Alabama hospital struggles to get COVID drug sotrovimab

 Even as Decatur Morgan Hospital struggles to treat all of its COVID patients, it can’t get an adequate supply of a drug that’s effective at keeping infected people out of the hospital.

Hospital CEO Kelli Powers on Tuesday said she gets daily emails on how many doses, if any, the hospital will receive of sotrovimab, which is administered on an outpatient basis intravenously. Since Jan. 1, the hospital has received 36 doses — a small fraction of the number of people whose doctors have requested that they receive it. At one point last week, she said, the hospital was allocated six doses.

“We had six doses and over 50 people really needing it,” she said. “Over 50 that were Priority 1, meaning they needed to get it that day, and we only had six doses.”

The first step in getting on the waiting list is for a physician to prescribe it. Then hospital staff prioritize the list, leaving only those who have the greatest need. Then they prioritize again based on the number of doses available that day.

“That’s one of the most frustrating things we’ve had. We have a huge waiting list of people whose physicians think they need to get it,” Powers said.

The Alabama Department of Public Health allocates the limited supply it receives to hospitals in the state. ADPH spokesperson Arrol Sheehan said sotrovimab is “in extremely short supply. ADPH makes every effort to ensure these medications are equitably and fairly distributed throughout the state.”

“I don’t know what that means,” Powers said. “It’s a shame. Why can’t they make more?”

While three different infusion products were effective against earlier variants of the coronavirus, only GlaxoSmithKline’s sotrovimab has been found to be effective against omicron. The drug company has not been able to meet demand, and two antiviral pills that are effective against COVID-19 are likewise in short supply.

Because of the shortage, the U.S. Department of Health and Human Services is purchasing sotrovimab and allocating it to states based primarily on their COVID-19 case burden, according to the HHS website. In the month of January, HHS allocated 2,868 doses of sotrovimab to Alabama, about 1.3% of the 204,950 doses allocated nationwide. Alabama’s population is about 1.5% of the U.S. population.

Because sotrovimab is designed to keep people from needing hospitalization, it is of particular value as Decatur Morgan Hospital struggles with a large number of COVID patients and a staff that’s depleted by COVID infections.

The hospital had 69 COVID patients Monday. One died and some were discharged, leaving 59 Tuesday. Seven of those patients were in intensive care and on ventilators. None of the patients hospitalized on Tuesday had received both their vaccinations and boosters, Powers said. None of those in ICU had received even the initial vaccine series.

“I really think if they would get their booster it would keep them out of the hospital,” Powers said. “People are still dying from it.”

She said the drop in COVID patients from Monday to Tuesday makes her cautiously optimistic.

“I hope the numbers keep coming down. That’s what I’m praying for,” Powers said, noting that she takes some hope from the fact that the percentage of people whose tests come back positive has dropped slightly in the county in recent days.

ADPH has recorded 15 COVID deaths among Morgan County residents in 2022, a number that generally lags well behind actual deaths as it takes time for both the hospital and ADPH to confirm that COVID was the cause of death. Since the pandemic began, 449 Morgan County residents have died of the disease.

Staffing

Powers said hospital staffing is not up to the influx of COVID patients.

“It’s still overtaking everything. We are currently not doing inpatient elective surgery because we have so many patients. We just don’t have enough beds or staff,” she said. “Last week we didn’t do any elective surgeries at all. We started the outpatient surgeries back Monday because some of the staff came back after being out with COVID.”

More than 70 staff were out Tuesday after either they or a member of their household tested positive for COVID, down from 117 last week. About 230 are “self-monitoring.”

“That means they either had a definite exposure to it or have some symptoms that make them think they might have it,” Powers said. Many of those who are self-monitoring must stay home, Powers said, although some can still work if they have a job that allows for isolation.

The hospital recently outsourced its walk-through COVID testing to Core Diagnostics, which administers tests Monday through Friday from 9 a.m. to 6 p.m. at the hospital’s Parkway campus at 1874 Beltline Road S.W., with no appointment necessary. The testing is not limited to Morgan County residents.

“We didn’t have enough people to do the testing,” Powers said. “It really stretched us to where we decided we had to focus on the inpatients and the ER and all that. We asked ( Core Diagnostics) to bring their own staff to do the testing so it’s not pulling from our staffing here.”

The hospital’s mobile medical unit, which has been used for testing, had mechanical problems Monday and remained out of service Tuesday. The Morgan County Sheriff’s Office, assisted by the Morgan County Emergency Management Agency, responded by loaning a large MASH-type tent with a generator, which has been set up in the parking lot of the Parkway campus.

People who wish to be tested should fill out paperwork at a table in front of the tent and then wait in line in the parking lot.

Al Ballesteros, a retired Decatur police officer, is the mobile medical unit coordinator for Decatur Morgan and is the liaison between the hospital and Core Diagnostics.

“The ERs are being overrun by people that are wanting to get tested, so we are assisting with that endeavor, trying to help them with that rush,” he said.

Ballesteros said he takes precautions and is not nervous about contracting the disease from those who are tested. Then, pointing toward the hospital: “It is nerve-wracking to me that my coworkers are under a lot of stress. They’re overworked.”

Lindsay Thrasher of Trinity, a collector with Core Diagnostics working at the testing tent Tuesday, said she was infected in January 2021, but has had no infections since, despite dealing with people who often test positive.

“We wear masks, sanitize everything and wash our hands as much as possible,” she said. “We’re outside and in a well-ventilated area.”

She said some people she has tested are so sick they’re struggling to walk and breathe, and she has directed some to go straight to the emergency room.

Thrasher said a courier comes twice a day and takes the swab samples to a lab in Birmingham. Test results come back within 48 hours, although she said they sometimes come back the next day.

https://www.al.com/news/2022/02/alabama-hospital-struggles-to-get-covid-drug-sotrovimab-why-cant-they-make-more.html

CA no longer letting health care staff with COVID go back to work without isolation

 Controversial California guidance that temporarily allowed coronavirus-positive health care workers return to work without isolation has expired.

The California Department of Public Health issued the guidance last month, letting health care workers who test positive for the virus or are exposed to it to return to work immediately — without isolation and without testing — if they are asymptomatic and wearing N95 masks.

The guidelines spurred backlash across the state, with health care workers holding protests to speak out against the new rules, which they believed put both patients and workers at risk.

Labor groups representing health workers quickly denounced the guidance.

State officials said the changes, which expired Tuesday, were made “due to the critical staffing shortages currently being experienced across the health care continuum because of the rise in the Omicron variant.”

At the time, about a third of California hospitals were reporting “critical staffing shortages,” according to the U.S. Department of Health and Human Services.

The omicron-fueled surge led to shortages across many sectors, including at hospitals dealing with more COVID-19 patients flooding in.

Hospitals started weighing which surgeries to delay during the COVID-19 surge.

As the temporary rule expired, California health officials said they’re seeing “positive signs” that the spread of COVID-19 is slowing statewide and that the looser quarantine guidelines are no longer needed.

“While our health care system is still stretched beyond usual capacity with COVID-19 and non-COVID patients, adding additional workers has improved staffing challenges in many regions of the state and we no longer need this temporary tool,” the Department of Public Health told KTLA in an email.

Still, many hospitals in California are strained.

In the San Joaquin Valley, ICUs were at or near capacity, the health department said Friday, activating surge protocols that allow the transfer of patients to other hospitals.

“California has measures in place to respond to the surge and changing dynamics of the pandemic,” Health and Human Services Secretary Dr. Mark Ghaly said Friday. “ICUs in the San Joaquin Valley, where vaccination rates are lower, are nearing capacity. Californians will get through this latest surge by continuing to follow the science, including by getting vaccinated and boosted, which is the safest way to protect yourself from the virus.”  

https://ktla.com/news/california/ca-no-longer-letting-health-care-staff-with-covid-go-back-to-work-without-isolation/

Proposed Bill Would Allow Ivermectin Use For Critically Sick Patients: Iowa Lawmakers

 by Jack Phillips via The Epoch Times,

Lawmakers in Iowa’s state Legislature have advanced a bill that would allow the use of ivermectin for critically sick COVID-19 patients.

Ivermectin has been used for decades to treat parasitic worms in humans, but during the COVID-19 pandemic, some patients and doctors have attested that the drug is effective in relieving symptoms.

The Iowa bill stipulates that COVID-19 patients who are on ventilators should have the ability to use ivermectin. Specifically, it expands the state’s “right to try” law, which allows terminally ill patients to access medicines that have passed under the first phase of the U.S. Food and Drug Administration’s trials.

“I completely support it. I think that we should give patients the right to try,” said Rep. Ann Meyer, a Republican and one of the bill’s cosponsors, told the Des Moines Register in late January.

Rep. Lee Hein, also a Republican, said he sponsored the measure after hearing that two families of critically ill COVID-19 patients had sought ivermectin but hospital policies prevented them from obtaining the medication. Both patients died of COVID-19, he said.

“I don’t know whether any of these drugs work, but I think at that late stage in the game, once you’re on a ventilator, families ought to have at least a glimmer of hope to try something,” Hein told Radio Iowa.

The FDA’s website says that its “currently available data” suggests that the medication isn’t effective at treating or preventing COVID-19. However, the agency courted controversy last year when it issued a Twitter post that suggested the drug is only used for “deworming” horses and other livestock, although it has long authorized ivermectin tablets as a treatment for worms in humans.

The FDA and other agencies, meanwhile, have warned against people taking livestock-grade ivermectin, which doesn’t require a prescription, amid reports of increases in people being admitted to hospitals after taking the livestock version of the drug.

The drug gained more attention after podcaster Joe Rogan confirmed that he took human-grade ivermectin in a bid to curb his COVID-19 symptoms. Ivermectin is also being used across Latin America for COVID-19, including in Peru, Guatemala, Bolivia, and other countries.

In December of last year, the family of an Illinois man, Sun Ng, who developed severe COVID-19 symptoms and was near death, said he recovered after taking ivermectin. It came after a court ordered the hospital to administer the drug to Ng, the family’s attorney told The Epoch Times at the time.

Rep. Meyer, who is a also nurse, said that ivermectin has “been around” for “many years.” The bill, she told Radio Iowa, would allow “off-label” use of the drug for COVID-19 patients who are on life support in hospitals.

Republicans advanced the measure through a subcommittee meeting on Jan. 26.

One Democrat on the subcommittee, Rep. Mary Mascher, voted against advancing the bill.

“There’s a lot of folks in the room who are medical folks,” Mascher said during last week’s hearing. “And I have heard no one in support of the bill.”

https://www.zerohedge.com/covid-19/proposed-bill-would-allow-ivermectin-use-critically-sick-patients-iowa-lawmakers

Should we let children catch Omicron?

 As we enter our third Covid year, much of the world is getting back to normal. Denmark yesterday dropped most of its Covid restrictions and welcomed back “the life we knew before”. In the UK, face masks and Covid passports are no longer a legal requirement. Some US red states have passed laws against local mask mandates and vaccine requirements.

But in many of America’s deep-blue cities and suburbs, stringent Covid measures are still the norm, especially for schoolchildren. In New York City public schools, for instance, all students must wear masks at all times, including outdoors, except while eating or during designated “mask breaks”. Palo Alto, the hometown of Stanford University, makes kids wear mask outdoors at recess. And LA public schools, responding to new evidence about the uselessness of cloth masks, recently required children to wear surgical masks or N95/KN95s.

These measures are premised on the idea that America’s children must be shielded from exposure to Covid-19. What kids really need, however, is a return to normal. And when it comes to infectious disease, normality means a world where they are routinely exposed to, and overcome, viral illness. For children, getting sick and recovering is part of a natural and healthy life.

It has become common to criticise restrictions for children on the grounds that they harm mental health and social development. These concerns are valid, but it is important to emphasise that a more laissez-faire approach to kids and Covid makes public health sense, too. Dropping masks, quarantines, distancing, and all other mitigations will allow children to develop the kind of broad immunity gained by living a normal life.

Shielding kids from exposure only increases their future risk. This is partly why the UK does not vaccinate against chickenpox. Serious complications from the disease are rare among children, and the circulating virus allows adults to be naturally boosted against reactivation-driven shingles. By rebuilding population immunity among the least at-risk, moreover, we help buffer risk for those most vulnerable.

With Covid, the nadir of risk is between 5–11 years old — an age where children develop more robust and durable immunity from infection than adults, even with asymptomatic silent infections.

Some parents may think this sounds like a call to put their children at risk of serious illness or death. But it is important to remember that exposure to Covid-19 is inevitable. Vaccines protect against severe disease and side-effects such as MIS-C, but they cannot stop breakthrough infections, and the rapidity of Omicron’s spread suggests that no matter what we do, we cannot avoid the virus. In January, Anthony Fauci admitted as much, saying that Omicron will eventually “find just about everybody”.

The epidemiologist and researcher Francois Balloux puts it this way:

I'm not sure how to convey this message in a half-acceptable way. But, if the objective were to send SARCoV2 into endemicity, then healthy kids have to be exposed to the virus, ideally earlier than later. This is not 'eugenism'; it is bog-standard infection disease epidemiology.

— Prof Francois Balloux (@BallouxFrancois) January 26, 2022

This idea is not as frightening as it may sound. We know that even unvaccinated children generally do well after Covid-19 infection. A study from Germany found that among healthy, unvaccinated children aged 5–11 who became infected with the disease, just 8 in 100,000 ended up in the ICU and none died. Even children for whom vaccination is not yet an option are at lower risk now than they were last summer: the Omicron variant resulted in 66% fewer hospitalisations than Delta in a study of children younger than 5 years.

In some countries, this data informs policy. In Norway, for instance, parents of 5–11 year-olds can get vaccines for their children if they want them, but vaccines are only recommended for children with serious underlying conditions. This is not because vaccines are ineffective but because, according to the Norwegian Institute of Public Health, “the risk of a severe disease course at this age is small, and the need for vaccines for children and adolescents is limited”.

For children who are vaccinated, however, exposure at the lowest-risk age — roughly between kindergarten and middle school — could also be the safest way for young people to develop superior “hybrid” immunity. Last week, the CDC released a large study demonstrating that natural immunity is superior to vaccinated immunity and that hybrid immunity is superior to both. Vaccination provided a 19.8-times reduction in hospitalisation risk, but prior infection provided a 55.3-times reduction and a combination of the two conferred a 57.5-times reduction. Other studies suggest that hybrid immunity confers better cross-variant protection than vaccines alone.

And so schoolchildren, already at the lowest possible risk for severe Covid-19, have now exited what should be their last winter of restrictions. Many have already recovered from infection or been vaccinated, meaning that their risk has dropped from low to miniscule.

“Normal” has been an option for adults — it’s time to allow children to resume normal life, not simply because their exclusion is unfair or hurts them socially and psychologically, but because it is immunologically in their best interest. Parents must consider that exposures are how we best protect our children against the variants of the future. In fact, it is reckless to let children age into a more serious encounter with a disease best dealt with while younger.

This view is shared by the authors of a May 2021 paper in The British Journal of Medicine, who wrote: “Once most adults are vaccinated, circulation of SARS-CoV-2 may in fact be desirable, as it is likely to lead to primary infection early in life when disease is mild, followed by booster re-exposures throughout adulthood… This would keep reinfections mild and immunity up to date.” In fact, Norwegian authorities believe that natural infection will better protect children than vaccines that rely on out-of-date variants of the virus.

For parents worried that dropping restrictions will put their children at risk, the way forward is to realise that many of the protective measures we’ve been relying on, including masks — and especially the cloth masks that many American schoolchildren have been wearing for over a year — were never as protective as we’d thought, and are no match for omicron.

Some parents understandably fear the consequences of long Covid in kids, but the largest study to date is profoundly reassuring. Children who tested positive for Covid-19 were only 0.8% more likely to report long Covid symptoms, such as fatigue and muscle weakness, than those who had never tested positive. As the authors of the study concluded: “Long Covid in children is rare and mainly of short duration”.

Anxious parents should also put the risks in perspective. Children in many parts of Europe have been subject to less draconian restrictions than their US counterparts — without disastrous results. And while the death of any child is a tragedy, Covid-19 is less deadly to children than many other risks we accept as a matter of course, including drowning, vehicle accidents, and even cardiovascular disease.

Yes, diseases will continue to circulate, as they always have done. Schools are not sterile, nor should they be. Immunity is built through illness. If we can’t return our children to normalcy now, knowing what we know about the small risks facing children and the serious harms inflicted on them by pandemic-era restrictions, there is a real risk, at least in the more progressive parts of America, that the current arrangement will become the new normal. And that is a risk none of us should be willing to take.

Allison Krug is an epidemiologist based in Virginia Beach.

Vinay Prasad is Associate Professor of Epidemiology and Biostatistics at the University of California, San Francisco. He is a practising hematologist and oncologist, and author of more than 300 peer-reviewed publications.

https://unherd.com/2022/02/should-we-let-children-catch-omicron/

Donated kidneys from deceased COVID patients 'can be safely transplanted'

 Researchers at Johns Hopkins Medicine report the successful and safe transplantation of a kidney from a donor who died of complications from COVID-19. The case, which involved careful collection and sensitive molecular testing of the donor organ for evidence of the virus, demonstrates that healthy kidneys from such donors, previously discarded, can be safe to transplant.

While some kidneys from deceased donors infected with the coronavirus have been successfully transplanted in the United States since the start of the pandemic, the Johns Hopkins Medicine investigators say their transplant is one of the first documented cases in which tissue samples from the donor were analyzed with sophisticated tools that can detect molecular evidence of the virus. A report on the methods used and the transplant outcome was published Jan. 13 in the American Journal of Transplantation.

Concerns have emerged about the use of such donor kidneys because the kidneys could be a target of infection for the virus, based on autopsy findings and high levels of virus receptors in kidneys.

"What distinguishes this case from others is the fact that we studied the donor kidney by using pre-transplant biopsy samples to investigate the presence of the virus," said Kyungho Lee, M.D., a Johns Hopkins Medicine fellow and first author of the manuscript. "Instead of just doing a nasal swab test on the recipient after the transplant to check for infection after the fact, we obtained the donor kidney tissue prior to transplant and studied it carefully," he said.

Lee cautioned that large studies are needed to confirm the validity of the molecular analysis he and his team used, and to track the long-term outcome of recipients of such donor organs. Currently, there are no standardized tissue-based testing platforms or validated protocols to follow.

To test donor samples for virus, the researchers used a standard PCR test, which amplifies genetic material from the virus, along with another sensitive technique known as in situ hybridization.

"In this case, surgeon Dr. Desai informed me that an organ was available, but other centers had turned it down because the donor died from COVID-19 complications," says Hamid Rabb, M.D., medical director of the Johns Hopkins Kidney Transplant Program and corresponding author of the published report. Rabb and his team, based on the limited data in the field, agreed that the organ had a good chance of being used safely for the recipient, but decided to assess the risk by using precise molecular methods to evaluate infection in the donor organ.

The donor patient, the team reported, was a woman in her early 30s who was otherwise very healthy for her age, but was admitted to the hospital in March 2021 due to severe COVID-19 pneumonia and eventually placed on extracorporeal membrane oxygenation (ECMO), which is a blood pump outside the body to give oxygen to the body. She developed hypoxic brain injury (when not enough oxygen is being supplied to the brain) and progressed to brain death. Her kidney function was stable during her hospital course, and she tested negative for the virus by nasal swab three days prior to donation.

Tissue samples from the donor's kidney and aorta (a blood vessel known to have a high level of receptors for SARS-CoV-2, the virus that causes COVID-19) were collected and tested by PCR and by in situ hybridization. The samples were then compared with a separate positive COVID-19 case for accurate data interpretation.

The recipient patient was a 55-year-old man with end-stage kidney disease who had been on dialysis for more than five years. The Johns Hopkins Medicine patient had no prior COVID-19 history, was fully vaccinated and tested negative for the virus on the day of transplantation. Since the procedure, which occurred within 24 hours of the donor's death, the recipient has tested negative for COVID-19 by a PCR nasal swab test 20, 30 and 90 days following the transplantation, and has shown no signs or symptoms of the virus.

As of publication, the recipient has been off dialysis with excellent kidney function since the transplant, says Niraj Desai, M.D., surgical director of the Kidney and Pancreas Transplant program at Johns Hopkins Medicine. Desai says there have been about a dozen kidney and liver transplants from COVID-19-positive donors since this case, but this specific case was unique in that sophisticated tissue molecular testing was performed to provide hard data to justify using these organs.

"Some of this was a leap of faith, based on experience throughout the years with donors who had other viral infections such as hepatitis C," Desai said. "Although this case wasn't exactly like those others, we had some measure of confidence in a safe outcome."

Rabb says decisions on whether to accept organs other than lungs from donors who have died from COVID-19-related causes should be made on a case-by-case basis, but the risk of COVID-19 transmission through kidney transplant appears to be very low based on his team's cases to date.

"We know our case may not be representative of many possible COVID-19 donors, particularly since the donor was negative for COVID-19 at the time of transplantation," says Rabb. "However, it's a step forward using highly sensitive molecular testing to show it can be safe to use organs from deceased COVID-19 donors. Organs can be individually considered for kidney transplant instead of being routinely discarded."

According to the U.S. Department of Health and Human Services, some 95,000 Americans with kidney failure are awaiting donor organs. As reported by the U.S. Centers for Disease Control and Prevention, nearly 9,000 of these patients drop off the wait list each year because they cannot get a kidney in time, resulting in death or deteriorating health that makes transplantation no longer possible.

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More information: Kyungho Lee et al, Successful kidney transplantation from a deceased donor with severe COVID‐19 respiratory illness with undetectable SARS‐CoV‐2 in donor kidney and aorta, American Journal of Transplantation (2022). DOI: 10.1111/ajt.16956

https://medicalxpress.com/news/2022-02-donated-kidneys-deceased-covid-patients.html