaging, may not be cost effective nor accessible to the broader at-risk population. FibroScan directly measures physical properties of stiffness and fat liver to provide reproducible results and allow for both diagnosis and monitoring of liver stiffness and liver fat. It is also recognized worldwide as the reference for non-invasive liver diagnosis supported with more than 2,000 medical publications and 40 guideline recommendations.

About Echosens

Echosens, the developer of FibroScan®, is an innovative high-technology company offering a full range of products and services supporting physicians in their assessment and management of patients with chronic liver diseases. FibroScan is supported by over 2,500 peer-reviewed publications and examinations are covered by Medicare, Medicaid and many insurance plans. For more information, please visit http://www.echosens.us and follow us on Twitter (@echosensNA).

View source version on businesswire.com: https://www.businesswire.com/news/home/20201026005599/en/

Contacts

Media:
Brittany Tedesco
CPR Communications
btedesco@cpronline.com
201.641.1911 x 14

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Fauci says findings will be known by early December

(Photo by Alex Edelman-Pool/Getty Images)

Pool | Getty Images News | Getty Images

LONDON — Hopes are rising that a Covid-19 vaccine could be approved by the end of the year, with drugmakers and research centers scrambling to help bring an end to the pandemic.

Dozens of candidate vaccines are in clinical evaluation, according to the World Health Organization, with some already conducting late-stage tests before seeking formal approval.

The outcome of the trials is being closely monitored around the world.

The U.S.’s leading expert on infectious disease believes it will only be a matter of weeks before the findings of a potential vaccine will be known.

“We will know whether a vaccine is safe and effective by the end of November, the beginning of December,” White House coronavirus advisor Dr. Anthony Fauci said in a BBC interview on Sunday.

“The question is: Once you have a safe and effective vaccine, or more than one, how can you get it to the people who need it as quickly as possible?”

Fauci said a vaccine deemed safe and effective would be rolled out according to a set prioritization, with individuals such as health care workers and those in a higher risk category likely to receive the first doses. He said it would be “several months into 2021” before a vaccine becomes more widely available.

The development of a vaccine, Fauci warned, would not replace the need for public health measures to help protect people from the disease for some time.

To date, more than 43 million people have contracted the coronavirus worldwide, with 1.15 million related deaths, according to data compiled by Johns Hopkins University.

Vaccine race

The race for a Covid vaccine has seen governments step in to try to help the process along by providing funds to allow companies to scale up manufacturing even before drugs have been approved.

Leo Varadkar, Ireland’s deputy prime minister, has said he is hopeful an inoculation against the coronavirus could be approved before the end of the year.

“I’m increasingly optimistic, as is government, that we will see a vaccine approved in the next couple of months and that in the first half or first quarter of next year it’ll be possible to start vaccinating those most at risk,” Varadkar, who is a qualified doctor, told RTE radio on Sunday.

A Rehab Support worker checks on patient notes as the first patients are admitted to the NHS Seacole Centre at Headley Court, Surrey, a disused military hospital, which has been converted during the coronavirus pandemic.

Victoria Jones | PA Images via Getty Images

Not all public health experts share the same level of optimism about the development of a Covid vaccine before year-end, however.

The Mail on Sunday reported plans had been drawn up for frontline National Health Service staff to receive a coronavirus vaccine within weeks, citing an email sent by an NHS Trust chief to his staff.

In response to the report, U.K. Health Minister Matt Hancock said on Monday that

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Santa actors were offered early vaccine as part of scrapped federal PSA campaign: HHS

Oct. 25 (UPI) — Federal health officials in a scrapped $250 million promotional campaign offered professional Santa Claus actors early access to a vaccine for COVID-19 in exchange for participating in pro-vaccine public service announcements, the Department of Health and Human Services said Sunday.

Santa Claus actors, as well as those playing Mrs. Claus and Christmas elves, were to be hired as part of a cancelled celebrity campaign to promote getting vaccinated, an HHS official told the New York Times.

The campaign was envisioned by President Donald Trump’s then-appointee Michael Caputo, a former HHS assistant secretary, who has been on medical leave since September after being diagnosed with cancer and posting conspiracy theories on his Facebook page, including a video accusing the Centers of Disease Control and Prevention of harboring a “resistance unit” seeking to undermine Trump.

The office of HHS Secretary Alex M. Azar said this week that the program had been cancelled. The Santa “collaboration will not be happening,” a spokesperson told the Wall Street Journal.

In late August, as the coronavirus pandemic peaked across parts of the United States, Caputo and the agency approached Ric Erwin, chairman of the Fraternal Order of Real Bearded Santas, to ask if members would participate in TV, radio, social media and podcast ads and live events in 35 cities.

The campaign was titled “Covid 19 Public Health and Reopening America Public Service Announcements and Advertising Campaign” designed to “defeat despair, inspire hope and achieve national recovery,” the Wall Street Journal reported.

The Santa group agreed to participate and asked to be given the vaccine early, as Santa actors had been vaccinated early in 2009 for H1N1.

The actors who play Santa are in an “at risk” category because of their “advanced age” and “underlying health issues,” Erwin wrote in a newsletter for Santa actors.

“Furthermore, health care officials all concurred that our high rate of interpersonal contact with young children (who are notorious vectors for disease dissemination) further highlighted our need for the vaccine,” he added.

Christmas seasonal workers are watching their livelihoods disappear as stores like Macy’s have cancelled in-person visits with Santa Claus, Mrs. Claus and their elves. Some tech-savvy Santas have offered a Zoom alternative or pre-recorded video messages.

Caputo told Erwin in August that the vaccine was likely to be approved in the late fall and that Santas and other seasonal workers would have it by Thanksgiving, the Wall Street Journal reported.

“If you and your colleagues are not essential workers, I don’t know what is,” Caputo said on a call, which was recorded by Erwin. “I cannot wait to tell the president,” Caputo added. “He’s going to love this.”

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Fauci says findings on a potential coronavirus vaccine are expected by early December

Dr. Anthony Fauci

“We will know whether a vaccine is safe and effective by the end of November, beginning of December,” the director of the US National Institute of Allergy and Infectious Diseases said. “The amount of doses that will be available in December will not certainly be enough to vaccinate everybody — you’ll have to wait several months into 2021.”

Speaking to the BBC’s Andrew Marr Show, Fauci added that the vaccination of a “substantial proportion of the population” so there could be a “significant impact on the dynamics of the outbreak” may not be possible until the second or third quarter of 2021.

Pence adviser Marty Obst tests positive for coronavirus

“What I do foresee is that with a successful vaccine and the continuation of some form of public health measures, as we go and progress through the months of 2021, getting towards the third and fourth quarter, we will see a considerable approach towards some form of normality,” Fauci told Marr.

Pressed on whether he believes US President Donald Trump is correct in saying that the United States is “rounding the corner” in the course of the pandemic, Fauci said he believes this is untrue.

“The data speak for themselves,” Fauci said.

“Unfortunately, I am sorry to see what I’m viewing from a distance, what I’m seeing in the UK … after getting hit pretty badly the way we did, you went down to a pretty low level, but now you’re starting to escalate in the same manner that we are here,” he added.

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Non-Invasive Prostate Cancer Test Boosts Early Treatment


For years, men with an elevated PSA had two options: adopt a wait-and-see approach, or, to find out with certainty whether they had cancer, get a biopsy, a painful procedure where a physician puts a needle through the wall of the rectum and into the prostate. It also carries risk of bleeding or infection.

Instead, Ripken’s urologist, Ronald Tutrone Jr., chief of the Division of Urology at the Greater Baltimore Medical Center, recommended the ExoDx Prostate Test, a newer, simple urine test that looks for genetic changes indicating prostate cancer. When that test came back elevated, Ripken went ahead with a biopsy that indeed revealed he had prostate cancer. He underwent successful surgery in March, and is now in remission.

Ripken feels fortunate his cancer was caught in the early stages, and that he was able to get the ExoDX Prostate Test. “Without it I might have decided to simply watch my PSA levels for a while, and the cancer might have spread.”

For more than thirty years, the PSA has been the gold standard when it comes to detecting prostate cancer. But it’s also had its share of controversy. “There have been concerns that a positive PSA test has led to overdiagnosis and overtreatment,” says James Wysock, M.D., a urologic oncologist and assistant professor of urology at NYU Grossman School of Medicine in New York City. In men with PSA levels in the 4.0 to 10 range, biopsy confirms cancer about 25 percent of the time. This means that the remaining 75 percent would have to undergo a procedure that’s painful, anxiety-producing, and carries risks including infection and bleeding. And even if the test successfully picks up cancer, Wysock adds, many prostate cancers grow so slowly that they will not cause harm during a man’s lifetime. But to be on the safe side, many men opt for treatment, which carries risk of side effects such as incontinence and impotence.

Now, not only can several new blood and urine tests more accurately measure your risk for prostate cancer, they can also detect how aggressive your cancer is, so that both you and your doctor can come up with a targeted treatment. “Not all prostate cancers need to be treated — we can sometimes do what’s known as active surveillance, where you’re monitored over time to see if your levels rise,” explains Wysock.

The ExoDx, which has been available since 2017, works by checking a man’s urine for specific prostate cancer biomarkers that would indicate tumor cell growth. If the test comes back with a score under 15.6, it’s considered low risk or benign. Anything higher could indicate cancer. Ripken’s score was 45.

Similar specific tests to diagnose prostate cancer have been available for close to a decade. Two of the earliest ones were the Prostate Health Index (PHI), FDA approved in 2012, and the 4Kscore test, approved in 2015. These both combine the results of different types of PSA to get an overall score that reflects the chance a man

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Poverty Might Raise Black Kids’ Health Risks as Early as Age 5 | Health News

By Steven Reinberg, HealthDay Reporter

(HealthDay)

FRIDAY, Oct. 23, 2020 (HealthDay News) — Kids growing up in poverty show the effects of being poor as early as age 5 — especially those who are Black, a new study suggests.

The research adds to mounting evidence that children of Black parents who are also poor face greater health inequities than whites.

“Our findings underscore the pronounced racialized disparities for young children,” said lead author Dr. Neal Halfon, director of the Center for Healthier Children, Families and Communities at the University of California, Los Angeles.

For the study, teachers administered a standardized test to measure physical, social, emotional and language development of kindergarteners in 98 school districts across the United States. More than 185,000 kids took the test from 2010 to 2017.

Analyzing the data, the researchers found that 30% of the poorest children were vulnerable in one or more areas of health development, compared with 17% of children from wealthier areas.

These differences in vulnerability varied among from different ethnic and racial groups. Black children were at the highest risk, followed by Hispanic children. Asian children were at the lowest risk.

The difference between Black children and white children was most striking at the higher socioeconomic levels and tended to narrow for kids from lower-income areas.

The disparities can have a profound effect on kids’ long-term development and lead to higher rates diabetes, heart disease, drug use, mental health disorders and dementia, the researchers said.

“Many other studies have highlighted patterns of income and racial inequality in health and educational outcomes. What this study shows is that these patterns of inequality are clearly evident and measurable before kids start school,” Halfon said in a university news release.

The findings were published in the October issue of the journal Health Affairs.

Copyright © 2020 HealthDay. All rights reserved.

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Study: HIV-positive adults show early signs of aging, even after antiretroviral therapy

Oct. 22 (UPI) — People with HIV may experience aging-related illnesses, such as heart disease and brain disorders, earlier than those without the virus, even if they have been on antiretroviral therapy, a study published Thursday by the journal Pathogens and Immunity found.

The analysis, which compared 15 HIV-positive adults on antiretroviral therapy to 15 age-matched people without the virus, found that those being treated with the drugs showed increased evidence of cellular aging, the researchers said.

Antiretroviral therapies, or ART, are intended to slow the progression of HIV and reduce the level of the virus in the body.

While ART has led to people with HIV living longer, they are still at higher risk for having a “reduced healthspan” — or developing age-related health complications — than those without the virus, according to the researchers.

“Most individuals living with HIV probably already know that they are facing more health challenges than their uninfected peers, so the main takeaway from this study is that we’re now beginning to better understand why that is,” study co-author Beth D. Jamieson told UPI.

“It’s clear that the antiretroviral therapies aren’t causing this aging acceleration. It appears to be the virus and … the antiretroviral therapies appear to help reverse some of this aging, but the changes are less robust and much slower than we’d like to see,” said Jamieson, a professor of medicine in the division of hematology and oncology at UCLA’s David Geffen School of Medicine.

About 1.4 million adults in the United States have HIV, and nearly 40,000 are diagnosed with the virus each year, according to the Department of Health and Human Services.

Research suggests that ART drugs bolster the immune systems of those with the disease, allowing them to better fight off infections and, effectively, enabling them to live close-to-normal lifespans.

However, treated HIV-infected adults still experience earlier declines in physical functions, as well as higher rates of heart disease, diabetes, osteoporosis, kidney failure, liver cancer and neurological disorders than otherwise healthy adults, Jamieson and her colleagues said.

For their research, the UCLA-based team assessed 30 study participants — 15 receiving ART for HIV and 15 healthy controls — for signs of cellular aging. DNA samples collected from all study subjects were analyzed using the epigenetic clock, a biochemical test used to measure aging.

In the HIV-positive participants, DNA samples were collected at three points — six months to one year before starting ART, six to 12 months after beginning treatment and 18 to 24 months later.

Before starting ART, the DNA participants with HIV all had significantly higher levels of four measures for cellular aging — age acceleration residual, extrinsic epigenetic age acceleration, phenotypic epigenetic age acceleration and Grim epigenetic age acceleration — than the uninfected adults, the researchers said.

That remained true six to 12 months after the HIV-positive participants started ART. However, 18 to 24 months after starting therapy, only levels of residual and extrinsic epigenetic age acceleration remained higher in those with HIV, the analysis

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