California Votes to Require Paid Sick Leave for Virus Cases

 When Crystal Orozco got sick with the coronavirus last month, she missed nearly two weeks' worth of her salary as a shift leader at a fast food restaurant and had to ask family members for a loan to help pay her rent.

"My check was literally $86," she said. "I was like, 'Oh my god.'"

Now, Orozco is likely to get that money back. The California Legislature passed a bill Monday requiring many companies to give workers up to two weeks of paid time off if they get sick from the coronavirus. The bill is retroactive to Jan. 1, so Orozco could be eligible for backpay for the days she missed when she was sick.

At the start of the pandemic, state and federal laws required most employers to give workers paid time off for the coronavirus. But many of those laws expired as more people got vaccinated and case numbers declined. California's law expired in September.

Since then, omicron — a more contagious version of the coronavirus — has spread rapidly throughout the world. The variant set a record in California for the average number of new cases and contributed to an increase in hospitalizations, mostly among the unvaccinated population.

Labor unions have been pressuring their Democratic allies in the Legislature to renew the state's sick leave law — culminating in a deal reached last month between Gov. Gavin Newsom and legislative leaders. Lawmakers approved the bill Monday and sent it to Newsom, who is expected to sign it into law.

When he does, it will make California the fourth state to require paid time off for workers who get sick with the coronavirus. Similar mandates are still in effect in Massachusetts, Colorado and New York, according to the National Conference of State Legislatures.

Five other states — Nevada, New Jersey, Oregon, Rhode Island and Washington — have paid sick leave laws that, while not COVID-specific, can be used cover time off from the coronavirus.

Orozco is a member of Fight for $15, a group advocating for a $15 minimum wage and union rights for fast food worker. She said she wasn't offered paid time off when she got sick.

At least six of the 16 people who work at her restaurant — more than one-third of the workforce — had coronavirus symptoms or missed work because of the virus, according to a complaint filed by the workers with state and local officials. The complaint is still pending, Orozco said.

Orozco said she and her husband had to skip their car insurance payment and used borrowed money to help pay rent. She said the new bill, once signed into law, will allow her to "know I'm able to pay back my family that let me borrow that money."

"It's going to help everybody in the same industry (that are) tight on money," she said.

https://www.medscape.com/viewarticle/968131

Promising Leads to Crack Long COVID Discovered

 It's a story of promise at a time of urgent need.

Scientists are optimistic about new evidence into what is causing long COVID, a panel of research experts brought together by the New York State Department of Health said.

They proposed many theories on what might be driving long COVID. A role for a virus "cryptic reservoir" that could reactivate at any time, "viral remnants" that trigger chronic inflammation, and action by "autoimmune antibodies" that cause ongoing symptoms are possibilities.

In fact, it's likely that research will show long COVID is a condition with more than one cause, the experts said during a recent webinar.

People might experience post-infection problems, including organ damage that takes time to heal after initial COVID-19 illness. Or they may be living with post-immune factors, including ongoing immune system responses triggered by autoantibodies.

Determining the cause or causes of long COVID is essential for treatment. For example, if one person's symptoms persist because of an overactive immune system, "we need to provide immunosuppressant therapies," Akiko Iwasaki, PhD, said. "But we don't want to give that to someone who has a persistent virus reservoir," meaning remnants of the virus remain in their bodies.

Interestingly, a study pre-print, which has not been peer reviewed, found dogs were accurate more than half the time in sniffing out long COVID, said Iwasaki, professor of immunobiology and developmental biology at Yale University.

The dogs were tasked with identifying 45 people with long COVID versus 188 people without it. The findings suggest the presence of a unique chemical in the sweat of people with long COVID that could someday lead to a diagnostic test.

Viral Persistence Possible

If one of the main theories holds, it could be that the coronavirus somehow remains in the body in some form for some people after COVID-19.

Mady Hornig, MD, agreed this is a possibility that needs to be investigated further.

"A weakened immune response to an infection may mean that you have cryptic reservoirs of virus that are continuing to cause symptoms," she said during the briefing. Hornig is a doctor-scientist specializing in epidemiology at Columbia University in New York City.

"That may explain why some patients with long COVID feel better after vaccination," because the vaccine creates a strong antibody response to fight COVID-19, Iwasaki said.

Researchers are unearthing additional potential factors contributing to long COVID.

Viral persistence could also reactivate other dormant viruses in the body, such as Epstein-Barr virus (EBV), said Lawrence Purpura, MD, MPH, an infectious disease specialist at New York Presbyterian/Columbia University in New York City. Reactivation of Epstein-Barr is one of four identifying signs of long COVID revealed in a Jan. 24 study published in the journal Cell.

Immune Overactivation Also Possible?

For other people with long COVID, it's not the virus sticking around but the body's reaction that's the issue.

Investigators suggest autoimmunity plays a role, and they point to the presence of autoantibodies, for example.

When these autoantibodies persist, they can cause tissue and organ damage over time.

Other investigators are proposing "immune exhaustion" in long COVID because of similarities to chronic fatigue syndrome, Hornig said.

"It should be 'all hands on deck' for research into long COVID," she said. "The number of disabled individuals who will likely qualify for a diagnosis of [chronic fatigue syndrome] is growing by the second."

Forging Ahead on Future Research

It's clear there is more work to do. There are investigators working on banking tissue samples from people with long COVID to learn more, for example.

Also, finding a biomarker unique to long COVID could vastly improve the precision of diagnosing long COVID, especially if the dog sniffing option does not pan out.

Of the thousands of biomarker possibilities, Hornig said, "maybe that's one or two that ultimately make a real impact on patient care. So it's going to be critical to find those quickly, translate them, and make them available."

In the meantime, some answers might come from a large study sponsored by the National Institutes of Health. The NIH is funding this "Researching COVID to Enhance Recovery" project using $470 million from the American Rescue Plan. Investigators at NYU Langone Health are leading the effort and plan to share the wealth by funding more than 100 researchers at more than 30 institutions to create a "meta-cohort" to study long COVID. More information is available at recovercovid.org.

"Fortunately, through the global research effort, we are now really starting to expand our understanding of how long COVID manifests, how common it is and what the underlying mechanisms may be," Purpura said.

Sources

Akiko Iwasaki, PhD, professor of immunobiology and molecular, cellular and developmental biology, Yale University, New Haven, CT.

Mady Hornig, MD, associate professor of epidemiology, Mailman School of Public Health, Columbia University, New York City.

Lawrence Purpura, MD, MPH, infectious disease specialist, New York Presbyterian/Columbia University Irving Medical Center, New York City.

https://www.medscape.com/viewarticle/968125

AMGEN PROVIDES LONG-TERM GUIDANCE THROUGH 2030 IN BUSINESS REVIEW

 In connection with its virtual business review, Amgen (NASDAQ:AMGN) provided preliminary long-term guidance between 2022 and 2030 in addition to full year 2022 guidance.

In addition, the Company discussed its 2022 share repurchase plans of between $6 billion and $7 billion, including its plans to buy back up to $6 billion of its shares during the first quarter of 2022.

Amgen's business review is taking place February 8, 2022 from 8:00 a.m. to approximately 12:00 p.m. ET  and financial analysts, investors, members of the news media and the general public may access the business review and other webcasts and presentations regarding developments in Amgen's business given at investor and medical conferences via www.amgen.com under the Investors tab. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

At the conclusion of the meeting, Amgen will issue a press release reviewing the content of the meeting that provided a comprehensive overview of the Company's strategy, commercial operations, pipeline, research and development capabilities.

https://www.biospace.com/article/releases/amgen-provides-long-term-guidance-through-2030-during-business-review-meeting/

Alzheon Alzheimer's Asset Poised for Phase III with High Hopes

 Alzheon today posted positive results from its Phase II biomarker trial on ALZ-801 (valiltramiprosate) in patients diagnosed with neurodegenerative disorders such as Alzheimer's disease. 

ALZ-801 is administered orally and works by blocking the formation of neurotoxic soluble amyloid oligomers that later lead to cognitive decline in Alzheimer's patients. It has also shown potential for safety and efficacy in Alzheimer's patients who are the most exposed to risk, particularly those who have two copies of the apolipoprotein ε4 allele (APOE4/4). Alzheon is poised to move forward to its Phase III APOLLOE4 trial, which focuses on this population. 

The Phase II biomarker study is fully enrolled with 84 patients and is still ongoing. It is evaluating the use of ALZ-801 in early Alzheimer's patients who have one or two copies APOE3/4 heterozygotes and APOE4/4 homozygotes. APOE4 is one of the leading risk factors for Alzheimer's after aging. 

Patients received 265mg of ALZ-801 orally twice a day and were assessed for the primary outcome of change from baseline in plasma p-tau181. The analysis of biomarkers was based on results from 80 patients who completed the week 26 visit. 

In this study, participants saw a 29% reduction in plasma p-tau181 after 26 weeks and an 18% reduction after 13 weeks. The plasma p-tau181/Aβ42 ratio dropped 30% after 26 weeks and 21% after 13 weeks. Researchers said there is strong potential for disease modification with the effects on these biomarkers. 

"Rather than slowing the cognitive decline of patients as seen in trials with other agents, subjects treated with ALZ-801 demonstrated significant cognitive gain from baseline status on memory tests, showing improvement over the course of treatment. These well-differentiated results position ALZ-801 to potentially become the first oral agent that can slow or even stop and prevent Alzheimer's pathology in patients and healthy individuals at risk for the disease," said Martin Tolar, M.D., Ph.D., the founder, president and chief executive of Alzheon, in a statement. 

Apart from the biomarker results, the Alzheon's Phase II study also identified a memory and standard of living test called the Rey Auditory Verbal Learning Test (RAVLT) as its secondary outcome. Patients showed significant improvement from baseline records for an immediate and delayed recall after week 26. No severe events or evidence of vasogenic edema was seen. 

"ALZ-801 is in a class of its own as an easy-to-administer oral tablet that has shown the potential for robust efficacy with a favorable safety profile, avoiding the vascular complications of brain edema and microbleeds seen with infusions of plaque-clearing anti-amyloid antibodies," added John Hey, Ph.D., the chief scientific officer of Alzheon, in the same press release. 

The National Institute on Aging has given Alzheon a $47 million grant to fund its Phase III trial, which looks into the efficacy, safety, biomarker and imaging effects of taking 265mg of ALZ-801 two times a day. This randomized, double-blind trial will go for 78 weeks. 

https://www.biospace.com/article/alzheon-posts-positive-results-from-phase-ii-alzheimer-s-biomarker-trial-phase-iii-commences/

COVID-19 vaccine production quietly suspended at Johnson & Johnson: report

 Johnson & Johnson temporarily halted production of its COVID-19 vaccine in the Netherlands, the only manufacturing hub making usable doses for the pharmaceutical company, according to a New York Times report on Tuesday.

The company stopped production of the vaccine at its facility in the Dutch city of Leiden at the end of 2021 and has instead turned its attention to making another vaccine for an unrelated virus, the Times reported. The pause is temporary and is expected to last just a month — but it could reduce Johnson & Johnson's vaccine supply by a few hundred million doses.

While the Johnson & Johnson vaccine from Janssen Pharmaceuticals has been linked to rare blood clots and is considered less effective than Pfizer's and Moderna's shots by the Centers for Disease Control and Prevention, it is extremely important in Africa and low-income countries, which rely on the simpler one-dose shot.

The vaccine also avoids the requirement of storage in ultra-cold temperatures, which makes shipment of Moderna and Pfizer doses more difficult.

In October, Johnson & Johnson said it was committing about 50 million vaccines to 40 countries through COVAX, the vaccine-sharing initiative from the World Health Organization and the United Nations.

But Ayoade Alakija, a co-head of the African Union’s vaccine-delivery program, told the Times that switching up production could endanger the vaccination effort.

“This is not the time to be switching production lines of anything, when the lives of people across the developing world hang in the balance,” she said.

A spokesperson for the company told The Hill that millions of doses were in inventory and they were still planning to "fulfill our contractual obligations" related to COVAX and the African Union.

"We strive to improve human health and have worked tirelessly to forge partnerships and build a global manufacturing network across four continents to produce our COVID-19 vaccine. In addition, we expanded the capacity of our facility in Leiden in 2021, and the site continues to play a role in our vaccine manufacturing in 2022," the spokesperson said.

"Our manufacturing sites produce multiple products as we have an obligation to supply life changing medicines to patients around the world and bring forward our innovative pipeline of new medicines and vaccines. We manage our production planning accordingly and are currently supplying from our extensive global network based on the demand for our vaccine and the needs of our patients and customers," the spokesperson added.

Millions of Americans have received Johnson & Johnson's vaccine, and the company earned $2.39 billion in vaccine sales in 2021. Johnson & Johnson is estimating even higher sales in 2022, ranging between $3 billion and $3.5 billion.

According to the report from the Times, Johnson & Johnson is planning to revive three other manufacturing plants to produce its COVID-19 vaccine, including a facility in Baltimore that was shut down in April following a failure to meet federal guidelines.

https://thehill.com/policy/healthcare/593316-covid-19-vaccine-production-quietly-suspended-at-johnson-johnson-plant

Overdose epidemic costs US $1T per year

 The ongoing opioid epidemic is costing the U.S. $1 trillion every year, posing "a threat to our national security and global competitiveness," according to a bipartisan congressional report released on Tuesday.

Rep. David Trone (D-Md.) and Sen. Tom Cotton (R-Ark.), the chairs of the Commission on Combating Synthetic Opioid Trafficking, released a final report examining the cost of the opioid epidemic and the potential strategies to mitigate it as the crisis has worsened during the pandemic.

A record-breaking number of overdose deaths were reported in the 12-month period ending in April, according to the Centers for Disease Control and Prevention. The 100,306 overdose deaths reported during that period were increase of 28.5 percent from the 78,056 deaths the prior year. 

In a Tuesday press release, lawmakers said the epidemic is having a "devastating human impact" on American society. The Centers for Disease Control and Prevention (CDC) estimates opioids have killed nearly 500,000 Americans from 1999 to 2019, but Trone pointed out there have been more than 1 million drug overdose deaths in the U.S. since 1999.

“Since 1999, we’ve lost more than one million Americans to drug overdoses. That’s one million moms, dads, sons, and daughters lost because our country’s response to the opioid epidemic has failed,” he said in a statement. “It’s time to come together, from all levels of government and both sides of the aisle, to address this epidemic and put an end to it once and for all."

The Commission on Combating Synthetic Opioid Trafficking, established in 2020, also includes Sen. Edward Markey (D-Mass.) and Rep. Fred Upton (R-Mich.), along with overdose experts and officials from the Drug Enforcement Administration, Department of Defense, Office of the Director of National Intelligence and the Treasury Department, among others.

The commission's report calls for the government to streamline data collection and increase prevention resources and access to treatment; develop a central body to review U.S. drug control policies; collaborate with other nations producing synthetic opioids; and disrupt the drug supply through "targeted oversight and enforcement."

Commission members said the government should crack down on Mexican cartels and other gangs distributing opioids into the U.S., as well as China, a primary supplier of synthetic opioids like the lethal drug fentanyl.

“We must destroy the cartels and drug trafficking networks that flood our streets with these poisons to protect our communities," Cotton said in a statement.

According to a study published last week from researchers at Stanford University, 1.2 million more people could die from overdoses by 2029 if more drastic measures are not taken to curb the epidemic.

https://thehill.com/policy/healthcare/593278-overdose-epidemic-costs-us-1t-per-year-research

Texas governor seeks to block vaccine mandate for National Guard members

 Texas Gov. Greg Abbott (R) filed a motion Tuesday seeking to block the military from enforcing its vaccine mandate for certain National Guard members in his state.

The motion, which was filed in the U.S. District Court for the Eastern District of Texas, argues that President Biden has not federalized the Texas National Guard, and therefore has no authority to enforce the mandate.

“This Court should enjoin the Biden Administration’s attempt to commandeer Governor Abbott’s commander-in-chief power. That lawless shortcut would undermine the chain of command, blur the lines of accountability, and hollow out the Texas National Guard in a way that puts all Texans at risk,” reads the motion.

“A preliminary injunction is needed to prevent these imminent and irreparable harms to Governor Abbott and the sovereign state he serves,” it adds.

The Pentagon had no comment on the motion because it is pending litigation. 

The request comes a month after Abbott sued the Pentagon over the vaccine mandate, claiming it conflicted with an order he gave to not punish Guardsmen who choose not to be vaccinated.  

Defense Secretary Lloyd Austin mandated vaccinations for the entire military in late August but left it up to each service to implement the mandate.

Air National Guard members had until Dec. 31 to be inoculated, but Army National Guard members still have until June 30 to be inoculated.

Alaska Gov. Mike Dunleavy (R) joined Abbott’s lawsuit on Jan. 27, but Monday’s motion focuses solely on the Texas National Guard.

The National Guard is unique, as it operates under two federal statutes. Abbott’s motion seeks to protect members of his state’s National Guard operating under Title 32 of the U.S. Code — which places them under state authority.

But Title 10 of the U.S. code stipulates that the president can mobilize the Guard, thereby placing them under federal authority.

Late last month, the Defense secretary wrote letters to Abbott, Dunleavy and five other GOP governors who have objected to the mandate, telling them that he had the power to implement the mandate “regardless of duty status.”

He further warned that failing to comply “will lead to a prohibition on participation in drills, training, and other duty conducted under title 32 and will jeopardize the member's status in the National Guard.”

“President Biden must be held accountable for his unconscionable willingness to hollow out the Texas National Guard with another illegal vaccine mandate,” Abbott said in a statement. “As the commander-in-chief of Texas’ militia, I will deploy every legal tool in defense of these American heroes."

https://thehill.com/policy/defense/593272-abbott-asks-for-preliminary-injunction-of-national-guard-vaccine-mandate-for