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Friday, September 3, 2021

Cal. Nurse Shortage Reaches "Crisis Level" As Vaccine Mandate Wards Off Traveling Nurses

 As America's hospital beds have again filled with sick COVID  patients, nurses and other healthcare workers have been quitting at the fastest rate since the early days of the pandemic, when nurses in some NYC hospitals were using garbage bags instead of PPE. Across the Internet, on subreddits and in Facebook groups, nurses have gathered to commiserate.

But it's not just remote areas of Arkansas and Mississippi that are having problems. Local media in California have reported that across the Golden State, low staffing levels have reached a "crisis point".

According to a story published by a newspaper in Bakersfield, in the past month, no fewer than four emergency room nurses have quit at one Eureka hospital.

And aside from the burnout and the pressure and the stress, nurses have also cited California's mandatory vaccination rule as one reason they're thinking about leaving the state. Traveling nurses have been turning down assignments in the Golden State at record rates  because they don't want to get vaccinated - and the mandate hasn't even taken effect yet.

Cole of Scripps Health said the state’s testing requirement, imposed last week, already has discouraged some out-of-state, traveling nurses from taking temporary jobs at California hospitals.

"If they don’t want to get vaccinated, they are turning down California assignments,” he said.

Here's more according to Bakersfield.com:

Hospitals are struggling to comply with the state’s nurse staffing requirements as pandemic-induced burnout has exacerbated an already chronic nursing shortage nationwide.

But burnout isn’t the only thing compounding California’s nursing shortage: The state’s new vaccine mandate for health care workers is already causing headaches for understaffed hospitals before it is even implemented. Some traveling nurses - who are in high demand nationwide - are turning down California assignments because they don’t want to get vaccinated.

 With more people coming in for routine care that can't be delayed any longer, hospitals are nearing a "crisis point" as the staffing shortages leave them in danger of not meeting the state's legal minimum staffing requirements.

Hospitals say they are reaching a crisis point, straining under the dual forces of more people seeking routine care and surging COVID-19 hospitalizations driven by the Delta variant.

"Oftentimes at hospitals there are long waits and long delays,” said Dr. Tom Sugarman, an emergency physician in the East Bay and senior director of government affairs at Vituity, a physicians’ group. “There’s not enough staff to keep beds open, and patients can languish waiting."

Nursing shortages were common in California even before the pandemic. But now resources are nearing "the breaking point". Every time case numbers seem like they're finally about to subside, a new wave of cases rises up.

Emotional and physical exhaustion is the primary reason nurses are fleeing the bedside, experts say. It has been a long and brutal 18 months.

"We thought the pandemic would be over soon and could take time later to deal with our emotions,” said Zenei Triunfo-Cortez, president of National Nurses United, the largest nursing union in the country, which has more than 100,000 members in its California association. “Then the second surge hit, and the third and now it’s the fourth."

Mary Lynn Briggs, an ICU nurse in Bakersfield, said of the dozens of COVID-19 patients she has treated since the pandemic began, only three have survived.

"Some days coming home from the hospital I yell at God, I yell at myself, I yell at COVID and cry. And that’s all before I pull into my driveway," Briggs said.

A surprising number of nurses are wary of the vaccines, so Gov. Newsom's requirement that nurses and hospital staff must get vaccinated could end up being the straw that breaks the camel's back.

Hospital administrators worry that the state’s vaccine mandate for health care workers, which goes into effect Sept. 30, could drive some of their workers out. Already, some report resistance among employees.

“One hospital told us they had 474 unvaccinated employees. They did a big education and incentive push. Only 12 people signed up,” said Richardson, the hospital association’s attorney.

Administrators are particularly concerned about low vaccination rates among support staff like janitors and food service workers. However, some nurses also are wary of the COVID-19 vaccine. Some nurses with large social media followings have participated in protests in Southern California, arguing that the mandates violate their personal freedom.

With staffing levels low across the US, traveling nurses working in temporary roles have been critical to help shore up hospital staff. But they're also allowing nurses who don't want to comply with vaccine mandates to simply pick up and leave. One expert said traveling nurses in Texas and Florida might be coming from California.

Nationwide more than 52,000 temporary health care jobs are posted, and Aya is only able to fill about 3,000 per week, she said.
“In the 16 years I’ve been in this space, I have never seen this high a need,” Morris said.

That need is creating intense competition for a limited pool of nurses nationwide.

“Nurses are getting paid premiums to work in Texas and Florida where it’s surging right now,” Sugarman said. “Those nurses have to come from somewhere, and I wouldn’t be surprised if some are coming from California.”

In short: vaccine mandates for health-care workers (most of whom have already been infected with COVID) are probably doing more harm than good as far as creating a safe and stable health-care system in the Golden State. Maybe Gov. Newsom (or his successor) should give it a rethink?

https://www.zerohedge.com/covid-19/california-nurse-shortage-reaches-crisis-level-vaccine-mandate-wards-traveling-nurses

U.S. job growth seen slowing in August as Delta variant curbs services demand

 U.S. employment growth likely pulled back in August after gaining nearly 2 million jobs in the past two months as soaring COVID-19 cases reduced demand for travel and entertainment, but the pace was probably enough to sustain the economic expansion.

The Labor Department’s closely watched employment report on Friday would come as economists have been sharply marking down their gross domestic product estimates for the third quarter. Reasons cited include the resurgence in infections, driven by the Delta variant of the coronavirus, and relentless shortages of raw materials, which are depressing automobile sales and restocking.

Surging COVID-19 cases could also have kept some unemployed people home, frustrating efforts by employers to boost hiring.

“The Delta variant is like a sandstorm in an otherwise sunny economy,” said Sung Won Sohn, a finance and economics professor at Loyola Marymount University in Los Angeles. “If it weren’t for that, employment in August would have been even higher.”

According to a Reuters survey of economists nonfarm payrolls likely increased by 750,000 jobs last month. The economy created 1.881 million jobs in June and July. Should job growth in August meet expectations, that would leave the level of employment about 5 million jobs below its peak in February 2020.

But the forecast is highly uncertain, with estimates ranging from 375,000 to 1.027 million.

High frequency indicators have suggested a softening in demand for air travel, hotel accommodation and in-person dining, which some economists expect led to a moderation in leisure and hospitality job growth.

Reports this week showed a measure of factory employment contracting and private payrolls undershooting expectations. But hiring by small businesses accelerated and consumers’ views of the labor market remained fairly upbeat.

Over the last several years, including in 2020, the initial August payrolls print has undershot expectations and been slower than the three-month average job growth through July.

“COVID effects may make this comparison to the trend less useful, however, August payrolls have been revised higher with the subsequent two jobs reports in 11 of the last 12 years, including last year,” said Conrad DeQuadros, senior economic advisor at Brean Capital in New York.

Friday’s report will be crucial for financial markets as investors try to gauge the timing of the Federal Reserve’s announcement on when it will start scaling back its massive monthly bond buying program.

Fed Chair Jerome Powell last week affirmed the ongoing economic recovery, but offered no signal on when the U.S. central bank plans to cut its asset purchases beyond saying it could be “this year.”

Jim O’Sullivan, chief U.S. Macro Strategist at TD Securities in New York, who is forecasting a 400,000 rise in payrolls in August, does not believe this would be weak enough for the Fed to back away from their “this year” signal.

“But it would probably increase the probability of a formal announcement coming at the December rather than the November meeting,” said O’Sullivan. “We certainly don’t expect an announcement at this month’s meeting, even if the August data are stronger than expected.”

SUPPLY CONSTRAINTS BITE

Despite the flare-up in COVID-19 cases, the leisure and hospitality sector likely accounted for a big chunk of payroll gains last month. Some economists expect the hit to restaurant and bars would be in the form of reduced hours.

Government employment likely increased solidly as schools reopened for in-person learning, though the pace slowed from July’s whopping 240,000 jobs.

Manufacturing payrolls are expected to have advanced by 25,000 jobs last month. Factory hiring is being constrained by input shortages, especially semiconductors, which have depressed motor vehicle production and sales.

Raw material shortages have also made it harder for businesses to replenish inventories.

Motor vehicle sales tumbled 10.7% in August, prompting economists at Goldman Sachs and JPMorgan to slash third-quarter GDP growth estimates to as low as a 3.5% annualized rate from as high as 8.25%.

“At some point production should pick up, allowing for the restocking of inventories and supporting sales, but it is unclear exactly when this will occur,” said Daniel Silver, an economist at JPMorgan in New York. “The recent spread of the Delta variant and persistence of broader supply chain issues has generated some downside risk to the near-term outlook.”

The economy grew at a 6.6% rate in the second quarter.

The unemployment rate is expected to have declined to 5.2% in August from 5.4% in July. It has, however, been understated by people misclassifying themselves as “employed but absent from work.”

The pandemic has upended labor market dynamics, creating worker shortages even as 8.7 million people are officially unemployed. There were a record 10.1 million job openings at the end of June. Lack of affordable childcare, fears of contracting the coronavirus, generous unemployment benefits funded by the federal government as well as pandemic-related retirements and career changes have been blamed.

There is cautious optimism the labor pool will increase because of schools reopening and government-funded benefits expiring on Monday. But the Delta variant likely delayed the return to the labor force for some.

“While we believe the trend in labor force participation is higher due to reopening and mass vaccination, we expect a pause in August due to concerns around the Delta variant,” said Spencer Hill, an economist at Goldman Sachs in New York.

With labor scarce, average hourly earnings likely increased 0.3% after rising 0.4% in July. That would keep the annual increase in wages at 4% in August.

https://www.reuters.com/article/usa-economy/u-s-job-growth-seen-slowing-in-august-as-delta-variant-curbs-services-demand-idUSKBN2FZ09H

CytoDyn Webcast Sept. 8 on HIV BLA Status, COVID-19 and NASH Trials

 CytoDyn Inc. (OTCQB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today Nader Pourhassan, Ph.D., President and Chief Executive Officer, Scott Kelly, M.D., Chairman, Chief Medical Officer and Head of Business Development, and Christopher Recknor, M.D., Chief Operating Officer and Head of Clinical Development, will host an investment community webcast on Wednesday, September 8, 2021.

Management will provide an overview of the results from the recently reported data from the mTNBC trials, along with updates on COVID-19 and NASH trials, and the status of the resubmission of the BLA for HIV.

Management will provide approximately 60 minutes to address questions submitted online by analysts and investors.

Date:Wednesday, September 8, 2021
Time:1:00 pm PT / 4:00 pm ET
Dial-In:None
Questions: 
  • Prior to the webcast, questions can be submitted online to ir@cytodyn.com.
  • During the webcast, questions can be submitted through the webcast link below.

This is a “listen only” webcast, which can be accessed via CytoDyn’s corporate website at www.cytodyn.com under the Investors section/IR Calendar and will be archived for 30 days. Participants are encouraged to go to the website 15 minutes prior to the start of the webcast to register, download and install any necessary software. Please note the below website will not be operational until approximately 60 minutes prior to the start of the webcast, which can be accessed via the following link:

https://78449.themediaframe.com/dataconf/productusers/cydy/mediaframe/46521/indexl.html

The replay will be available approximately 60 minutes after the conclusion of the webcast and can be accessed via the above link until October 8, 2021.

https://www.globenewswire.com/news-release/2021/09/02/2291228/0/en/CytoDyn-to-Hold-Webcast-on-September-8-to-Discuss-Results-from-mTNBC-Trials-HIV-BLA-Status-and-Updates-on-COVID-19-and-NASH-Trials.html

Cellect Biotech: ApoGraft™ Bone Marrow Transplantation of First Patient in U.S.

 Cellect Biotechnology Ltd. (NASDAQ: “APOP”), announced the first ApoGraftTM transplantation in a Leukemia patient in the Company’s clinical trial at Washington University in the U.S. ApoGraftTM is a product based on the Company’s cell selection technology designed to optimize immune therapy, in this application - prevent graft-versus-host disease (GVHD) following bone marrow transplantation.

Following the closing of the previously announced strategic merger transaction between Cellect and Quoin Pharmaceuticals, ApoGraftTM development will be pursued by EnCellX, the privately held U.S. based company that is acquiring Cellect’s proprietary technology concurrently with such merger. The trial will enroll 18 patients with hematological malignancies who are undergoing a haploidentical Bone Marrow Transplantation (BMT). EnCellX, led by Founder and CEO Adi Mohanty, is raising funds from leading healthcare institutional investors to expedite and expand clinical development.

“This is an important milestone for Cellect and demonstrates the team’s professionalism and dedication for getting us to this occasion,” commented Dr. Shai Yarkoni, Chief Executive officer. “We look forward to working closely with EnCellX as its U.S. based team will work closely with Washington University to continue patient enrollment. This achievement, following the release of positive topline data from the Israeli ApoGraftTM trial, is timely as EnCellX is seeking to strengthen its balance sheet in the near term to fund continuing clinical development.”

https://finance.yahoo.com/news/cellect-biotechnology-announces-apograft-bone-202000784.html

SupernusL Qelbree™ sNDA for Adult ADHD Accepted for Review by FDA

 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that the U.S. Food and Drug Administration (FDA) has acknowledged it has received the supplemental new drug application (sNDA) for Qelbree (viloxazine extended-release capsules) for the treatment of attention-deficit hyperactivity disorder (ADHD) in adult patients. The sNDA is now considered filed, with a user fee goal date (PDUFA date) of April 29, 2022.

In December 2020, Supernus announced positive topline results from a Phase III study of Qelbree in adults for the treatment of attention deficit hyperactivity disorder (ADHD). The results showed that at a daily dose of up to 600mg, the trial met the primary endpoint with robust statistical significance (p=0.0040) compared to placebo in improving the symptoms of ADHD from baseline to end of study as measured by ADHD Investigator Symptom Rating Scale. In addition to meeting the primary efficacy endpoint, the Phase III study met the key secondary efficacy endpoint with statistical significance (p=0.0023) in the change from baseline of the Clinical Global Impression – Severity of Illness Scale at week 6. The active dose was well tolerated.

Qelbree was approved in the U.S. in April 2021 for the treatment of ADHD in pediatric patients 6 to 17 years of age.

https://finance.yahoo.com/news/supernus-announces-qelbree-snda-adult-224500388.html

Thursday, September 2, 2021

Some vaccinated lose over 80% of COVID-19 immunity 6 months after Pfizer shot: study

 A new, multi-institutional study led by Case Western Reserve University—in partnership with Brown University—found that COVID-19 antibodies produced by the Pfizer vaccine decreased sharply in senior nursing home residents and their caregivers six months after receiving their second shots.

David Canaday, professor at the School of Medicine, and the research team studied blood samples of 120 Ohio nursing home residents and 92 health care workers. In particular, they looked at humoral immunity—also called antibody-mediated immunity—to measure the body's defenses against the coronavirus.

The researchers, including a lab team at Harvard University, found that individuals' antibody levels decreased more than 80% after six months; the results were the same in seniors (median age 76) and caregivers (median age 48) and old alike, according to the study.

After presenting their unpublished results directly to the senior staff at the Centers for Disease Control and Prevention (CDC), researchers were urged to get the data out in the public domain as soon as possible "so we could enter conversation and the decision-making process for booster vaccine recommendations," Canaday said. As a result, the researchers published the findings on medRxiv, an online preprint server for health sciences studies co-founded by Cold Spring Harbor Laboratory (CSHL), Yale University and the BMJ, a global healthcare knowledge provider, while the study is under review at a traditional peer-reviewed journal.

The sharp decline is particularly problematic for the seniors, because earlier research by Canaday and his colleagues found that within two weeks of receiving the second dose of vaccine and being considered "fully vaccinated," seniors who had not previously contracted COVID-19 already showed a reduced response in antibodies that was substantially lower than the younger caregivers experienced. By six months after vaccination, the blood of 70% of these nursing home residents had "very poor ability to neutralize the coronavirus infection in laboratory experiments," Canaday said.

The new research is part of a $2.3 million grant from the National Institutes of Health to CWRU and Brown University. That work led to another $4.9 million grantawarded in early August, from the CDC to Canaday and two other principal investigators—Stefan Gravenstein and Elizabeth White, at Brown University—to examine how long immunity lasts in nursing home residents and to research booster vaccines.

The results, Canaday said, support the CDC's recommendation for booster shots—especially for the elderly—due to fading immunity. And that boosters are even more important as the Delta variant spreads nationwide.

Early in the pandemic, higher COVID-19 mortality among nursing home residents led to making them a priority for vaccination. Most nursing home residents received the Pfizer vaccine under the emergency use authorizations because it was the first available vaccine on the market.


Explore further

Moderna vaccine gives bigger antibody boost than Pfizer in elderly, say researchers

More information: David H. Canaday et al, Significant reduction in humoral immunity among healthcare workers and nursing home residents 6 months after COVID-19 BNT162b2 mRNA vaccination, medRxiv (2021). DOI: 10.1101/2021.08.15.21262067
https://medicalxpress.com/news/2021-09-vaccinated-covid-immunity-months-pfizer.html

Prior COVID infection doesn't guarantee good immunity: study

 You caught a case of COVID-19 and then you got your first dose of a vaccine. Maybe you now think you are protected from coronavirus infections in the future.

Think again: New research shows that prior COVID-19 infection alone doesn't guarantee a high level of  against the coronavirus or a strong response after just one dose of two-dose vaccines.

The new study included 27 vaccinated Chicago-area adults; some had previously tested positive with the coronavirus. They submitted  two to three weeks after their first and second dose of either the Pfizer or Moderna vaccines, and two months after the second dose.

Northwestern University researchers analyzed the blood samples for antibodies against the coronavirus.

"When we tested blood samples from participants collected about three weeks after their second vaccine dose, the average level of inhibition was 98%, indicating a very high level of neutralizing antibodies," said Thomas McDade, professor of anthropology and a faculty fellow with the Institute for Policy Research.

But antibody levels against emerging variants were significantly lower, ranging from 67% to 92%.

Also, blood samples from previously infected people collected two months after the second vaccine dose showed antibody responses had declined by about 20%, according to the study published Aug. 30 in the journal Scientific Reports.

Another finding was that participants who'd had multiple COVID-19 symptoms had a stronger immune response to the vaccines than those who had mild symptoms or were asymptomatic.

"Many people, and many doctors, are assuming that any prior exposure to SARS-CoV-2 will confer immunity to reinfection. Based on this logic, some people with prior exposure don't think they need to get vaccinated. Or if they do get vaccinated, they think that they only need the first dose of the two-dose Pfizer/Moderna vaccines," McDade said in a university news release.

"Our study shows that prior exposure to SARS-CoV-2 does not guarantee a high level of antibodies, nor does it guarantee a robust antibody response to the first vaccine dose," he said. "For people who had mild or asymptomatic infections, their antibody response to vaccination is essentially the same as it is for people who have not been previously exposed."

The study was conducted before the emergence of the Delta variant, but the findings still apply, according to McDade.

"As far as protection goes after vaccination, the story is the same for all the variants, including Delta—the vaccine provides good protection, but not as good protection as the original version of the virus for which the  was designed. Combine that with the fact that immunity wanes over time, you get increased vulnerability to breakthrough infection," he said.

"So, it's two strikes right now—Delta plus waning immunity among the first wave of the vaccinated," McDade warned.


Explore further

COVID-19 antibody study shows downside of not receiving second shot

More information: Thomas W. McDade et al, Durability of antibody response to vaccination and surrogate neutralization of emerging variants based on SARS-CoV-2 exposure history, Scientific Reports (2021). DOI: 10.1038/s41598-021-96879-3
https://medicalxpress.com/news/2021-08-prior-covid-infection-doesnt-good.html