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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 Centers for Disease Control and Prevention is set to shorten the recommended length of quarantine after exposure to someone positive for COVID-19, as the virus rages across the nation.According to a senior administration official, the new guidelines, which are set to be released as soon as Tuesday evening, will allow people who have come in contact with someone infected with the virus to resume normal activity after 10 days, or 7 days if they receive a negative test result.That's down from the 14 days recommended since the onset of the pandemic.According to the Associated Press, the agency adjusted its guidance in July by shortening it from 14 days to 10.The agency presented the new guidance during a White House coronavirus task force meeting on Tuesday for final approval, the AP reported. 812
The Chicago Police Department announced that they arrested the mother of a 5-year-old girl who was stabbed to death on Saturday.CPD Superintendent David O. Brown announced the news during a press conference on Monday. 225
The Federal Aviation Administration (FAA) has cleared the Boeing 737 Max to return to the skies, The Associated Press reports.The plane has been grounded in the U.S. since March 2019 after it was involved in two deadly crashes just months after initial orders for the model had been fulfilled. The two crashes — one which occurred in Africa, the other in Asia — killed a combined 346 people.In Congressional hearings last September, Boeing officials say the plane's software included a fatal flaw that caused a nosedive in certain situations.In addition to the human cost of the software error, the Boeing 737 Max has proven to be malignant for Boeing's business. According to CNN, Boeing says the grounding of the 737 Max has resulted in billion in direct costs. Boeing's stock fell 100 points between March 2019 and January 2020 — a massive loss even before the COVID-19 pandemic dragged the entire market down with historic losses. "These 20 months they took to look at every possible issue with the aircraft is more than enough time to make it safe to go back in the air," said Kevin Kuhlmann, an Aviation and Aerospace Science Professor at Metro State University. "It's no small undertaking to go through and develop this training, put the pilots through the training and absorb the cost of the training."In October, American Airlines announced it would begin using the plane on certain routes in late December, pending FAA approval. The company says it will provide flexibility to passengers who do not want to fly on the plane.Other airlines like Southwest say they won't be putting the plane back in rotation until April. 1641
The classified ads website Backpage.com has been seized by federal law enforcement agencies, according to a banner that popped up on the site Friday.The banner says, "backpage.com and affiliated websites have been seized as part of an enforcement action" by the FBI, US Postal Inspection Service and the IRS Criminal Investigation Division.Lawmakers on Capitol Hill and advocacy groups have long called for an investigation into Backpage.com for allegedly facilitating prostitution and sex trafficking.A spokesperson for the Justice Department confirmed to CNN that the website has been seized and that additional information would be made available Friday evening. However, a judge decided that the federal case should remain sealed on Friday night. No other additional information was provided.A two-year Senate investigation into online sex trafficking found that found that Backpage.com knowingly aided criminal sex trafficking of women and young girls, simply scrubbing terms from ads such as "Lolita," "teenage," "rape," "amber alert," and publishing them on its site. After the investigation was published in January 2017, Backpage.com shut down its adult ads section.The company has been targeted with several lawsuits over the years, but has been largely protected by Section 230 of the 1996 Communications Decency Act, a legal protection that gives a broad layer of immunity to online companies from being held liable for user-generated content. Companies are supposed to act in good faith to protect users, but critics argue the law can be used as a shield. The law, however, does not, protect sites from federal liability against criminal law, like child-pornography laws.Last month, however, the Senate approved bipartisan legislation called the Stop Enabling Sex Traffickers Act. The legislation would create an exception to Section 230, which would pave the way for victims of sex trafficking to hold websites accountable for facilitating abuse.Two days after the Senate approval, Backpage competitor Craigslist removed its personal ads section.The-CNN-Wire 2080