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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 calendar just turned to November but some companies are already in the Christmas spirit. Starbucks and McDonald's have already released their 2017 holiday cups.Starbucks scrapped its traditional red design for a DIY cup. There's a stack of presents, a Christmas tree, doves, two people holding hands and lots of white space. Customers are encouraged to color the cups themselves. 412

The first cruise in the Caribbean since the start of the pandemic is reporting a COVID-19 case.A passenger aboard SeaDream Yacht Club’s SeaDream 1 received a preliminary positive COVID-19 test.According to passengers, the captain informed them about the preliminary positive test over the ship’s intercom system while they were anchored off the coast of Grenadines.The vessel is now headed back to Barbados, where it is based.The SeaDream is carrying 53 passengers and 66 crew, with the majority of passengers hailing from the U.S. according to Sue Bryant, who is aboard the ship and is a cruise editor for The Times and The Sunday Times in Britain.The SeaDream is the first vessel to resume sailing in the Caribbean since earlier this year when coronavirus pandemic concerns docked the cruise industry following high profile infections.Passengers were tested both in advance of traveling, before boarding, and again a few days into the trip.The SeaDream has a capacity of about 110 guests and 95 crewmembers. It also sails outside of U.S. waters. This puts it below the 250 guests threshold and outside the area under the CDC’s orders about cruising. 1159
The Department of Justice announced Wednesday the indictment of two fighters affiliated to the Islamic State group who are alleged to have killed American journalists and aid workers.El Shafee Elsheikh and Alexanda Kotey were previously in U.S. military custody in Iraq and have been transported to Virginia to face trial.Elsheikh and Kotey, both of the United Kingdom, are two of the four ISIS fighters nicknamed "The Beatles" by intelligence officers because of their British accents. They've been linked to the killings of aid workers Peter Kassig and Kayla Mueller and journalists Steven Sotloff and James Foley.“These charges are the product of many years of hard work in pursuit of justice for our citizens slain by ISIS. Although we cannot bring them back, we can and will seek justice on behalf of their memories,” Attorney General William Barr said in a statement. “My message to other terrorists around the world is this — if you harm Americans, you will face American arms on the battlefield, and if you survive that ordeal, you will face American law in our courtrooms with the prospect of many years in an American prison. Either way, you will never live in peace — you will be pursued to the ends of the earth until justice is done.”Barr was not present at Wednesday's press conference as he is currently self-isolating amid a COVID-19 outbreak in the Trump administration. 1395
The estimated jackpot for the next Powerball drawing is 5 million after Wednesday's drawing provided no winners.The cash value is 9.4 million and the next drawing takes place Saturday, March 17, which is also St. Patrick's Day.Click here to visit the Powerball website. 283
来源:资阳报