"We will continue to work with the Senate and House on a bipartisan basis for a phase four relief package. I believe a bipartisan agreement still should be reached," Mnuchin said during a hearing of the Select Subcommittee on the Coronavirus Crisis, adding that he hopes such an agreement would provide funding for schools, testing, vaccines, child care and other key priorities.
House Majority Whip Jim Clyburn, a South Carolina Democrat and the chairman of the select subcommittee on the coronavirus crisis, opened the hearing with a plea for further relief, saying that "additional fiscal stimulus is urgently needed," and that he hopes Mnuchin "will return to the negotiating table prepared to find common cause" on legislation.
Mnuchin said during the hearing that he is "prepared to sit down with the speaker at any time to negotiate," adding, "the President and I do support additional fiscal response and we've been working hard to try to get a negotiated agreement on a bipartisan basis."
The Treasury secretary later indicated that he would call House Speaker Nancy Pelosi Tuesday in response to questioning from Democratic Rep. Maxine Waters of California, saying, "Can I tell her you suggested I call her right after the hearing? Done, I will call her right after the hearing."
Mnuchin indicated during Tuesday's hearing that he does not support the overarching price tag that Democrats are asking for, saying at one point, "I do not support $2.2 trillion."
"Unfortunately, Sen. Schumer and Speaker Pelosi do not want to sit down at the negotiating table unless we publicly agree on a top line. My own opinion is we should go piece by piece and any area of the legislation we can agree on, we should have the House and the Senate pass," Mnuchin said.
Democratic leaders have argued that any additional stimulus must be dealt with through a comprehensive package, and not on a piecemeal basis.
During Tuesday's hearing, however, Mnuchin said that he believes stand-alone action related to the Paycheck Protection Program would receive "overwhelming support" on Capitol Hill.
"We have over $130 billion left in PPP, which I believe if Congress was willing to take up a stand-alone action to repurpose this money for additional funds, I believe this would pass with overwhelming support in the House and the Senate and I would encourage the House to move forward with that," he said.
"As it relates to jobs, the area that has overwhelming bipartisan support that I believe would be easiest to pass on a stand-alone basis would be the PPP," Mnuchin added.
"Let's not get caught on a number. Let's agree on things we can move forward on a bipartisan basis now. I don't think the right outcome is zero. Nobody thinks the right outcome is zero," Mnuchin said later on.
During the hearing, Clyburn was critical of the Trump's administration's handling of the pandemic response, saying that Treasury Department "must improve its implementation of relief programs passed by Congress."
"So far, the administration has prioritized big businesses over small businesses and the American workers that Congress intended to protect," Clyburn said, adding, "The administration needs to refocus the Paycheck Protection Program, payroll support for the airline industry, and other relief programs to ensure that they are preserving jobs -- not lining the pockets of wealthy executives."
The chairman argued that the Treasury Department also needs to "improve oversight and accountability to ensure that taxpayers' dollars are not squandered."
Clyburn said that the panel is releasing a staff report, which raises "serious concerns about potential waste, fraud, and abuse in the Paycheck Protection Program," a program established under the CARES Act coronavirus relief legislation intended to bolster small businesses hard hit by the pandemic.
Mnuchin broadly defended the Treasury Department's efforts to mitigate the toll of the pandemic, saying, "For the last five months, Treasury has been working hard to provide fast and direct economic assistance to American workers and their families. We remain committed to making sure that every American gets back to work as quickly as possible."
Republican Rep. Jim Jordan of Ohio defended the federal response to the crisis, saying, "What you have put in place, the programs you have recommended, the programs that the Congress approved -- they have worked."
"Democrats keep their states locked down, then they complain about unemployment," Jordan said, adding "Here's a novel idea, let people go back to work and I bet you'll get a lot less of it, you'll get stronger economic growth that will build on what we have seen in the last three months."
The hearing is being conducted as a hybrid of in-person and remote participation with Mnuchin and Clyburn appearing in person.
Mnuchin highlighted the actions taken by the President, saying, "When it became clear that previous negotiations were not moving forward, the President took executive action to provide critical relief to Americans through lost wage assistance and other important items."
He noted, however, "While we continue to see signs of a strong economic recovery, we are sensitive to the fact there is more work to be done, and certain areas of the economy require additional relief."
This story has been updated with additional developments Tuesday.
CNN's Katie Lobosco and Phil Mattingly contributed to this report.
Jos spent three months in the hospital being treated for COVID-19. "All of the nurses clapped for me as I was leaving the hospital," he says. But now he faces a long recovery at home. Eddie Quiones for NPR hide caption
Jos spent three months in the hospital being treated for COVID-19. "All of the nurses clapped for me as I was leaving the hospital," he says. But now he faces a long recovery at home.
In early August, Jos came home to the Chicago apartment he shares with his wife and five children. He'd just spent three months in the hospital after contracting the coronavirus.
"We were all so happy," says his daughter Alondra, describing that day. "Everybody in the hospital was like, he was about to die. There was no more hope for him. ... So now we're like, 'Thank God, he's still here with us.' "
Jos, who is from Mexico, is undocumented. His children were all born in the United States and have U.S. citizenship. NPR agreed to use just first names for him and his family.
Once Jos was home, it fell to his family, and especially Jos's wife, to take care of him. He came home on a portable ventilator and needed to use a feeding tube.
Latinos are more likely to deal with a more severe illness from COVID-19 and when they're undocumented, they're less likely to be able to get the medical care they need to address it. It's hard to track how many undocumented immigrants get COVID-19. But they are high risk, says David Hayes-Bautista, who directs the Center for the Study of Latino Health and Culture at the David Geffen School of Medicine at UCLA. Not only do they often lack health insurance, many live in crowded homes with multiple generations of families. And many work in jobs where exposure to the coronavirus is high as aides in nursing homes, as farmworkers or in meat-packing plants or, like Jos, in restaurants.
And, like many people with COVID-19, Jos faces a long recovery. There is growing evidence that a significant number of people perhaps even hundreds of thousands of Americans will experience long-term complications from COVID-19. Many of these people, sometimes referred to as "long haulers," will need continued medical care, and that means the ability to recover could be even harder for the nation's 10.5 million to 12 million undocumented immigrants.
In late April, when Jos started feeling sick with a cough he was afraid to go to the hospital. He'd heard that people with COVID-19 died in hospitals. He was also afraid that, without insurance, his family would get a large bill for his care.
Then came shivers, fever and eventually so much pain that Jos could no longer avoid seeking medical care.
In the three months Jos was in the hospital, his family couldn't visit. The hospital, in line with hospital policies across the country, had banned visitors to control the spread of the virus. Instead, the hospital staff helped Jos with video phone calls to his family.
From the perspective of his family, the doctors and nurses seemed pessimistic about his prognosis as he lingered on a ventilator. "We were about to lose hope," says his daughter Alondra, 24. "We were praying and praying."
Then things changed. Jos got better. He moved from the ICU to the rehab wing. "Thank you very much to the hospital," he says, praising the doctors, nurses and staff who cared for him. "For me, kisses. Besos for the people. Thank you."
Now that he's back home, Jos spends his days propped up on pillows in a hospital bed. A bandage on his neck covers the spot where a surgeon cut a slit into his neck to insert a tube for the ventilator.
Jos came home initially still using a portable ventilator to help him sleep and breathe. His wife, trained by the hospital, managed it. She learned how to connect the tubes and other pieces to the machine and to adjust his mask so the air did not leak. He stopped needing the ventilator after several days.
A feeding tube lies underneath his dark blue polo shirt. His wife learned how to do the feedings, first checking that his stomach was empty and moving him into the proper sitting position so there would be no dangerous reflux into his esophagus and filling a syringe with the nutrients to send through that tube connected to his stomach.
When Jos came home, his wife took on his medical care. Jos still cannot eat solid food, so his wife trained by nurses uses a syringe to send formula through his feeding tube. Eddie Quiones for NPR hide caption
Nurses come by and check on him from time to time, Alondra says. Some hospitals got money in the CARES Act to provide medical treatment to the uninsured. But some hospitals say the rules are confusing and have had difficulty getting the funding, notes Hayes-Bautista, the UCLA professor who sits on the board of a hospital in East Los Angeles, the heart of the city's Latino population.
When someone comes home from the hospital after COVID-19, that's an overlooked but dangerous time, says Aida Giachello, a research professor of preventive medicine at Northwestern University's Feinberg School of Medicine.
"Most of the research on COVID that is emerging is indicating a pretty high number of individuals are being released from the hospital with severe conditions," says Giachello, who studies health care disparities for Latino and Black patients.
"They cannot walk. They cannot talk. The virus impacts the brain and all the major organs. It's going to take a long time to recuperate in totality, if they ever recuperate in totality."
Bob Shea sees this all the time, too. He's co-founder of the nonprofit Devices 4 the Disabled. Along with a neighbor, Ed Kane, he started the nonprofit in 2015 to distribute durable medical equipment to people who couldn't afford it.
Alondra and her brother pick up medical equipment donated by Devices 4 the Disabled for their father's return home from the hospital. Juan Martinez/Devices 4 the Disabled hide caption
Alondra and her brother pick up medical equipment donated by Devices 4 the Disabled for their father's return home from the hospital.
"We see them all week, every week, now," says Shea. "Where people are getting discharged with scarred lungs, damaged heart, complete loss of mobility, neurological issues. They are still significantly limited. And then it's up to the family to somehow figure it out."
Both men got into this work from personal experience: Shea had dealt with Guillain-Barre syndrome and spent seven months in a hospital. Kane, who died in 2016 of ALS, discovered that even though he had private health insurance, it covered only $5,000 of a $30,000 wheelchair.
Now, many of the clients of Devices 4 the Disabled are undocumented immigrants in Chicago who don't have health insurance.
Shea says the group gets calls to help from hospital social workers or from the families of patients when they are discharged. In May, a hospital social worker called to alert him that the hospital was starting to release a wave of uninsured immigrants who'd been treated for COVID-19.
"For Jos and his family, just to get discharged to a bed is putting them at huge risk for pneumonia, for pressure sores that can turn into sepsis," he says.
For Jos, Shea's group donated equipment to help with that care a wheelchair, a hospital bed, a shower chair and other medical equipment. Those can cost thousands of dollars, Shea notes, especially if you don't have health insurance.
Or if you don't have a job.
Jos worked at a Chicago restaurant before he got sick. He'd like to work again, but he doesn't know when he'll have the strength. Eddie Quiones for NPR hide caption
Jos is out of work. There is an advantage to living in his multigenerational family: Jos's older children are working. For now, they're paying the rent. And they're buying his medicine. He would like to go back to working in a restaurant, but his old job is gone.
Meanwhile, he has months and months maybe longer to recover.
A Detroit resident is tested for free for the coronavirus disease (COVID-19) and antibodies at the Sheffield Center in Detroit, Michigan, April 28, 2020.
Rebecca Cook | Reuters
Coronavirus cases in the Midwest are beginning to increase following warnings from top U.S. health officials that the country's heartland could be vulnerable to new outbreaks.
Coronavirus cases were growing by 5% or more, based on a weekly average to smooth out daily reporting, in 21 states and Washington D.C. as of Saturday, according to a CNBC analysis of data collected by Johns Hopkins University, an increase from 12 states on Monday.
Several Midwestern states were among those reporting growing cases Indiana, Iowa, Kansas, Michigan, Minnesota, Nebraska, North Dakota, Ohio and South Dakota.
Nationally, however, cases continue to decline, though at a slower pace than reported in previous days.The U.S. reportedan average of 41,638new infections a day over the last week, a decline of more than 5% compared with the prior week, according to a CNBC analysis of Hopkins' data.
Sun Belt states that have spent the summer months grappling with outbreaks are showing signs of improvement. Texas, Florida, California and Arizona all reported declines greater than 15% compared with a week ago.
The nation's top health officials, including White House coronavirus task force members Dr. Anthony Fauci and Dr. Deborah Birx, have warned that hotspots could arise in the Midwest, which hasn't witnessed the worst of the nation's outbreak so far.
In July, Fauci pointed to theso-called positivity rate, or the percentage of tests run that are positive, that appeared to be rising in those states an early indication that the outbreak is worsening.
Centers for Disease Control and Prevention Director Dr. Robert Redfield toldDr.Howard Bauchnerwith the Journal of the American Medical Association last week that there are worrying signs in the middle of the country where cases appear to be plateauing but not falling. The area "is getting stuck," which is a concern as seasonal influenza threatens to overwhelm hospitals and cause preventable deaths, he said.
"We don't need to have a third wave in the heartland right now," Redfield said. "We need to prevent that particularly as we're coming to the fall."
The virus is likely to spread in rural America, which has been"largely unaffected to date" by the worst of the nation's coronavirus outbreak, and "every community is vulnerable," former Food and Drug Administration Commissioner Dr.Scott Gottliebtold CNBC last week.
"Really, an outbreak can happen anywhere," he said.
State officials have taken some action to prevent further spread. Ohio Gov. Mike DeWine ordered K-12 students to wear face coverings when they return to school and limited the events at the state's county fair. Iowa Gov. Kim Reynolds ordered bars to close in some of the states most populated counties on Thursday and continued to urge residents to wear face coverings, though they're not enforced.
The troubling hotspots in the Midwest come as universities try to return students to campus this fall, though some have reported hundreds of cases and students in quarantine only a few weeks into the semester.
"People need to understand that there are going to be cases of Covid when you have 50,000 people together,"said Dr. Preeti Malani, chief health officer and professor of medicine and infectious disease at the University of Michigan.
"It's a matter of if you have the infrastructure in place to identify cases testing, surveillance, random testing of asymptomatic people, quarantine, contact tracing, isolation and you have done what you can to reinforce public health mitigation efforts," she said.
The University of Notre Dame in South Bend, Indiana, has reported more than 500 cases since the beginning of this month. The university nearly sent students homebeforedeciding on Fridayto allow students to return to class once its positivity rate declined from above 10% to nearly 6%.
The University of Iowa reported 130 cases after the first week of class for a positivity rate of 13.6%, though the university said it still has "adequate isolation and quarantine housingavailable."
Kansas State University reported an outbreak at four sorority houses on Friday, resulting in more than 20 cases, according to the Riley County Health Department. The university canceled all sorority and fraternity events until Sept. 10.At the University of Kansas, the sorority and fraternity community reported 270 cases for a 10.01% positivity rate, according to an update Friday, though the university said the total cases so far are manageable.
Correction: 21 states and Washington D.C. are reporting rising coronavirus cases. A previous version of this story misstated the number of states.
The Jefferson County racetrack that health officials took to court for violating social distancing requirements at its events is hosting a Stop the COVID Chaos rally Tuesday, renewing concerns from the county health department about public safety amid a pandemic.
Colorado House Minority Leader Patrick Neville and right-wing activist Michelle Malkin are slated to attend the evening rally at Bandimere Speedway, according to a statement on the racetracks website.
Attorney Randy Corporon, who has represented the racetrack, and members of the Bandimere family will also attend the event, which will include speeches and a presentation on why public health orders regarding coronavirus precautions are unconstitutional, according to the statement.
Malkin and Neville filed a lawsuit against Gov. Jared Polis earlier this month in which they asked the state Supreme Court to strike down the statewide mask mandate on the grounds that the governor and health departments overstepped their authority. The court on Friday declined to hear the case.
Corporon, John Bandimere III and Neville did not immediately return requests for comment Monday.
Ashley Sever, a spokeswoman for Jefferson County Public Health which previously took the racetrack to court to enforce social distancing requirements at the speedways events said in a statement that the department was concerned about the rally.
People have a right to express their opinions and grievances, and we fully respect freedom of speech and expression, the statement said. At the same time, we are concerned about public health and safety.
Under current county public health orders, the health department must pre-approve large events, and masks must be worn in outdoor settings when social distancing cant be maintained, according to the statement. The health department has notified Bandimere Speedway of its requirements under the law, the statement said.
The racetracks announcement made no mention of enforcing social distancing, limiting crowd size or taking any other coronavirus precautions during the event.
It did say the rally may include some casual racing, with all local media personalities invited to attend and challenge one of the co-hosts to a safe, supervised run down the race track in one of Bandimeres challenge cars, according to the statement.
The rally will end with a photo of attendees on the racetrack, according to the statement, which encouraged attendees to wear red, white and blue clothing.
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In the battle for Colorados precious water resources, there turns out to be no contest: Between drought and pandemic, drought wins every time.
While two of the largest water providers in Colorado noticed big drops in certain kinds of water use early on in the coronavirus pandemic, those savings are now overwhelmed by residents and business owners trying to keep their parched grass thriving with irrigation.
Commercial use of Aurora Water Departments flow dropped more than 14% from March to April, as coronavirus work and travel restrictions truly kicked in, according to department statistics. Restaurants and other heavy retail water users also emptied.
Out came the sun and dried up all the rain. Average irrigation use in Aurora jumped nearly 30% in the first seven months of 2020 when compared to the average use in 2015-19, department officials said. Some of that may be from bored, work-at-home gardeners dousing the back yard as a respite from bad news. But the vast majority of it comes from the relentless impact of a near-record number of plus-90 degree summer days in the Denver metro area.
Auroras daily water use chart has been spiking high above normal levels nearly every day since about May 1.
Denver Water, the largest Colorado water utility with 319,000 metro customers in 2019, saw industrial use drop 8% through July, and office building use drop 11%, spokesman Todd Hartman said. Restaurants were down a whopping 30%.
As in Aurora, though, any differences in how people used Denver water amid the pandemic were obliterated by the larger forces of southwestern drought. The months of April to July were the fifth-driest on record in Colorado, and were the second-driest on record for the southwestern climate region of Colorado-Utah-Arizona-New Mexico, the Four Corners, according to the U.S. Drought Monitor operated by the University of Nebraska-Lincoln.
MORE: Nearly all of Colorado is under some drought status. A year ago, almost none of the state was parched.
Denver meteorologist Chris Bianchi has tracked 68 days at 90 degrees or higher this year, the second longest tally on record. He said he believes theres a decent shot of reaching or beating the record of 73 days of 90-plus in 2012.
While there was an uptick in indoor residential use due to the stay-at-home orders, the high water use can be explained primarily by the warm, dry weather that we have been having, Hartman wrote, in an email.
The short story from our perspective is that we are seeing higher use this watering season because of very hot, dry conditions, he wrote. This year is tracking at the 80th percentile, which means that it is hotter and drier than 80% of years that we measure against.
MORE: The most thrilling commute in Colorado: How Grizzly Reservoirs caretakers keep water flowing
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This is where the large western water systems get to brag only when prompted, of course about the forethought and wisdom of their pipes-and-buckets storage system that that moves and collects runoff for Colorado cities when nature takes the summer off. Denver Waters reservoir system, from Dillon Reservoir to Cheesman and Gross and beyond, were 91% full on Aug. 24, slightly below the average of 93% at this point in the summer. Last year, with more precipitation and cooler temperatures, Denver Water was at 97% in late August.
Aurora is in good shape for the remainder of 2020, said Greg Baker, manager of public relations for Aurora Water. Reservoirs operated by Aurora including Quincy, Spinney Mountain, Rampart are at 83% of capacity. In May 2019, after a previous period of drought in Auroras catchment basins, capacity was at 61%.
Post-traumatic tics from the bad years are never far below the surface Baker mentioned how in March 2003, after the notorious drought and wildfires of summer 2002, Aurora was at 26% of capacity. That constituted only a nine-month supply for Auroras customers.
In a sign of this years drought actually biting into current water flows, though, water officials in northwest Colorado announced last week that users on the upper part of the Yampa River now have restrictions in order to send more to downstream rights holders.
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A new report that aims to prioritize groups to receive Covid-19 vaccine focuses on who is at risk, rather than using job categories or ethnic groups to determine who should be at the front of the line.
It was widely expected that health care workers would be the first priority grouping, and some though not all are. There were also many voices arguing for people of color to be given priority access, because the pandemic has exacted a disproportionately heavy toll on Black and Latinx people, both in terms of overall numbers of infections and deaths.
But in the end the panel of experts that wrote the priority setting framework for the National Academies of Sciences, Engineering, and Medicine chose instead to focus on the factors that create the risk for some people of color systemic racism that leads to higher levels of poor health and socioeconomic factors such as working in jobs that cannot be done from home or living in crowded settings. The report, a draft, was issued Tuesday.
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This virus has no sense of skin color. But it can exploit vulnerabilities, said Bill Foege, a former director of the Centers for Disease Control, who is co-chair of the committee. The committee was set up by the National Academies at the request of Francis Collins, director of the National Institutes of Health, and Robert Redfield, director of the Centers for Disease Control and Prevention.
Foege said he expects pushback. A virtual public meeting on the recommendations will be held Wednesday afternoon, and written comments can be submitted until Friday. The committees final report will be submitted later in September.
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When Covid-19 vaccines are approved for use, initial supplies will be tight potentially in the tens of millions of doses. Most of the vaccines under development will require two doses per person: a priming dose followed by a booster either three or four weeks later.
The resulting recommendations put health workers in high risk settings and first responders to the very front of the vaccination line, in what the committee called the jumpstart phase. Closely behind are adults of any age who have medical conditions that put them at significantly higher risk of having severe disease, primarily heart or kidney failure or a body mass index of 40 and over. Also in this group are older adults living in long-term care homes or other crowded settings.
The report suggests that a second phase of vaccinations should involve critical risk workers people in industries essential to the functioning of society as well as teachers and school staff; people of all ages with an underlying health problem that moderately increases the risk of severe Covid-19; all older adults not vaccinated in the first phase; people in homeless shelters and group homes, and prisons; and staff working in these facilities.
Young adults, children, and workers in essential industries not vaccinated previously would make up the third priority group. Remaining Americans who were not vaccinated in the first three groups would be offered vaccine during a fourth and final phase.
The report is meant to serve as a guide for more detailed prioritization plans on the order in which Americans will be offered vaccine. That more granular work is already being conducted by the Advisory Committee on Immunization Practices, an expert panel that crafts vaccination guidance for the CDC, and by state, local, and tribal health authorities, who must identify the actual people in their regions who fall into the priority groups.
The ACIPs recommendations will go to the CDC. It remains unclear, however, whether the CDC, Operation Warp Speed the task force set up to fast-track development of Covid-19 vaccines, drugs, and diagnostics or the White House will make the final determinations on who will be vaccinated first.
The draft report, produced in just a little over a month, earned some early praise.
I think they did a really good job, said Eric Toner of the Johns Hopkins Center for Global Security, calling the report credible and based on sound reasoning.
Toner and colleagues published their own report on the issue recently, recommending two tiers. Health workers and others essential to the Covid-19 response in the first tier and other health workers in the second.
In that report, people at greatest risk and their caregivers, and workers most essential to maintaining core societal functions would also be designated to be in the first tier.
The task of determining who should be at the front of the vaccines line is not an easy one, and must be made without crucial pieces of information. Its not yet known how many vaccines will prove to be successful, when they will be approved for use, and in what quantities. Critically, some vaccines may prove to be more effective in key groups the elderly, for instance than others. Knowing that in advance could influence the recommendations, but people working on the priority groups cannot wait for that information to become available.
Initial discussions suggest, depending on how some of the target groups are defined, large numbers of Americans would qualify as members of priority groups, a reality that will likely require additional tough decisions to be made.
The CDC estimates that there are between 17 million and 20 million health care workers in the country, and roughly 100 million people with medical conditions that put them at increased risk of severe illness if they contract Covid-19. There are roughly 53 million Americans aged 65 and older, and 100 million people in jobs designated as essential services. There is some overlap among these groups health workers, for instance, are also essential workers.
BRUSSELS (Reuters) - It is hard enough developing a vaccine in record time to halt a global pandemic. But what if you need to print the instructions with every dose in Portuguese, Lithuanian and Greek?
FILE PHOTO: A woman holds a small bottle labeled with a "Vaccine COVID-19" sticker and a medical syringe in this illustration taken April 10, 2020. REUTERS/Dado Ruvic/Illustration/File Photo
Drugmakers are asking the European Union to loosen rules that require medicines sold in the bloc to include full documentation in 24 separate languages, worried that this could slow down the rapid deployment of hundreds of millions of doses.
We need an early agreement from EU authorities on the language to be used on the packs and labels for COVID-19 vaccines, said Michel Stoffel, head of regulatory affairs at Vaccines Europe, which represents big vaccine makers including GlaxoSmithKline, Sanofi and AstraZeneca.
He told Reuters the industry was pushing EU regulators to quickly choose one language for all 27 EU states for labelling, packaging and instructions on possible COVID-19 vaccines.
The EUs executive Commission promised in June it would temporarily soften language requirements for COVID-19 vaccines, but has not yet put forward a proposal. A spokesman said work was underway to be flexible without compromising on safety.
An EU official said Brussels was considering having printed information in a limited set of languages. Other versions would be available online.
An industry official said even that might be too difficult: labels may not have enough space for more than two versions.
Consumer groups say leaving any languages off of packaging could hurt patients, particularly those less capable of looking up details online.
The urgency of getting a vaccine should not be an excuse for companies to cut corners on consumer protection, said Monique Goyens, the head of BEUC which represents major European consumer organisations.
The EU translates all its rules into all member languages. Commission staff use English, French and German as working languages.
Reporting by Francesco Guarascio @fraguarascio; Editing by Josephine Mason and Peter Graff
BALTIMORE, Sept. 1, 2020 /PRNewswire/ -- Elixirgen Therapeutics, Inc., a Baltimore-based biotechnology company focused on the discovery, development and commercialization of therapies for genetic diseases and vaccines, announced that Fujita Health University has received acontract from the Japan Agency for Medical Research and Development (AMED) to initiate Phase I/II clinical trials of the company's COVID-19 vaccine candidate, EXG-5003. Clinical trials are expected to begin at Fujita Health University Hospital in Aichi, Japan in Q1 2021.
EXG-5003 is a temperature-sensitive self-replicating RNA vaccine expressing the receptor binding domain of the SARS-CoV-2 spike protein. EXG-5003 was optimized for intradermal injection withpotential dose-sparing and safety benefits.
About Elixirgen Therapeutics, Inc.
Elixirgen Therapeutics, Inc. is a Baltimore-based biotechnology company, which is focused on curing humanity's ailments through innovations in gene and cell therapy, including stem cell therapy. Elixirgen Therapeutics, Inc. is now applying its RNA technology to the development of a COVID-19 vaccine.For more information visit www.ElixirgenTherapeutics.com
About Fujita Health University
Fujita Health University plays a major role in treating COVID-19 patients and conducting its clinical trials in Japan. For more information visit www.fujita-hu.ac.jp/en/
Forward-Looking Statements
This press release may contain "forward-looking" statements, including statements regarding the potential to develop a COVID-19 vaccine and our planned clinical relationship with Fujita Health University. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in vaccine research and development. Any forward-looking statements in this press release speak only as of the date of this press release, and Elixirgen Therapeutics undertakes no obligation to update or revise the statementsin the future, even if new information becomes available.
ContactMedia RelationsElixirgen Therapeutics, Inc.(443) 869-5420Media@ElixirgenTherapeutics.com
View original content:http://www.prnewswire.com/news-releases/elixirgen-therapeutics-planning-to-begin-phase-iii-clinical-trials-of-its-covid-19-vaccine-candidate-exg-5003-at-fujita-health-university-301121932.html
SOURCE Elixirgen Therapeutics
Six months into the COVID-19 pandemic in the United States, everyone is looking for hopeful signs that life can return to normal on any level. Encouraging news reports indicate that the race to develop a COVID vaccine is progressing, with hopes that one will receive approval and become commercially available by early in 2021.
With a vaccine comes some difficult questions for employers. Can employers mandate a vaccine as a condition of employment? Even if they can do so legally, should they?
Private employers likely have the legal right to require employees to obtain a COVID vaccine as a condition of employment. For years, many employers in high-risk workplaces (e.g., hospitals and nursing homes) have required their employees to obtain an annual flu vaccine. This does not pose problems in the ordinary course. Given the estimated 180,000 Americans (and counting) who have died from COVID, it seems unlikely that lawmakers will enact legislation that would preclude employers generally from mandating a COVID vaccine.
With that said, employers may also have a legal duty under the Americans with Disabilities Act to allow certain employees to opt out of the vaccine. For example, given the speed with which the vaccine candidates are moving through clinical trials, employees in high-risk categories may receive advice from their health care providers not to receive the vaccine at least initially until the complications are better understood. Alternatively, perhaps young, healthy employees who are at relatively low risk from COVID may obtain notes indicating that the vaccine is not necessary for their own health.
If employees request an accommodation from an employers COVID vaccine mandate, the employer will need to determine whether the accommodation is a reasonable one and whether it imposes an undue burden on operations and on the health and safety of coworkers. As with all ADA accommodation requests, employers will need to carefully consider the facts on a case-by-case basis.
Additionally, employees may object to the vaccine on religious grounds. Again, employers must balance employees right to be free from religious discrimination against the burden that the accommodation would create in the workplace. (Note that the Supreme Court has stated that employers have less obligation to accommodate employees religious objections than their medical needs. In religious discrimination cases, the employer can deny the request if it imposes more than a minimal burden on the business.)
As the legal rules above suggest, implementing a mandatory vaccine program will likely require employers to devote considerable time and energy to the program. In addition to dealing with accommodation requests, employers will need to decide questions such as:
In addition, employers who mandate a vaccine will need to consider the potential liability that arises from doing so. What happens if an employee has a severe reaction to the vaccine and then argues that he would not have gotten the vaccine except that his employer required it? Could the employer be held liable because of the mandatory vaccine policy? Its difficult to say right now, but employers cannot simply ignore this possibility.
Ultimately, this will likely involve risk balancing. For employers that cannot effectively socially distance and those who work with high-risk populations, a mandate probably makes sense to minimize the risk of a COVID outbreak. (For example, imagine a nursing home not requiring a vaccine and then experiencing a spread of COVID through its elderly population. Hindsight being 20/20, it would be easy to say that the employer should have mandated a COVID vaccine.) For other employers, the risks may outweigh the benefits, especially in the first few months after a vaccine is released.
For now, the questions remain hypothetical. Until a vaccine is made available and we have more information about its efficacy and risk factors, it is difficult to answer these questions in a vacuum. Nevertheless, employers ought to start thinking about their proposed approach to COVID vaccinations so that they are ready to implement a plan when the time comes (hopefully in the not-too-distant future).
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