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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 Broadway League, the trade association that regulates theater performances in New York City, said Monday that all Broadway shows would be canceled through the end of 2020 due to the coronavirus pandemic.The group says that those who have purchased tickets to shows before Jan. 3, 2021 will automatically receive an email detailing refund and exchange information."Every single member of our community is eager to get back to work sharing stories that inspire our audience through the transformative power of a shared live experience," Thomas Schumacher, the Broadway League's Chairman of the Board, said in a statement released Monday. "The safety of our cast, crew, orchestra and audience is our highest priority and we look forward to returning to our stages only when it’s safe to do so. One thing is for sure, when we return we will be stronger and more needed than ever.”“Our membership is working closely with the theatrical unions and in concert with key experts and some of the greatest minds inside and outside of the industry to explore protocols for all aspects of reopening. We are focused on identifying and implementing necessary measures that will enable us to resume performances safely for Broadway audiences and employees,” Charlotte St. Martin, the president of the Broadway League, said in a statement. “We are determined to bring back the people who rely on this industry for their livelihood, and to welcome back all those who love this vital part of New York City, as soon as it is safe to do so. "Broadway performances in New York shut down on March 12, the day before President Donald Trump declared the pandemic a national emergency. Last month, the Broadway League said it was canceling all performances through Sept. 6. 1759

The Food and Drug Administration warned pregnant women on Thursday of using some pain and fever medications during the second half of pregnancies.According to the FDA, these nonsteroidal anti-inflammatory drugs can cause rare but serious kidney problems in the unborn baby, which can cause pregnancy-related complications. Nonsteroidal anti-inflammatory drugs include ibuprofen, naproxen, diclofenac, and celecoxib. The FDA added that its warning does not apply to low-dose aspirin.“It is important that women understand the benefits and risks of the medications they may take over the course of their pregnancy,” said Patrizia Cavazzoni, M.D., acting director of FDA’s Center for Drug Evaluation and Research. “To this end, the agency is using its regulatory authority to inform women and their health care providers about the risks if NSAIDs are used after around 20 weeks of pregnancy and beyond.”The FDA says that warnings on prescription nonsteroidal anti-inflammatory drugs already advise of complications past 30 weeks. The newest guidance calls on health care providers to only prescribe the lowest effective dose for the shortest period possible for women 20 to 30 weeks into their pregnancy.More information on the warning can be found here. 1259

The CEOs of T-Mobile and Sprint are confident that their proposed merger will get approval from US regulators and create jobs — and that it won't raise prices for wireless subscribers.T-Mobile's John Legere and Sprint's Marcelo Claure told CNN's Richard Quest on Monday that the merger of the two companies would make it easier for them to build out a national, high-speed 5G network before their rivals Verizon and AT&T do."The country needs 5G," Claure said. He said the United States can't fall further behind China and South Korea, which are ahead in deploying 5G technology. 591

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

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