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Tuesday, May 28, 2024

US 'Looking Closely' At Vaccinating Workers Exposed To Bird Flu: Official

 by Zachary Stieber via The Epoch Times (emphasis ours),

Officials in the United States, Canada, and Europe are considering the vaccination of workers and others against the highly pathogenic avian influenza.

The U.S. government is “looking closely” at the possibility of vaccinating farm workers and others in close contact with the virus, according to Dawn O'Connell, the assistant secretary for preparedness and response at the U.S. Administration for Strategic Preparedness and Response.

Angela Rasmussen, a virologist at the University of Saskatchewan, said she has been in discussions with U.S. and Canadian officials about using vaccines to protect workers after the influenza, or bird flu, jumped from birds to cattle.

The first cases of H5N1, a strain of the flu, in cattle were detected earlier this year, although some scientists say available evidence points to the cases cropping up in late 2023.

Discussions about using vaccines to try to prevent a pandemic are ongoing at the government level and among scientists in several places, including the UK, said Wendy Barclay, chair in influenza virology at University College London, who also researches avian flu for the UK Health Security Agency.

The UK government did not comment but said it is monitoring the situation in the United States.

In the European Union, the European Commission’s Health Emergency Preparedness and Response Authority is working on a joint procurement of CSL Seqirus’s vaccine to “potentially prevent a pandemic” sparked by individuals exposed to infected birds and animals, spokesman Stefan De Keersmaecker said.

A spokeswoman for CSL, which has contracts for pandemic influenza vaccines with 30 governments, said the company has been in talks with several governments about procuring vaccines since 2022.

The U.S. Food and Drug Administration approved a CSL influenza A vaccine in 2020, based largely on immunogenicity and safety results from a small clinical trial of 319 people.

Dr. Peter McCullough, an epidemiologist based in Texas, said on the social media platform X that without larger trials, it’s not possible to know whether the vaccine is safe or effective in humans.

The formulation for the CSL shot has been updated to more closely match the bird flu, which is an influenza A virus.

U.S. officials said recently that they’re planning to produce 4.8 million doses of the updated CSL vaccine. European health officials also said they were in talks to acquire CSL’s shot.

Canadian health officials said they have met with GSK, maker of Canada’s seasonal flu shots, to discuss acquiring and manufacturing a prepandemic bird flu vaccine.

The United States is in talks with Pfizer and Moderna, which make messenger ribonucleic acid (mRNA) COVID-19 vaccines, about potential pandemic vaccines.

University of Pennsylvania researchers said in a May 23 paper that their experimental mRNA bird flu vaccine performed well in preclinical testing in ferrets.

Since the bird flu cases in cattle were first detected, cases have been confirmed in 63 herds across nine states, including Colorado, Michigan, and South Dakota, according to the U.S. Department of Agriculture.

Human cases

Two cases in humans—one in Michigan and one in Texas—have also been confirmed. Both have since recovered. Analysis of virus samples from the patients showed high similarities to the virus spreading in cows.

Richard Webby, a St. Jude Children’s Research Hospital virologist who studies flu in animals and birds for the World Health Organization, said the situation in dairy cattle merits vaccine use.

“If we look at the exposure levels that some of these farmers are getting, it’s high,” Mr. Webby said.

The decision on how and when to use the vaccine will hinge on evidence of increased transmission, severity of disease, cases in people with no link to a dairy farm, and mutations in the virus, U.S. Centers for Disease Control and Prevention (CDC) Principal Deputy Director Nirav Shah said.

The agency says on its website that the government is developing bird flu vaccines “in case they are needed.”

Human exposure to the virus in poultry and dairy operations could increase the risk that the virus will mutate and gain the ability to spread easily in people. Vaccines that perform poorly can also increase that risk.

So far, only one change has been detected in the human cases, the CDC said on May 24.

These data indicate viruses detected in both cows and the two human cases maintain primarily avian genetic characteristics and lack changes that would make them better adapted to infect or transmit between humans,” the agency stated.

For now, CDC officials say the best way to avoid bird flu is to stay away from infected animals, fluids, and feces.

Workers who must come into contact with animals are advised to wear protective equipment and monitor themselves for symptoms, which include fatigue.

People who do become sick can take influenza antivirals, which are more effective when received shortly after symptoms develop.

Health officials also recommend cooking eggs and poultry to at least 165 degrees Fahrenheit, cooking beef to appropriate temperatures, and only consuming pasteurized milk.

Testing of beef found a surrogate virus was still present in burgers cooked rare, according to the Department of Agriculture. High levels of bird flu virus have been detected in raw milk. Some pasteurized samples tested positive, but further testing showed no viable virus, according to the Food and Drug Administration.

https://www.zerohedge.com/medical/us-looking-closely-vaccinating-workers-exposed-bird-flu-official

Agios Breaks Out On 'Buffed Up' Financials After Inking Massive Brain Cancer Deal

Agios Pharmaceuticals (AGIO) agreed Tuesday to sell its 15% royalty in a brain cancer drug to Royalty Pharma (RPRX) for $905 million upfront. Agios stock broke out at the opening bell.

Under the terms of the deal, Agios will sell its royalty on potential U.S. net sales of Servier's vorasidenib to Royalty Pharma. If the Food and Drug Administration approves vorasidenib on Aug. 20 — the review date — Agios will receive a $200 million milestone payment.

But Agios isn't letting go of vorasidenib entirely. Royalty will receive the entire 15% royalty on U.S. sales up to $1 billion. After $1 billion, Royalty Pharma will get a 12% royalty on sales, while Agios will retain a 3% royalty.

In a report to clients, RBC Capital Markets analyst Gregory Renza called it a "welcome and optimal move on monetizing a valuable noncore asset." Agios sells a drug called Pyrukynd for patients with anemia and PK deficiency, a disease that chronically destroys red blood cells. But Agios is working to expand the same drug, under the test name mitapivat, to other blood diseases.

https://www.investors.com/news/technology/agios-stock-break-out-royalty-pharma-brain-cancer-deal-servier-vorasidenib/

Sarepta cut to Sector Perform from Outperform by RBC

 Target to $142 from $157

https://finviz.com/quote.ashx?t=SRPT&p=d

'White House and 21 states to announce grid modernization program'

 The Biden administration is set to announce a new initiative with 21 states Tuesday to modernize the U.S. power grid, ahead of a summer likely to tax its capacity.

Under the initiative, the participating states will give priority to electric grid modernization efforts, including those aimed at increased capacity and efficiency. The states, all of which have Democratic governors, will also commit to exploring ways to expand transmission capacity through legislative and executive action.

The federal government, meanwhile, will commit to ensuring states have access to technical assistance and loan programs, according to a fact sheet from the White House.

The Biden administration has set ambitious goals for renewable energy deployment, with a target of a carbon-neutral grid by 2035. Reaching this point will require a major buildout in modernized electrical transmission lines to handle the expansion. In the absence of this buildout, the administration faces a bottleneck in adding that renewable capacity to the grid. The backlog comprises about 2,600 gigawatts of energy, increasing 30 percent last year due in large part to solar and wind demand, according to an April report from the Lawrence Berkeley National Laboratory.

Congressional action on transmission has come to naught, with Senate Majority Leader Chuck Schumer (D-N.Y.) saying earlier this month that “I’ve told [Sen.] Joe Manchin [D-W.Va.] it’s going to be virtually impossible to get something done” in 2024, specifically citing opposition to transmission reforms by the House’s GOP majority.

The White House has taken several actions at the executive level, announcing a plan in April to shake loose the backlog by reducing interconnection cost differences and wait times.

Around the same time as Schumer’s remarks, the independent Federal Energy Regulatory Commission approved a rule aimed at clearing backlogs for regional transmission projects, which disproportionately but not exclusively affect renewables.

Grid reliability is top of mind for many Americans after storms knocked out power for about 750,000 households in the Dallas area, which is part of Texas’s independent power grid. Reps. Greg Casar (D-Texas) and Alexandria Ocasio-Cortez (D-N.Y.) have introduced legislation that would add the independent grid, the Electric Reliability Council of Texas, to the national grid.

https://thehill.com/policy/energy-environment/4689058-power-grid-modernization-program-white-house-21-states/

Nursing home industry sues Biden administration over staffing rule

 An industry lawsuit is urging a federal court to overturn the Biden administration’s new mandatory minimum staffing requirements on nursing homes, arguing the federal Medicare agency exceeded its authority. 

The complaint argues Congress never gave the Centers for Medicare and Medicaid Services (CMS) the authority “to impose such onerous and unachievable mandates on practically every nursing home in the country,” so the rules are a violation of the Administrative Procedure Act. 

It was filed last week in the Northern District of Texas by the American Health Care Association (AHCA), its Texas counterpart and the operators of three nursing homes in the state. 

“Setting one-size-fits-all staffing requirements that will require some four-fifths of the nation’s nursing homes to hire additional personnel, even though almost no state has deemed those higher levels necessary … is the height of arbitrary and capricious agency action,” the complaint stated.    

The lawsuit argues the requirements will force facilities to close or downsize, displacing tens of thousands of residents and “forcing countless other seniors and family members to wait longer, search farther, and pay more for the care they need.” 

Under the requirements unveiled last month, all nursing homes that receive federal funding through Medicare and Medicaid will need to have a registered nurse on staff 24 hours per day, seven days per week and provide at least 3.48 hours of nursing care per resident per day. 

The rules will cost nursing homes $43 billion over the next decade, according to estimates from the Department of Health and Human Services (HHS).   

The requirements of the rule will be introduced in phases, with longer timeframes for rural communities. Limited, temporary exemptions will be available for both the 24/7 registered nurse requirement and the underlying staffing standards for nursing homes in workforce shortage areas that demonstrate a good faith effort to hire.   

Nonrural facilities must meet the requirements by May 2027, and rural facilities have five years, until May 2029. 

But according to the lawsuit, the staffing requirements “flunk basic principles of administrative law at every turn.” 

“We had hoped it would not come to this; we repeatedly sought to work with the Administration on more productive ways to boost the nursing home workforce,” Mark Parkinson, President and CEO of AHCA, said in a statement.  

Notably, the lawsuit was filed in federal court in Amarillo, Texas. Texas is a popular venue for groups looking to get favorable rulings against the Biden administration, and the district court in Amarillo has only one judge, Matthew Kacsmaryk. 

Kacsmaryk, an appointee of former President Trump, is the same judge who suspended approval of the abortion pill mifepristone and has ruled against the Biden administration on several other issues, including immigration and LGBTQ protections. 

https://thehill.com/policy/healthcare/4689441-nursing-home-industry-lawsuit-biden-administration-staffing-rule/

'Biden administration issues guidelines on carbon credit integrity'

 

'DNC plans to virtually nominate Biden ahead of convention amid Ohio ballot concerns'

 The Democratic National Committee (DNC) is planning to virtually nominate President Biden ahead of the party’s convention after the Ohio state Legislature deadlocked on a fix last week to get the president on the ballot in November.

DNC Chair Jaime Harrison announced Democrats would be holding a virtual roll call to ensure Biden gets on the ballot in all 50 states — an announcement made on the same day Ohio state lawmakers returned to the Capitol for a special session to solve Biden’s ballot access issue. 

Joe Biden will be on the ballot in Ohio and all 50 states, and Ohio Republicans agree. But when the time has come for action, they have failed to act every time, so Democrats will land this plane on our own,” Harrison said in a statement.

“Through a virtual roll call, we will ensure that Republicans can’t chip away at our democracy through incompetence or partisan tricks and that Ohioans can exercise their right to vote for the presidential candidate of their choice,” he added.

Democrats were notified earlier this year that the timing of their convention didn’t meet a state deadline to certify the party’s presidential nominee. Democrats needed to certify Biden by Aug. 7 in order to make the Ohio ballot, but the Democratic National Convention kicks off beginning Aug. 19.

Ohio legislators struggled to reach a legislative fix; Senate Republicans passed a bill that would allow a one-time fix that would move the certification deadline back so Democrats could make it. But it was also paired with a provision that would ban foreign contributions in ballot initiatives, which Democrats rejected.

The state House had worked on a more permanent solution that would change the certification deadline, but ultimately neither of those bills was officially voted on in the lower chamber.  

Liz Walters, chair of the Ohio Democratic Party, accused Republicans of “playing politics with our democracy” in a statement Tuesday.

Ohio Gov. Mike DeWine (R) ordered lawmakers last week to return to the Capitol this week to find a solution to get Biden on the ballot, expressing support for a solution similar to what the Senate proposed, which included the foreign contribution provision. 

That raised questions around how Democrats in the state would proceed, given their opposition to the state Senate’s proposal. The DNC’s solution offers Biden an avenue onto the ballot while avoiding an expensive lawsuit.

https://thehill.com/homenews/campaign/4689635-joe-biden-dnc-ohio-ballot-convention/