FDA Committee Says It’s Safe For All Adults Who Got J&J’s COVID-19 Vaccine To Get a Booster

The Food and Drug Administration should authorize a second “booster” dose of Johnson & Johnson’s JNJ, +0.74% COVID-19 vaccine for adults who were initially vaccinated with this vaccine, according to a group of scientists and clinicians that advises the regulator.

The FDA’s Vaccines and Related Biological Products Advisory Committee voted 19-0 that allowing adults who were initially vaccinated with the J&J shot to get a booster is safe and effective. Their recommendation is based on giving a booster to those 18 years old and older at least two months after they got their first shot.

“This does look more like a two-dose vaccine,” Dr. Michael Nelson, a professor of medicine UVA Health and the UVA School of Medicine and a temporary voting member of the FDA committee.

One difference with this booster recommendation is that the group of people who would qualify for the J&J booster can get it two months after getting their first dose, compared with six months after the primary series of shots for the mRNA vaccines developed by Moderna Inc. MRNA, -2.31% and BioNTech SE BNTX, -1.06% /Pfizer Inc. PFE, -0.43%.

If the FDA follows the advice of the committee, which it is not required to do but often does, it means that all three COVID-19 vaccines that are available in the U.S. have authorized boosters, with the caveat that there are restrictions in place on who can get a mRNA booster.

The mRNA boosters are reserved at this time for people older than 65 years old, adults who are at high risk of severe disease, and those who face higher exposure to the virus because of their jobs.

About 15 million people in the U.S. have received the J&J’s adenovirus-based COVID-19 vaccine. J&J’s stock is up 2.6% so far this year, while the broader S&P 500 SPX, +0.75% has gained 18.1%.

By: Jaimy Lee

Jaimy Lee is a health-care reporter for MarketWatch. She is based in New York.

Source: FDA committee says it’s safe for all adults who got J&J’s COVID-19 vaccine to get a booster – MarketWatch

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Critics:

The Janssen COVID‑19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized by FDA through an Emergency Use Authorization (EUA) for active immunization to prevent Coronavirus Disease 2019 (COVID‑19) in individuals 18 years of age and older.

The emergency use of this product is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the medical product under Section 564(b)(1) of the FD&C Act, unless the declaration is terminated or authorization revoked sooner.

Healthcare professionals should be alert to the signs and symptoms of thrombosis with thrombocytopenia in individuals who receive the Janssen COVID-19 Vaccine. In individuals with suspected thrombosis with thrombocytopenia following administration of the Janssen COVID-19 Vaccine, the use of heparin may be harmful and alternative treatments may be needed.

Consultation with hematology specialists is strongly recommended. The American Society of Hematology has published considerations relevant to the diagnosis and treatment of thrombosis with thrombocytopenia following administration of the Janssen COVID-19 Vaccine (https://www.hematology.org/covid-19/vaccine-induced-immune-thrombotic-thrombocytopenia).

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More Men Than Women Are Now Single. It’s Not a Good Sign

Almost a third of adult single men live with a parent. Single men are much more likely to be unemployed, financially fragile and to lack a college degree than those with a partner. They’re also likely to have lower median earnings; single men earned less in 2019 than in 1990, even adjusting for inflation. Single women, meanwhile, earn the same as they did 30 years ago, but those with partners have increased their earnings by 50%.

These are the some of the findings of a new Pew Research analysis of 2019 data on the growing gap between American adults who live with a partner and those who do not. While the study is less about the effect of marriage and more about the effect that changing economic circumstances have had on marriage, it sheds light on some unexpected outcomes of shifts in the labor market.

Over the same time period that the fortunes of single people have fallen, the study shows, the proportion of American adults who live with a significant other, be it spouse or unmarried partner, also declined substantially. In 1990, about 71% of folks from the age of 25 to 54, which are considered the prime working years, had a partner they were married to or lived with. In 2019, only 62% did.

Partly, this is because people are taking longer to establish that relationship. The median age of marriage is creeping up, and while now more people live together than before, that has not matched the numbers of people who are staying single.

But it’s not just an age shift: the number of older single people is also much higher than it was in 1990; from a quarter of 40 to 54-year-olds to almost a third by 2019. And among those 40 to 54-year-olds, one in five men live with a parent.

The trend has not had an equal impact across all sectors of society. The Pew study, which uses information from the 2019 American Community Survey, notes that men are now more likely to be single than women, which was not the case 30 years ago.

Black people are much more likely to be single (59%) than any other race, and Black women (62%) are the most likely to be single of any sector. Asian people (29%) are the least likely to be single, followed by whites (33%) and Hispanics (38%).

Most researchers agree that the trendlines showing that fewer people are getting married and that those who do are increasingly better off financially have a lot more to do with the effect of wealth and education on marriage than vice versa. People who are financially stable are just much more likely to find and attract a partner.

“It’s not that marriage is making people be richer than it used to, it’s that marriage is becoming an increasingly elite institution, so that people are are increasingly only getting married if they already have economic advantages,” says Philip Cohen, a professor of sociology at the University of Maryland, College Park.

“Marriage does not make people change their social class, it doesn’t make people change their race, and those things are very big predictors of economic outcomes.”

This reframing of the issue may explain why fewer men than women find partners, even though men are more likely to be looking for one. The economic pressures on men are stronger. Research has shown that an ability to provide financially is still a more prized asset in men than in women, although the trend is shifting.

Some studies go so far as to suggest that the 30-year decrease in the rate of coupling can be attributed largely to global trade and the 30-year decrease in the number of stable and well-paying jobs for American men that it brought with it.

When manufacturing moved overseas, non-college educated men found it more difficult to make a living and thus more difficult to attract a partner and raise a family.

But there is also evidence that coupling up improves the economic fortunes of couples, both men and women. It’s not that they only have to pay one rent or buy one fridge, say some sociologists who study marriage, it’s that having a partner suggests having a future.

“There’s a way in which marriage makes men more responsible, and that makes them better workers,” says University of Virginia sociology professor W. Bradford Wilcox, pointing to a Harvard study that suggests single men are more likely than married men to leave a job before finding another. The Pew report points to a Duke University study that suggests that after marriage men work longer hours and earn more.

There’s also evidence that the decline in marriage is not just all about being wealthy enough to afford it. Since 1990, women have graduated college in far higher numbers than men.

“The B.A. vs. non B.A. gap has grown tremendously on lots of things — in terms of income, in terms of marital status, in terms of cultural markers and tastes,” says Cohen. “It’s become a sharper demarcation over time and I think that’s part of what we see with regard to marriage. If you want to lock yourself in a room with somebody for 50 years, you might want to have the same level of education, and just have more in common with them.”

By Belinda Luscombe

Source: More Men Than Women Are Now Single. It’s Not a Good Sign | Time

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The Role of Empathy In Improving Patient Care and Decreasing Medical Liability

Studies reveal that more than half of all practicing physicians demonstrate signs of burnout. Contemporary physicians face tremendous pressures due to a confluence of factors, including balancing heavy patient loads within constrained schedules, the increasing complexity of patient health problems, and increasingly burdensome COVID-related documentation requirements.

These circumstances—and more—challenge physician empathy, and even to some extent dampen it even further. Multiple research studies document a decline in empathy that appears to begin in the third year of medical school and persists during residency.  The pandemic has exacerbated this deterioration. In the past, empathy rebounded after the rigors of training were over, but today, empathy needs to be refreshed to help both patients and providers. Physicians who lose sight of the meaning, purpose, and rewards of their roles in patients’ lives suffer more from burnout than those who remain connected to their purpose.

The role of empathy training

In response to patients’ pleas for more empathic care and national media headlines calling for more compassion in medicine, which have been growing since about 2005, empathy training courses grounded in the neuroscience of emotions and emotional intelligence can be helpful. In fact, recent neuroscience research on the brain’s plasticity in up-regulating and down-regulating empathy provided evidence that empathy could be taught.

The research team in the Empathy and Relational Science program at Massachusetts General conducted a study of the effectiveness of the three, 60-minute empathy training courses in physicians. Researchers found statistically significant improvement in patient perception of physician empathy on a validated and reliable empathy rating scale called the “CARE measure.” Another study by the same team show that empathic physician behaviors resulted in higher ratings of both physician warmth and competence.

One of the most frequently asked questions about empathy training is, “Doesn’t this just add even more time to a busy doctor’s day?” Actually, it does not. Empathic care does not have to take more time. Courses on empathy training help health care professionals detect subtle emotional cues and nuances that indicate patient concerns so they can be addressed right away.

In addition, when physicians convey empathy, they put patients at ease, increasing trust in the provider-patient relationship. This creates a dynamic that ensures that small problems are addressed before they become bigger problems. Multiple studies have demonstrated that better medical outcomes are also correlated with strong empathy and relational skills.

Empathy training offers many benefits 

Courses based on empathy research and principles provide training for each of the following predictors of risk of increasing medical professional liability claims:

  1. Physicians’ uncaring attitudes, attitudes of superiority, or callousness
  2.  Communication failures including not listening, interrupting, or not being clear about availability or backup coverage
  3. Disparagement of previous care
  4. Failure to learn and manage patient expectations

Physicians can learn how to perceive patient emotions, manage difficult interactions, and communicate bad news. Empathy education teaches how to respond with empathy and compassion even in challenging situations, including informed consent conversations and inter-team conflicts.

In addition to greater patient satisfaction, doctors also discover the personal satisfaction that connecting with their patients in a more meaningful way provides.  “After empathy training, I feel that I like my work again, and instead of resenting all the demands, I’m remembering why I chose this profession in the first place,” a physician reported.

Interviews and research around empathy-based practices reveal that greater empathy not only improves patient satisfaction, but also helps to reduce physician burnout and improve physician job satisfaction. By using empathy-based skills, physicians, nurses, and other providers become more attuned to the needs of patients and their families. With this greater perception and shifts in attitudes, communication between providers and patients improves.

More empathic conversations will enable patients to trust their care to physicians who are confident in their skills without demeaning prior care they may have received. Patients will appreciate physicians who explain things clearly, ask about and understand their expectations, and form alignment about what is desired, likely, and possible.

Empathy-based training brings rewards

Through empathy-based training, physicians and other health care providers learn the skills to have honest informed consent discussions without causing undo fear, while also preparing patients for all possible outcomes. Empathic skills make for better physicians, better communications, and better conversations for all outcomes.

With a strong alliance, a reduction in medical professional liability claims is the result of increased trust, better understanding and expectations of all possible outcomes, and knowledge that physicians deeply care about their patients, because, when it comes to health care, empathy matters.

Helen Riess is a psychiatrist and author of The Empathy Effect: Seven Neuroscience-Based Keys for Transforming the Way We Live, Love, Work, and Connect Across Differences. This article originally appeared in Inside Medical Liability.

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Empathy Is The Most Important Leading Skill According To Research

Empathy has always been a critical skill for leaders, but it is taking on a new level of meaning and priority. Far from a soft approach it can drive significant business results.

You always knew demonstrating empathy is positive for people, but new research demonstrates its importance for everything from innovation to retention. Great leadership requires a fine mix of all kinds of skills to create the conditions for engagement, happiness and performance, and empathy tops the list of what leaders must get right.

The Effects of Stress

The reason empathy is so necessary is that people are experiencing multiple kinds of stress, and data suggests it is affected by the pandemic—and the ways our lives and our work have been turned upside down.

  • Mental Health. A global study by Qualtrics found 42% of people have experienced a decline in mental health. Specifically, 67% of people are experiencing increases in stress while 57% have increased anxiety, and 54% are emotionally exhausted. 53% of people are sad, 50% are irritable, 28% are having trouble concentrating, 20% are taking longer to finish tasks, 15% are having trouble thinking and 12% are challenged to juggle their responsibilities.
  • Personal Lives. A study in Occupational Health Science found our sleep is compromised when we feel stressed at work. Research at the University of Illinois found when employees receive rude emails at work, they tend to experience negativity and spillover into their personal lives and particularly with their partners. In addition, a study at Carleton University found when people experience incivility at work, they tend to feel less capable in their parenting.
  • Performance, Turnover and Customer Experience. A study published in the Academy of Management Journal found when people are on the receiving end of rudeness at work, their performance suffers and they are less likely to help others. And a new study at Georgetown University found workplace incivility is rising and the effects are extensive, including reduced performance and collaboration, deteriorating customer experiences and increased turnover.

Empathy Contributes to Positive Outcomes

But as we go through tough times, struggle with burnout or find it challenging to find happiness at work, empathy can be a powerful antidote and contribute to positive experiences for individuals and teams. A new study of 889 employees by Catalyst found empathy has some significant constructive effects:

  • Innovation. When people reported their leaders were empathetic, they were more likely to report they were able to be innovative—61% of employees compared to only 13% of employees with less empathetic leaders.
  • Engagement. 76% of people who experienced empathy from their leaders reported they were engaged compared with only 32% who experienced less empathy.
  • Retention. 57% of white women and 62% of women of color said they were unlikely to think of leaving their companies when they felt their life circumstances were respected and valued by their companies. However, when they didn’t feel that level of value or respect for their life circumstances, only 14% and 30% of white women and women of color respectively said they were unlikely to consider leaving.
  • Inclusivity. 50% of people with empathetic leaders reported their workplace was inclusive, compared with only 17% of those with less empathetic leadership.
  • Work-Life. When people felt their leaders were more empathetic, 86% reported they are able to navigate the demands of their work and life—successfully juggling their personal, family and work obligations. This is compared with 60% of those who perceived less empathy.

Cooperation is also a factor. According to a study published in Evolutionary Biology, when empathy was introduced into decision making, it increased cooperation and even caused people to be more empathetic. Empathy fostered more empathy.

Mental health. The study by Qualtrics found when leaders were perceived as more empathetic, people reported greater levels of mental health.

Wired for Empathy

In addition, empathy seems to be inborn. In a study by Lund University, children as young as two demonstrated an appreciation that others hold different perspectives than their own. And research at the University of Virginia found when people saw their friends experiencing threats, they experienced activity in the same part of their brain which was affected when they were personally threatened. People felt for their friends and teammates as deeply as they felt for themselves. All of this makes empathy an important part of our human condition—at work and in our personal lives.

Leading with Empathy

Leaders can demonstrate empathy in two ways. First, they can consider someone else’s thoughts through cognitive empathy (“If I were in his/her position, what would I be thinking right now?”). Leaders can also focus on a person’s feelings using emotional empathy (“Being in his/her position would make me feel ___”). But leaders will be most successful not just when they personally consider others, but when they express their concerns and inquire about challenges directly, and then listen to employees’ responses.

Leaders don’t have to be experts in mental health in order to demonstrate they care and are paying attention. It’s enough to check in, ask questions and take cues from the employee about how much they want to share. Leaders can also be educated about the company’s supports for mental health so they can provide information about resources to additional help.

Great leadership also requires action. One leader likes to say, “You’re behaving so loudly, I can hardly hear what you’re saying.” People will trust leaders and feel a greater sense of engagement and commitment when there is alignment between what the leader says and does. All that understanding of someone else’s situation should turn into compassion and action. Empathy in action is understanding an employee’s struggles and offering to help.

It is appreciating a person’s point of view and engaging in a healthy debate that builds to a better solution. It is considering a team member’s perspectives and making a new recommendation that helps achieve greater success. As the popular saying goes, people may not remember what you say, but they will remember how you made them feel.

In Sum

Empathy contributes to positive relationships and organizational cultures and it also drives results. Empathy may not be a brand new skill, but it has a new level of importance and the fresh research makes it especially clear how empathy is the leadership competency to develop and demonstrate now and in the future of work.

Follow me on Twitter or LinkedIn. Check out my website or some of my other work here.

I am a Ph.D. sociologist and the author of The Secrets to Happiness at Work exploring happiness, fulfillment and work-life. I am also the author of Bring Work to Life by

Source: Empathy Is The Most Important Leadership Skill According To Research

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SEC Signs Deal To Investigate DeFi Transactions

Blockchain analytics firm AnChain.AI has signed a deal with the U.S. Securities and Exchange Commission (SEC) to help monitor and regulate the turbulent decentralized finance (DeFi) industry, according to a company spokesperson. The initial value of the contract is $125,000, with five separate one-year $125,000 option years for a total of $625,000.

According to CEO and co-founder Victor Fang, “The SEC is very keen on understanding what is happening in the world of smart contract-based digital assets…so we are providing them with technology to analyze and trace smart contracts.”

AnChain.AI is a San Jose-based artificial intelligence and machine learning blockchain startup that focuses on tracking illicit activity across crypto exchanges, DeFi protocols, and traditional financial institutions. In revealing the SEC contract, which started in May 2021, the company also announced today a $10 million Series A round of funding led by an affiliate of Susquehanna Group, SIG Asia Investments LLP, at an undisclosed valuation.

The deal comes on the heels of the SEC taking further interest in DeFi as it rapidly matures and grows in size. The industry currently manages more than $82 billion, and the largest decentralized exchange, Uniswap, processed over $1.8 billion worth of transactions in the last 24 hours, many of which included tokens that could be determined to be securities by the SEC.

Additionally, these platforms are becoming increasingly complex. Fang noted that the Uniswap platform is actually an amalgam of 30,000 separate smart contracts that execute the actual exchange of tokens.

The SEC’s first major action against the DeFi space came in 2018, when it shut down EtherDelta, a ‘DeFi’ exchange that it deemed to be operating illegally.

In an August interview with The Wall Street Journal, SEC Chairman Gary Gensler warned that DeFi operations are not immune from oversight because they use the word decentralized, and that “There’s still a core group of folks that are not only writing the software, like the open source software, but they often have governance and fees…There’s some incentive structure for those promoters and sponsors in the middle of this.”

SEC Commissioner Hester Peirce echoed this sentiment in a March interview with Forbes, but perhaps in an acknowledgement of the potential in DeFi asked these projects to come forward and be pro-active with the regulator, “When you start to look at the tokens themselves and try to figure out whether they’re securities, it does get kind of confusing.

In particular, it’s so hard in the DeFi landscape because there’s such variety. This is why I encourage individual projects to come in and talk to the SEC because it really does require a look at the very particular facts and circumstances.”

In addition to cataloguing and monitoring known wallets tied to illicit actors, AnChain.AI has built a predictive engine that can be used to identify unknown addresses and transactions that could be suspicious. This is all part of Fang’s goal to move beyond doing “post-incident investigations” to move the “defense all the way up to the upstream” and make it “preventive”.

Aside from government clients, AnChain.AI’s technology is also being used by centralized cryptocurrency exchanges and traditional financial institutions. In a press release, Ye Li, Investment Manager at SIG said of the investment, “AnChain.AI has made great progress in developing its market-leading crypto security technology to meet its customers’ broad demand in regulatory compliance and transaction intelligence.”

The SEC declined to comment.

Follow me on Twitter or LinkedIn. Check out my website. Send me a secure tip.

I am director of research for digital assets at Forbes. I was recently the Social Media/Copy Lead at Kraken, a cryptocurrency exchange based in the United States.

Source: SEC Signs Deal To Investigate DeFi Transactions

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How Much Money Is ‘Enough’? Try This Experiment to Get an Exact Number to Aim For

a wad of money secured with a blue paper clip on a pink background

Have you ever read those articles where some extremely well-off family details their budget and then bemoans that they’re barely getting by?

It’s ridiculous that anyone could complain about raking in $350,000 a year, and it’s clear many of these folks are wildly out of touch with how privileged they are. But while these families may be extreme (and annoying), they aren’t alone. It’s not just the wealthy who fall into the trap of earning more only to spend more and feel just as dissatisfied.

How do you get off this treadmill?

The answer is not to compare yourself with others (Jeff Bezos will always be there to make you feel bad), or to blindly try to keep making more (there will always be some shiny, new thing to covet). The answer is to take a hard look at your own financial realities and aspirations and come up with a goal number. How much money is enough for you?


The Science of Money and Happiness

That number will be different for everyone, depending on your circumstances and values, but science can give us some sense of how much money might be “enough.” Research shows that up to a certain threshold (studies consistently put it at about $75,000 dollars a year, give or take a bit depending on cost of living) money has a big impact on both day-to-day happiness and life satisfaction.

If you’re below this level, making more will likely make you significantly happier. But beyond that point, each additional dollar adds a little less to your life. There is a level of wealth way before Bill Gates status that trading more effort and time for more money ceases to make sense (even Bill Gates says so).


Name Your Number

One way to calculate that point is to figure out how much money you’d need to make decisions based entirely on enjoyment and impact, without pressure to earn. This is the goal of the catchily named FIRE movement (for financial independence, retire early). Its boosters generally say that 25X your expected annual expenses is enough. So if $50,000 a year is enough for you to live comfortably, you need to save $1.25 million.

There are other more elaborate calculators that can give you a sense of what financial independence means for you. But perhaps the best way to get a feeling for your goal number isn’t math but a simple thought experiment from writer Brad Stollery:

Suppose you’re one of five people who have been selected by a mysterious philanthropist to participate in a contest. The five of you all have comparable debt-levels and costs-of-living, as well as similar, middle-class financial situations. You’re all roughly the same age, equally healthy, have the same number of children, and you all live moderately low-risk lifestyles. Privately, and one by one, a representative of the donor approaches each of you with a blank check and a pen, and poses the following question:

How much money would you have to be paid, right here and now, to retire today and never receive another dollar of income (from any source) for the rest of your life?

The catch this time is that whoever among the five players writes the lowest amount on the check will be paid that sum. The other four players will get nothing.

This thought experiment forces you to cut away the natural impulse to aim ever upward (if you do that you’ll bid too high and get nothing). That result is however much you ask for is your number, the amount you’d need to live comfortably and pursue your goals if status and lifestyle inflation weren’t a factor.

Your answer might be a little bit higher or lower than mine or your neighbor’s. That’s fine. It’s not important everyone agree on a number. The important thing is that we each reflect enough to have one.

Because the alternative is being one of those people confessing online how you burn through a healthy six-figure salary and still feel stressed and dissatisfied. Your expenses and desires can be infinite. If you don’t want to chase them miserably forever, you need to put a cap on your financial ambitions yourself.

By: Jessica Stillman

This post originally appeared on Inc. and was published February 5, 2020. This article is republished here with permission.

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