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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 funeral for Aretha Franklin will be held August 31 in Detroit, according to the singer's publicist, Gwendolyn Quinn.The service, for family and friends, will be held at 10 a.m. ET that day at Greater Grace Temple.Public viewings will be held August 28 and 29 from 9 a.m. to 9 p.m. at the Charles H. Wright Museum of African American History in Detroit, Quinn said.Franklin will be entombed at Woodlawn Cemetery in Detroit.The legendary soul singer died Thursday from advanced pancreatic cancer. She was 76. 518

The FDA continued on Monday to warn the public about using methanol-based hand sanitizers that the agency calls “dangerous.”The FDA has published a “Do Not Use” list of products. As of Monday afternoon, 87 products are on the do not use list. Adding to the confusion for consumers, many of the products do not have methanol on the label.Methanol can be toxic when absorbed through the skin as well as life-threatening when ingested, the FDA said. Retailers are being encouraged to recall these products.Methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death, the FDA warns."Practicing good hand hygiene, which includes using alcohol-based hand sanitizer if soap and water are not readily available, is an important public health tool for all Americans to employ. Consumers must also be vigilant about which hand sanitizers they use, and for their health and safety we urge consumers to immediately stop using all hand sanitizers on the FDA's list of dangerous hand sanitizer products," said FDA Commissioner Stephen M. Hahn, M.D. "We remain extremely concerned about the potential serious risks of alcohol-based hand sanitizers containing methanol. Producing, importing and distributing toxic hand sanitizers poses a serious threat to the public and will not be tolerated. The FDA will take additional action as necessary and will continue to provide the latest information on this issue for the health and safety of consumers."The FDA’s warnings come following a hand sanitizer shortage in the consumer and commercial markets. Amid the shortage companies that do not ordinarily produce hand sanitizers began bottling products before obtaining FDA approval. 1771

The death of a missing six-year-old boy with autism whose body was found in a North Carolina creek in September has been classified as a "probable drowning," according to an autopsy report from the Mecklenburg County Medical Examiner.Maddox Ritch went missing while on a walk with his father at a Gastonia park on September 22. In an extensive search, authorities used dogs, drones and sonar, and partially drained an 80-acre lake to better see its shoreline.Maddox's body was found five days later in a creek about a mile east of Rankin Lake Park, where he was last seen with his father and a friend, authorities said."The findings are not inconsistent with drowning," the medical examiner's report said. "In conjunction with investigative information at this time, which gives no indication of other than an accidental drowning, it seems reasonable to conclude that the likely cause of death is drowning."The body was partially submerged in 2 to 3 feet of water. The area, thick with underbrush, had been searched numerous times."We appreciate everyone's patience and support while we worked to uncover every piece of evidence available to bring our death investigation to this conclusion," Gastonia Police Chief Robert Helton said in a statement Thursday, adding that no criminal charges were expected to be filed in connection with the death."I ask for continued prayers for Maddox's family and everyone touched by this child's tragic death."Maddox's father, Ian Ritch, said in late September that he and a friend were walking when his son ran ahead, likely triggered by a passing jogger. Maddox was about 25 to 30 feet away when he broke into a sprint, Ritch said.Ritch said he "was giving him just a little leeway, freedom" but he had a clear view of his son. Maddox often would run ahead but let him catch up, Ritch said."I couldn't catch up with him. I feel guilt for letting him get so far ahead of me before I started running after him," Ritch told reporters.The FBI became involved in the case, with investigators waiting to determine the cause and manner of death, as well as the boy's exact movements. At the time, authorities pleaded for anyone with information to come forward.In an emotional Facebook post after the discovery of his son's body, Ritch wrote: "I had big plans with my son. I wanted us to go fishing play ball go camping. I wanted to be his hero. I wanted him to say I was more than superman or batman to him. I wanted people to ask him who his hero is and him say my daddy. Now I'm no hero I couldn't save him or protect him at all. I would give anything to go back and save him." 2624

The Carr Fire raging in Northern California is so large and hot that it is creating its own localized weather system with variable strong winds, making it difficult for experts to predict which way the blaze will spread.At least 19 people were still reported missing in Shasta County, California, officials said at a community meeting Monday evening, after shifting winds, dry fuel and steep terrain helped the monstrous fire engulf more than 103,000 acres.The fire has claimed six lives, including a firefighter and bulldozer operator working to extinguish the blaze.Authorities have received 48 missing person reports but 29 people have since been found safe, according to Shasta County Sheriff Tom Bosenko.The fire, which started a week ago, has burned 103,772 acres and is just 23% contained, according to the California Department of Forestry and Fire Protection, known as Cal Fire. It has scorched an area bigger than the size of Denver. 951

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