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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 exhibition fight between former heavyweight boxing champion Mike Tyson and Roy Jones Jr. has a new date.According to a press release by Triller, the 8-round showdown was slated for Sept. 12 but has been pushed back to Nov. 28."Changing the date to November 28 will give more people the opportunity to see the biggest comeback in boxing history," Tyson said in the news release. "This temporary inconvenience will last longer than Roy Jones Jr. He better be ready, I'm coming full force."New fights on the undercard were also announced. Badou Jack will face off against Blake McKernan and Viddal Riley will take on Rashad Coulter as they join the previously-announced bout between Youtube star Jake Paul vs. former NBA player Nate Robinson."Given the enormous interest, the holiday weekend will make this historic battle an even bigger viewing event, marking the first live Pay-Per-View event brought to the world by Triller as the first of the "Triller Battles" series," Triller said in the release.The full fight card:MAIN CARDMain EventMike Tyson vs. Roy Jones Jr.8 rounds - HeavyweightFeatured Bout 2Jake Paul v. Nate Robinson6 rounds - 188lbsFeatured Bout 3Badou Jake vs. Blake McKernan8 rounds - 192lbsFeatured Bout 4Vidal Riley vs. Randy Coulter6 rounds - 210lbsUNDERCARDBout 5Jamaine Ortiz v. Jesse Garcia8 rounds - 135lbsBout 6Irvin Gonzalez vs. Edward Vasquez8 rounds - 140lbsBout 7Giuseppe Cusumano vs. Nick Jones8 rounds - HeavyweightThe event is to take place at Dignity Health Sports Park in California and the California State Athletic Commission is sanctioning the bout.The "Frontline Battle" will be available to watch on Pay-Per-View and the social media platform Triller. 1701

The Department of Justice on Monday filed complaints against 11 individuals believed to be members of the?Central American migrant caravan, accusing them of illegally entering the United States.After a month-long journey by bus, train and on foot, about 100 migrants arrived at the San Ysidro port of entry on the US-Mexico border on Sunday evening, preparing to claim asylum. About 20 to 30 migrants spent the night inside an immigration processing center in Tijuana, Mexico.An organizer of the caravan vowed they would remain at the immigration processing center until "every last one" is admitted into the United States.Two Salvadorans, six Hondurans, and three Guatemalans face charges, a federal law enforcement official told CNN.Ten of them face a misdemeanor charge for allegedly entering the US illegally. Another individual is alleged to have entered the country after they were previously deported, and faces a felony charge.The probable cause statement alleges many of those charged were seen in an area known as Goat Canyon, about 4 miles to the west of the San Ysidro port of entry, on the US side of the border, the official said. Others were seen on the US side of the border about 2 miles west of San Ysidro in an area known as "W-8." 1263

The family of a Pennsylvania woman who died in jail in 2015 from heroin withdrawal symptoms was awarded .75 million in a wrongful death suit settlement this week, CBS News reported. Victoria "Tori" Herr, then 18, died on April 5, 2015, nine days after being arrested after police found drugs in the woman's apartment. Herr told police that she had consumed 10 bags of heroin a day. During her first four days in custody, Herr reportedly suffered from bouts of vomiting and diarrhea. She was treated with water and Ensure, but was unable to keep her fluids down. The result of those symptoms led her to cardiac arrest and to lose consciousness, CBS News reported. Herr's lawyers claimed that the Lebanon County Correctional Facility did not meet her basic medical needs, and then lied. "Anyone who looked at her would have known that she was very sick and that she needed attention," Herr's family lawyer Jonathan Feinberg told CBS. "There was a complete disregard for her needs, which can only be tied back to the fact that she was addicted to drugs."As part of the multi-million-dollar settlement, the jail's warden, nurses and other employees agree that there was no wrongdoing. To read CBS News' full report, click here.  1284

The elections board in Florida's Miami-Dade County has collected a set of mysterious ballots in the Opa-locka mail facility after Democrats raised concern about the uncounted votes.The uncounted ballots have emerged as one of many battles over the fiercely contested Florida elections that moved this weekend into a recount phase.Suzy Trutie, a spokesperson for the county's supervisor of elections, told CNN there were 266 ballots in the shipment and that the votes will not be counted. Florida law requires all ballots sent by mail to arrive at the election facility by 7 p.m. on Election Day, and these ballots did not meet that standard, Trutie said.The US Postal Service said in a statement on Friday that it was operating in "close coordination and partnerships with election officials at the local, county and state levels." But as of Sunday morning, it still did not confirm ballots had not been provided in time to local election officials. 957