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Tuesday, November 2, 2021

COVID-19 still rages, but some U.S. states reject federal funds to help

 As the resurgent COVID-19 pandemic burns through the rural U.S. state of Idaho, health officials say they don’t have enough tests to track the disease’s spread or sufficient medical workers to help the sick.

It’s not for want of funding.

The state’s Republican-led legislature this year voted down $40 million in federal aid available for COVID-19 testing in schools. Another $1.8 billion in pandemic-related federal assistance is sitting idle in the state treasury, waiting for lawmakers to deploy it.

Some Idaho legislators have accused Washington of overreach and reckless spending. Others see testing as disruptive and unnecessary, particularly in schools, since relatively few children have died from the disease.

"If you want your kids in school, you can't be testing," said state Representative Ben Adams, a Republican who represents Nampa, a city of about 100,000 people in southwestern Idaho.

Meanwhile, the state is reporting the fifth-highest infection rate in the United States, at 369 confirmed cases per 100,000 people, according to the U.S. Centers for Disease Control and Prevention.

Schools in at least 14 of Idaho's 115 districts, including Nampa, have had to close temporarily due to COVID-19 outbreaks since the start of the year, according to Burbio, a digital platform that tracks U.S. school activity.

Idaho's experience illustrates how political ideology and polarization around the COVID-19 epidemic have played a role in the decision of mostly conservative states to reject some federal funding meant to help locals officials battle the virus and its economic fallout.

For example, Idaho was one of 26 Republican-led states that ended enhanced federally funded unemployment benefits before they were due to expire in September. Gov. Brad Little claimed that money was discouraging the jobless from returning to work. At least six studies have found that the extra benefits have had little to no impact on the U.S. labor market.

Idaho has also rebuffed $6 million for early-childhood education, as some Republicans in the state said mothers should be the primary caretakers of their children.

The state also did not apply for $6 million that would have bolstered two safety-net programs that aid mothers of young children and working families. Little's administration said it had enough money already for those programs.

Idaho has accepted some federal COVID-19 help. In fact, the rejected funds are just a small portion of the nearly $2 billion in federal relief Idaho has spent since March 2020 to fight the virus and shore up businesses and families, state figures show.

But hundreds of millions more remain untouched. Idaho has deployed just $780 million, or 30%, of the $2.6 billion it received under the federal American Rescue Plan Act, signed into law in March.

Neighboring Washington state, by contrast, has parceled out nearly three-quarters of the $7.8 billion it received under that legislation. Washington has recorded roughly 60% as many cases per capita as Idaho since the start of the pandemic, according to the U.S. Centers for Disease Control and Prevention.

Some in Idaho are exasperated that a state of just 1.8 million people would turn down a dime of assistance when it’s struggling to tame the pandemic.

With no testing in place, nurses in Nampa schools rely mainly on parents to let them know when a child is infected, the district's top nurse, Rebekah Burley, told the school board in September. She said she needed three or four more staffers to track existing cases and attempt to keep people quarantined.

"We're tired, we are stressed, and something needs to change," she said.

REJECTING FEDERAL MONEY

The refusal by red states to accept some types of federal aid that would benefit their constituents isn't new.

For example, a dozen Republican-controlled states have rejected billions of dollars available through the landmark 2010 Affordable Health Care Act to cover more people under the Medicaid health program for the poor, which is jointly funded by the federal government and the states. Lawmakers from these places contended their states couldn’t afford to pay their share of an expansion. (Idaho initially was among them, but its voters opted in to the Medicaid expansion through a 2018 ballot referendum, bypassing state leaders.)

That same dynamic has played out during the coronavirus crisis. Since March 2020, Congress has approved six aid packages totaling $4.7 trillion under Republican and Democratic administrations, including the bipartisan CARES Act in March 2020 and the Democratic-backed American Rescue Plan Act this year.

Florida and Mississippi didn't apply for benefits that would give more money to low-income mothers of young children. Four states, including Idaho, North Dakota and Oklahoma, opted not to extend a program that provided grocery money to low-income families with school-age kids in summer months.

Iowa, like Idaho, turned down federal money for COVID-19 testing in schools. New Hampshire rejected money for vaccinations.

Republican lawmakers in Idaho, like those elsewhere, cite concerns about local control, restrictive terms attached to some of the aid, and the skyrocketing national debt.

"We are chaining future generations to a lifetime of financial slavery," said Adams, the Idaho legislator.

Yet even before the pandemic, Idaho long relied on Washington for much of its budget. Federal funds account for 36% of state spending in Idaho, according to the National Association of State Budget Officers, above the national average of 32%.

State officials say they have enough money to handle the COVID-19 crisis for now.

Critics say Idaho's reluctance to use more federal aid is a symptom of its hands-off approach to COVID-19 safety. Few public schools require masks, and local leaders have refused to impose mask mandates, limits on indoor gatherings and other steps to contain the virus.

"There's a lot of people in our legislature and some local officials who really have not taken this seriously," said David Pate, the former head of St. Luke's Health System, the state's largest hospital network.

Idaho has one of the lowest vaccination rates in the nation, with only 55% of adults and teens fully immunized, compared to 67% nationally.

HOSPITALS FULL

COVID-19 is pummeling Idaho even as cases have plunged in much of the nation. Intensive-care units statewide are full, forcing hospitals to turn away non-COVID patients. At least 627 residents died of the disease in October, well above the previous monthly death toll of last winter, records show.

Idaho received $18 million through the American Rescue Plan to hire more public-health workers, but lawmakers did nothing with that money this year.

Some local public health departments say they do not have enough staff to track the virus. "We have a lot of people doing two or three jobs right now," said Brianna Bodily, a spokesperson for the public-health agency serving Twin Falls, a southern Idaho city of 50,000. The department is working with a 12% smaller budget than last year.

Such staff shortages have contributed to a backlog of test results statewide, which the Idaho Department of Health and Welfare says is hurting its ability to provide an up-to-date picture of the disease's prevalence.

With funding bottled up in the state capitol, Little, the governor, announced in August that he would steer $30 million from a previous round of COVID-19 aid to school testing.

The Nampa school district has requested some of that money but has yet to set up a testing program, spokeswoman Kathleen Tucker said. Roughly 80% of the district's students were not attending class regularly in the first weeks of the school year due to outbreaks, according to superintendent Paula Kellerer.

Nampa resident Jaci Johnson, a mother of two children, ages 10 and 13, said she and other parents have been torn over whether to send their children to class, due to the potential risk.

"Do we feed our kids to the lions, or do we keep them home and make them miserable?" Johnson said.

https://www.reuters.com/world/us/covid-19-still-rages-some-us-states-reject-federal-funds-help-2021-11-02/

U.S. worker rebellion swells over vaccine mandates

 In Wichita, Kansas, nearly half of the roughly 10,000 employees at aircraft companies Textron Inc and Spirit AeroSystems remain unvaccinated against COVID-19, risking their jobs in defiance of a federal mandate, according to a union official.

"We're going to lose a lot of employees over this," said Cornell Adams, head of the local Machinists union district. Many workers did not object to the vaccines as such, he said, but were staunchly opposed to what they see as government meddling in personal health decisions.

The union district has hired a Texas-based lawyer to assist employees and prepare potential lawsuits against the companies should requests for medical or religious exemptions to vaccination be denied.

A life-long Democrat, Adams said he would no longer vote for the party. "They'll never get another vote from me and I'm telling the workers here the same thing."

The clock is ticking for companies that want to continue gaining federal contracts under an executive order by Democratic President Joe Biden, which requires all contractor employees be fully vaccinated against COVID-19 by Dec. 8.

That means federal contract workers need to have received their last COVID-19 shot at least two weeks before the deadline to gain maximum protection, according to U.S. government guidance.

With a three-week gap between shots of the Pfizer /BioNTech vaccine, workers must get the first jab by Wednesday. If the government holds fast to its deadline, it is already too late to choose Moderna's vaccine, which is given in two doses four weeks apart. Workers could opt to get Johnson & Johnson's single-shot vaccine until Nov. 24 to meet the deadline.

The mandate has stirred protests from workers in industries across the country, as well as from Republican state officials.

Opposition to the mandate could potentially lead to thousands of U.S. workers losing their jobs and imperil an already sluggish economic recovery, union leaders, workers and company executives said.

More legal clashes are likely over how companies decide requests for vaccination exemptions.

For the companies, time is getting tight, though the Biden administration has signaled federal contractors will not have to immediately lay off unvaccinated workers who miss the Dec. 8 deadline.

Under government guidance https://www.saferfederalworkforce.gov/faq/contractors published on Monday, companies will have flexibility over how to implement the mandate, which may allow them to avoid mass firings.

"A covered contractor should determine the appropriate means of enforcement with respect to its employee," the guidance said.

For Boeing Co in the United States, more than 7,000 workers have applied for religious exemptions and around 1,000 are seeking medical exemptions, people familiar with the matter told Reuters. That amounts to some 6% of the planemaker's roughly 125,000 U.S employees.

'ILLEGAL, IMMORAL AND IMPRACTICAL'

At a rally last week outside Boeing property in Auburn, south of Seattle, many of the three dozen workers gathered in driving rain said they would rather be escorted off Boeing property on Dec. 8 than take a vaccine. Others said they would pursue early retirement.

"The mandate is illegal, immoral and impractical," said one veteran Boeing program analyst who attended the rally. "We are standing together against a company and government trampling on our rights."

Many legal experts have said vaccine mandates in the interest of public health are legal.

The rebellion has put Boeing executives in a bind. The company could lose skilled staff, but must comply with a presidential order.

A Boeing spokesperson said the company was committed to maintaining a safe working environment for its employees.

The order's provision for religious and medical exemptions is causing more tension.

Two Textron workers who requested religious exemptions told Reuters the company's human resources representatives quizzed them on the name of their church leaders and asked detailed questions about their faith.

Textron declined to respond to questions, but in a statement said it was obligated to comply with Biden's order and was taking steps to do so.

"Employees who are unable to receive the COVID-19 vaccination due to a medical condition or sincerely held religious belief are being provided an opportunity to request an accommodation from this requirement," Textron said.

Spirit AeroSystems did not respond to a request for comment.

Raytheon Technologies' CEO Greg Hayes last week warned the U.S. defense firm will lose "several thousand" employees because of the mandate.

A group representing FedEx Corp, United Parcel Service Inc and other cargo carriers said it would be virtually impossible to have all their workforces vaccinated by the deadline.

Some companies have imposed vaccine mandates even absent immediate government regulation.

Mercedes-Benz USA, the U.S. unit of German carmaker Daimler AG which is not a U.S. government contractor, told employees in an October email seen by Reuters that proof of vaccination against COVID-19 would become a condition of employment beginning Jan. 4.

The carmaker said it implemented the move in anticipation of a separate U.S. government vaccine mandate that would apply to businesses with at least 100 employees, affecting some 80 million workers nationwide.

Less than half of the company's workers at U.S. import processing centers are vaccinated and many refuse to get a shot, according to a source familiar with the matter.

Mercedes USA in a statement said it had given employees 90-day notice to fulfill the requirement, adding that two thirds of its U.S. employees - not including factory workers in Alabama - have provided proof of vaccination to date.

"We expect that the vast majority of our employees will provide proof of vaccination before the deadline," the company said.

https://www.dailymail.co.uk/wires/reuters/article-10156227/From-Boeing-Mercedes-U-S-worker-rebellion-swells-vaccine-mandates.html

BioNTech to Present New Clinical Data from First-in-Class CAR-T Program

 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company"), a next generation immunotherapy company pioneering novel therapies for cancer and infectious diseases, today announced that new clinical data from the first-in-human Phase 1/2 trial evaluating the Company's novel CAR-T cell therapy candidate, BNT211, will be presented in an oral presentation. The presentation is scheduled for the late-breaking abstract poster session at the 36(th) Annual Meeting of the Society for Immunotherapy of Cancer (SITC), being held both in person and virtually from November 10 - 14, 2021.

"Our goal is to leverage our understanding of immunology and tumor biology together with our advanced technologies to provide cancer patients with novel treatments," said Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. "Claudin-6 is a new target that we believe is well-suited for CAR-T therapy and presents a differentiated avenue for the treatment of solid tumors. We appreciate the opportunity to present initial data from our first-in-human study of the CAR-T product candidate to leading immuno-oncology experts in this prestigious late-breaking forum, which further underline the potential of our technology."

BNT211 is an autologous CAR-T cell therapy targeting the oncofetal antigen Claudin 6 (CLDN6) and the first CAR-T product candidate in the Company's clinical development. BNT211 is currently being investigated as a monotherapy and in combination with a CLDN6-encoding mRNA-based vaccine (CARVac) in a first-in-human Phase 1/2 clinical trial

For more information, please visit https://www.globenewswire.com/Tracker?data=mPha8Ludm7WWUzo93omVJFw3-C9oJIc9SAjfIcyUdW_6LKSt2XqWNUoQOOPN0siuoAhkKZX9NM2plQLRW19Drw== www.BioNTech.de

https://www.marketscreener.com/quote/stock/BIONTECH-SE-66771992/news/Press-Release-BioNTech-to-Present-New-Clinical-Data-from-First-in-Class-CAR-T-Program-BNT211-in-La-36856352/

Fresenius Medical Care cuts jobs as Delta variant takes toll

 

German dialysis specialist Fresenius Medical Care (FMC) plans to cut costs and up to 5,000 jobs globally - or about 4% of its workforce - as the Delta variant caused another spike in coronavirus-related patient deaths in the third quarter.

FMC had expected the death toll among dialysis patients, who are more susceptible to the virus, to normalise during the second half of the year, but said on Tuesday it now saw a decline in the mortality rate only in the fourth quarter.

"The existence of the Delta variant has caused excess mortality among our patients to rise again in the third quarter," Chief Executive Rice Powell said.

"This means that we must absorb a sizeably larger COVID-19 effect on our business than we projected at the beginning of the year."

The world's largest provider of dialysis treatments aims to reach annual cost cuts of 500 million euros ($580 million) by 2025, as it plans to replace its four regions and some global functions with two divisions: care enablement and care delivery.

Fresenius group, FMC's parent company, had previously announced plans to cut spending by 100 million euros a year in 2021-2025.

FMC maintained its forecast for net income to decline by a high-teens to mid-twenties percentage and sales growth in the low- to mid-single-digits, but warned the numbers would come in the lower end of the ranges.

Fresenius group firmed up its 2021 net income forecast after reporting quarterly results slightly above expectations.

JP Morgan analysts said Fresenius reported "a solid set of results" that should drive the shares today. "However, our concern on outer-year forecasts for FMC leaves us cautious on how much the shares can progress from here."

https://www.marketscreener.com/quote/stock/FRESENIUS-MEDICAL-CARE-AG-436087/news/Fresenius-Medical-Care-cuts-jobs-as-Delta-variant-takes-toll-36863172/

Lilly to supply additional bamlanivimab and etesevimab to U.S. for Covid treatment, post-exposure prevention

  Eli Lilly and Company (NYSE: LLY) today announced an additional purchase by the U.S. government for bamlanivimab with etesevimab for administration together. This neutralizing antibody therapy is authorized for emergency use for the treatment of mild to moderate COVID-19 or for post-exposure prophylaxis of COVID-19 in certain individuals. As part of the agreement, Lilly will supply 614,000 doses of bamlanivimab with etesevimab no later than January 31, 2022 for a total of $1.29 billion. A minimum of 400,000 doses will be supplied no later than December 31, 2021.

The estimated impact of the new purchase to the 2021 guidance provided in Lilly's earnings release dated October 26, 2021 is $840 million of additional revenue and approximately 25 cents of additional earnings per share. The expected impact in 2022 will be reflected in the company's financial guidance to be provided in December 2021. 

http://kokomoperspective.com/politics/indiana/lilly-to-supply-614-000-additional-doses-of-bamlanivimab-and-etesevimab-to-the-u-s/article_789b1213-a2bf-5889-a045-49abc5ac195b.html

Pfizer raises Covid vaccine sales forecast to $36 billion for 2021

 

  • Pfizer on Tuesday raised the full-year sales forecast for its Covid-19 vaccine by 7.5% to $36 billion, as it signs deals with countries for booster doses and receives clearances for using its shots in children.
  • The company said it is also on track to deliver 2.3 billion doses of the vaccine, out of the roughly 3 billion it plans to make this year.
  • The vaccine brought in sales of $13 billion in the third quarter. Analysts had expected $10.88 billion on average, according to seven analysts polled by Refinitiv.
  • Pfizer on Tuesday raised the full-year sales forecast for its Covid-19 vaccine by 7.5% to $36 billion, as it signs deals with countries for booster doses and receives clearances for using its shots in children.

    The company said it is also on track to deliver 2.3 billion doses of the vaccine, out of the roughly 3 billion it plans to make this year.

    Driven by an unprecedented vaccination drive against the Covid-19 pandemic globally, Pfizer’s shot has quickly become one of the best-selling products in the company’s roughly 172-year history. The company equally splits expenses and profit from the vaccine with its German partner BioNTech.

    Other rivals such as Moderna and Johnson & Johnson have faced production snags, helping Pfizer extend its lead in signing supply deals with countries.

    Pfizer is also rolling out booster doses of the vaccine, while waiting for the outcome of a U.S. regulatory meeting later in the day on using its shots in children aged five to 11.

    The vaccine brought in sales of $13 billion in the third quarter. Analysts had expected $10.88 billion on average, according to seven analysts polled by Refinitiv.

  • https://www.cnbc.com/2021/11/02/pfizer-raises-covid-vaccine-sales-forecast-to-36-billion-.html

California judge delivers drugmakers 1st trial win in opioid litigation

 A California judge on Monday said he would rule against several large counties that accused four drugmakers of fueling the U.S. opioid epidemic, saying they failed during a trial to prove their $50 billion case.

Orange County Superior Court Judge Peter Wilson issued a tentative ruling finding Johnson & Johnson (JNJ.N), Teva Pharmaceutical Industries Ltd (TEVA.TA), Endo International PLC (ENDP.O) and AbbVie Inc's (ABBV.N) Allergan unit not liable.

It marked the first trial win for any drug companies in the more than 3,300 lawsuits filed by states and local governments over a drug abuse crisis that the U.S. government says led to nearly 500,000 opioid overdose deaths over two decades

The ruling came as J&J and the three largest U.S. drug distributors - McKesson Corp, Cardinal Health Inc and AmersourceBergen -- work to finalize a proposed deal to pay up to $26 billion to settle the thousands of cases against them.

A bankruptcy judge in August approved a settlement by OxyContin maker Purdue Pharma and its wealthy Sackler family owners of the claims against them that the company values at more than $10 billion.

During a months-long, non-jury trial, the populous Santa Clara, Los Angeles and Orange counties and the city of Oakland argued the drugmakers' marketing downplayed opioids' addictive risks and promoted them for broader uses than intended.

They argued the advertising led to billions of pain pills flooding their communities and a rise in overdose deaths. They said the companies should pay more than $50 billion to cover the costs of abating the public nuisance they created, plus penalties.

But Wilson said even if the drugmakers' marketing contained any misleading statements, the counties put forward no evidence to show that their promotional activities caused any medically inappropriate prescriptions to be written.

He agreed with the companies that the epidemic could not be considered a legal public nuisance because the federal government and the state had at the time determined the benefits of medically appropriate prescriptions outweighed their harms.

"There is simply no evidence to show that the rise in prescriptions was not the result of the medically appropriate provision of pain medications to patients in need," Wilson wrote.

J&J in a statement said the decision showed its marketing was "appropriate and responsible." John Hueston, Endo's lawyer, said it demonstrated his client's "lawful conduct did not cause the widespread public nuisance at issue in plaintiffs' complaint."

Teva in a statement said it continues to pursue a national settlement framework and that the ruling was a "clear win" for patients who would benefit from comprehensive settlements being finalized.

Representatives for the California plaintiffs did not respond to requests for comment. They could potentially challenge the tentative ruling before it becomes final. Tentative decisions are typical in California state courts.

In a statement, the lead lawyers overseeing related federal lawsuits against the companies -- Jayne Conroy, Paul Farrell and Joe Rice -- said they strongly disagreed with the ruling and stressed that it did not impact related cases nationally.

The only other opioid trial to reach a verdict resulted in an Oklahoma judge in 2019 ordering J&J to pay $465 million to the state. J&J is appealing that decision.

Trials are currently underway a New York case against Teva and AbbVie and in Ohio against three pharmacy chain operators. A West Virginia federal judge recently finished hearing evidence in a trial involving the distributors.

https://www.reuters.com/world/us/california-judge-rules-drugmakers-major-opioid-lawsuit-2021-11-02/