MHRA Grants HAE Patients Early Access to BioCryst’s Berotralstat in United Kingdom

RESEARCH TRIANGLE PARK, N.C., Oct. 30, 2020 (GLOBE NEWSWIRE) — BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted oral, once-daily berotralstat a positive scientific opinion through the Early Access to Medicines Scheme (EAMS).

Under the EAMS, hereditary angioedema (HAE) patients in the UK aged 12 years and older can gain access to berotralstat for the routine prevention of recurrent attacks of HAE before the drug is granted marketing authorization by the European Commission (EC).

HAE is a serious, and potentially life-threatening, rare genetic illness characterised by periodic episodes of acute swelling of the skin, pharynx, larynx, gastrointestinal tract, genitals and/or extremities.

Medicines included in the EAMS are those that have a high unmet need, are intended to treat, diagnose or prevent seriously debilitating or life-threatening conditions where there are no adequate treatment options, and are likely to offer significant advantage over methods currently used in the UK. Under the scheme, the MHRA provides a scientific opinion on the benefit-risk balance of the medicine, based on the data available when the EAMS submission was made.

“There are many patients in the UK that don’t have a realistic option for effective HAE prophylaxis. The addition of berotralstat through the EAMS will bring a much needed option for HAE patients suffering with this debilitating disease,” said Dr. Sorena Kiani, Consultant Immunologist at Royal London Hospital, London.

“HAE patients around the world are waiting for an oral, once-daily therapy to prevent attacks and reduce their burden of therapy. With this decision by the MHRA, the wait for many HAE patients in the UK can end sooner,” said Jon Stonehouse, chief executive officer of BioCryst.

The European Medicines Agency (EMA) is reviewing the marketing authorisation application (MAA) for berotralstat under the centralized procedure. An opinion from the Committee for Medicinal Products for Human Use (CHMP) is expected approximately 12 months from MAA validation, which the company announced on March 30, 2020.

About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including ORLADEYO(berotralstat), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst’s first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company’s website at www.BioCryst.com.

Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding future results, performance or achievements. These statements are identified by use of terms such as “expect,” “will,” and similar words, although

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Early results from DETECT study suggest fitness trackers can predict COVID-19 infections

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IMAGE: The DETECT study uses a mobile app to collect smartwatch and activity tracker data from consenting participants, and also gathers their self-reported symptoms and diagnostic test results. Any adult living…
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Credit: Scripps Research

LA JOLLA, CA–Examining data from the first six weeks of their landmark DETECT study, a team of scientists from the Scripps Research Translational Institute sees encouraging signs that wearable fitness devices can improve public health efforts to control COVID-19.

The DETECT study, launched on March 25, uses a mobile app to collect smartwatch and activity tracker data from consenting participants, and also gathers their self-reported symptoms and diagnostic test results. Any adult living in the United States is eligible to participate in the study by downloading the research app, MyDataHelps.

In a study that appears today in Nature Medicine, the Scripps Research team reports that wearable devices like Fitbit are capable of identifying cases of COVID-19 by evaluating changes in heart rate, sleep and activity levels, along with self-reported symptom data–and can identify cases with greater success than looking at symptoms alone.

“What’s exciting here is that we now have a validated digital signal for COVID-19. The next step is to use this to prevent emerging outbreaks from spreading,” says Eric Topol, MD, director and founder of the Scripps Research Translational Institute and executive vice president of Scripps Research. “Roughly 100 million Americans already have a wearable tracker or smartwatch and can help us; all we need is a tiny fraction of them–just 1 percent or 2 percent–to use the app.”

With data from the app, researchers can see when participants fall out of their normal range for sleep, activity level or resting heart rate; deviations from individual norms are a sign of viral illness or infection.

But how do they know if the illness causing those changes is COVID-19? To answer that question, the team reviewed data from those who reported developing symptoms and were tested for the novel coronavirus. Knowing the test results enabled them to pinpoint specific changes indicative of COVID-19 versus other illnesses.

“One of the greatest challenges in stopping COVID-19 from spreading is the ability to quickly identify, trace and isolate infected individuals,” says Giorgio Quer, PhD, director of artificial intelligence at Scripps Research Translational Institute and first author of the study. “Early identification of those who are pre-symptomatic or even asymptomatic would be especially valuable, as people may potentially be even more infectious during this period. That’s the ultimate goal.”

For the study, the team used health data from fitness wearables and other devices to identify–with roughly 80% prediction accuracy–whether a person who reported symptoms was likely to have COVID-19. This is a significant improvement from other models that only evaluated self-reported symptoms.

As of June 7, 30,529 individuals had enrolled in the study, with representation from every U.S. state. Of these, 3,811 reported symptoms, 54 tested positive for the coronavirus and 279 tested negative. More sleep and less activity than an individual’s normal levels were significant

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Pakistan orders early closure of businesses

ISLAMABAD — Pakistani authorities have ordered all businesses, including restaurants, wedding halls and markets, be closed after 10 p.m. to contain a coronavirus resurgence that began this month.



A health official from the district office wearing protective gear, walks near a banner showing a precaution against the coronavirus in Seoul, South Korea, Thursday, Oct. 29, 2020. (AP Photo/Lee Jin-man)


© Provided by Associated Press
A health official from the district office wearing protective gear, walks near a banner showing a precaution against the coronavirus in Seoul, South Korea, Thursday, Oct. 29, 2020. (AP Photo/Lee Jin-man)



An Indian family wearing face masks as a precaution against the coronavirus bargain for a ride with an autorickshaw driver in Bengaluru, India, Thursday, Oct. 29, 2020. India's confirmed coronavirus caseload surpassed 8 million on Thursday with daily infections dipping to the lowest level this week, as concerns grew over a major Hindu festival season and winter setting in. India's trajectory is moving toward the worst-hit country, the United States, which has over 8.8 million cases. (AP Photo/Aijaz Rahi)


© Provided by Associated Press
An Indian family wearing face masks as a precaution against the coronavirus bargain for a ride with an autorickshaw driver in Bengaluru, India, Thursday, Oct. 29, 2020. India’s confirmed coronavirus caseload surpassed 8 million on Thursday with daily infections dipping to the lowest level this week, as concerns grew over a major Hindu festival season and winter setting in. India’s trajectory is moving toward the worst-hit country, the United States, which has over 8.8 million cases. (AP Photo/Aijaz Rahi)

Also, authorities in the capital, Islamabad, asked police to arrest anyone violating social distancing rules by not wearing masks at public places.

The government Thursday reported some of its highest single-day totals, more than 900 new cases and 16 deaths. The numbers are almost double those reported some days last month.

Pakistan has reported 311,108 confirmed coronavirus infections, including 6,775 deaths.

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HERE’S WHAT YOU NEED TO KNOW ABOUT THE VIRUS OUTBREAK:

— US data Thursday expected to show blowout economic growth in summer, but it’s already fading

— Biden is focusing on COVID-19, while Trump would rather talk about just about anything else

— US health officials are issuing insurance coverage rules anticipating COVID-19 vaccines

— On the road in Mississippi, AP finds a story of love in the time of coronavirus

— Australia’s pandemic travel ban brings family heartbreak and questions about how long it can be justified

Video: Dr. Patel on how the White House should be dealing with the virus outbreak: ‘This should go well beyond what’s standard’ (MSNBC)

Dr. Patel on how the White House should be dealing with the virus outbreak: ‘This should go well beyond what’s standard’

UP NEXT

UP NEXT

— India’s cases surpass 8 million as concerns grow over Hindu festivals, winter and social distancing fatigue

— Follow AP’s coronavirus pandemic coverage at http://apnews.com/VirusOutbreak and https://apnews.com/UnderstandingtheOutbreak

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HERE’S WHAT ELSE IS HAPPENING:

BEIJING — Officials in the northwestern China region of Xinjiang say they believe they have contained the country’s latest coronavirus outbreak.

Xinjiang reported 23 new confirmed cases Thursday, all involving people who had initially tested positive but displayed no symptoms. It was the second consecutive day in which newly confirmed cases emerged entirely among such people.

Officials say that development appears to show new infections have been curbed in Kashgar prefecture, where the outbreak appeared Saturday. They say all the cases seem to be linked to a garment factory that employs 252 people and has since being sealed off.

More than 4.7 million people in Kashgar have been tested for the virus.

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ANCHORAGE, Alaska — Officials in Anchorage,

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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
[email protected]
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)

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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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Leronlimab Shows Early, but Promising Clinical Responses in First Two Patients Recovering from Stroke

VANCOUVER, Washington, Oct. 26, 2020 (GLOBE NEWSWIRE) — CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today two patients have demonstrated noticeable signs of improvement following treatment with leronlimab (PRO 140) in helping their recovery from stroke.

The most recent stroke patient, a physician in Mississippi, requested leronlimab, which was administered to him under Mississippi’s recently expanded “Right to Try” statute. The physician’s son, commenting on his father, stated, “He is doing good. Yesterday, he received his second treatment. He said he has been feeling better, and he thinks it is working. He said parts of his body and face that have been numb are starting to change/wake up.”

Scott A. Kelly, M.D., CytoDyn Chairman of the Board, Chief Medical Officer and Head of Business Development, commented, “We are encouraged by leronlimab’s potential to help patients recover from stroke and traumatic brain injury. Independent research has concluded CCR5 is upregulated in neurons after stroke, blocking CCR5 induces motor recovery after stroke, and CCR5 antagonism may enhance learning, memory, and plasticity. CCR5 is rapidly becoming an important target for neural repair in stroke and traumatic brain injury. Our recent data that leronlimab crosses the blood-brain barrier with 70-75% receptor occupancy of the CCR5 receptors in the brain (Macaque model) is encouraging for the potential to enhance recovery in stroke and traumatic brain injury and explore a variety of central nervous system pathology.”

A second stroke patient was receiving treatment with leronlimab as part of her therapy for breast cancer. The treating physician noted her partial paralysis was mitigated relatively quickly, which may have been causally related to the posited role of CCR5 in stroke.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, “Leronlimab’s ability to cross the blood-brain barrier potentially presents numerous opportunities for the treatment of patients suffering from diseases related to the central nervous system. Therefore, we are accelerating the filing of a Phase 2 protocol to evaluate leronlimab’s potential as a therapeutic for stroke recovery. We continue to focus our energies on our most important task of enrolling more patients in our severe-to-critical COVID-19 Phase 3 trial as quickly as possible. In addition to moving forward rapidly to complete our Biologics License Application for HIV, in multiple countries, our extensive plan includes filing a protocol and IND for Phase 2 clinical trials for both stroke and Long Haulers COVID-19 indications. We continue to strongly believe leronlimab has the potential to provide therapeutic benefit to patients suffering from a variety of diseases, and this incredible prospect drives our management team every day. CytoDyn is committed to fulfilling this obligation to patients of the world.”

About Leronlimab’s Ability to Cross BloodBrain Barrier
The blood-brain barrier (BBB) mediates the communication between the periphery and the central nervous system (CNS). The BBB separates the circulation from the brain. It is a highly selective permeable border

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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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