More Hospitals Sued Over Right to Try Ivermectin

 As hospitals continue to admit COVID-19 patients, some are contending with demands from family members to attempt to treat their loved ones with ivermectin.

Just last week, the CDC warned healthcare professionals to steer patients away from the drug. But that hasn't stopped the pressure on hospitals, and the outcomes of new legal cases to force hospitals to provide the drug to struggling, ventilated patients have been mixed.

In the case of Memorial Medical Center in Springfield, Illinois, a Sangamon County judge earlier this week ruled in favor of the hospital, the State Journal-Register reported.

Anita Clouse had sought to force Memorial Medical Center, part of Memorial Health System, to allow her husband, Randy Clouse, 61, to receive ivermectin, the State Journal-Register reported. Ralph Lorigo, a New York lawyer who represents Anita and has also taken on a bevy of other ivermectin cases, said in a court hearing that "she should have a right to try to save her husband."

However, Memorial Medical Center countered in court documents that Randy Clouse's condition was improving, and that he no longer had an active COVID infection, the State Journal-Register reported. The hospital further said that Clouse's physicians "believe administration of ivermectin will likely result in kidney and lung damage, which can lead to organ failure and death."

Randy and Anita Clouse were both unvaccinated and contracted COVID in July, the State Journal-Register reported. Anita had only mild symptoms, but Randy was admitted to the hospital shortly after he tested positive, and has since been placed on a ventilator and started on dialysis, the State Journal-Register reported, citing court documents.

Anita Clouse told the State Journal-Register that she and her husband knew about ivermectin before it was discussed by Fox News commentators because the couple bred German Shepherds and had given the drug to their dogs for parasites. She said that her husband previously told her he would want to receive the drug should he become sick with COVID.

Though the courts sided with the hospital in the Springfield case, a judge in Cincinnati, Ohio recently ruled in favor of a patient's family.

Last week, a Butler County judge ordered West Chester Hospital, part of the University of Cincinnati (UC Health) network, to provide Jeffrey Smith, 51, with ivermectin, the Ohio Capital Journal reported. In that case, Jeffrey's wife, Julie Smith, found ivermectin on her own and filed suit against the hospital. Julie is also represented by Lorigo.

The Ohio Capital Journal reported that court records show Jeffrey Smith contracted COVID in July, was subsequently admitted to the hospital, and placed on a ventilator at the beginning of August. It is not clear whether he was vaccinated.

Court records in the case against West Chester Hospital further show that Julie Smith reached out to Fred Wagshul, MD, who prescribed ivermectin to her husband before the hospital refused to provide it, according to the Ohio Capital Journal. Wagshul is listed in the suit as a founding physician of the Front Line Covid-19 Critical Care Alliance, which as MedPage Today previously reported, has long promoted ivermectin.

Though federal agencies have continued to warn against the use of ivermectin for the prevention and treatment of COVID as well as about its potentially deleterious side effects, proponents have pointed to purported success stories.

Earlier this year, in another case in Illinois, a DuPage County judge ordered Edward-Elmhurst Hospital to allow 68-year-old COVID patient Nurije Fype to receive ivermectin.

Chicago internist, Alan Bain, MD -- who administered ivermectin to Nurije Fype (and prescribed it to Randy Clouse, along with other COVID patients) -- testified at a court hearing this week that Fype was weaned off a ventilator and discharged from the hospital after receiving small amounts of the drug for 20 consecutive days, the State Journal-Register reported.

Nurije Fype's daughter, Desareta Fype, had learned of ivermectin after reading about its use in another COVID patient in the Buffalo News, the Chicago Tribune reported. That story detailed how, after a judge ordered Western New York's Millard Fillmore Suburban Hospital to give 80-year-old Judith Smentkiewicz ivermectin, her family and attorneys believed the drug saved her life.

It was not immediately clear, however, what direct effect ivermectin may have had on the hospital discharges of Nurije Fype or Judith Smentkiewicz. Physicians say these patients may have recovered on their own, without the drug.

The CDC reiterated in its warning to healthcare professionals last week that ivermectin is not authorized or approved by the FDA for the prevention or treatment of COVID. The agency added that the NIH has also determined there are currently insufficient data to recommend ivermectin for the treatment of COVID.

The CDC did say that there are ongoing clinical trials that might provide more information about these "hypothesized uses."

Lorigo did not immediately respond to a request for comment on the recent ivermectin cases in Illinois and Ohio. A spokesperson for Memorial Health System declined to comment, as did a spokesperson for UC Health.

https://www.medpagetoday.com/special-reports/exclusives/94325

Novavax COVID vaccine U.S. trial participants count as fully vaccinated 2 weeks after dosing - CDC

 Participants in Novavax Inc's late-stage COVID-19 vaccine trial can be considered fully vaccinated two weeks after completing their two-dose vaccine regimen, the U.S. Centers for Disease Control and Prevention said on Monday.

The CDC said the guidance does not imply an endorsement of the shot, which has not yet been authorized for use in the United States. Novavax expects to file for U.S. emergency use authorization in the fourth quarter of 2021.

The guidance offers clarity to participants in U.S. clinical vaccine trials at a time when more employers around the United States are mandating that staff get vaccinated against COVID-19.

https://news.yahoo.com/novavax-covid-19-vaccine-u-204253236.html

Common factors of COVID-19 cases and deaths among most affected 50 countries

 Md ManjurMorshedShowmitra KumarSarkar

DOI: https://doi.org/10.1016/j.dsx.2021.102247

PDF: https://www.sciencedirect.com/science/article/pii/S1871402121002678/pdfft?md5=1910bd7bc0421e885c9efd8202f9697e&pid=1-s2.0-S1871402121002678-main.pdf

Highlights

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The objective to explore the common factors of COVID-19 cases and deaths among the 50 most-affected countries.

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A total of 14 indicators are used to explain the COVID-19 cases and deaths.

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Ordinary least square statistics are used to find the significant factors affecting the number of cases and deaths.

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Obesity is found to be a common factor for the number of COVID-19 cases and consequent deaths.

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Our findings call for global awareness about obesity and investment in health infrastructure for a pandemic adaptive future.

Abstract

Aims

The Coronavirus (COVID-19) is a global pandemic requiring global responses. The objective of this paper is to identify the common factors of COVID-19 cases and deaths among the 50 most affected countries.

Methods

We performed Ordinary least squares among a wide range of socio-economic, environmental, climatic and health indicators to explain the number of cases and deaths.

Results

The findings are: (i) obesity is the only significant global denominator for the number of COVID-19 cases and deaths; (ii) the percentage of the population over the age of 65 and number of hospital beds per 1000 population inversely correlated to mortality from COVID-19.

Conclusions

Obesity increases vulnerability to COVID-19 infections and mortality. Global awareness of obesity and social investment in health infrastructure are pre-requisite for a pandemic adaptive future. However, the study is limited to cross-sectional data of April 17, 2020.

https://www.sciencedirect.com/science/article/pii/S1871402121002678

NYC Plan to Test Unvaccinated Students Lets Parents Opt Out, With No Consequences

 Some parents and educators are expressing alarm at New York City’s revised COVID-19 testing policy for public schools. Part of a series of protocols announced last week, the plan calls for randomly testing 10% of unvaccinated students and staff twice a month. That’s compared to last winter’s requirement that a random sample of 20% of students and staff had to be tested weekly.

But a loophole exists for parents of unvaccinated children. Unlike last year when students were told they would have to switch back to remote learning if they didn’t consent to testing via the city’s online portal, there will be no consequences for declining in the coming term. Some critics worry that the testing pool will be too limited to detect cases and catch outbreaks as they boil over.

Liz Rosenberg, a member of Parents for Responsive Equitable Safe Schools (PRESS NYC), said the city should be increasing testing, not reducing it. “It’s not responsive to the current risk levels due to community spread … and all the evidence that [the] delta [variant] is different,” she said.

The Centers for Disease Control and Prevention have recommended that unvaccinated students and staff get tested weekly, although the federal guidance affirms local school districts can decide the precise details about how to screen students. “More frequent testing can increase effectiveness, but feasibility of increased testing in schools needs to be considered,” the guidance says.

“We need to be testing as often as possible, especially in schools where the students are too young to be vaccinated,” said middle school math teacher Nina Kulkarni. All staff are required to have at least one dose of the vaccine by September 27th, but so far, there is no mandate for students. And only students over the age of 12 are eligible for the vaccines.

Mayor Bill de Blasio has said the city could scale up testing if necessary. “If we see in any school a need to do more, we can easily send more testing in, literally [on] the same day,” he said. “We always have that option.”

The mayor emphasized that testing is one part of a multi-prong approach to keep schools safe. The strategy includes one of the country’s strictest vaccine mandates for educators, and an ongoing push to inoculate eligible students and their families.

That’s on top of other measures such as ventilation upgrades and social distancing that kept the positivity rate inside schools very low last year. But questions are emerging about the city’s ventilation standards as some don’t fit CDC guidelines, and several hundred classrooms are still under repairs. Some principals are worried they may not be able to keep all students three feet apart. But de Blasio is optimistic: “We're really confident here about the ability to keep kids safe.”

Denis Nash, a professor of epidemiology at the City University of New York, said regular COVID testing in schools could serve two purposes: to more quickly identify cases and limit the amount of time children who are infected are in the classroom; and to gauge whether other mitigation strategies — such as masking, distancing, ventilation — are working to prevent outbreaks.

Nash believes the city’s plan will not adequately prevent students with COVID-19 from entering classrooms, nor will it effectively reduce the exposure time created by infected kids in classrooms. For that, a school system must test everyone more often. It would offer critical data about how well safety measures are working, too.

“It's going to tell you, okay, our mitigation strategies that we have in place are doing what we hope they would do in terms of limiting the potential of spread within the walls of the school,” he said. “A 10% sample, if the sampling strategy is well designed, could yield very useful information to achieve that goal.”

However, Nash reiterated that testing should happen at least weekly. “Every two weeks is a mistake,” he said. “Delta is too fast to be doing every other week.” He said he hopes officials consider increasing the frequency of testing. In Los Angeles, both unvaccinated and vaccinated students and staff will be tested weekly.

He added that “ideally” students would not be allowed to opt out because that could skew the information gained from testing. He recommends either requiring the testing of all students, or if that is not possible, carefully tracking the numbers of students opting out in any week, including their school, neighborhood and age, to help better understand the trends.

At a New York City Council oversight hearing on Wednesday, New York City Health Commissioner Dr. Dave Chokshi said the city is prepared to expand testing if necessary, either targeting resources at a given school or increasing the frequency of tests more broadly. In addition to the 10% screening, he said there would also be diagnostic tests available to anyone who is symptomatic.

“We should think about [the current testing policy] as a floor rather than a ceiling,” Chokshi said. “This is an area where we will continue to follow the science and the data, and if there are adjustments that need to be made as time goes on, of course, we will make them.”

A spokesperson for the principals’ union, the Council of School Supervisors and Administrators (CSA), said leaders also have logistical concerns, including how to respond to positive tests in their community.

“Though a smaller percentage of students will be tested less frequently, testing will be more complicated because the city must determine who is unvaccinated and who has given consent at every school,” the spokesperson said. “Most importantly, the city must decide what actions to take if testing reveals an uptick in cases within a school community.”

Unlike the testing plan, the city’s quarantine policy is stricter than the CDC recommendations. The federal health agency advises all students in a classroom do not have to be quarantined if they are masked and socially distanced.

City officials announced last week that, when there’s exposure in a classroom, unvaccinated students will have to quarantine, but they did not give a specific threshold for when whole buildings have to shut down, saying decisions will be made on a “case by case basis.”

With less than two weeks until the nation’s largest school system opens its doors, COVID cases among children and teenagers are rising. Data from the city now show teenagers ages 13-17 have a positivity rate of 5.38%, as of the week ending August 21st. Children 5-12, who are too young to be vaccinated, have a positivity rate of 4.78%. The citywide average among all ages is 3.74%. Children 5-17 are also averaging 150 infections per 100,000 kids, a case rate that’s higher than those for everyone older than 45.

Nash said, based on last year’s experience, there’s “good reason to think that solid masking and ventilation plus vaccine coverage among many, many other people might be enough.” But he said the delta variant presents a “question mark.”

https://gothamist.com/news/nycs-plan-for-testing-unvaccinated-students-allows-parents-to-opt-outwith-no-consequences

Requiring customers to be vaccinated can draw $5,000 fines starting soon in Florida

 Florida businesses and governments that require proof of COVID-19 vaccination from customers or members of the public will soon face $5,000 fines, according to a new Department of Health rule.

Earlier this year, the Republican-led Florida Legislature passed a bill, SB 2006, banning businesses, governments and schools from requiring “vaccine passports” — essentially proof that people seeking their services have gotten a COVID-19 vaccine. In May, Gov. Ron DeSantis signed that bill into law. The legislation allowed the state’s Department of Health to issue fines “not to exceed $5,000 per violation.”

On Aug. 27, the department filed a rule that lays out how it will enforce the measure. Businesses, governments and schools will be fined $5,000 “per individual and separate violation,” the rule states. That’s the maximum penalty allowed by law.

Violators will be issued a notice of their infraction, and they’ll have a chance to appeal their fines, the rule says. Once a fine is finalized, entities will have 30 days to pay it.

The rule will go into effect Sept. 16.

The course of the pandemic has changed considerably since DeSantis signed the bill banning vaccine passports. The delta variant has proven more transmissible and harder to combat than past iterations of COVID-19. Thousands of Floridians — the vast majority of whom were unvaccinated — have become seriously ill from the virus this summer. The state is not finished counting its dead, but the surge looks to be the worst on record.

However, available vaccines have held up well against delta. And last month, the federal Food and Drug Administration fully approved the Pfizer-BioNTech coronavirus shot. For months, Pfizer’s shot had been allowed under the agency’s emergency use authorization. Although Florida requires a variety of vaccinations for schoolchildren, coronavirus vaccination requirements for students are illegal.

Under SB 2006, businesses and governments are allowed to mandate vaccinations for employees, but DeSantis has said he does not support such requirements. In hospitals and nursing homes, where protection against the virus is perhaps most critical, DeSantis has argued that vaccine mandates would exacerbate existing staffing shortages.

Although several countries have implemented “vaccine passport” programs to encourage people to get shots, DeSantis has argued they are a violation of personal freedom. Before he signed SB 2006 into law, DeSantis also issued an executive order banning mandatory vaccinations at businesses.

Florida currently ranks 19th of the 50 states in vaccination rate, according to the Centers for Disease Control and Prevention. The state reported last week that 68% of eligible residents have gotten at least one shot.

It’s unclear how many businesses have already been cited under the new vaccine passport law. A spokesperson for the Department of Health did not immediately respond to a request for information.

But there is evidence that some businesses are working around the statute. For example, the concert promoter Live Nation has announced it will mandate proof of vaccination or a negative test to customers hoping to attend one of its concerts starting Oct. 4.

DeSantis spokesperson Christina Pushaw said this practice would not violate the law, because Live Nation is allowed to deny a customer entry if they fail to produce a negative test result.

The DeSantis administration is currently fighting Norwegian Cruise Line over the law in federal court. The cruise line won a favorable ruling from U.S. District Judge Kathleen Williams last month, but DeSantis is appealing.

The Bahamian government also said last month it would only allow ships full of vaccinated passengers into its ports, further complicating Florida’s ban on vaccination mandates. Since those rules were announced, Disney and Carnival have also mandated vaccination for travelers on cruises to the Bahamas. That country’s rules apply to passengers aged 12 and older.

The new rule spurred criticism from Democrats, including one of DeSantis’ challengers in next year’s governor’s race, Agriculture Commissioner Nikki Fried.

“This not only goes against common sense — it’s also an insult to the free-market principles he claims to champion,” Fried said in a statement. “He [DeSantis] has made it abundantly clear that he’s more interested in getting revenge against Floridians who are trying to do the right thing than he is in stopping the spread of COVID or supporting our local businesses.”

https://www.miamiherald.com/news/coronavirus/article253922128.html

Worried about Covid, most parents no longer want kids in school full time: survey

 Parents aren’t just anxious about sending their children back to school as the delta variant rages.

They’re so worried about their kids’ health and the safety of their communities that many parents — especially Black and Hispanic parents — now say they’d rather keep them home learning remotely, at least part time, new research finds.

“It’s not just that parents aren’t OK,” said Adam Burns, a partner at Edge Research, who led the nationwide parent survey released Wednesday from the National Parent Teacher Association.

“They’ve been not-OK for about 18 months.”

Many parents believed in the spring that the worst of the Covid-19 pandemic was behind them, hoping that widely available vaccines would mean no longer having to contend with the technical glitches, academic struggles and emotional challenges of online instruction.

Then, on July 27, the Centers for Disease Control and Prevention updated its health guidance in response to the more contagious delta variant, urging vaccinated people to resume precautions such as wearing masks.

For parents, the news about the delta variant was “another hit to the gut,” Burns said.

The survey, which was funded by the CDC through the Atlanta-based nonprofit CDC Foundation and polled a sample of 1,448 public school parents and guardians from July 23 to Aug. 8, captured the spike in their concerns after the CDC updated its guidance.

Before July 27, 58 percent of those surveyed said they wanted their children in a classroom full time this year.

Afterward, that figure dropped to 43 percent.

“It’s a huge concern,” said Kizzy Dogan, a mother in Washington, D.C., whose 12-year-old twin sons struggled with online classes last year.

“Even though I’m like, ‘Oh, my God, yes, take them back to the building to get them out the house,’ in all actuality, it is a fear,” she said, noting that last week, just days before her sons were due to start in-person classes, she was informed that someone who had been in the school had tested positive for Covid. Her sons’ school is only offering an online option to children with medical needs, so her boys aren't eligible.

Black parents like Dogan were less likely to want their children to be in a classroom, with just 41 percent saying after July 27 that they wanted a full-time in-person program, the survey found. For Hispanic parents, that figure fell to 37 percent.

Black and Hispanic parents expressed a preference for online programs despite the fact that they’re more likely to have essential worker jobs that can’t be done remotely and are more likely to rely on in-person school so they can work, said Chris Mathias, a senior affiliate at HCM Strategists, who interviewed parents in focus groups as part of the survey.

Many Black and Hispanic parents did not have a great experience with online instruction last year and were more likely to experience internet or connection issues.

Yet in the survey and focus groups, they were more likely to say students and parents need to sacrifice in-person instruction to keep their families and communities safe.

They’re “begrudgingly going back to school and really don’t want to be,” Mathias said. “They wish there were more online options — quality online options.”

‘On a roller coaster’

Parents’ increasing demand for remote instruction has triggered a scramble among school districts.

At the end of July, just 41 of the nation's 100 largest school districts were planning to offer a remote learning option in the new academic year, according to the University of Washington’s Center on Reinventing Public Education, which tracks school Covid responses.

By this week, that figure had more than doubled to 92 districts, though only 56 of them were making online programs available to all students.

“We heard from parents loud and clear,” said Michael Hinojosa, superintendent of the Dallas Independent School District, which launched a temporary virtual academy Aug. 24 for students younger than 12, who are not yet eligible for the Covid vaccine.

In the weeks since Dallas and many other districts in the South began the school year in early August, Covid rates and deaths have spiked across the country. Many schools that started the school year last month have been forced to close down or quarantine large numbers of students and teachers.

“It’s like we’re on a roller coaster,” Hinojosa said. “Just when we thought we might have some normalcy this year, everybody was excited about back-to-school, and it all changed. It pivoted on a dime.”

The politics around Covid safety measures have only made things more difficult. Protesters have swarmed school boards and health departments around the country, waging increasingly nasty battles over mask and vaccine mandates.

The tension has undermined parents’ confidence in school safety — and in one another.

The National PTA and the CDC Foundation survey found that a majority of parents — 75 percent — consider mask use by all students, teachers and staff, regardless of their vaccination status, to be the most important or a very important measure that schools can take to reduce health risks, but many schools are not mandating masks.

Some states have barred mask mandates. Others have prohibited online instruction.

The survey also found that 1 in 4 parents — disproportionately men, people with high incomes and people whose children are vaccinated — said they would definitely or probably send their children to school with mild cold symptoms that could be Covid-19.

In Texas, Dallas is among districts fighting to continue requiring masks despite an order from Gov. Greg Abbott, a Republican, barring these mandates.

The Dallas district also made the decision to offer the virtual program despite the fact that Texas currently won't fund it. Nearly 2,000 students have opted in so far, which will cost the district $20 million, Hinojosa said; if more make that choice, the cost will rise.

It’s worth the expense, he said. Though he believes most students need the attention from teachers that comes from in-person instruction, he didn’t want parents to keep their children out of school altogether.

“Our kids have really fallen far behind, but we’d rather have them here than not have them at all,” he said.

‘It’s starting all over again’

Parents have been making impossible choices since the pandemic began, weighing health concerns against children’s academic and emotional needs.

But the whiplash of these last few weeks has been particularly difficult, said Liz Parlett-Butcher, a mother of four from Egg Harbor Township, New Jersey, who participated in one of the parent focus groups.

“It’s like ‘Groundhog Day,’” she said. “You feel like you’re waking up and it’s starting all over again.”

She’s counting on him being able to go back to school full time but worries the virus will shutter school again.

“I see some signs on the wall and I’m fearful,” she said.

Another parent, Mary Cotofan, a mother of two from North Olmsted, Ohio, wishes her district offered an online option.

She worries that her children, who at 8 and 11 are too young to be vaccinated, could get sick and come down with “long haul” Covid symptoms. She also worries they could infect her father or prevent her from seeing him regularly.

“I feel like we’re entering a much riskier time in terms of kids than we have the whole pandemic,” she said. “And we’re just sending them all back in together and hoping for the best.”

https://www.nbcnews.com/news/education/worried-about-covid-most-parents-no-longer-want-kids-school-n1278128

English study finds long COVID affects up to 1 in 7 children months after infection

 As many as 1 in 7 children may have symptoms linked to the coronavirus months after testing positive for COVID-19, the authors of an English study on long COVID in adolescents said on Wednesday.

Children rarely become severely ill with COVID-19 but they can suffer lingering symptoms, and the study is one of the largest of its kind on how common so-called long COVID is in the age group.

The study, led by University College London and Public Health England, found that 11- to 17-year-olds who tested positive for the virus were twice as likely to report three or more symptoms 15 weeks later than those who had tested negative.

Researchers surveyed 3,065 11- to 17-year-olds in England who had positive results in a PCR test between January and March, and a control group of 3,739 11- to 17-year-olds who tested negative over the same period.

Among those who tested positive, 14% reported three or more symptoms such as unusual tiredness or headaches 15 weeks later, compared with 7% reporting symptoms by that time among the control group.

The researchers said that while the findings suggested as many as 32,000 teenagers might have had multiple symptoms linked to COVID-19 after 15 weeks, the prevalence of long COVID in the age group was lower than some had feared last year.

“Overall, it’s better than people would’ve guessed back in December,” Professor Terence Stephenson of the UCL Great Ormond Street Institute of Child Health, told reporters.

The findings were a pre-print which had not been peer-reviewed. The authors said that any decision to extend vaccination to 12- to 15-year-olds in Britain was unlikely to be based on this study as there was not enough data on whether vaccination protects against long COVID.

“We are getting increasing evidence on the safety of the vaccine in the 12- to 15-year-olds and that’s more likely to be taken into consideration,” Liz Whittaker, a paediatrician at Imperial College London, told reporters.

https://kfgo.com/2021/09/01/english-study-finds-long-covid-affects-up-to-1-in-7-children-months-after-infection/