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The Food and Drug Administration resisted pressure from the Trump administration on Tuesday by releasing a set of guidelines that could push an emergency use authorization of a coronavirus vaccine past Election Day.The FDA’s new guidance notes that an Oct. 22 meeting of its Vaccines and Related Biological Products Advisory Committee will not be to discuss specific vaccine candidates. The FDA noted that a vaccine candidate must be at least 50% effective. Vaccine candidates should include a median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s risk-benefit."Being open and clear about the circumstances under which the issuance of an emergency use authorization for a COVID-19 vaccine would be appropriate is critical to building public confidence and ensuring the use of COVID-19 vaccines once available,” Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research, said. The FDA's new guidance on emergency use authorization of COVID-19 vaccines underscores that commitment by further outlining the process and recommended scientific data and information that would support an emergency use authorization decision.“In addition to outlining our expectations for vaccine sponsors, we also hope the agency's guidance on COVID-19 vaccines helps the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy for any vaccine that is authorized or approved."Trump previously said he would consider overruling the FDA on its vaccine guidelines in hopes of speeding up the process. There is both health and economic pressure for a vaccine to be developed as the coronavirus continues to claim an average of 800 US lives a day, according to Johns Hopkins University data. The number of deaths per day related to the coronavirus is expected to increase as the weather gets colder, according to the University of Washington’s Institute for Health Metrics and Evaluation.On Tuesday, House Speaker Nancy Pelosi blasted the Trump administration for involving itself in the vaccine approval process.“Trust in the vaccine is key to the acceptance of the American people, which is essential to crushing the virus.“The White House’s decision to reject FDA medical experts’ minimum safety and efficacy standards for emergency use authorization of a vaccine is an extremely dangerous act. We are all praying for a safe and effective vaccine as soon as possible, but the damage of the Trump Administration rushing a vaccine before it is known to be safe and effective could be catastrophic."Dr. Anthony Fauci told CNN's Chris Cuomo on Monday that he expects a vaccine candidate to be given an emergency use authorization by the end of 2020. "By the time we get to November, December, maybe earlier, I don't think it's going to be earlier, but it's still possible," Fauci said. "It will be early, but I think comfortably around November or December we'll know whether or not the vaccine is safe and effective. I actually am cautiously optimistic from what I've seen about preliminary data in phase one, that there's a very good chance we'll have a safe and effective vaccine." 3256

The COVID-19 pandemic has given a new perspective to many people across the world. For some women, it's made them consider whether the career they've chosen is the right one.A new survey by AllBright Collective, a membership-based club created by women that aims to provide inspiration, career coaching, networking and more for women around the world, shows many women are ready for a change."And so what we wanted to do was, rather than just guess what people were thinking, we wanted to do this global survey to really try and understand how women were thinking about their careers when we emerge," said Anna Jones, the CEO of AllBright Collective. "And we were actually very pleasantly surprised."Jones says AllBright surveyed 800 members during the pandemic, and 61% of them said they were going to be pivoting in their career."Now, that may mean pivoting to a different industry or different job, or it may be pivoting within the organization they're working in. But we were very pleasantly surprised that it was quite positive and women were very keen to kind of grab this time as an opportunity and make their ambitions a reality," Jones said.The survey also showed 25% of women were already in the process of changing their careers."I think we've all gotten used to working in a different way," Jones said. "We're all sitting on Zoom and connecting digitally in a way that we could never have imagined. I think for many women who wanted to work more flexibly, they're proving that they can."Elizabeth Middleton, a former teacher and mom of four, isn't surprised by the survey's results. She, too, is in the middle of a career change, starting her own business, Forward Function Health."It's been a major life shift," Middleton said. "I knew — and it wasn't just because of this pandemic, fortunately — before the pandemic, I was making this shift. But the pandemic just confirmed that it's the best for my family and self, and I think the pandemic has woken everybody up. It woke me up."Middleton is nearly finished with her courses relating to nutrition and wellness counseling and is thrilled to find a career that fills her soul."We launch fully in 2021. However, I've had already quite a few people on board with needs with this coronavirus," Middleton said. "I'm looking forward to helping people.""I also think that maybe it's just that we've had a bit of time," Jones said. "Admittedly, people have been juggling a lot. Juggling their households, chores and household responsibilities and their work but I think we've all had a little bit more time to think about, Well what would we like to do?"AllBright is hoping to continue working with its members who need additional support to make their new career moves — taking newfound time at home and turning a business idea into a reality. 2809

The CEO of a skincare company has issued an apology after she accused a man of "defacing private property" by chalking the words "Black Lives Matter" on the building where he lives in San Francisco.The CEO of LAFACE skincare, Lisa Alexander, issued a public apology to James Juanillo, the man she accosted."The last 48 hours has taught me that my actions were those of someone who is not aware of the damage caused by being ignorant and naive to racial inequalities. When I watch the video I am shocked and sad that I behaved the way I did. It was disrespectful to Mr. Juanillo and I am deeply sorry for that," Alexander's statement read, in part.The video, posted to social media on Friday, shows Alexander and another man, later identified as Robert Larkin, speaking with Juanillo. In the video, Alexander accuses Juanillo of "defacing private property" as he stenciled "Black Lives Matter" in yellow chalk on a wall at his home.Alexander and Larkin told Jaunillo that he was "free to express his opinion," but "that was not the way to do it."Juanillo then asked if it would be OK if he were chalking his own property. Alexander and Larkin said that they knew Juanillo didn't own the property because they "knew who lived there."Juanillo encouraged Alexander and Larkin to call the police if they felt unsafe. Juanillo told KGO in San Francisco that the two did call the police, but when officers arrived, they quickly recognized Juanillo as a resident."I didn't even show (the police) my ID," Juanillo told KGO.KGO also spoke to one of the property owners, who said he does not know Alexander or Larkin.The video of the incident spread quickly on social media, with many referring to Alexander as a "Karen" — a slang term for an entitled woman, often used in the context of racism.Alexander's identity was not independently confirmed until she came forward to apologize. However, Birchbox — a makeup subscription service — released a statement on Twitter denouncing Alexander's actions after Twitter users brought the video to their attention. Birchbox said that it had not worked with LAFACE in "several years," but nonetheless had "officially cut ties with the company."The video also prompted trolls to leave negative Yelp reviews of a Los Angeles-based skincare store, My LA Face, which has no connection to Alexander or her business, LAFACE. A representative for Yelp told KGO that those negative reviews would be removed.Read Alexander's full statement below.I want to apologize directly to Mr. Juanillo. There are not enough words to describe how truly sorry I am for being disrespectful to him last Tuesday when I made the decision to question him about what he was doing in front of his home. I should have minded my own business.The last 48 hours has taught me that my actions were those of someone who is not aware of the damage caused by being ignorant and naive to racial inequalities. When I watch the video I am shocked and sad that I behaved the way I did. It was disrespectful to Mr. Juanillo and I am deeply sorry for that. I did not realize at the time that my actions were racist and have learned a painful lesson. I am taking a hard look at the meaning behind white privilege and am committed to growing from this experience. I would love to have coffee with Mr. Juanillo in our neighborhood so I can apologize in person and share a dialogue where I can continue to learn and grow and be a better person.Robert Larkin also issued an apology statement.Over the last two days, I have had my eyes opened wide to my own ignorance of racial inequity, and I have thought a lot about my own personal blind spots. I was wrong to question Mr. Juanillo, and I was wrong to call the neighborhood police watch. It was wrong, and I am profoundly sorry for treating him with disrespect.I have a lot to learn about how racism impacts people in their lives, daily, I have hurt my neighbor. I am full of regret and very sorry. I am hoping to meet with him soon to express my sincere apology and to ask for his forgiveness and guidance in helping me begin the journey towards being a kinder, more thoughtful and sensitive person. 4144

The freewheeling entrepreneur who built Tower Records into a global business and pioneered a new way to sell music has died at 92.Russ Solomon, who started selling records at his father's pharmacy in the 1950s, passed away on Sunday at his home near Sacramento, California.The founder of Tower Records died while watching the Academy Awards, his son Michael Solomon told the Sacramento Bee."He was giving his opinion of what someone was wearing that he thought was ugly, then asked [his wife] Patti to refill his whiskey," Michael Solomon told the newspaper.Solomon had passed away by the time his wife returned.The first Tower Records opened in Sacramento in 1960, and by 1968 the company had expanded to San Francisco. Its iconic yellow and red signs would later be seen as far away as London and Tokyo.Fans flocked to the stores, attracted by a relaxed atmosphere where it was easy to bond with other music aficionados. Solomon did not have a dress code for employees, who mixed easily with customers."If you came into town, you went into Tower Records," Bruce Springsteen said in a documentary about the company called "All Things Must Pass."Solomon told Billboard Magazine in 2015 that his favorite regular was Elton John."He probably was the best customer we ever had," Solomon said of the pop star. "He was in one of our stores every week, literally, wherever he was -- in L.A., in Atlanta when he lived in Atlanta, and in New York."The chain thrived on massive demand for physical music -- first records and then CDs. Solomon built sprawling mega stores where fans could find everything from pop hits to obscure albums.But the retailer was soon undermined by dramatic changes in the music industry.The rise of music sharing sites such as Napster put it under pressure, and the company's debt ballooned. Tower declared bankruptcy in 2004, and was liquidated in 2006."The banks said 'we don't need a visionary,'" Solomon lamented in "All Things Must Pass," which was directed by Colin Hanks."When we met Russ," Hanks told Billboard in 2015, "it took less than a second to realize this guy is a great character and one of the most humble people I had ever met."  2180

The first snowflakes flew into the lower 48 this week.A big winter storm blew through the higher elevations of western Montana and northern Idaho earlier this week, and now, a few of those snowflakes may fall in parts of western Wyoming and in the mountains of Utah and Colorado. 287

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