Dozens of lawsuits seek to force hospitals to treat COVID-19 with ivermectin

 There have been at least two dozen lawsuits filed around the U.S. demanding hospitals give ivermectin, a deworming drug, to COVID-19 patients, The Associated Press reported.

The lawsuits follow much of the same format; families have gotten a prescription for the drug, but hospitals refuse to use it on the patients, many of whom are on a ventilator, close to death, the news outlet noted.

Many of the lawsuits are filed by Ralph Lorigo, an attorney in Buffalo, N.Y. who says doctors "are not gods because they wear white jackets," adding that he takes issue with the choice not to use ivermectin on patients, according to the AP.

He also said hospital administrators are the only ones able to make the decision.

"I’m not accepting that as a rule of law for us,” he told the AP.

Lorigo filed his first of many ivermectin cases in January after the family of an 80-year-old woman in the hospital on a ventilator came to him for help. Another lawsuit came later that month, this time for a hospitalized 65-year-old woman. In both cases, the judges ruled to give the women ivermectin as their families wanted. Both survived their hospital visits.

While the drug was approved by the Food and Drug Administration (FDA) to treat tiny parasites in people, the administration, state health departments and even the drug’s leading manufacturer, Merck, have all warned against using it for COVID-19. 

The FDA also warned that taking it in large doses can cause harmful side effects, such as vomiting, seizures and even death. However, Lorigo said his clients have not asked for those types of doses.

Nevertheless, other judges have refused to order hospitals to administer the drug. Hospitals have argued their standards of care will not allow doctors to give patients a drug not yet approved for COVID-19, adding that it could potentially cause harm, the AP reported.

Arthur Caplan, professor of bioethics at New York University’s Grossman School of Medicine, said he is also concerned that allowing laypeople and judges to overrule hospitals is a dangerous road.

“The way medicine works is, they are the experts, the doctors and ... the hospitals,” he said, according to the AP. “When you go there, you’re not going to a restaurant. You don’t order your own treatments.

“You can’t have a medical field that’s subjected to having to practice according to patient demand backed up by court orders," he added. "That is positively horrible medicine."

https://thehill.com/policy/healthcare/577066-dozens-of-lawsuits-seek-to-force-hospitals-to-treat-covid-19-with

States can reserve COVID-19 shots for younger kids next week

 U.S. health officials are setting the stage for a national COVID-19 vaccination campaign for younger children, inviting state officials to order doses before the shots are authorized.

Pfizer's coronavirus vaccine is currently being given to people as young as 12 in the U.S. In the next three weeks, federal officials plan to discuss making smaller-dose versions available to the nation's 28 million children between the ages of 5 and 11.

To help states and cities prepare, the Centers for Disease Control and Prevention this week sent out a seven-page document with guidance on how to set up expanded vaccination programs.

For example, it notes pharmacies in every state can give COVID-19 shots to children, but it clarifies that only doses prepared and packaged specifically for children are to be used for those under 12.

It doesn't speak to some thornier questions, however, such as how much school-based clinics should be relied on or whether kids should be required to get then shots as a condition of school attendance.

Those questions will have to be worked out in each state and city.

The guidance comes as communities are gearing up for a new phase in the 10-month-old effort to vaccinate as many people as possible against a virus that has killed more than 720,000 in the U.S.

The disease has been most dangerous to older adults, who have higher rates of death and hospitalization than children. But some kids are at risk for severe illness, and more than 540 U.S. children have died from COVID-19, according to the American Academy of Pediatrics.

Just as important, health officials believe that vaccinating children will reduce virus spread to vulnerable adults.

Pfizer and its German partner BioNTech are furthest along in researching use of their vaccine in younger children. They say a two-dose vaccine series—one-third as potent as the version giving to people over 12 years old—is safe and effective in 5- to 11-year-olds.

An independent expert panel that advises the Food and Drug Administration is scheduled to publicly debate the evidence at a meeting in late October. If the FDA authorizes the kid-size doses, a different expert panel advising the CDC would take up the matter in early November, and then offer a recommendation to the CDC.

It's not yet clear how many people will get shots for their younger kids right away, said Dr. Marcus Plescia, chief medical officer of the Association of State and Territorial Health Officials.

"We're going to have potentially a very busy, and perhaps modestly chaotic time" initially, he said.

But there probably will not be the kind of heavy demand seen when shots first became available for adults, he added.

The new CDC guidance calls for shots to be given at the offices of pediatricians and family-practice doctors, and at pharmacies, rural health clinics and federally-qualified health centers.

The CDC discussed the option of vaccination clinics at schools, but stopped short of endorsing that as a primary way to get kids vaccinated. School clinics are logistically appealing, but many parents may not be comfortable with the idea, Plescia said.

The guidance also warns health care providers to only use doses that have been prepared especially for kids, and not try to fraction adult doses, Plescia noted.

CDC guidance said immunization program managers can start ordering doses Wednesday, though vials wouldn't be delivered until the FDA and CDC sign off.

When the coronavirus vaccines were first authorized in December, the U.S. government prioritized having hospitals and pharmacies administer them. Some office-based physicians felt left out.

Dr. Jesse Hackell registered early with New York state to be able to administer the shots to teens. He said his office, located 25 miles north of New York City, didn't receive doses for that until May.

But Hackell said the CDC has reassured pediatricians that once authorization happens for 5- to-11-year-olds, the process will go more smoothly and pediatricians' offices will be able to get shipments quickly.

Dr. Richard Besser called on the government to do more to address racial and economic disparities that might emerge in the push to vaccinate younger kids.

For example, kids may not get shots if parents can't get time off from work to bring them in.

"It's really important that we recognize the barriers to vaccinations," said Besser, chief executive of the Robert Wood Johnson Foundation and former acting director of the CDC.

https://medicalxpress.com/news/2021-10-states-covid-shots-younger-kids.html

A new way to prevent COVID-related clots and a biomarker that spots highest risk

 No aspect of SARS-CoV-2 infection has been more startling—or problematic—than the elevated risk for blood clotting, a concern that throughout the pandemic has been associated with severe COVID-19, frequently characterized by clotting events that have led to stroke, heart attack and organ damage.

But a team of medical scientists from a dozen institutions throughout the United States has made two key treatment-altering findings: Patients with moderate disease can also develop life-threatening clots, and need to be identified early and treated. The same team of medical investigators has pinpointed the most effective way to address the clotting problem, a finding that may have ramifications worldwide in the treatment of COVID-19 and its impact on the blood.

Dr. Alex Spyropoulos, a professor at the Feinstein Institutes for Medical Research in Manhasset New York, found that moderately ill patients hospitalized after a COVID diagnosis and who had elevated blood levels of a protein known as d-dimer, were at especially high risk for dangerous clots. Spyropoulos, principal investigator of the study discovered along with his team, that treating these patients with a high-dose of the blood thinner called low-molecular weight heparin (LMWH) significantly reduced the potential for clot formation and death.

The medication is readily available worldwide and is a cost-effective way to prevent clots and spare lives, the research found.

The results are expected to be practice-changing, affecting the way clinicians identify and treat hospitalized COVID patients—potentially reversing the course of the disease and increasing survival.

Reporting in JAMA Internal Medicine, Spyropoulos and colleagues sound a powerful note of caution–and hope–from the clinical study titled the HEP-COVID trial: Just because patients are hospitalized with moderate COVID symptoms doesn't mean they're at lower risk of life-threatening COVID-related blood clots.

"The HEP-COVID trial was able to identify an exquisite biomarker—very elevated d-dimer—that not only predicted a high risk COVID-19 inpatient population, but those whose risk was ameliorated by early use of therapeutic heparin anticoagulation for thromboprophylaxis," Spyropoulos told Medical Xpress, referring to clot prevention.

D-dimer is a degradation product of fibrin, which is intimately involved in blood clotting. Fibrin is formed through the action of the protease thrombin on fibrinogen, which causes it to create a polymer. The polymerized fibrin combines with the tiny cells known as platelets and other cellular debris to form a clot.

As a breakdown product, d-dimer is a small protein fragment in the blood after a clot has undergone enzymatic attack through fibrinolysis, a process that attempts to prevent clots from growing. The dimer gets its name, meanwhile, because, chemically, it has two 'D' fragments of the fibrin protein. The amount of d-dimer present in the blood can be determined by a blood test to help diagnose clots.

Thrombosis refers to clot formation, obstructions that have been a pernicious cause of disability and death throughout the pandemic. For example, venous thromboembolism, or VTE, refers to clots that develop in a vein, such as in deep vein thrombosis. Pulmonary embolism refers to a clot that may travel to the lungs, and arterial thromboembolism, or ATE, describes clots that can cause ischemic stroke or myocardial infarction—heart attacks. All have been common among adults hospitalized because of COVID.

"The virus can directly damage the endothelium causing endothelialitis, an immune response within the endothelium in blood vessels, as well as the host response, which in susceptible individuals, is manifested by a hyperinflammatory response and cytokine storm, activating the clotting system as well as platelets," Spyropoulos said. Platelets are the tiny sticky disks that circulate in the blood and help the body form clots. They're a welcome population of cells when plugging a wound—but potentially lethal when coalescing with other factors in the blood to form clots.

The HEP-COVID randomized clinical trial recruited 253 hospitalized adult COVID patients with d-dimer levels more than four times the upper limit of normal. Patients also were recruited into the trial with a diagnosis of excessive clotting induced by sepsis. Patients were studied from May 8, 2020 through May 14, 2021 at 12 academic centers throughout the United States.

Major thromboembolism and death in patients was 28.7 percent for those given a therapeutic-dose of low-molecular-weight heparin, which again, is a high dose measuring four times the current standard of care. Major thromboembolism and death were 41.9 percent for patients receiving standard of care doses, or intermediate-dose heparins, the study found.

"The current standard has been [around] for the past 30 years or so in hospitalized medical patients—including those with pneumonia and sepsis," said Spyropoulos, who worked with an additional international team in an arm of the study reported in the journal Thrombosis Research.

The treatment benefit from low-molecular-weight-heparin therapy was not seen in patients who were critically ill requiring ICU care, a discovery during the research that Spyropoulos said can be understood within the context of the findings. "They were too far advanced in their hyperinflammatory/cytokine storm/coagulopathic state to see any treatment effects by simply increasing heparin dosing."

Regarding the data published in JAMA Internal Medicine, he noted that "HEP-COVID now presents compelling data that we should, in high-risk hospitalized patients with elevated d-dimers, use therapeutic doses of heparins to prevent clots. This is a major change in hospital guidelines."

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Explore further

High-dose of readily available blood thinner reduces risk of death for moderately ill COVID-19 patients

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More information: Alex C. Spyropoulos et al, Efficacy and Safety of Therapeutic-Dose Heparin vs Standard Prophylactic or Intermediate-Dose Heparins for Thromboprophylaxis in High-risk Hospitalized Patients With COVID-19The HEP-COVID Randomized Clinical Trial JAMA Internal Medicine (2021) DOI: 10.1001/jamainternmed.2021.6203

https://medicalxpress.com/news/2021-10-covid-related-clots-biomarker-highest.html

Immuno-oncology biotech IO Biotech files for a $100M IPO

 IO Biotech, a Phase 3-ready biotech developing immunotherapies for melanoma and other cancers, filed on Friday with the SEC to raise up to $100 million in an initial public offering.

IO Biotech is developing is targeting immunosuppresive mechanisms of cancer survival mediated by key immunosuppressive proteins Indoleamine 2,3-dehydrogenase (IDO) and programmed death ligand (PD-L1). The company's lead candidate, IO102-IO103, was granted Breakthrough Therapy Designation for the treatment of unresectable/metastatic melanoma and plans to enroll for a Phase 3 trial in combination with pembrolizumab. 

The Copenhagen, Denmark-based company was founded in 2014 and plans to list on the Nasdaq under the symbol IOBT. IO Biotech filed confidentially on June 3, 2021. Morgan Stanley, Jefferies, Cowen, and Kempen are the joint bookrunners on the deal. No pricing terms were disclosed.

Relevant Profile: IOBT

https://www.renaissancecapital.com/IPO-Center/News/87333/Immuno-oncology-biotech-IO-Biotech-files-for-a-$100-million-IPO

One coronavirus vaccine may protect against other coronaviruses

 Northwestern Medicine scientists have shown for the first time that coronavirus vaccines and prior coronavirus infections can provide broad immunity against other, similar coronaviruses. The findings build a rationale for universal coronavirus vaccines that could prove useful in the face of future epidemics.  

“Until our study, what hasn’t been clear is if you get exposed to one coronavirus, could you have cross-protection across other coronaviruses? And we showed that is the case,” said lead author Pablo Penaloza-MacMaster, assistant professor of microbiology-immunology at Northwestern University Feinberg School of Medicine.

The findings were recently published in the Journal of Clinical Investigation.

The three main families of coronaviruses that cause human disease are:

• Sarbecovirus, which includes the SARS-CoV-1 strain that was responsible for the 2003 outbreak of Severe Acute Respiratory Syndrome (SARS), as well as SARS-CoV-2, which is responsible for COVID-19
• Embecovirus, which includes OC43, which is often responsible for the common cold
• Merbecovirus, which is the virus responsible for Middle East Respiratory Syndrome (MERS), first reported in 2012.

Vaccines demonstrated cross-protective immunity 

Plasma from humans who had been vaccinated against SARS-CoV-2 produced antibodies that were cross-reactive (potentially providing protection) against SARS-CoV-1 and the common cold coronavirus (OC43), the study found. The study also found mice immunized with a SARS-CoV-1 vaccine developed in 2004 generated immune responses that protected them from intranasal exposure by SARS-CoV-2. Lastly, the study found prior coronavirus infections can protect against subsequent infections with other coronaviruses. 

Mice that had been immunized with COVID-19 vaccines and later were exposed to the common cold coronavirus (HCoV-OC43, which is different from a SARS strain) were partially protected against the common cold, but the protection was much less robust, the study found. The reason, the scientists explain, is because both SARS-CoV-1 and SARS-CoV-2 are genetically similar — like cousins of one another —while the common cold coronavirus is more divergent from SARS-CoV-2. 

“As long as the coronavirus is greater than 70% related, the mice were protected,” Penaloza-MacMaster said. “If they were exposed to a very different family of coronaviruses, the vaccines might confer less protection.”

Will there ever be 1 universal coronavirus vaccine? 

Given how different each coronavirus family is, that answer is “likely no,” said the study authors. But there may be a path forward for developing a vaccine for each coronavirus family (Sarbecovirus, Embecovirus and Merbecovirus), they said.  

“Our study helps us re-evaluate the concept of a universal coronavirus vaccine,” Penaloza-MacMaster said. “It’s likely there isn’t one, but we might end up with a generic vaccine for each of the main families of coronaviruses, for example a universal Sarbecovirus vaccine for SARS-CoV-1, SARS-CoV-2 and other SARS-related coronaviruses; or a universal Embecovirus for HCoV-OC43 and HKU1 that cause common colds.”

In the study, Penaloza-MacMaster collaborated with Northwestern Medicine physician Dr. Igor Koralnik, chief of neuro-infectious disease and global neurology at Feinberg, and Lavanya Visvabharathy, a postdoctoral research associate in neurological manifestations of COVID-19 at Feinberg, to evaluate immune responses in humans who received SARS-CoV-2 vaccines, as well as in COVID-19 patients admitted to Northwestern Memorial Hospital.  

“We found that these individuals developed antibody responses that neutralized a common cold coronavirus, HCoV-OC43,” Penaloza-MacMaster said. “We are now measuring how long this cross-protection lasts.”

Years of HIV research led the team to this discovery

Prior to the COVID-19 pandemic, Penaloza-MacMaster had studied HIV vaccines for a decade. His knowledge about how the HIV virus mutates led him to question cross-reactivity within coronavirus vaccines. 

“A reason we don’t have an effective HIV vaccine is because it’s hard to develop cross-reactive antibodies,” Penaloza-MacMaster said. “So, we thought, ‘What if we tackle the problem of coronavirus variability (which is critical for developing universal coronavirus vaccines) the same way we’re tackling HIV vaccine development?’”

First co-authors of the study are Tanushree Dangi and Nicole Palacio, both from Penaloza-MacMaster’s lab.

Funding for the study was provided by the National Institutes of Health (grant DP2 DA051912-01).

https://news.northwestern.edu/stories/2021/10/one-coronavirus-vaccine-may-protect-against-other-coronaviruses/

Walmart launches go-to-market solution for self-insured plans

 Through a partnership with Transcarent, Walmart is offering its savings on pharmaceuticals and other services to self-insured employers for the first time.

The collaboration, announced Oct. 15, offers Walmart's healthcare services to employers of all sizes. 

Walmart's offerings provide access to pharmacy, optical, telehealth, over-the-counter treatments, the Walmart health center and low-cost fresh food savings.

"We are committed to providing care to customers and the communities we serve through an integrated, omnichannel approach that improves engagement, health equity and outcomes," said Cheryl Pegus, MD, executive vice president of health and wellness at Walmart. "Most of America lives within 10 miles of a Walmart, which makes us uniquely positioned to deliver the right care at the right time in the right way. We are proud to bring our size and scale to make it simple to live healthier and leverage our collaboration with Transcarent to reach even more people where they live and work."

Offerings from Transcarent include no upfront or per-employee, per-month fees for employers, and providers are paid upfront for surgeries, according to the news release. 

Transcarent also will assist with onboarding employees with their newfound benefits and savings.

https://www.beckershospitalreview.com/payer-issues/walmart-launches-go-to-market-solution-for-self-insured-plans.html

U.S. will accept mixed doses of vaccines from international travelers

 The U.S. Centers for Disease Control and Prevention (CDC) said late on Friday that it will accept mixed-dose coronavirus vaccines from international travelers, a boost to travelers from Canada and other places.

The CDC said last week that https://www.reuters.com/world/us/us-will-accept-who-approved-covid-19-vaccines-international-visitors-2021-10-08 it would accept any vaccine authorized for use by U.S. regulators or the World Health Organization. "While CDC has not recommended mixing types of vaccine in a primary series, we recognize that this is increasingly common in other countries so should be accepted for the interpretation of vaccine records," a CDC spokeswoman said.

The White House said Friday the new vaccine requirements for foreign nationals traveling to the United States will begin Nov. 8 for visitors crossing at land borders as well as international air travelers.

Representative Brian Higgins, a New York Democrat representing a district along the Canadian border, had on Friday asked the CDC if it would accept the mixed vaccine doses noting "nearly four million Canadians, equivalent to 10% of their fully vaccinated population, have received mixed doses of the available mRNA COVID-19 vaccines – this includes the AstraZeneca vaccine."

The CDC said the vaccines approved by the Food and Drug Administration (FDA) for use, as well as those authorized by the WHO, will https://covid19.trackvaccines.org/agency/who be accepted for entry into the United States, including the AstraZeneca vaccine.

The CDC said "individuals who have any combination of two doses of an FDA approved/authorized or WHO emergency use listed COVID-19 two-dose series are considered fully vaccinated."

The CDC plans to answer other questions and release a contact tracing order for international air visitors by Oct. 25.

https://finance.yahoo.com/news/1-u-accept-mixed-doses-230226335.html