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Sunday, July 3, 2022

CDC recommends 6 Washington counties should wear masks

 People in six Washington counties should begin wearing masks indoors in public and on public transportation again, according to recommendations from the federal Centers for Disease Control and Prevention.

The latest information from the CDC shows that Lewis County, Pacific County, Thurston County, Grays Harbor County, Garfield County and Spokane County all have COVID-19 community levels rated “high,” meaning they have had 200 or more new COVID-19 cases per 100,000 people in the last seven days, or they’ve had more than 20 new COVID-19 hospital admissions per 100,000 people within a seven-day period.

KOIN-TV reported the counties range from Pacific County’s 418 cases per 100,000 people to Spokane County’s 207 cases per 100,000 people.

These community levels were calculated on June 23.

The CDC said anyone at risk for severe illness in those six counties should consider taking additional precautions besides simply wearing a mask, like staying 6 feet away from others, avoiding crowds and poorly ventilated spaces, and washing their hands often.

https://apnews.com/article/covid-health-washington-centers-for-disease-control-and-prevention-b8e3f7a1e3c8cacfc06b0d882e95f965

Northern Kentucky free pharmacy moving, expanding

 Faith Community Pharmacy, a nonprofit that for 20 years has provided free prescription medications to Northern Kentucky residents, is moving and expanding.

The pharmacy recently relocated from Florence to Newport, where they have more than three times the space of the former location, The Cincinnati Enquirer reported. The pharmacy currently serves about 1,000 patients a year, but they hope the new location will help them bring their services to more people, Executive Director Aaron Broomall said.

Faith Community Pharmacy will provide 90 days of medication to anyone in a 14-county Northern Kentucky area who is seeking the help. It provides medications on an ongoing basis for those earning 300% of the poverty level and below.

Costs of the pharmacy are covered with funding from Boone, Campbell and Kenton counties, St. Elizabeth Healthcare, foundations including the Spaulding Foundation, grants and donations. Most of the medications come from nonprofit Americares.

For the community, the costs are far offset by better health, Broomall said.

Clients’ emergency room visits drop by at least half from the year before they are enrolled to the first year of enrollment, the nonprofit has found. Hospitalizations drop by 70% based on the entire patient population.

The new office is in a hub of social services, and Broomall said the visibility will bring Faith Community Pharmacy more clients. The new location is also on a bus line – helpful to people with limited transportation options or gas money, and it’s in the urban core of Northern Kentucky, where many of the pharmacy’s clients live.

In recent years, the pharmacy has seen its client base expand from primarily seniors on a fixed income to include the working poor who have either no or inadequate health insurance. The pharmacy’s client base has jumped 60% since 2017, with 30% of that enrollment coming in 2020. The surge has slowed as the pandemic has eased, Broomall said, but enrollment continues to grow.

To bring the service to more people, the organization plans to increase outreach at churches, schools, clinics and emergency and urgent care departments. For rural clients, the pharmacy will even deliver their prescriptions.

Kellee Yelton has been receiving medications for diabetes and hypertension from Faith Community Pharmacy since she lost her job in 2020. Yelton has remained enrolled at the pharmacy even after getting hired eight months ago as a receptionist. She said her high-deductible insurance makes it impossible for her to afford her medications at this time.

“What we do is critical,” Broomall said. “It really allows people to live their lives. What we do allows them to stay at work, provide for their family, be healthy for their kids.”

“It’s hard to be poor,” he said. “It’s hard to have a low income, and it’s really hard to have a chronic illness.”

https://apnews.com/article/health-kentucky-medication-9f4ddbe2604236bb951ff64a280097a9

COVID cases up by more than 30% in Britain last week

 The number of new coronavirus cases across Britain has surged by more than 30% in the last week, new data showed Friday, with cases largely driven by the super infectious omicron variants.

Data released by Britain’s Office for National Statistics showed that more than 3 million people in the U.K. had COVID-19 last week, although there has not been an equivalent spike in hospitalizations. The number of COVID-19 deaths also fell slightly in the last week.

“COVID-19 has not gone away,” said Dr. Mary Ramsay, of the Health Security Agency. “It is also sensible to wear a face covering in crowded, enclosed spaces,” she said. Britain dropped nearly all its coronavirus measures, including mask-wearing and social distancing months ago and masks are rarely seen on public transport.

The latest jump in coronavirus cases comes after an earlier increase of about 40% last month, following the large street parties, concerts and festivities held to mark the platinum jubilee celebrations marking 70 years of Queen Elizabeth II’s reign.

British officials said the latest wave of COVID-19 infections were likely caused by omicron subvariants BA.4. and BA.5. Omicron has tended to cause a milder disease than previous variants like alpha or delta, but scientists warn its ability to evade the immune system means that people may be more susceptible to being reinfected, including after vaccination.

“The constant bombardment of waves we are seeing does cause clinical impact that is not to be underestimated,” said Dr. Stephen Griffin, an associate professor of medicine at the University of Leeds, explaining that any infection can lead to long COVID.

Despite widespread immunization across Britain, the protection from vaccines is likely fading and omicron and its subvariants have evolved to become more infectious. Britain’s Health Security Agency said they were seeing more outbreaks in care homes for older people and a rise in admissions to intensive care units of people over 65.

Dr. Jonathan Van-Tam, a former deputy chief medical officer for the U.K., told the BBC that COVID-19 is now “much, much, much closer to seasonal flu” than when it first emerged. Still, he said experts should be vigilant for any signs the virus was causing more severe illness.

Germany’s Robert Koch Institute also reported a similar rise in the coronavirus, with cases increasing especially among older people, children and teenagers. France has seen a jump in the COVID-19 hospitalization rate and officials recently recommended that people begin wearing masks again on public transport.

Globally, the World Health Organization said this week that COVID-19 is increasing in more than 100 countries worldwide. The U.N. health agency warned that relaxed testing and surveillance measures mean it may be more difficult to catch emerging variants before they spread more widely.

https://apnews.com/article/covid-health-0ec170659b40806416df763686a4003c

From one July Fourth to the next, a steep slide for Biden

 Last Fourth of July, President Joe Biden gathered hundreds of people outside the White House for an event that would have been unthinkable for many Americans the previous year. With the coronavirus in retreat, they ate hamburgers and watched fireworks over the National Mall.

Although the pandemic wasn’t over yet, Biden said, “we’re closer than ever to declaring our independence from a deadly virus.” Across the country, indoor masking requirements were falling as the number of infections and deaths plummeted.

Within weeks, even some of the president’s allies privately admitted that the speech had been premature. Soon the administration would learn that the delta variant could be transmitted by people who had already been vaccinated. Masks went back on, then came polarizing vaccination mandates. The even-more-contagious omicron variant would arrive months later, infecting millions and causing chaos during the holiday season.

“We were hoping to be free of the virus, and the virus had a lot more in store for us,” said Joshua Sharfstein, vice dean of the Johns Hopkins Bloomberg School of Public Health. The number of people in the United States who died from COVID-19 nearly doubled, from 605,000 to more than 1 million, over the past year.

That sunny speech one year ago marked a crossroads for Biden’s presidency. The pandemic appeared to be waning, the economy was booming, inflation wasn’t rising as quickly as today and public approval of his job performance was solid.

As Biden approaches his second Fourth of July in the White House, his standing couldn’t be more different. A series of miscalculations and unforeseen challenges have Biden struggling for footing as he faces a potentially damaging verdict from voters in the upcoming midterm elections. Even problems that weren’t Biden’s fault have been fuel for Republican efforts to retake control of Congress.

The pandemic’s resurgence was swiftly followed last summer by the debacle of the U.S. withdrawal from Afghanistan, when the Taliban seized control of the country faster than the administration expected as the U.S.-backed regime collapsed. Then, negotiations over Biden’s broader domestic agenda stalled, only to collapse altogether in December.

The Russian invasion of Ukraine in late February caused a worldwide spike in gas prices, exacerbating inflation that reached a 40-year high. Another blow came last month, when the Supreme Court overturned the constitutional right to abortion under Roe v. Wade and curtailed the Environmental Protection Agency’s ability to regulate greenhouse gas emissions.

Suddenly a reactive president, Biden has been left trying to reclaim the initiative at every step, often with mixed results. The coronavirus is less of a threat than before and infections are far less likely to lead to death, but Congress is refusing to supply more money to deal with the pandemic.

He signed new gun restrictions into law after massacres in New York and Texas, and he’s leading a reinvestment in European security as the war in Ukraine enters its fifth month. But he has limited tools at his disposal to deal with other challenges, such as rising costs and eroding access to abortion.

“People are grouchy,” said Lindsay Chervinsky, a presidential historian.

The latest poll from The Associated Press-NORC Center for Public Affairs Research shows that his approval rating remains at 39%, the lowest since taking office and a steep slide from 59% one year ago. Only 14% of Americans believe the country is headed in the right direction, down from 44%.

Douglas Brinkley, another historian, said Biden suffered from a case of presidential hubris after a largely successful run in his first five months in office, which included an overseas trip to meet with allies excited about welcoming a friendly face back to the international scene. He compared Biden’s Fourth of July speech last year to President George W. Bush’s infamous “Mission Accomplished” moment during the second Iraq War.

“He was trying to deliver good news but it didn’t pan out for him,” Brinkley said. “Suddenly, Biden lost a lot of goodwill.”

White House officials reject the comparison, noting that Biden warned about the “powerful” delta variant in his 2021 speech. Chris Meagher, a spokesman, said deaths from the virus are at a record low now, reducing disruptions in workplaces and classrooms.

“Fighting inflation and lowering prices is the president’s number one economic priority, and he’s laser focused on doing everything he can to make sure the economy is working for the American people,” he said. “And we’re in a strong position to transition from our historic jobs recovery to stable and steady growth. Because of the work we’ve done to bring the pandemic under control, COVID is not the disruptive factor it has been for so long.”

The promise to competently address the COVID-19 pandemic is what helped put Biden in the Oval Office and send President Donald Trump to defeat. From the start of Biden’s tenure, his public pronouncements were sober and cautious, wary of following his predecessor in predictions that went unfulfilled. The nation’s vaccination program found its stride under Biden, and by April 19, 2021, all adults were eligible to be vaccinated.

Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, was an adviser to Biden’s transition team. But as the Fourth of July approached last year, he was worried and felt that the administration wasn’t heeding his warnings.

“Everyone was in this position of wanting to believe it was over with, and not fully understanding or appreciating the potential of the variants,” he said.

Even now, a full year later, Osterholm is reluctant to say what the future holds.

“I want answers too,” he said. “But I don’t know what the variants are going to bring us. I don’t know what human immunity is going to look like.”

Biden said the virus “has not been vanquished” in his Fourth of July speech, and he held another event two days later to talk about the delta variant.

“It seems to me that it should cause everybody to think twice,” he said as he appealed to people who had not yet been vaccinated.

Leana Wen, a public health professor at George Washington University, said there’s more reason to be optimistic this year than last. Immunity from vaccines or previous infections is much more widespread, and antiviral treatments are effective at preventing hospitalization and death in vulnerable patients.

“It was premature to declare independence from COVID-19 last year,” she said. “But this year the country is in a totally different place, and in a much better place.”

But Wen said Biden might be wary, given how things went before.

“The administration is hesitant to make those proclamations now, when actually this is the time to do so,” she said.

Biden’s early strategy of underpromising and overdelivering on COVID-19 was part of a concerted strategy to rebuild the public’s trust in government. The resurgence of the virus eroded some of that trust and diminished confidence in Biden’s job performance.

Rebuilding that has proved difficult, especially as the country faces challenges, some, frustratingly for Biden, outside of his control.

“We expect the president to be all powerful and be able to fix every problem,” said Chervinsky, the presidential historian. “It’s a completely unrealistic expectation and, frankly, a dangerous one.”

President Bill Clinton stumbled through his first two years in office, then faced a wave of Republican victories in his first midterm elections. But he later became the first Democratic president to be reelected since Franklin Delano Roosevelt.

Chervinsky cautioned that today’s political polarization could make such a rebound more difficult for Biden.

A key question, she said: “Is our partisan system so inflexible that it won’t allow for him to go back?”

https://apnews.com/article/abortion-inflation-biden-covid-politics-7d366e0e3ff52a58150254829a87df38

Plug-and-play test for keeping track of immunity to Sars-CoV-2 variants

 The experts agree -- the pandemic is not over. Infections are ticking up again, fueled by the new variants our immune systems are ill prepared for.

That's according to a study by Canadian and US researchers who found that the antibodies generated in people who were vaccinated and/or recovered from COVID-19 prior to 2022 failed to neutralize the variants circulating today.

The study was led by Igor Stagljar, a professor of biochemistry and molecular genetics, at the Donnelly Centre for Cellular and Biomolecular Research, at Temerty Faculty of Medicine, and Shawn Owen, an associate professor of pharmaceutics and pharmaceutical chemistry, at the University of Utah.

The journal Nature Communications published their findings.

The researchers expect that the antibody test they developed to measure immunity in the study's participants will become a valuable tool for deciding who needs a booster and when, which will help save lives and avoid future lockdowns.

"The truth is we don't yet know how frequent our shots should be to prevent infection," said Stagljar. "To answer these questions, we need rapid, inexpensive and quantitative tests that specifically measure Sars-CoV-2 neutralizing antibodies, which are the ones that prevent infection."

Many antibody tests have been developed over the past two years. But only a few of the authorized ones are designed to monitor neutralizing antibodies, which coat the viral spike protein so that it can no longer bind its receptor and enter cells.

It's an important distinction, as only a fraction of all Sars-CoV-2 antibodies generated during infection are neutralizing. And while most vaccines were specifically designed to produce neutralizing antibodies, it's not clear how much protection they give against variants.

"Our method, which we named Neu-SATiN, is as accurate as, but faster and cheaper than, the gold standard, and it can be quickly adapted for new variants as they emerge," he said.

Neu-SATiN stands for Neutralization Serological Assay based on split Tri-part Nanoluciferase, and it is a newer version of SATiN, which monitors the complete IgG pool, which they developed last year.

The development of Neu-SATiN was spearheaded by Zhong Yao, a senior research associate in Stagljar's lab, and Sun Jin Kim, a postdoctoral fellow in Owen's lab, who are the co-first authors on the paper.

The first of its kind, the pin prick test is powered by a protein-complementation strategy using the fluorescent luciferase protein from a deep-water shrimp. It measures the ability of the viral spike protein to bind the human ACE2 receptor, each of which is attached to a luciferase fragment. The binding brings the luciferase pieces into proximity so that they reconstitute a full-length protein, which gives off a glow of light that is captured by the luminometer instrument. When patient blood sample is added into the mixture, the neutralizing antibodies will bind the spike protein, preventing it from contacting ACE2. Consequently, luciferase remains in pieces, with an accompanying drop in light signal. The plug and play method can be adapted to different variants within a couple of weeks by engineering variant mutations into the spike protein.

The researchers applied Neu-SATiN to blood samples collected from 63 patients with different histories of COVID-19 infection and vaccination up to November 2021. Patient neutralizing capacity was assessed against the original Wuhan strain and the variants, Alpha, Beta, Gamma, Delta and Omicron.

"We thought it would be important to monitor people that have been vaccinated to see if they still have protection and how long it lasts," said Owen, who did his postdoctoral training in the Donnelly Centre with distinguished bioengineer and University Professor Molly Shoichet. "But we also wanted to see if you were vaccinated against one variant, does it protect you against another variant?"

The neutralizing antibodies were found to last about three to four months when their levels would drop by about 70 per cent irrespective of infection or vaccination status. Hybrid immunity, acquired through both infection and vaccination, produced higher antibody levels at first, but these too dropped significantly four months later.

Most worryingly, infection and/or vaccination provided good protection against the previous variants, but not Omicron, or its sub-variants, BA.4 and BA.5.

The data match those from a recent UK study, which showed that both neutralizing antibodies and cellular immunity, a type of immunity provided by memory T cells, from either infection, vaccination, or both, offered no protection from catching Omicron. In a surprising twist, the UK group also found that infections with Omicron boosted immunity against earlier strains, but not against Omicron itself, for reasons that remain unclear.

It's important to stress that vaccines still confer significant protection from severe disease and death, said Stagljar. Still, he added that the findings from his team and others call for vigilance in the coming period given that the more transmissible BA4 and BA5 sub-variants can escape immunity acquired from earlier infections with Omicron, as attested by rising reinfections.

"There will be new variants in the near future for sure," Stagljar said. "Monitoring and boosting immunity with respect to circulating variants will become increasingly important and our method could play a key role in this since it is fast, accurate, quantitative and cheap."

His lab is already collaborating with the Canadian vaccine maker Medicago to help determine the efficacy of their vaccine candidates against Omicron and its subvariants. Meanwhile, U of T is negotiating to license Neu-SATiN to a company which will scale it up so that it can be used for population immunosurveillance and in the pharmaceutical industry for vaccine development.


Story Source:

Materials provided by University of Toronto. Original written by Jovana Drinjakovic. Note: Content may be edited for style and length.


Journal Reference:

  1. Sun Jin Kim, Zhong Yao, Morgan C. Marsh, Debra M. Eckert, Michael S. Kay, Anna Lyakisheva, Maria Pasic, Aiyush Bansal, Chaim Birnboim, Prabhat Jha, Yannick Galipeau, Marc-André Langlois, Julio C. Delgado, Marc G. Elgort, Robert A. Campbell, Elizabeth A. Middleton, Igor Stagljar, Shawn C. Owen. Homogeneous surrogate virus neutralization assay to rapidly assess neutralization activity of anti-SARS-CoV-2 antibodiesNature Communications, 2022; 13 (1) DOI: 10.1038/s41467-022-31300-9

The Most Important Piece of Information for Active Traders

 

Just about everyone looks at volume, but do they actually *see* volume?

Volume tells us who is in the market.  Who is in the market determines how the market will move.  

Since 2019, yesterday's volume in SPY correlates with today's volume by over .80.

Since 2019, today's volume correlates with today's high-low range in SPY by a little under .60.

When volume expands, it's a sign that institutional participants are active in the market.  Because many of them trade directionally, their involvement/non-involvement contributes to volatility and the ways in which moves continue or reverse.

Since 2019, daily SPY volume correlates with VIX by over .80.

When we look at relative volume--how today's volume at a given intraday period compares to average volume for that time of day--and track its evolution through the day, we can clearly see who is playing at the poker table and who isn't.  That helps us handicap the odds of moves continuing or not.

When we have stable volume trading day over day, the odds are increased that the cyclical behavior of recent markets will continue in the near future.  There can be a tremendous trading edge in this information.

The market magician has us looking at the hand that waves price in front of us.  But the magic is being done with the other hand, the volume hand that few people truly see.



Seagen: Positive Results of Pivotal Phase 2 Colorectal Cancer Combo Trial

 Seagen Inc. announced full results from the pivotal phase 2 MOUNTAINEER trial, which showed TUKYSA (tucatinib) in combination with trastuzumab was well-tolerated with durable responses in patients with previously treated HER2-positive metastatic colorectal cancer (mCRC). These late-breaking data were presented in an oral session at the European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer on July 2 in Barcelona, Spain. At a median duration of follow-up of 20.7 months (interquartile range: 11.7, 39.0), results of the MOUNTAINEER trial showed a 38.1% confirmed objective response rate (cORR) (95% Confidence Interval [CI]: 27.7, 49.3) per blinded independent central review (BICR) in the HER2-positive patients who were assigned to receive tucatinib in combination with trastuzumab (n=84 with a median age of 55.0 years [range 24 to 77]). In these patients, the median duration of response (DoR) per BICR was 12.4 months (95% CI: 8.5, 20.5). Median progression-free survival per BICR was 8.2 months (95% CI: 4.2, 10.3), and median overall survival was 24.1 months (95% CI: 20.3, 36.7). At study entry, 64.3% and 70.2% of these patients had liver or lung metastases, respectively, and had received a median of 3.0 (1, 6) prior lines of systemic therapy. In a cohort of patients who received tucatinib monotherapy (n=30), the ORR per BICR by 12 weeks was 3.3% (95% CI: 0.1, 17.2) and the disease control rate was 80.0%. Participants who did not respond to tucatinib monotherapy by 12 weeks or progressed at any time had the option to receive the combination of tucatinib and trastuzumab. The most common (greater than or equal to 20%) treatment-emergent adverse events (AEs) in patients assigned to receive tucatinib and trastuzumab (n=86) were diarrhea (Grade 1 or 2: 60.5%, Grade 3: 3.5%), fatigue (Grade 1 or 2: 41.9%, Grade 3: 2.3%), nausea (Grade 1 or 2: 34.9%) and infusion-related reaction (Grade 1 or 2: 20.9%). The most common Grade =3 AE was hypertension (Grade 3: 7.0%). AEs leading to discontinuation of any treatment occurred in 5.8% of patients. No deaths due to AEs were reported.

https://www.marketscreener.com/quote/stock/SEAGEN-INC-10808/news/Seagen-Inc-Announces-Full-Results-from-the-Pivotal-Phase-2-MOUNTAINEER-Trial-Which-Showed-TUKYSA-i-40887206/