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Daily Archives: September 6, 2021
New Paid Leave for COVID-19 | Paid Family Leave
Posted: September 6, 2021 at 2:55 pm
In response to the outbreak of novel coronavirus (COVID-19), New York State implemented programs that guarantee workers job protection and financial compensation in the event they, or their minor dependent child,are subject to a mandatory or precautionary order of quarantine or isolation issued by the state of New York, the Department of Health, local board of health, or any government entity duly authorized to issue such order due to COVID-19.* See Guidance For Obtaining An Order For Mandatory Or Precautionary Quarantine.
Most employees will get financial compensation by using a combination of benefits, which may include new employer-provided paid sick leave (depending on the size of the employer), Paid Family Leave and disability benefits. These benefits are not available to employees who are able to work through remote access or other means.
Paid Family Leave may also be used to care for a family member who has contracted COVID-19, which may qualify as aserious health condition.
*These benefits are not available to New Yorkers who take non-work related trips to any state other than a contiguous state for more than 24 hours.
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Tracking COVID-19 in Mississippi: 5,781 new coronavirus cases reported over the weekend – Clarion Ledger
Posted: at 2:55 pm
COVID-19 and children under 12: How the pandemic affects the unvaccinated
COVID-19 cases have spiked among children especially those under 12 who are unvaccinated. Heres how to protect them.
Just the FAQs, USA TODAY
The Mississippi State Department of Health reported 5,781new coronavirus cases Monday for the period Friday through Sunday.The highly contagious delta variant is fuelingnew cases.
On Monday, the state reported 125new coronavirus-related deaths. Seventy-six deaths occurred between July 23and Sept. 4, according to the health department's website. Forty-nine deaths occurred between Aug. 1and Aug. 30, as identified from death certificate reports.
COVID-19 in MS: 'Not nearly as bad as predicted': Already packed hospitals avoid further crowding from Ida
Since COVID-19 hit the state in March 2020, a total of 452,664COVID-19 cases and 8,664coronavirus-related deaths have been reported.
The health department on Monday reported 146 outbreaks at Mississippi nursinghomes. There have been 10,993cases of the coronavirus in long-term care facilitiesand 2,047deaths reported as of Monday.
According to aNew York Times database, at least 377new coronavirus deaths and 44,417 new cases were reported in the U.S. on Sunday. Over the past week, there has been an average of 161,327cases per day,an increase of 8% from two weeks prior.
Residents between the ages of 25 and 39represent the largest portion of the infected population in the state,with 101,441cases reported Friday, the latest figureavailable.
Among patients under18, children between the ages of 11 and 17 have the highest infection rate, with 40,615cases identified. The 65 and older age group has the highest total number of deaths with 6,227reported.
According tohealth department data, at least 1,433,469people began thevaccination process in Mississippias of Thursday. Since December, about 1,185,057people have been fully immunized against COVID-19. At least 28,002have received a third dose of the Pfizer or Moderna vaccines.
Approximately 372,119 people are presumed recovered from the virus as of Tuesday, according tothe health department's website.
Read More: No COVID-19 vaccine mandate for public Mississippi universities for now, board says
Since the beginning of the pandemic, Harrison County numbers have steadily climbed, overtaking Hinds County to record the highest number of reported cases with 30,666; Hinds County follows with 29,896cases. DeSoto County is reporting 28,381cases. Jackson County is reporting 21,932cases and Rankin County has 20,526total cases.
Daily number of new deaths: 2
Daily number of new cases: 374
Total deaths: 543
Total cases:29,896
Daily number of new deaths: 3
Daily number of new cases: 189
Total deaths:259
Total cases:13,607
Daily number of new deaths: 9
Daily number of new cases: 334
Total deaths:338
Total cases:20,526
Have an education-relatednews tip? Contact Keisha Rowe at nrowe@gannett.com, on Twitter or at (601) 760-2483.
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COVID-19: What you need to know about the coronavirus pandemic on 6 September – World Economic Forum
Posted: at 2:55 pm
Confirmed cases of COVID-19 have passed 220.6 million globally, according to Johns Hopkins University. The number of confirmed deaths stands at more than 4.56 million. More than 5.46 billion vaccination doses have been administered globally, according to Our World in Data.
Authorities in New South Wales say they expect daily COVID-19 cases to peak next week.
Israel is set to present data from its COVID-19 booster shot programme to the US Food and Drug Administration, which is weighing up White House plans to begin the US's own booster drive.
The Vietnamese ministry of health has said all adult residents in Ho Chi Minh City and capital Hanoi must have received at least one dose of a COVID-19 vaccine by 15 September.
India reported 42,766 new COVID-19 infections yesterday, taking its tally to nearly 33 million confirmed cases.
Moderna said on Friday that it's seeking approval from the EU drugs regulator for a booster shot of its COVID-19 vaccine.
New Zealand has reported its first death from the Delta COVID-19 variant. The woman was in her 90s and had a number of underlying health conditions, officials said in a statement.
Spain's two-week COVID-19 contagion rate fell below 200 cases per 100,000 inhabitants for the first time in over two months, according to official data last week.
New modelling shows an 'urgent need' to vaccinate more young adults in Canada, the public health agency announced on Friday.
Each of our Top 50 social enterprise last mile responders and multi-stakeholder initiatives is working across four priority areas of need: Prevention and protection; COVID-19 treatment and relief; inclusive vaccine access; and securing livelihoods. The list was curated jointly with regional hosts Catalyst 2030s NASE and Aavishkaar Group. Their profiles can be found on http://www.wef.ch/lastmiletop50india.
Top Last Mile Partnership Initiatives to collaborate with:
Former British Prime Minister Gordon Brown has accused rich countries of committing a 'moral outrage' by stockpiling supplies of COVID-19 vaccines, while poor countries continue to go without.
Brown, who is a United Nations special envoy, called on US President Joe Biden and other Group of Seven leaders to urgently ship vaccines from warehouses in America and Europe to Africa.
"We are in a new 'arms' race to get vaccines into people as quickly as possible but this is an arms race where the West have a stranglehold on the vaccine supplies," Brown said.
By Christmas, the West is set to have 1 billion surplus doses even if every European and American adult has received a booster shot and all children over 12 are injected, he said.
COVID-19 vaccine doses administered by country income group.
Image: Our World in Data
Britain has begun delivering COVID-19 vaccines to delegates attending the COP26 conference who cannot access a vaccine at home.
The COP26 conference, which was delayed last year, takes place from 31 October to 12 November. Typically delegates from more than 190 countries attend the talks, but with many countries still grappling with the novel coronavirus, climate and health experts have said poorer nations struggling to access COVID-19 vaccines could find sending delegates difficult.
"Vaccines are shipping and vaccination will begin next week and through mid-September before second jabs in October well ahead of COP26," British COP26 Envoy John Murton said on Twitter on Friday.
Written by
Joe Myers, Writer, Formative Content
The views expressed in this article are those of the author alone and not the World Economic Forum.
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70% reached: Utahns with the highest, lowest COVID-19 vaccination rates – ABC 4
Posted: at 2:55 pm
(ABC4) It is a milestone we have heard about since President Joe Biden took office having 70% of adults in America having received at least one dose of the COVID-19 vaccine. He originally set the goal for July 4 but it was not hit until early August.
Utah did not meet the July 4 vaccination goal. On July 5, the Utah Health Department confirmed Utah had fallen short by about 8%. The next day, Governor Spencer Coxs office changed course, saying that after federal doses had been counted,Utah had reached the July 4 goalwith 70.2% of those 18-years-old and older receiving at least one shot. Nearly a week later, state officials walked the data back, saying an error had been found and Utah had fallen short by about 3%.
As of September 6, 70.4% of Utahns ages 12-years-old and older have received at least one dose of the COVID-19 vaccine, according to data from UDOH. Among the same age group, 61.4% are fully vaccinated.
Here is a look at the most and least vaccinated Utahns based on location, age, and race and ethnicity.
According to UDOH, Summit County has the highest percentage of vaccinated residents. A total of 34,219 people in Summit County have received at least one vaccine dose, with just over 30,000 fully vaccinated. Over 81% of Summit County residents have received one dose and 71.4% are listed as fully vaccinated.
Runner-up was Salt Lake County, reporting 62.1% as receiving at least one dose and 55.2% as being fully vaccinated.
The counties within the TriCounty Health Department Uintah, Daggett, and Duchesne have the lowest vaccination rate. As of Labor Day, about 19,500 residents have received one dose, equating to about 34.5%. Over 16,100 have been fully vaccinated, a rate of 28.5%.
The Central Utah Health Department, covering Wayne, Piute, Sevier, Sanpete, Juab, and Millard counties, has the second-lowest vaccination rate. In total, this health department is reporting 38% of residents have received one dose while 32.1% are fully vaccinated.
The age group making up the second-lowest percentage of the eligible population, 70 to 79-years-old, has the highest vaccination rate. According to UDOH, Utahns in this age range make up 6.2% of the states eligible population to receive the COVID-19 vaccine. Nearly 95% of these Utahns have received at least one dose and 86.5% are fully vaccinated.
Utahns 80-years-old and older make up about 3% of the states eligible population. UDOH reports 89.7% of this age group has received one dose while 81.4% are fully vaccinated.
The youngest Utahns eligible for the vaccine, 12 to 18-years-old, make up 14.2% of the eligible population and have the lowest vaccination rate. According to UDOH, 54.3% have received at least one dose and 42.6% are fully vaccinated.
The next oldest age group, 19 to 29-years-old, is 60.9% partially vaccinated and 51.3% fully vaccinated.
Utahns identifying as white have the highest vaccination rate, with 63.9% having received at least one dose, according to UDOH. Just over 56% are fully vaccinated.
Hispanic or Latino Utahns have the second-highest rate, with 54.4% receiving at least one dose and 46.5% considered fully vaccinated.
Utahns identifying as American Indian or Alaska Native have the lowest vaccination rate with 35% receiving at least one dose and 31% being fully vaccinated. According to UDOH, Utahns identifying as Black or African American have the second-lowest rate with 38.6% with one dose and 32.5% fully vaccinated.
This data comes just a few weeks after the Pfizer COVID-19 vaccine received full FDA approval. For more information on the COVID-19 vaccine, click here. For information on where to get the COVID-19 vaccine, who can get vaccinated, and for frequently asked questions, visit the Utah Department of Healths website.
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70% reached: Utahns with the highest, lowest COVID-19 vaccination rates - ABC 4
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Majority of Alabamians hospitalized with COVID-19, on ventilators, are unvaccinated – alreporter.com
Posted: at 2:55 pm
The vast majority of Alabamians hospitalized with COVID-19, being cared for in ICUs and hooked to ventilators are unvaccinated. State hospitals on Sunday had a negative 92 ICU beds, and more than half of the beds occupied were COVID-19 patients.
Of the 2,713 people hospitalized with COVID-19 statewide on Sunday, 84 percent were unvaccinated, according to the Alabama Hospital Association.
At UAB Hospital in Birmingham on Friday, 134 of 149 COVID-19 patients were unvaccinated, or 89 percent. Of those patients who needed ICU care, 91 percent were unvaccinated, and the same percentage of the 49 COVID patients hooked to ventilators on Friday were unvaccinated.
State hospitals had a negative 92 ICU beds on Sunday, according to the Alabama Hospital Association, meaning there were 92 more patients needing ICU bed care than the states hospitals had formal ICU beds. While some hospitals had available ICU beds to care for the critically ill, others had patients awaiting that care. More than half of the states 1,618 ICU patients on Sunday had COVID-19.
East Alabama Health, which operates hospitals in Opelika and Valley, on Friday was just one COVID-19 patient shy of the hospital systems record, set in January. The two hospitals combined number of COVID-19 patients on ventilators reached a new high of 23 on Thursday. East Alabama Health on Friday had seven fewer ICU beds than patients needing those beds.
And the numbers would be even higher, but COVID has claimed the lives of 26 patients since August 1, the system said in a statement Friday.
Those 26 COVID-19 patients who died since Aug. 1 are just shy of the 28 patients who died of COVID at East Alabama Healths hospitals over the span of five months, from March 1 through July 31.
Of the 91 COVID-19 patients hospitalized at East Alabama Health hospitals on Friday, 80 percent were unvaccinated. of those patients on ventilators, 81 percent were unvaccinated.
We are doing everything we can to save every life that comes through our doors, and I mean everything, Dr. Meshia Wallace, a pulmonologist and critical care physician at East Alabama Health, said in a statement. Patients are on the ventilator, paralyzed, in a prone position, getting high doses of steroids, interleukin inhibitors, antivirals, dialysisas I said, were doing everything.
Seeing patients, including a new mom, fight for their lives on a ventilator is excruciating, Wallace said. Especially when its extremely clear now after eight months that the vaccines are safe and effective at keeping the vast majority of people out of the hospital and limiting critical care and deaths. This peak was very avoidable. Its sad to watch so many people suffer.
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Majority of Alabamians hospitalized with COVID-19, on ventilators, are unvaccinated - alreporter.com
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University of Texas sees relatively low COVID-19 numbers early in the semester – Austin American-Statesman
Posted: at 2:55 pm
COVID-19: New variant is here, but Fauci says not 'immediate threat'
A new COVID variant has emerged called mu, but Dr. Fauci says they are "keeping a very close eye on it."
Staff video, USA TODAY
Since classes began, the University of Texas has reported thousands of COVID-19 tests and a relatively small number of positivecases in the campus community.
UT welcomed an estimated 50,000 students to campus for fall classes starting Aug. 25, along with staff and faculty members. The university is holding nearly all classes in-person or in a hybrid format this fall, and it has reopened buildings such as the residence halls at full capacity.
UT reported an estimated 179 total active COVID-19 cases among students, staff and faculty as of Thursday. However, the university has not announced further requirements for community members to get tested, so the actual total number of cases remains unclear.
More: UT boosts graduate student funding by $11 million
Art Markman, the head of the academic working group for COVID-19 planning, said officials will have a better sense of student behavior and how the semester is going to look after another week, but things are looking pretty good so far. He said the university has not received a lot of reports of large indoor gatherings or of COVID-19 spread related to classroom activities.
The number of cases on campus is actually on the low to medium end of what the modeling team predicted. And I think that's in part because we did get a number of students who might have brought COVID-19 to campus ... to stay home a few extra days, Markman said. But obviously, we're going to continue to monitor.
A report by UT's COVID-19 Modeling Consortium published in August before classes started estimated that there would be between 187 and 236 UT students infected with COVID-19 during the first week of the semester.
Campus officials have implemented a number of precautions for the fall semester, including requiring students to submit a negative COVID-19 test resultbefore returning to classand allowing faculty members to temporarily reduce classroom density. UT spokeswoman Eliska Padilla said all students moving into the residence halls submitted proof of a negative test, and nearly 40,000 students reported negative test results to the university.
UT also is encouraging community members to wear masksand isoffering incentives for people who upload proof of vaccination. Gov. Greg Abbott has prohibited agencies that receive public funding in Texas from instituting vaccine and mask requirements.
The university encourages all students in Austin who have not yet done so, to get tested through the UT Proactive Community Testing (PCT) Program. .... Just as we have seen throughout the pandemic, we expect our community will remain committed to good health and safety behaviors on our campus, Padilla said in a statement.
More: Wear a mask, get a cookie: UT professors can offer incentives for students to mask up
UT publishes the number of daily positive COVID-19 cases, proactive community tests, clinical tests and positivity rate among students, staff and faculty on a campus dashboard.The dashboard also lists the estimated active cases, which includes cases for 10 days after the onset of symptomsor 10 days after the test date if details about symptom onset are not available.
During the week that classes began, the university reported more than 10,000 weekly proactive community COVID-19 tests among the UT community, with a positivity rate of about 0.5% for students and 0.3% for faculty and staff. Lastweek, as ofFriday, the combined positivity rate for PCT tests in the last seven dayswas about 0.7% among students, faculty and staff, with55 positive tests out of 8,220.
While reported cases have been somewhatlow for the past two weeks even with increased testing, some UT students and faculty members said theyre still anxious about being on campus. They also said theyre concerned about the potential for more COVID-19 spread as the semester continues.
Stephennie Mulder, a UT associate professor in art history, said shes only teaching one small in-person class a week, but she worries about going home and infecting her unvaccinated daughter. She said she believes if UT mandated weekly testing of all students, it would help provide more data about the spread of COVID-19 in the campus community.
I feel very helpless, Mulder said. I'm a little bit less concerned for my own safety, because I'm vaccinated. If I'm wearing an N95 mask while teaching and I'm able to keep a distance from my students, the chance that I would bring that home to my daughter is relatively low, but it's possible.
Travis County COVID-19 vaccine tracker: 61% of people fully vaccinated
UT senior Apoorva Chintala said its been overwhelming and stressful for her to jump back into the routine of being back on campus with crowds of people and attending in-person classes for the past week and a half. She said, for her, the next few weeks will be critical to figuring out what's going to happen with COVID-19 the rest of the semester.
I hope more people get tested so that we can quarantine people that have COVID and minimize the spread, but it's not nearly enough, Chintala said. It's not the only thing we should be doing on campus to help stop the spread, because at that point people have already been around and spread out by the time they find out they're contagious.
Markman said the anxiety in the UT community is understandable, and he encourages people to engage in safe behavior. He said UT believes it has laid out a set of procedures that will keep people safe, but if there is evidence that that's not the case, the university will make changes.
We're doing a lot of daily testing right now, ... but we're not going to get exact numbers, Markman said. Generally speaking, if there's widespread illness on campus, we would see a lot more people coming in to get the clinical tests because they're symptomatic, and wed be seeing a much higher positivity rate on those tests.
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The increased risks of COVID-19 in pregnancy and why doctors are urging the vaccine – KELOLAND.com
Posted: at 2:55 pm
SIOUX FALLS, S.D. (KELO) According to the CDC, the nation has seen an increase in pregnant people getting infected with the coronavirus. And doctors say the virus can lead to severe illness, which is why they are urging pregnant people to get vaccinated.
Throughout the last year and a half, Dr. Kimberlee McKay with Avera Medical Group has had to see multiple pregnant patients become severely sick and, in some cases, give birth early because of complications from a COVID-19 diagnosis.
Last year, the worst I ever felt was when we had a pregnant mom who we were getting ready to C-section and she needed to be intubated, McKay, the clinical vice president of the Ob/Gyn Service Line at Avera Medical Group, said. And before we intubated her, in order to deliver her baby and then take her to the ICU, I just looked over the top of the C-section curtain and I said, Im going to take really good care of you, and she just looked me straight in the eye and she said, please, let me wake up to see my baby.'
And now she says it seems patients are getting even sicker with the Delta variant spreading.
If your risk as a young person who is not pregnant is 0.8 percent chance of being admitted to the ICU, a pregnant womans, they say, is 22 times higher.
Most of them are unvaccinated and so when they come in its just with the full blown disease, McKay said. Whats hard is that, when mom cant breathe, what youll see is changes in the babys heart rate. And when mom is having trouble oxygenating, the baby, of course, is going to have trouble.
McKay says COVID-19 also targets blood vessels, which is what the placenta is primarily made of.
And so, even in mild cases of the disease, were seeing a good number of these patients, probably 25 to 30 percent, who go on to develop things like preeclampsia and have other maternal sicknesses that necessitate an early delivery.
Other risks include miscarriage and stillbirth.
And, of course, any time that a baby needs to be delivered early, there are acute needs, meaning more care thats needed right then and also long-term health effects for the baby.
Thats why doctors are urging pregnant patients to get vaccinated against COVID-19. Dr. Elizabeth Miller is an Ob/Gyn with Sanford Health; shes also a mom.
So one of the things that I share with my patients to help them feel confident about getting the vaccine is that I got the vaccine when I was fifteen weeks pregnant with my son, Miller said. And it was one of the first times that I felt hopeful in this pandemic, knowing that I was more protected and that my son would be born with protection as well.
Dr. Miller says 150,000 pregnant people have received the vaccine nationally. She says the vaccine is safe for expecting parents, but it also provides extra safety for the baby.
And also, when moms get the vaccine in pregnancy, it passes antibodies through the placenta to baby and can help protect babies against COVID when theyre born, Miller said. Babies cant get the vaccine so this is one of the best ways that moms can protect their babies too.
Getting vaccinated in pregnancy is one of the best ways that you can help keep you and your baby safe.
Doctors also urge parents who are breastfeeding to get the vaccine, as antibodies can also pass into breast milk.
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Covid Ravaged South America. Then Came a Sharp Drop in Infections. – The New York Times
Posted: at 2:55 pm
RIO DE JANEIRO Just a few weeks ago, Covid-19 was spreading with alarming ease across a cluster of nations in South America, overwhelming hospital systems and killing thousands of people daily.
Suddenly, the region that had been the epicenter of the pandemic is breathing a sigh of relief.
New infections have fallen sharply in nearly every nation in South America as vaccination rates have ramped up. The reprieve has been so sharp and fast, even as the Delta variant wreaks havoc elsewhere in the world, that experts cant quite explain it.
Brazil, Argentina, Chile, Peru, Colombia, Uruguay and Paraguay experienced dramatic surges of cases in the first months of the year, just as vaccines started to arrive in the region. Containment measures were uneven and largely lax because governments were desperate to jump-start languishing economies.
Now the situation has cooled across South America, said Carla Domingues, an epidemiologist who ran Brazils immunization program until 2019. Its a phenomenon we dont know how to explain.
There have been no new sweeping or large-scale containment measures in the region, although some countries have imposed strict border controls. A major factor in the recent drop in cases, experts say, is the speed with which the region ultimately managed to vaccinate people. Governments in South America have generally not faced the kind of apathy, politicization and conspiracy theories around vaccines that left much of the United States vulnerable to the highly contagious Delta variant.
In Brazil, which had a slow, chaotic vaccine rollout, nearly 64 percent of the population has received at least one dose of a vaccine, a rate that exceeds that of the United States. That led President Jair Bolsonaro, who had initially sowed doubts about vaccines, to brag last month.
Brazil has one of the best performances on vaccination globally, he said in a Twitter post.
In Chile and Uruguay, more than 70 percent of the population has been fully vaccinated.
As cases have dropped, schools in much of the region have resumed in-person classes. Airports are becoming busier as more people have started traveling for work and leisure.
Sept. 6, 2021, 12:36 p.m. ET
The drop in caseloads led the United Nations this past week to provide a more optimistic projection of economic growth in the region. It now expects economies in Latin America and the Caribbean to grow by 5.9 percent this year, a slight increase from its 5.2 estimate in July.
Weve managed to delay major circulation of the Delta variant and move forward with the biggest vaccination campaign in our history, Carla Vizzotti, Argentinas health minister, said last week.
In Argentina, more than 61 percent of the population has received at least one dose of a vaccine.
Chrystina Barros, a health care expert at the Federal University of Rio de Janeiro, said she worries that falling caseloads will lead people to become complacent about wearing masks and avoiding crowds while the epidemic remains a threat.
UnderstandVaccine and Mask Mandates in the U.S.
There is a serious risk of putting the very effectiveness of the vaccine at risk, she said. The cooling of the pandemic cannot inspire people to relax in relation to the crisis.
Jairo Mndez Rico, a viral diseases expert advising the World Health Organization, said the Delta variant may have been slow to gain traction in South America because so many people in the region have natural immunity from having had the virus. But he said the variant could still lead to new surges.
Its not easy to explain, he said. Its too early to say what is happening.
Despite the uncertainty, governments in South America are moving to reopen borders in coming months. President Alberto Fernndez of Argentina said in late July that the path to normalcy was in sight.
We deserve another life, a life in which we enjoy music, painting, sculptures, movies, theater, he said. A life in which we can laugh without a face mask, where we can hug those we love.
Jennifer Mac Donnell, a cosmetologist in Buenos Aires, is days away from a mid-September wedding a milestone that has felt uncertain for much of the year.
We feared we were going to be forced to cancel it, the 39-year-old said. Now were much more calm, cases are down, most of our friends are vaccinated and everyone is just focused on having a good time.
Daniel Politi reported from Buenos Aires, and Flvia Milhorance from Rio de Janeiro.
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ExeVir Q&A: the llama-derived antibody that could fight Covid-19 – Pharmaceutical Technology
Posted: at 2:55 pm
Despite being founded just last June, Belgian biotech ExeVir is making serious headway in the race to develop effective antibodies against Covid-19. The companys llama-derived antibody, XVR011, is currently being trialled in healthy individuals and hospitalised Covid-19 patients and the data so far looks promising.
The antibodies were originally extracted from a llama named Winter, who is now being left to his own devices at a private animal park in Belgium as the antibodies can be synthesised in a lab. The small, llama-derived nanobodies have demonstrated strong neutralising activity against Covid-19 and all of its variants of concern. ExeVir, which was spun out from the Flanders Institute for Biotechnology, has moved its lead candidate from laboratory tests to human clinical trials at an impressive pace, and beyond the current pandemic, the firm is hoping to build a broader platform for the treatment of infectious diseases of all kinds, both viral and bacterial.
Pharmaceutical Technology speaks to ExeVir CEO Torsten Mumenbrauer about the companys research and why XVR011 has the edge over other Covid-neutralising antibody programmes.
Darcy Jimenez: How did research into this therapeutic candidate begin, and why were llama-derived antibodies chosen?
Torsten Mummenbrauer: The technology as such is pretty old. It had been invented at the University of Brussels almost 20 years ago, then the Flanders Institute for Biotechnology (VIB) in Ghent took it on board and continue to develop the technology.
The big benefit of the technology is the small size of the nanobodies, and the resulting advantages. In our special case, we have a very specific epitope on the spike protein, which is targeted by our lead candidate. And because the molecule is so much smaller than human antibodies, it can bind in this small groove or niche, and that makes it special. Its applicable for any use thats why we believe its a platform technology which can be used broadly in infectious disease development.
The fact that the nanobody is that much smaller also makes it applicable for different presentation in humans so you can consider inhaled versions, we will develop a subcutaneous version, and you can fuse it to the Fc receptor to make it look like a human antibody. Thats what we have done with our lead molecule, specifically to stabilise it. When its fused to an Fc, its roughly only half of the size of a human antibody, so if you put a certain amount per dose in your therapeutic approach, you have roughly double the number of molecules in the patient.
Then you can think about future variations or design changes. The FDA advised, for Covid-19 products, to go for a combination product thats what we see with the Regeneron product, which is a combination of two [monoclonal antibodies], and Lillys as well. In our case, we could simply fuse two different nanobodies to one molecule or on one Fc and mimic the combination approach, but keep all the advantages of the technology.
DJ: What have studies shown so far about the antibodys efficacy against Covid-19?
TM: We started off against the wild type, the Wuhan strain, of course, and we showed efficacy in picomolar range in the hamster model. We have done the same experiment against Alpha, Beta, Gamma and Delta variants, and we see no change. We have very much the same potency against all variants which are [circulating] so far. We are looking at the variants of interest, and well follow up and test these as well.
The key importance here is the epitope of your binder. If this epitope starts to mutate, then that allows the virus to escape. And this is what happens on the antibodies from Regeneron, which were originally derived from plasma from convalescent patients. They are all binding to the outer part of the RBD (receptor binding domain), and this is where you find the mutation hotspots of the virus.
We are on a side niche, and we are not impacted by any of these mutations; we have a crystal structure, and we can clearly show that these mutation hotspots are in other areas of the virus. We have shown on sequencing data that our epitope is very highly conserved over the SARS-COV virus family.
An interesting aspect is that originally, our llama Winter had been immunised against SARS-COV-1 already four or five years ago thats the reason why the company could be that fast. The library against SARS-COV-1 existed already in February last year, when the SARS-COV-2 sequence was published. So we immediately did a screen, and we found 100% cross-reactive binders, and that resulted in our lead candidate. Thats probably another reason why we have this highly conserved and very stable epitope, because its conserved on the whole virus family.
We of course are looking into the sequencing database available for all virus isolates worldwide, and there you can see the mutation hotspots coming. In our binding area there is extremely limited mutation frequency, so it seems that this highly conserved epitope is important for the viability of the virus itself, and thats probably the reason why its so stable.
DJ: Dosing of Phase I trial participants began last month, and hospitalised Covid-19 patients were also dosed recently. Are you confident about the antibody being studied in a hospital setting?
TM: We decided a while ago to silence our Fc component, and Ive mentioned that weve fused the Fc of the antibody to the nanobody thats specifically for safety reasons. Its one of our key differentiators compared to other antibodies, where you have the concern of antibody-derived enhancement of the disease, because of the activation of the immune system through the antibody. Our Fc is silenced, so we just neutralise the virus and we do not activate the immune system.
Were extremely confident about [the study], and we strongly believe that the early-stage, mild-to-moderate hospitalised patients have the highest medical need, because there you want to avoid progression of the disease and ICU, of course.
To add on to that, the first cohort in Phase I healthy subjects have been completely dosed without any severe side effects. There is a bit of redness at the infusion site, which is normal for antibodies, and the same [was found] for the first hospital patient who has been dosed.
DJ: Developing a promising candidate to help combat the pandemic is an impressive feat for a company that was founded only last year. What else is ExeVir working on that youre particularly excited about?
TM: This is our lead candidate; we were focusing very much over the last year on the lead, otherwise it wasnt going to happen. We were always thinking, if you want to make a difference in a disease like Covid-19, in a crisis, you need to be extremely fast. And so that has to be the focus, but we definitely see this as a platform technology to fight infectious diseases, and there we split that into two parts.
One is the future of pandemic preparedness: I strongly believe that people have realised that vaccines, in the case of a pandemic outbreak, are an important component of a response, but it also requires therapeutics. If you want to ringfence a local outbreak, a therapeutic is much more efficacious. You dont need to wait for onset of immunity, you can use antibodies in prophylactic and therapeutic settings, and I think we have proven with the pre-immunisation of the llama that you can be very fast with this technology.
We definitely want to be part of pandemic preparedness of the future, but thats not where you can really build the commercial future of a company in my view, because you dont know if or when your pre-developed product might be required. So we are also working on a pipeline for infectious diseases with high medical need, and we are in the last step, I would say, of the process to come up with a shortlist of candidates. It will target infectious diseases with the highest medical need and hospitalisation relevance, so the technology can be used against bacterial diseases as well as viral. There is an ongoing programme on universal flu at VIB, which is very exciting for us, so there will be definitely a strong pipeline path for the next year beyond Covid-19.
We are really proud to demonstrate with [XVR011] that you can bring a molecule from early R&D and preclinical to a patient within a year. And for a small company, under all the circumstances of the pandemic, we believe thats a really cool achievement.
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Too Few Hospitals In COVID Hotspots Are Equipped To Offer ECMO : Shots – Health News – NPR
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ECMO is the highest level of life support beyond a ventilator, which pumps oxygen via a tube through the windpipe into the lungs. Instead, the ECMO process basically functions as a heart and lungs outside of the body routing the blood via tubing to a machine that oxygenates it, then pumps it back into the patient. Blake Farmer/Nashville Public Radio hide caption
ECMO is the highest level of life support beyond a ventilator, which pumps oxygen via a tube through the windpipe into the lungs. Instead, the ECMO process basically functions as a heart and lungs outside of the body routing the blood via tubing to a machine that oxygenates it, then pumps it back into the patient.
Hospital discharge day for Phoua Yang was more like a pep rally.
On her way rolling out of Centennial Medical Center in Nashville, she teared up as streamers and confetti rained down on her. Nurses chanted her name as they wheeled her out of the hospital for the first time since she arrived in February with COVID-19, barely able to breathe.
The 38-year-old mother is living proof of the power of ECMO a method of oxygenating a patient's blood outside the body, then pumping it back in. Her story helps explain why a shortage of trained staff who can run the machines that perform this extracorporeal membrane oxygenation has become such a pinch point as COVID-19 hospitalizations surge.
"One hundred forty six days is a long time," Yang says of the time she spent on the ECMO machine. "It's been like a forever journey with me."
For nearly five months, Yang had blood pumping out a hole in her neck and running through the rolling ECMO cart by her bed.
ECMO is the highest level of life support beyond a ventilator, which pumps oxygen via a tube through the windpipe, down into the lungs. The ECMO process, in contrast, basically functions as a heart and lungs outside the body.
The process, more often used before the pandemic for organ transplant candidates, is not a treatment. But it buys time for the lungs of patients who have COVID-19 to heal. Often they've been on a ventilator for a while. Even when it's working well, a ventilator can have its own side-effects after prolonged use including nerve damage or damage to the lung itself through the excessive air pressure.
Doctors often describe ECMO as a way to let the lungs "rest" especially useful when even ventilation isn't fully oxygenating a patient's blood.
Many more people could benefit from ECMO than are receiving it, which has made for a messy triaging of treatment that could escalate in the coming weeks as the delta variant surges across the South and in rural communities with low vaccination rates.
The ECMO logjam primarily stems from just how many people it takes to care for each patient. A one-on-one nurse is required, 24 hours a day. The staff shortages that many hospitals in hot zones are facing compound the problem.
Yang says she sometimes had four or five clinical staff members helping her when she needed to take a daily walk through the hospital halls to keep her muscles working. One person's job was just to make sure no hoses kinked as she moved, since the machine was literally keeping her alive.
Of all the patients treated in an ICU, those on ECMO require the most attention, says nurse Kristin Nguyen who works in the ICU at Vanderbilt University Medical Center.
"It's very labor-intensive," she tells us one morning, after a one-on-one shift with an ECMO patient who had already been in the ICU three weeks.
The Extracorporeal Life Support Association says the average ECMO patient with COVID-19 spends two weeks on the machine, though many physicians say their patients average a month or more.
"These patients take so long to recover, and they're eating up our hospital beds because they come in and they stay," Nguyen says. "And that's where we're getting in such a bind."
It's not that there aren't enough ECMO machines to go around or the high cost which is estimated at $5,000 a day or significantly more, depending on the hospital.
"There are plenty of ECMO machines it's people who know how to run it," says Dr. Robert Bartlett, a retired surgeon at the University of Michigan who helped pioneer the technology.
Every children's hospital has ECMO, where it's regularly used on newborns who are having trouble with their lungs. But Bartlett says prior to the pandemic, there was no point in training teams elsewhere to use ECMO when they might only use the technology a few times a year.
It's a fairly high risk intervention with little room for error. And it requires a round-the-clock team.
"We really don't think it should be that every little hospital has ECMO," Bartlett says.
Bartlett says his research team is working to make it so ECMO can be offered outside an ICU and possibly even send patients home with a wearable device. But that's years away.
Only the largest medical centers offer ECMO currently, and that's meant most hospitals in the south have been left waiting to transfer patients to a major medical center during the recent pandemic surge. But there's no formal way to make those transfers happen. And the larger hospitals have their own COVID patients eligible for ECMO who would be willing to try it.
"We have to make tough choices. That's really what it comes down to how sick are you, and what's the availability?" says Dr. Harshit Rao, chief clinical officer overseeing ICU doctors with physician services firm Envision. He works with ICUs in Dallas and Houston.
There is no formal process for prioritizing patients, though a national nonprofit has started a registry. And there's limited data on which factors make some patients who have COVID-19more likely to benefit from ECMO than others.
ECMO has been used in the United States throughout the pandemic. But there wasn't as much of a shortage early on when the people dying from COVID-19 tended to be older. ECMO is rarely used for anyone elderly or with health conditions that would keep them from seeing much benefit.
Even before the pandemic, there was intense debate about whether ECMO was just an expensive "bridge to nowhere" for most patients. Currently, the survival rate for COVID-19 patients on ECMO is roughly 50% a figure that has been dropping as more families of sicker patients have been pushing for life-support.
But the calculation is different for the younger people who make up this summer's wave of largely unvaccinated COVID-19 patients in ICUs. So there's more demand for ECMO.
"I think it's 100% directed at the fact that they're younger patients," says Dr. Mani Daneshmand, who leads the transplant and ECMO programs at Emory University Hospital.
Even as big as Emory is, the Atlanta hospital is turning down multiple requests a day to transfer COVID-19 patients who need ECMO, Daneshmand says. And calls are coming in from all over the Southeast.
"When you have a 30-year-old or 40-year-old or someone who has just become a parent, you're going to call. We've gotten calls for 18-year-olds," he says. "There are a lot of people who are very young who are needing a lot of support, and a lot of them are dying."
Even for younger people, who tend to have better chances on ECMO, many are debilitated afterward.
Laura Lyons was a comedian with a day job in New York City before the pandemic. Though just 31 years old when she came down with COVID-19, she nearly died. ECMO, she says, saved her life. But she may never be the same.
"I was running around New York City a year and half ago, and now I'm in a wheelchair," she says. "My doctors have told me I'll be on oxygen forever, and I'm just choosing not to accept that. I just don't see my life attached to a cord."
Lyons now lives at her parents' house in central Massachusetts, and spends most days doing physical therapy. Her struggle to regain her strength continues, but she's alive.
Since it's kind of the wild west to even get someone an ECMO bed, some families have made their desperation public, as their loved one waits on a ventilator.
As soon as Toby Plumlee's wife was put on a ventilator in August, he started pressing her doctors about ECMO. She was in a north Georgia community hospital, and the family searched for help at bigger hospitals looking 500 miles in every direction.
"But the more you research, the more you read, the more you talk to the hospital, the more you start to see what a shortage it really is," he says. "You get to the point, the only thing you can do is pray for your loved one that they're going to survive."
Plumlee says his wife made it to sixth in line at a hospital 200 miles away Centennial Medical Center where Phoua Yang was finishing her 146-day ECMO marathon.
Yang left with a miracle. Plumlee and their children were left in mourning. His wife died before ever getting ECMO a few days after turning 40.
This story was produced as part of NPR's partnership with Kaiser Health News and Nashville Public Radio.
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