Category: Covid-19

The secret to fighting COVID-19 could be in recovered patients. Here's how antibodies could lead to a treatment for those fighting coronavirus. USA TODAY

President Donald Trump, former New Jersey Gov. Chris Christie and former New York City Mayor Rudy Giuliani all receivedmonoclonal antibodies when they were treated for COVID-19.

And despite having risk factorssuch as age and weightthat put them at risk of getting really sick,they recovered quickly, although Christie spent a week in intensive care.

They all creditmonoclonal antibodies.

But only a fractionof those doseshavereached the people who could benefit from them, Health and Human Services Secretary Alex Azar said Monday.

The reason is a mix of science and politics,with some logistical and staffing challenges thrown in.

Monoclonal antibodiesmimic the natural process of the immune system, providing it with moleculesthe body normally manufactures to fightdisease. They are specific to each disease, but have been shown highly effective against other conditions, including Ebola, rheumatoid arthritisand some types ofcancer.

Fact check: What's true and what's false about the COVID-19 vaccine

Trump was so impressed with monoclonal antibodies, he promised to make them freely available to everyone in the United States. The government has since bought and delivered more than 250,000doses of two therapies to hospitals across the country.

Butresearch isn't clear that monoclonal antibodies help patients recover faster. Two key panels that recommend how doctors should treat COVID-19 patients declined to support monoclonal antibodies. Until they do,doctors may be hesitant to prescribe the treatment.

"Although these look promising, there's not enough conclusive evidence to know that these are having a clinical benefit," said Dr.Rajesh Gandhi, an infectious diseases doctor at Massachusetts General Hospital and Harvard Medical School, who sits on both guideline panels.

Most hospitalized patients are too sick to benefit from the drugs, and it's challenging to deliver drugs to COVID-19 patients who aren't sick enough to be hospitalized, Gandhisaid.

Hospitals have limited staff available to deliver monoclonal antibodiesbecause COVID-19 has filled their beds andare busy deliveringthe first vaccinations.

The drugs are hard to deliver, requiring a one-hour infusion followed byone to two hours of observation. And the people who need monoclonal antibodies are at the most contagious stage of disease, making it tricky to deliver the drugs in facilities like cancer or dialysis centers that commonly delivermedication by infusion.

As of last week, about 20% of the 250,000 doses of monoclonal antibodies delivered to stateshave beenused, according to a Health and Human Services spokesperson.

U.S. President Donald Trump removes his mask upon return to the White House from Walter Reed National Military Medical Center on October 5, 2020 in Washington, DC. Trump spent three days hospitalized for coronavirus.(Photo: Win McNamee, Getty Images)

To improve usage,Azar said the federal Operation Warp Speed has begun delivering doses to retail pharmacies that have infusion centers, to skilled nursing facilities, and to at-home infusion services.

Azar said people at high risk for serious diseaseshould ask their doctors for the monoclonal antibodies as soon as they're diagnosed with COVID-19.

"We simply can't have this very valuable tool sitting on the shelves," Azar said.

Former FDA Commissioner Scott Gottlieb said the only people getting monoclonal antibodies now are those like Trump and his friends who have the right doctor or know what to ask for.

"Patients who already face obstacles to getting good care run the risk of having a hard time finding doctors and centers that are able to infuse these drugs, while those connected to better sites of service are able to seek out these medicines," he said. "This runs the risk of widening the disparities we already see in COVID outcomes."

Your vaccine questions, answered: I had COVID, should I still get vaccinated? What are the side effects? What are its 'ingredients?'

When Trump received the therapy made byRegeneron Pharmaceuticals of New York, he was among fewer than10 people to receive the drug outside of a trial, under a "compassionate use" exemption. Christie also received the treatment that way, although the combination of two antibodies,casirivimab and imdevimab,had been FDA authorized by the time Giuliani fell ill.

A similar treatment, bamlanivimab,made by Eli Lilly and Co. ofIndianapolis, Indiana, has also received emergency use authorization, which requires a lower standard of effectiveness than full approval.

Since the earliest days of the pandemic, health officials have promised monoclonal antibodies would be a game-changerin the fight against COVID-19.

On March 2, in a White House meeting with drug company executives, Dr. Deborah Birx, who had recently taken the job ofCoronavirus Response Coordinator for the White House Coronavirus Task Force, touted the combination of monoclonal antibodies, therapeutics and vaccines to fight COVID-19."It's very encouraging," she said.

"It is very exciting. And the speed is very exciting, too," Trump replied.

Two months later, the administration announced the creation of Operation Warp Speed, a $10 billiongovernment effort to rapidly develop vaccines, therapeutics and diagnostics to fight COVID-19.

Vaccines were developed in record time. ButGottlieb, the former FDA commissioner,said the administration did not work quickly enough to expand the manufacturing capacity ofmonoclonal antibodies.

Millions of doses could be available and in use today, if the government had done more early on, Gottlieb said. He said officials should have used the government's authority to get other drug companies to manufacture these monoclonals.

Antibodies used in medicine are Y-shaped proteins that attach to problematic molecules and cells, to flag them for destruction or block their activity [3,10].(Photo: Getty Images)

The government also could have invested in special sites to administer monoclonals, said Gottlieb, who also sits on the board of Pfizer, the pharmaceutical giant behind one of the two COVID-19 vaccines authorized so far.

"Many of us, including myself, were writing and advocating back in April and May that we should start trying to requisition biologics manufacturing capacity, recognizing that the antibodies were going to be available at some point in the fall,' Gottlieb said.

If they had started making the drugs earlier, and if people had understood their potential, we might not be in the current situation, he said."We just didn't do it."

Gandhi, at MassachusettsGeneral, said clinical trials of monoclonal antibodies could have moved faster, too.

"These antibodies are going to give us an answer relatively soon," Gandhi said. "It would have been nice if the answer was months ago."

One hard lesson learned during the pandemic: The U.S needs a better system for conducting clinical trials during a disease outbreak, when the need for information is urgent but studies are more difficult, Gandhi said.

Although the data remains limited, monoclonal antibodies do seem generally safe.

"I do believe these two monoclonal antibodies can be lifesaving and prevent hospitalizations," Moncef Slaoui, the scientific chief of Operation Warp Speed, said Monday.

"They are effective at either eliminating the virus and giving time to the patient's own immune response to eliminate whatever (virus remains)," he said,"and on the other hand are very good at decreasing the virus load, which is very likely to translate into clinical benefit, but that benefit hasn't been confirmed."

In small clinical trials, both the Lilly and Regeneron antibodies both of which have been FDA-authorized for emergency use seemed to help people stay out of the hospital. Both drugs were authorized for use in non-hospitalized patients.

Never mind the political messengers: When it comes to COVID-19 guidance, trust the message, experts say

Among a high-risk group of people recently diagnosed with COVID-19,approximately 10% who received aplacebo ended up needing hospital care to treat their disease, compared to only 3% of those who received Lilly's monoclonal antibody. Regeneron's results were similar.

Regeneron, in a 275-person study published last week in the New England Journal of Medicine, showed that itsmonoclonal antibodies reduced the amount of virus in people diagnosed with COVID-19, particularly those who were carrying particularly high levels of virus and those whose bodies hadn't yet begun to fight it.

Gandhi saidit is not yet clear whether reducing someone'sviral load can help them recover faster or save their life.

And the studies were so small"that it's hard to be extremely confident in those results," Gandhi said.

That's why theInfectious Disease Society of American and the National Institutes of Health guidelines, which practitioners often use to directthe care they provide,declined to support the use of monoclonal antibodies, he said.

Azar complained Monday that both groups should be willing to accept less conclusive data during a global pandemic, when thousands of Americans are dying every day.

"We've been very disappointed that this incredibly important tool that should be getting used more frequently, that should be getting used to keep people out of the hospital" isn't reaching more patients,Azar said.

Both Regeneron and Lilly are continuing their monoclonal antibody trials, hoping to make more data available soon. Slaoui said Lilly is also investigating three casesin which the virus appeared to mutate to evade the drug, although all three trial participants recovered.

ContactKaren Weintraub at kweintraub@usatoday.com

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

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Monoclonal antibodies may have helped Donald Trump recover from COVID-19, but many others aren't getting them - USA TODAY

Governor Cuomo Announces New York Has Administered 38,000 Doses of COVID-19 Vaccine - Highest Total in the Nation | Governor Andrew M. Cuomo Skip to main content December 21, 2020

Albany, NY

346,000 Doses of Moderna Vaccine and 120,000 Additional Doses of Pfizer Vaccine Arriving this Week

New York Launches Vaccine Equity Task Force Chaired by Secretary of State Rosado, Attorney General James, National Urban League President & CEO Marc Morial, and Healthfirst President & CEO Pat Wang

New York Developing Community Vaccination Kits - Self-Contained Units Which Include All Items Necessary for Setting Up a Vaccination Site, Will Be Used Particularly in Health Care Deserts

Federal Program to Vaccinate Nursing Home Residents and Staff Began Today

Governor Andrew M. Cuomo today announced more than 38,000 vaccine doses have been administered in New York State as of Monday morning - the highest reported total in the nation thus far.

Bolstering this effort, the first 346,200 doses of the Moderna vaccine are expected to begin arriving in New York today, with an additional 120,000 doses of the Pfizer vaccine expected later this week.

The Governor also announced the launch of New York's Vaccine Equity Task Force chaired by Secretary of State Rossana Rosado, Attorney General Letitia James, National Urban League President & CEO Marc Morial, and Healthfirst President & CEO Pat Wang. The Task Force will work to ensure vulnerable and underserved communities are not left behind by breaking down the barriers to vaccination and ensuring there is equitable distribution of the vaccine across the state.

Audio Photos

Governor Cuomo also announced that New York is developing Community Vaccination Kits to provide communities, particularly those located within health care deserts, with the supplies and resources needed for standing up vaccination sites.

The Governor also announced that a federal program to vaccinate nursing home residents and staff began today in New York State and is expected to vaccinate residents and staff at 618 facilities across the state, with first doses administered starting today and over the next two weeks.

"We're now talking about who's getting vaccinated, and let me be clear: there is no politics in the vaccination process,"Governor Cuomo said."We went through this with COVID testing, with big shots, celebrities, and affluent people getting to the front of the line. This preferential treatment in COVID testing undermines our entire sense of democracy, equality and a government that works for all people. And in this time of COVID where we've seen gross injustices, politics has nothing to do with it. There's no governor, no county executive, and no mayor who controls the process, and anyone who says that is not telling the truth or violating the law. This is entirely done by medical professionals and our hospitals have already vaccinated more people than any state in the nation."

We're now talking about who's getting vaccinated, and let me be clear: there is no politics in the vaccination process.

Health experts have projected that in order to win the war against COVID-19, between 75 and 85 percent of the population needs to receive the vaccine and as such, New York has made it a top priority to ensure vulnerable and underserved communities are not left behind. To further this work, breakdown barriers to access and ensure equitable distribution of the vaccine, the Governor is launching New York's Vaccine Equity Task Force.

Task Force members include:

Community Vaccination Kits will be a key part of New York's efforts to increase access to vaccines in Black, Latino, rural, poor and public housing communities, as well as other health care deserts by providing all essential equipment and supplies to administer vaccines to those populations most in need of support.

Specifically, each kit includes step-by-step instructions for how to set up a site, and critical supplies and equipment such as:

Today, New York State began a federal program to vaccinate nursing home residents and staff at 618 facilities enrolled in the program to date. CVS will vaccinate 271 facilities, Walgreens will vaccinate 253 facilities, and other pharmacies will vaccinate 94 facilities. The program in its entirety is expected to take approximately six weeks, including three "clinical days" at each facility:

The State of New York does not imply approval of the listed destinations, warrant the accuracy of any information set out in those destinations, or endorse any opinions expressed therein. External web sites operate at the direction of their respective owners who should be contacted directly with questions regarding the content of these sites.

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Governor Cuomo Announces New York Has Administered 38000 Doses of COVID-19 Vaccine - Highest Total in the Nation - ny.gov

This is part two in a three-part series. Click here to read part one.

Earlier this year, San Diego Countys tribal casinos bet big that they could reopen and still keep COVID-19 at bay.

Its been a bad wager.

County records of community outbreaks obtained by KPBS show that at least 638 COVID-19 cases from late June through mid-December have been linked to seven area casinos.

Records show the highest numbers tied to the countys two largest casinos, Viejas Casino & Resort and Sycuan Casino & Resort. At least 166 cases have been linked to Viejas and 155 to Sycuan, according to a KPBS analysis of the records.

While the lions share of cases are associated with Viejas and Sycuan, the records show no major casino being spared. They reveal 102 cases connected to Barona Resort & Casino; 91 to Jamul Casino; 57 to Harrahs Resort Southern California; 45 to Valley View Casino & Hotel; and 22 to Pala Casino Spa & Resort.

To say that a case is linked with a location means that a person was there within two weeks of being diagnosed with COVID-19. It does not mean that the person contracted the virus at the location or infected anyone else there.

Yet, Christian Ramers, an infectious-disease doctor, says the numbers tied to the casinos are evidence of pretty consistent ongoing transmission.

Its very concerning that theres ongoing transmission in these settings, said Ramers, who heads Population Health at Family Health Centers of San Diego.

Ramers added that the transmission only helps to fuel the overall community spread.

It's like a chain reaction, he said. We're not going to be able to get our hands around this epidemic when there is just this ongoing transmission.

Health advocates are especially worried about seniors, who are some of the most avid casino patrons and especially vulnerable to severe cases of COVID-19.

Editors note: This interactive map and searchable database contains records obtained by KPBS of COVID-19 community outbreaks in San Diego County. When viewing these records it is important to keep in mind that just because you visited a place that had an outbreak doesnt necessarily mean you were exposed to the virus. And it doesn't mean you can catch COVID-19 by going there now. By the countys definition, an outbreak occurs when three or more people with COVID-19, who aren't close contacts, were known to be in a specific location during the same 14-day period. It's possible none of them caught the virus at the outbreak location. And being the site of an outbreak doesn't necessarily mean the businesses had unsafe practices.COVID-19 is a virus that spreads easily without fear or favor. KPBS is releasing the outbreak locations because transparency and public health information is vital for our community.

RELATED: County Vows To Fight Plans By Casinos To Reopen Next week

County officials rejected interview requests on KPBS' findings. And for months, theyve refused to release detailed information on community outbreaks, arguing that businesses and organizations wouldnt report them if they knew they would be public. KPBS and other news outlets sued for the records in San Diego County Superior Court but lost. The case is on appeal.

The county defines a community outbreak as three or more people with COVID-19, who arent close contacts, being in a specific place over the same 14-day period. However, it is important to note that just because someone may have visited a location with an outbreak, it doesnt necessarily mean they were exposed to the virus at that location. And being the site of an outbreak doesnt necessarily mean the business has unsafe practices.

'No outbreaks'

Tuari Bigknife, chief legal officer for Viejas Enterprises, labeled the case numbers attributed to its casino as erroneous.

While it is true that since reopening, Viejas Casino & Resort has learned of some guests and team members testing positive for COVID-19, those guests and team members typically interacted with numerous other persons and places other than Viejas Casino & Resort during the potential exposure period, Bigknife said in a written statement.

Sycuans Chief Administrative Officer Adam Day said the numbers may reflect a Thanksgiving bump. But he also sought to erase any impression that Sycuan casino was a source of community spread.

To date since the start of the pandemic, there have been no outbreaks linked to our casino and we will continue to operate responsibly with health and safety at the forefront in all of the decisions that we make, Day said in a written statement.

Representatives from the other tribal casinos linked to outbreaks either declined to comment or didnt respond to interview requests.

The casinos closed when the pandemic first struck in March, but reopened in May against the wishes of state and county health officials. Tribes are sovereign entities and not bound by state and county orders.

Since resuming business, the casinos have touted new precautions. Sycuan has said it offers COVID-19 testing of guests and provides rapid tests to its workers. Viejas says it does private contact tracing for each positive case associated with the casino.

Also, all the major casinos screen guests for symptoms and require masks and social distancing. Plexiglass divides guests from workers and sanitation of commonly used areas has intensified. And some have curtailed dining and other activities as cases have surged in recent weeks.

Both Viejas and Sycuan have made it clear they have no plans to close again despite a new stay-at-home order from Gov. Gavin Newsom.

As a tribal government who is responsible for providing medical care, education, police protection, fire protection, etc., to our tribal members, we are an essential business, Day wrote to KPBS. With that said, we feel that our safety protocols are stronger than any other essential business, government or otherwise.

Economic impact

SDSU business lecturer Miro Copic says the tribes position on another shutdown is not surprising given whats at stake.

From a purely economic perspective, shutting down for extended periods of time would be very detrimental because there is no one tribe that has a casino where its financial impact isnt important to that tribe, Copic said.

Copic added that the casinos are big job creators, employing more than 125,000 people statewide.

These tribes throughout California generate over $3.5 billion in tax revenues for the state and so it's a challenge both for the state to give up that level of tax revenue and also the employment numbers, Copic said. Its a very symbiotic relationship.

Newsom tried unsuccessfully in May to prod the states tribes to hold off on reopening. The state government is still trying.

The Administration is currently engaged in government-to-government consultation with tribal enterprises located within listed areas of concern to determine the appropriate measures to take moving forward to limit the transmission of COVID-19 on tribal lands, said the California Department of Public Health in a written response to KPBS.

Copic said he understands why California continues its efforts to persuade the casinos to shut down, especially as cases in the state now average up to 40,000 a day.

Its incumbent upon everybody to shut down because itll allow us to re-open more effectively and sooner, rather than these fits and starts, Copic said. But thats both a public policy and moral issue.

San Diego resident Tony Wolf quit his security guard job at Viejas in May because he said he didnt feel safe with the casinos reopening. He said he feels the tribes are putting profits over public health, and so are the players.

It's not essential to go gamble, Wolf said.

KPBS reporter Claire Trageser and investigative research assistant Katy Stegall contributed to this report.

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Hundreds Of COVID-19 Cases Tied To San Diego County Tribal Casinos - KPBS

Good evening Tennesseans. Its Christmas week, ordinarily a time when families across the state are gathering to celebrate. Unfortunately, these are not ordinary times. We are in a global pandemic thats been crippling our country for months and now Tennessee is ground zero for a surge in sickness. I am speaking with you tonight because I want to be clear with where we are and what we need to do together to get through this.

We now have around 10,000 Tennesseans getting sick every day. To put that in perspective, thats three times where we were around Halloween. Thousands of our neighbors are in the hospital tonight. More than 100 people are dying each day. We are in a war. With the arrivals of the first vaccine, we have launched an offensive that will end this war. But it is the next few weeks that is going to be the most critical for our state.

We have seen firsthand that Thanksgiving gatherings and extended time indoors have been the principal driver in spreading COVID-19 like wildfire. It only took a matter of days to see gatherings around Thanksgiving translate into a record level of sickness. Tennessee cannot sustain a similar surge after Christmas or New Years. Tonight, I am asking you to make some hard decisions.

I am asking you to not engage in indoor gatherings for the holidays that include anyone outside your household. Family time and celebrations are important. I understand deeply how much Tennessee families need each other. But we must do all that we can to blunt this surge and keep more Tennesseans from getting sick.

But beyond family gatherings and what I am asking you to do in your own home, we need to address public gatherings through these important weeks, as well.

I am signing an order that will limit indoor public gatherings to 10 people.

I believe high school sports are important for our kids and they should continue. In coordination with the TSSAA, we are limiting attendance at indoor sporting events.

We know that it is gatherings that have caused this surge. That is why we are making these decisions around gatherings that will help us blunt the rise in cases.

Additionally, I am asking business owners to let employees work from home for the next 30 days. If work from home is not available, masks should be worn at work. Plain and simple.

I want to talk about the importance of wearing masks around people who do not live in your home. Right now, 70% of Tennesseans are under a mask requirement. I commend the local officials who have implemented mask requirements. Because of that, 80% of Tennesseans report they wear their masks most or all of the time and I thank them for doing this. We need them to continue and the remaining 20% to wear a mask and protect their health.

Many think a statewide mandate would improve mask wearing, many think it would have the opposite effect. This has been a heavily politicized issue. Please do not get caught up in that and dont misunderstand my belief in local government on this issue. Masks work and I want every Tennessean to wear one.

Tennesseans have two weapons that they must use in the next 30 days: only gather with your household and wear a mask.

The State of Tennessee will continue to mobilize every effective resource in this war. COVID testing is available to everyone free of charge. Vaccines are being delivered to every corner of the state. We are getting hundreds of thousands of vaccines out to our nursing home residents and health care workers so they can be vaccinated.

As our hospitals face this surge of sick Tennesseans, we have authorized the National Guard medics to work in hospitals and provide lifesaving care. We have established COVID specific nursing homes so that we protect the most vulnerable and help hospitals free up critical bedspace. We will continue to utilize every effective resource but government cannot do this alone.

We are in a cold, cruel phase of this pandemic. It will get worse before it gets better. I know you are tired. But we have got to double down. I am reminded of Winston Churchills words during the darkest days of World War II: It would be foolish to disguise the gravity of the hour. It would be still more foolish to lose heart and courage.

I believe in the courage of Tennesseans to face this darkest hour. I believe that victory will be ours and we have the power to determine how long this extends. If we each do our part, we will win and move to a new season of health and prosperity for our state.

I extend my heartfelt thanks to each Tennessean for their attention and care tonight. God bless the State of Tennessee.

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Originally posted here:

Gov. Bill Lee Remarks as Prepared for Delivery on the COVID-19 Pandemic - tn.gov

News Release

Monday, December 21, 2020

RADx-rad program will fund non-traditional and repurposed technologies to combat the current pandemic and address future viral disease outbreaks.

The National Institutes of Health has awarded over $107 million to support new, non-traditional approaches and reimagined uses of existing tools to address gaps in COVID-19 testing and surveillance. The program also will develop platforms that can be deployed in future outbreaks of COVID-19 and other infectious diseases. A part of theRapid Acceleration of Diagnostics (RADx)initiative, theawards from theRADx Radical (RADx-rad)program will support 49 research projects and grant supplements at 43 institutions across the United States. It will focus on non-traditional viral screening approaches, such as biological or physiological markers, new analytical platforms with novel chemistries or engineering, rapid detection strategies, point-of-care devices, and home-based testing technologies.

To solve a problem as complicated as COVID-19, we need ideas, tools, and technologies that challenge the way we think about pandemic control, said NIH Director Francis S. Collins, M.D., Ph.D. These awards from the RADx-rad program provide superb examples of outside-the-box concepts that will help us overcome this pandemic and give us a cadre of devices and tactics to confront future outbreaks.

The grants will support new approaches to identifying and tracking the current SARS-CoV-2 virus, which causes COVID-19. Examples of these projects include:

Additionally, two intramural projects were supported by this initiative: a $1 million award to the National Institute of Environmental Health Sciences for developing barcoded screening of SARS-CoV-2; and a $200,000 award to the National Library of Medicine (NLM) for a Nationwide Early-Warning System and Data Platform to aid policy decisions for public health management of viral diseases with COVID-19 as a use case.

RADx-rad grants and supplements are supported by 11 NIH institutes and centers, including the National Center for Advancing Translational Sciences, the National Institute of Dental and Craniofacial Research, the National Heart, Lung, and Blood Institute, the National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institute on Deafness and Other Communication Disorders, the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute on Minority Health and Health Disparities, the National Institute of Nursing Research, and NLM.

About the Rapid Acceleration of Diagnostics (RADxSM) initiative: The RADx initiative was launched on April 29, 2020, to speed innovation in the development, commercialization and implementation of technologies for COVID-19 testing. The initiative has four programs: RADx Tech, RADx Advanced Technology Platforms, RADx Underserved Populations and RADx Radical. It leverages the existing NIH Point-of-Care Technology Research Network. The RADx initiative partners with federal agencies, including the Office of the Assistant Secretary of Health, Department of Defense, the Biomedical Advanced Research and Development Authority, and U.S. Food and Drug Administration. Learn more about the RADx initiative and its programs: https://www.nih.gov/radx.

About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

NIHTurning Discovery Into Health

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NIH to support radical approaches to nationwide COVID-19 testing and surveillance - National Institutes of Health

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The presence of a more infectious strain of the virus that causes Covid-19 is shutting down Europe, causing a wave of lockdowns and travel restrictions, prompting a logistics crisis in the U.K., and hammering stock markets across the continent.

The U.K. government said on Saturday that a coronavirus strain that is 70% more infectious is spreading in the U.K., which reported its highest-ever daily rise in infections on Sunday with 35,928 cases.

Experts believe that this mutated version of coronavirus, first detected in September, isnt more deadly than the typical variety that causes Covid-19, and say there is no proof that it should impact the efficacy of vaccines.

The variant found in the U.K., which is quickly replacing other versions of the virus, is believed to be linked to cases discovered in Italy, Denmark, the Netherlands, and Australia.

Plus:Global Stocks Fall as Stimulus Deal Vies With Travel Bans Over U.K. Covid-19 Strain

U.K. Prime Minister Boris Johnson announced the threat of the more infectious version of the virus on Saturday, when he canceled plans to ease social restrictions over the Christmas period.

The move meant around 18 million people in southeast England were plunged into a new lockdown, and thousands fled London in the hours before the restrictions took effect.

Matt Hancock, the U.K. health secretary, told the media on Sunday that everyone living in the new tier 4 areas of Englandunder lockdownneed to behave as if they have the virus.

European countries followed suit in cracking down on the spread of the mutant virus, with new bans on entry from the U.K. now in place, and the European Union set to announce a coordinated response on Monday after a meeting of its crisis-response committee.

More than 30 countriesincluding India, Germany, Canada, Turkey, and Saudi Arabiaand the special administrative region of Hong Kong have now banned all arrivals from the U.K.

After France closed its border for 48 hours from midnight on Sunday, the U.K. faces a logistics crisis in the busy run-up to Christmas, with the key trade route between the country and continental Europe cut off.

France halted all travel from the U.K., including inbound trade between the key ports of Calais and Dover and through the Eurotunnel. The Strait of Dover between England and France is one of the busiest maritime routes in the world, with up to 10,000 trucks shuttled across this passage of the English Channel each day.

Shortages of critical goods imported from Europe, like food and medicine, could happen if French drivers stop traveling to the U.K. because they are unable to return.

There are now thousands of trucks on each side of the English Channel, as Paris is calling for a strict new testing regime before opening the blockade on Wednesday morning.

A statement shared on Twitter by the French embassy in the U.K., attributed to the French minister of transport, said that in the next few hours, at European level, were going to establish a solid health protocol to ensure that movement from the U.K. can resume.

Also read:Europe Faces a Tough Six Months. These 21 Stocks Could Weather the Storm.

Sainsbury s, the third-largest grocery store in the U.K., warned that there could be gaps on supermarket shelves if the blockade goes on longer than 48 hours.

If nothing changes, we will start to see gaps over the coming days on lettuce, some salad leaves, cauliflowers, broccoli and citrus fruitall of which are imported from the Continent at this time of year, the company said.

Stock markets across Europe have been hammered with pessimism over this latest Covid-10 development, with the pan-European Stoxx 600 and Londons FTSE 100 both down near 3%. Frances CAC 40 and Germanys DAX are both down more than 3%.

Dow futures were pointing down near 500 points for a poor open, after closing at 30,179 on Friday.

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New Covid-19 Strain Shuts Down Europe. What You Need to Know. - Barron's

Californias first coronavirus lockdown order, in the spring, produced benefits within a month. By April, Gov. Gavin Newsom was able to crow that the statehad arguably flattened the curveon infections.

It has been two weeks since a second stay-at-home order was issued, and no such flattening has yet occurred across most of California. This may be because restrictions are looser than those in the spring, and because many Californians are so fatigued by public health orders or militantly resistant to them that they are mixing with people from outside their households.

But experts say the most pertinent explanation has to do with the amount of the coronavirus in the community. The latest orders came after the virus was already raging out of control, in part because of Thanksgiving travel a difference experts say will make the current surge much harder to corral.

The virus is unforgiving and relentless, and there is just so much community transmission, said Dr. Toms Aragn, who next monthwill take overas director of the California Department of Public Health.

Read the full story on LATimes.com.

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California once quelled COVID-19 with stay-at-home order; heres why this one isnt working - KTLA Los Angeles

A $900 billion coronavirus-relief package, expected to be passed by Congress Monday night, would give colleges and universities another $23 billion in relief aid, which the head of the American Council on Education blasted aswholly inadequate.

Congressional leaders are also expected to pass a larger $1.4 trillion budget deal they negotiated to fund the government through next September. The proposed dealwould bring an additional $1 billion in spending on medical research as well asmajor changes to financial aid, including simplifying the Free Application for Federal Student Aid from 108 to 36 questions, and giving Republican education committee chairman Lamar Alexander one of his top priorities days before he retires from Congress. It also includes a number of Democratic priorities, including allowing more incarcerated prisoners to be eligible for Pell Grants. President Trump is expected to sign both pieces oflegislation

A change in how eligibility for Pell Grants is determined would also make it easier for lower-income students to receive the maximum amountoffederal student aid.Alexanderand Patty Murray, the top Democrat on the Senate education committee,estimated the changes would mean an additional 555,000 students will qualify for Pell Grants each year and 1.7 more million students willqualify to receive the maximum Pell award each year. About $1.3 billion in capital loans owed to the federal governmentby historically Black colleges and universities is being forgiven as part of the budget deal.

The expansion offinancial aid eligibility and increase ingrant levelsare particularly important forlow-income students, many of whom struggle to afford college. The changes are also important because it's unlikely Congress will take up a rewrite of the nations main higher education law, the Higher Education Act, anytime soon, said Justin Draeger, president of the National Association of Student Financial Aid Administrators.

Congressional negotiators apparently removed a proposal by a bipartisan group of lawmakers last week to extend the suspensionof student loan paymentsuntil April. The moratorium was due to expire on Jan 1 butEducation Secretary Betsy DeVos extended it last month to Feb. 1.

However,the bill it also extends a provision allowing employers to contribute up to $5,250 tax-free to their employees student loans for another five years. The tax incentive, included in the CARES Act, was set to expire at the end of the year.

This is a win for employees, who get help paying off their student loans, saidRepublican Senate Majority Whip John Thune,who originally sponsored a bill creating the tax incentive with Democratic senator Mark Warner,And its a win for employers, as they look to attract and retain talented workers. Thune said on the Senate floor.

Ashley Harrington, federal advocacy director and senior counsel for the Center for Responsible Lending, blasted the decision not to continue excusing borrowers from making payments. Encouraging employers to make payments benefits borrowers who work for a generous employer, she said. Many borrowers dont have that luxury, especially now.

The COVID-19 relief to higher ed institutions represents only a sliver of the $120 billion associations representing colleges and universities had requested. It requires half of the funding to spent on emergency aid to struggling students, much like the CARES Act fundingapproved in April. Part of $82 billion in additional help for all of education, colleges and universities are getting a smaller slice than in the CARES Act.

In order to reach a deal on coronavirus relief -- which will also send Americans a $600 stimulus check and extend enhanced unemployment benefits -- Democrats also agreed to set aside their demands for additional aid to states and universities. Colleges had hoped for the additional aid to undo or forestall state cuts to higher education.

Though the $23 billion in covid aid is greater than the $14 billion colleges received in the CARES Act, higher education lobbyists said it is not enough to cover the financial hit institutions have suffered in the nine months that Congress and the White House have haggled over providing more aid.

The money provided in this bill will provide some limited relief, which is welcome news to struggling students and institutions, ACE President Ted Mitchell said in a statement Monday afternoon. But it is not going to be nearly enough in the long run or even the medium term. The financial impact of the pandemic and its economic fallout will be enormous, with more than half a million job losses on campuses already.

The new aid package creates a different and more complicated formula for divvying up the money than what was used in the CARES Act, and it was difficult to immediately estimate how much each institution may get, said Jon Fansmith, ACEs government relations director.

Mitchell called on President-elect Joe Biden and Congress to provide additional help in a larger relief package next year.

Thomas Harnisch, vice president for government relations at the State Higher Education Executive Officers Associationn, lamented the lack of additional aid to states.

State and local governments throughout the country are facing deep budget shortfalls going into the 2021 legislative session and the lack of federal relief in this package is a step backward in the effort to stabilize the economy, preserve jobs, and maintain funding for needed public services, he said.

Biden, after the congressional leaders announced agreement on the spending package Sunday night, said it is just the beginning. Our work is far from over.

During the last minute negotiations over the COVID-19 bill, Republicans also agreed to put off creating a shield law protecting businesses and colleges from lawsuits filed by coronavirus victims.The two sides agreed to take up the issue during negotiations next year for the next round of aid.Although the no such lawsuits are believed to have yet been filed during the pandemic, the American Council on Education said a shieldlaw is still needed to prevent colleges from having to fight frivolous lawsuits and to keep the fear of being sued from discouraging colleges from resuming in-person classes if they would do so otherwise.

Among the measures in the broader funding bill is an inflationary $150 increase in the maximum size of Pell Grants to $6,495, a far cry from the doubling of the grant groups like the National College Attainment Network areadvocating.

House and Senate education leaders had been close to a deal on simplifying the Free Application for Federal Student Aid, or FAFSA form before Alexander leaves office. The Republican from Tennessee, and former president of the University of Tennessee, has been pushing to simplify the form foryears. He often displayed the long, scroll-like form during speeches for effectand he mentioned the issue in his farewell speech on the Senate floor Dec. 4 as one of the things he cared most about and one of the footprints he wanted to leave behind.

After nearly seven years of work Congress and the President will simplify federal student aid for 20 million families who fill out these unnecessarily complicated forms every year, Alexander said in a statement Sunday night. Reducing the FAFSA from 108 questions to 36 will remove the biggest barrier to helping more low-income students pursue higher education."Former Governor Bill Haslam told him that the complex FAFSA form is the single biggest impediment to Tennesseans applying for two years of tuition free college.

Kim Cook, executive director of the National College Attainment Network, applauded simplifying the form. Each year, students leave $2.5-3 billion on the table by not completing the FAFSA. These changes, building upon last years FUTURE Act, will make it easier for students to complete the complicated federal aid application and qualify for the aid for which they are eligible. Easing access to federal student aid is a step toward a more equitable higher education system, especially for students of color and students from low-income backgrounds.

In addition,the bill would also simplify determining eligibility for maximum Pell Grant. Rather than forcing families to undergo the complicated process of determining how much their families could contribute towards the cost of attending college, only household size and the familys income relative to the poverty rate would be continued, said Karen McCarthy, the National Association of Student Financial Aid Administrators director of policy analysis.

Under the new process, according to a release from Murrays office, families who make under 175 percent, and single parents who make under 225 percent, of the federal poverty level will be eligible for the maximum grant.The poverty level varies by the size of the household but is $21,720 annually for a family of three.

The budget deal would also reset the clock on students' eligibility for Pell Grants if they have the student loans discharged because they had been defrauded by their institution. and It also would repeal a 1998 prohibition on students convicted of a drug offense from receiving federal financial aid.

The bill would also increase by a third the amount of money considered to be needed for necessities that is not counted as income in determining financial aid eligibility.

The budget deal wouldalso reset the clock on students' eligibility for Pell Grantsif they have the student loans dischargedbecause they had been defrauded by their institution. It also would repeal a 1998 prohibition on students convicted of a drug offense from receiving federal financial aid.

Every single person in this country should be able to access and afford a quality higher educationand today we move substantially closer to that goal," Murray said in a statement. "For too long, students who are incarcerated, students who have been defrauded by for-profit colleges, and students who have drug-related offenses have been blocked from receiving federal aid. But now, Im incredibly pleased that these students will finally be able to access aid and begin and continue their education."

Rep. BobbyScott, the Democratic chairman of the House education committee, said, the budget deal will make higher education more affordable for millions of Americans.

"The package released today includes a wide range of provisions secured by House Democrats that will make federal grants and loans more accessible and more generous, particularly for our most vulnerable students," he said. "While this is not the comprehensive overhaul of the Higher Education Act and there is still work to be done, this proposal will help millions of students.

In addition, the budget deal provides $42.9 billion for the National Institutes of Health, an $1.25 billion increase over last year. The funding includes $3.12 billion more for research to find treatments for Alzheimers disease and related dementias.

It also includes an increase of at least 1.5 percent for every NIH institute and center. The budget also directs NIH to require its grantees to notify the institutes when key personnel are removed for concerns of sexual harassment.

See the rest here:

Congressional agreement on COVID-19 would give higher ed $23 billion - Inside Higher Ed

In the letter (signed by 120 on Friday 18th but rapidly increasing) scientists are calling for immediate, widespread, increased vitamin D intake to 4,000 International Units (IU) per day (or at least 2,000) for healthy adults.

This comes just days after the UK government's health bodiesSACN and NICE, denied there is enough evidence to support increasing vitamin D intake forCOVID-19 specifically.

The scientists involved in the open letter say that global patterns and risk factors for the Covid-19 pandemic and Vitamin D deficiency match "precisely" due to theimpact on immune function.They say that research shows that low vitamin D levels markedly increase the likelihood of COVID-19 infections, hospitalisations and deaths.

The group of scientists are calling for immediate, widespread, increased vitamin D intakes with most signatories declaring that they personally take at least 4,000 International Units (IU) per day - many take more.

Theysay new mechanisms specific to SARS-Cov-2 are now very well-understood, with the body of evidence including: Multiple biological mechanisms that have been identified showing how vitamin D directly influences COVID-19 outcomes,more than 70 studies showing higher vitamin D levelsare associatedwithlower rates of infection and lower risk of hospitalisation, ICU, or death, as well as early causal inference studies confirmed by recently published randomised controlled trials (RCTs) and quasi-experimental studies.

The campaigns main organisers are Dr Karl Pfleger (USA) and Dr Gareth Davies (UK) - both have backgrounds in Artificial Intelligence and Data Science, as well as Medicine.The letter has a growing list of 120 signatories. More than one hundred are medical doctors or PhDs, or both, and more than 60 are professors. Two British MPs - David Davis and Rupa Huq - have also signed the letter.

Martin Hewison, Professor of Molecular Endocrinology at Birmingham University and one of the worlds leading authorities on Vitamin D, has signed the letter after hestrongly criticised SACN and NICE, calling their reports disappointing.

He reacted to the latest NICE report, stating: NICE, SACN and PHE continue to promote the idea of vitamin D 'toxicity', despite no evidence of this in trials where up to 4,000 IU/day vitamin D were used. This obsession has become a major hurdle to better vitamin D health in the UK. Many vitamin D researchers have worked tirelessly over the summer to provide a framework in which vitamin D supplementation could be incorporated into the general strategies being used to defeat COVID-19. NICE, SACN and PHE have rejected this, and their new recommendations provide little or no help at all for the UK public.

MP David Davis has been a vocal supporter of vitamin D throughout the pandemic. He says, The evidence from several dozen studies show that vitamin D deficiency/insufficiency is implicated in compromising the bodys immune response to respiratory diseases in general and COVID-19 in particular.

"The likely effect of correcting this deficiency is to reduce the susceptibility to infection and reduce the morbidity and mortality amongst those who are infected by the virus. In the unlikely event that all this evidence is an artefact, the costs and health risks are minimal.

"In the much more likely event that the multiple sources of observational evidence, and the evidence from the growing number of RCTs, show a real causal role of vitamin D in activating and modulating the immune system, it would be irresponsible not to give vitamin D to all the groups who are at risk from COVID-19. It will save lives, improve population immunity, and help reduce the medical and economic impact whilst we await the universal roll out of vaccines.

"Furthermore, if it is to have any material effect the dosage has to be sufficient to correct the existing deficiency, which means up to ten times the UK recommended daily intake.

Signatory Dr David S Grimes, a retired gastroenterologist, has campaigned to get vitamin D taken more seriously for years.He says:"[NICE and SACN] have ignored past and current research and instead assert there is not adequate evidence to support the use of vitamin D. They have denied the NHS the use of calcifediol, a rapid-acting form of vitamin D, in the treatment of Covid-19 pneumonia, despite it being shown in one clinical trial to have 96% efficacy. The UK has had 25,000 COVID-19 deaths since this study was published, yet NICE continues to claim not enough evidence. They have so much to answer for. Theyre a national disgrace.

The letter is published on the web at VitaminDforAll.org.

Read the original:

Experts send Vitamin D and Covid-19 open letter to world's governments - NutraIngredients.com

The Shawnee Mission Post is making much of its local coverage of the coronavirus pandemic accessible to non-subscribers. (If you value having a news source covering the situation in our community,we hope youll consider subscribing here).

A company that runs a testing lab in Lenexa says it will fully cooperate with the state of Kansas after being flagged by regulators for potential price gouging.

In a letter issued last week, the Kansas Insurance Department said it had been made aware of GS Labs, 15720 College Blvd., pricing a single diagnostic COVID-19 PCR test at $1,000.

The price listed on GS Labs website has since dropped to $699 per test, which state regulators say is still well above the national average of roughly $185.

These are prices that providers seek to get reimbursed by health insurers and are not typically charged to patients directly. Still, regulators say consumers could ultimately bear the burden if such exorbitant charges are allowed to go unchecked.

If these astronomical costs charged by unscrupulous providers are borne by the health plans and insurers without recompense, consumers will ultimately pay more for their health care as health insurance costs will rise, Justin McFarland, general counsel for the Kansas Insurance Department, wrote in last weeks letter.

GS Labs is a health care testing startup based in Omaha that began operations in January and now has 15 locations in 10 different states, including the Lenexa lab, which opened Nov. 28, according to company spokesman Kirk Thompson.

Johnson Countians may see billboards advertising GS Labs services, including one on southbound Interstate 35 near the Rainbow Blvd. exit.

Thompson said GS Labs offers daily testing from 8 a.m. to 8 p.m., with patients able to book same-day appointments and get results within 30 minutes.

We are here to help the community, he said. There is overwhelming demand for COVID-19 testing right now, and we take great pride in our services.

But he also said GS Labs is new to this and feeling this out as we go.

He said they discovered there were issues with their listed prices at the Lenexa lab when the Kansas Insurance Department sent its letter last week. Thompson said now GS Labs will fully cooperate with the state to work out its pricing.

Our ears are open, he said. The last thing we want is to be perceived as price gougers.

Thompson said individual customers are not billed at their Lenexa lab. He also said they have held back submitting any reimbursement claims to insurers while they work out their pricing with state regulators.

Like many health care costs, disputes over COVID-19 testing prices play out beyond the view of most patients. For Johnson Countians wanting to get tested, here are a few important things to note:

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Lenexa lab flagged for potential price gouging of COVID-19 tests what consumers need to know - Shawnee Mission Post