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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 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

The chemotherapy dripped through a catheter in his chest. Cancer patient Robert Goodman had burned through his paid sick days while undergoing surgery and chemotherapy for colon cancer.The Florida public school teacher figured he needed at least 20 additional sick days to deal with more chemotherapy, days he just didn't have. So on July 23, right there in a room at Tomsich Health and Medical Center of Palm Beach County, Goodman took a selfie, posted it on Facebook and appealed for help.Within four days he had enough sick days to cover an entire semester."I couldn't believe it happened so fast," Goodman, 56, told CNN.Teachers, staff members, administrators and even lunchroom workers who pay into the Florida retirement system transferred 75 sick days to Goodman."Educators all over the country were reaching out to me to donate their sick days, even professors over at Florida Atlantic University," he said. "I felt guilty because I knew there were people who had it much worse than me." 1003
The COVID-19 death of the speaker of the New Hampshire House of Representatives has raised fears that other members of one of the world's largest legislatures might have been exposed at their swearing-in ceremony last week. A medical examiner announced the cause of death Thursday of 71-year-old Dick Hinch. Hinch was found dead in his home.He was photographed at the outdoor swearing-in wearing a mask improperly, without it covering both his nose and mouth. Dozens reportedly attended without wearing masks at all. Several Republican lawmakers have tested positive after attending an indoor meeting in late November where many attendees didn't wear masks. One Republican representative says Hinch's death may be a result of “peer pressure exerted by those in the Republican Party who refuse to take reasonable precautions."At a news conference Thursday, New Hampshire Governor Chris Sununu, a fellow Republican, called Hinch a "tireless leader" and close friend. He then said Hinch's death was a "cautionary tale" about not wearing a mask properly.“For those who are just out there doing the opposite just to make some ridiculous political point, it is horribly wrong,” Sununu said. “Please use your heads. Don’t act like a bunch of children, frankly.”Other state Republicans were harsher in their messaging. Representative William Marsh, a retired doctor, posted on Twitter, “Those in our caucus who refused to take precautions are responsible for Dick Hinch’s death." 1479
The bull market turns 3,453 days old on Wednesday. It's the longest period of uninterrupted gains in American history.The remarkable run began on March 9, 2009, in the ashes of the Great Recession and the scariest financial crisis since the 1930s. The slow-but-steady economic recovery, coupled with unprecedented aid from the Federal Reserve, catapulted the Dow from around 6,500 to nearly 26,000 today. The S&P 500 has quadrupled from its 2009 low of 666. And market darlings like Netflix and Amazon have skyrocketed much further.The bull market narrowly survived countless panic attacks from crisis-scarred investors along the way. There was the downgrade of America's credit rating in 2011, the feared collapse of the euro, China's alarming economic slowdown and the dramatic crash in oil prices.Yet each scare failed to derail the steady rise of the economy and corporate profits that has underpinned Wall Street's record-breaking run. There were close calls, but the S&P 500 never dropped 20%, the trigger for a new bear market. 1050
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