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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 city of Philadelphia has settled with two black men arrested at a Starbucks in the city. Rashon Nelson and Donte Robinson settled for apiece while the city committed 0,000 for young entrepreneurs, according to the New York Daily News. The two men were arrested after sitting down at the Starbucks without ordering anything. Starbucks also reached a settlement with the two men, the company said in a statement. The deal includes a financial settlement. "I want to thank Donte and Rashon for their willingness to reconcile," Starbucks CEO Kevin Johnson said in the statement. "I welcome the opportunity to begin a relationship with them to share learnings and experiences. And Starbucks will continue to take actions that stem from this incident to repair and reaffirm our values and vision for the kind of company we want to be." 889

The City of Glendale plans to vote on adding a permanent American flag to the top of Thunderbird Mountain. The Glendale Chamber Military and Veterans Affairs Committee sent a proposal to the city council asking to erect a flag. The committee will also manage it. Thunderbird Mountain falls within a conservation park, which means it is to be left as is. The picnic tables, garbage cans, and signage are all a part of the city's master plan, which is why they are allowed in the park. "We want people to enjoy it but not to disturb the wildlife the plants and not erect any structures in the park either, at least if they're not part of the master plan," said Vice-Mayor Lauren Tolmachoff. She is one of the council members voting to hold off on the change. "Not everybody on the council felt there was a conservation national park because there are signs and roads, and I disagree with that," she said. "You know there are roads in national parks, but they are still to be preserved and protected."No word on when the council will take an official vote, but it will likely be before the end of June. 1153
The Country Music Association on Friday reversed its decision to ban reporters from asking questions about the Las Vegas mass shooting during its upcoming awards show.The CMA faced criticism after it sent out media guidelines for its "51st Annual CMA Awards" which will be held Wednesday, November 8 at Bridgestone Arena in Nashville, Tennessee, and broadcast live on ABC.The guidelines asked journalists to avoid discussing several politically charged topics, including the mass shooting at the Route 91 Harvest Festival in Las Vegas last month, which left 58 people dead and more than 500 injured."In light of recent events, and out of respect for the artists directly or indirectly involved, please refrain from focusing your coverage of the CMA Awards Red Carpet and Backstage Media Center on the Las Vegas tragedy, gun rights, political affiliations or topics of the like," a section of the guidelines read. "It's vital, more so this year than in year's past due to the sensitivities at hand, that the CMA Awards be a celebration of Country Music and the artists that make this genre so great."But on Friday, the organization reversed that edict."CMA apologizes for the recently distributed restrictions in the CMA Awards media guidelines, which have since been lifted," it said in a statement to CNNMoney. "The sentiment was not to infringe and was created with the best of intentions to honor and celebrate Country Music."The CMA Awards draw some of the music genres' biggest names and for the tenth straight year, it will be hosted by country superstars Carrie Underwood and Brad Paisley.The original guidelines included a warning to those who don't heed them, including potentially missing out on covering country music's premiere event."It's an evening to honor the outstanding achievements in Country Music of the previous year and we want everyone to feel comfortable talking to press about this exciting time," the guidelines state. "If you are reported as straying from these guidelines, your credential will be reviewed and potentially revoked via security escort."The tragedy has stirred a great deal of discussion in the country music community among fans and performers alike, given the genre's association with gun culture.Gun control debate enters country music community: 'Is this the kind of world we want to live in?'Paisley told Rolling Stone last month that he feels the pressure of handling the tragedy correctly while hosting the awards show."We're not going to ignore it, but we're not going to also dwell on that," he said.. "We have to make sure we honor those we've lost, but we also [have to] celebrate this music, which lives on, and do a good job having the heart we need to have on that night. And also the theme of the show this year is very much about unity and coming together as a format."Friday morning, the singer had slammed the ban in a tweet that urged the CMA to reverse the guidelines."I'm sure the CMA will do the right thing and rescind these ridiculous and unfair press guidelines," he wrote. "In 3...2....1....." 3070
The boy who made headlines when he was photographed hugging an officer during a 2014 protest against police brutality is missing after his family's SUV plunged 100 feet off a coastal highway in California, officials said Wednesday.The bodies of Jennifer and Sarah Hart, of Washington, and three of their six children, were found Monday in and around the vehicle, which landed on its roof in the Pacific Ocean, Mendocino County Sheriff Tom Allman said. Their three other children, including 15-year-old Devonte, are missing. 531
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