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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 coronavirus is shaking up America’s liquor laws.At least 33 states and the District of Columbia are temporarily allowing cocktails to-go during the pandemic. Only two — Florida and Mississippi — allowed them on a limited basis before coronavirus struck, according to the Distilled Spirits Council of the United States.Struggling restaurants say it’s a lifeline, letting them rehire bartenders, pay rent and reestablish relationships with customers. But others want states to slow down, saying the decades-old laws help ensure public safety.Julia Momose closed Kumiko, her Japanese-style cocktail bar in Chicago, on March 16. The next day, Illinois allowed bars and restaurants to start selling unopened bottles of beer, wine and liquor, but mixed drinks were excluded.Momose spent the next three months collecting petition signatures and pressing lawmakers to allow carryout cocktails. It worked. On June 17, she poured her first to-go drink: a Seaflower, made with gin, vermouth, Japanese citrus fruit and fermented chili paste. A carryout bottle, which serves two, costs .Momose has been able to hire back four of her furloughed employees. A group she co-founded, Cocktails for Hope, is now helping restaurants buy glass bottles in bulk for carryout.“Part of getting cocktails to go approved was embracing the fact that this isn’t going to fix everything, but it is going to fix something,” Momose said. “All these little things that we do will keep us open and keep our staff employed.”U.S. liquor laws — many of which date to the end of Prohibition in 1933 —are a confusing jumble that vary by state, city and county.Carryout cocktail regulations — which were passed starting in March — only deepen that confusion. Lawmakers approved carryout cocktails in some states; governors approved them in others. Nevada passed no statewide measure, but individual cities like Las Vegas and Reno allow them. In Pennsylvania, only restaurants and bars that lost 25% of average monthly total sales can sell cocktails to go.Most carryout cocktail regulations require customers to buy food with their mixed drinks. Lids or seals are generally required, but some states say drinks also need to be transported in the trunk. Marbet Lewis, a founding partner at Spiritus Law in Miami who specializes in the alcohol industry, says IDs should be checked — online or in person — by restaurants and bars as well as by delivery drivers.Some states, like Arizona, allow third party delivery companies like DoorDash to deliver cocktails; Kansas only allows delivery within a 50-foot radius.The laws also have different sunset dates. Alabama is only allowing carryout cocktails through Sept. 15, while Colorado and Massachusetts have extended them into next year. Michigan is allowing them through 2025.Last month, Iowa became the first state to permanently allow carryout and delivery of cocktails. Lawmakers in Ohio and Oklahoma are considering a similar measure, and the governors of Texas and Florida have expressed support for the change.There is overwhelming public support for making cocktails to go permanent, says Mike Whatley, vice president of state and local affairs for the National Restaurant Association. Between 75% and 80% of respondents have said they support carryout cocktails in numerous state polls, Whatley said.U.S. restaurants and bars have lost an estimated 5 billion since March due to lockdowns and social distancing requirements, the association said. In a May survey of 3,800 restaurants, the association found that 78% of operators who were selling alcohol to go had brought back laid-off employees, compared to 62% of operators overall.But some are urging states not to be too hasty. Mothers Against Drunk Driving worries that permanent carryout cocktails will lead to an increase in drunken driving unless laws make clear that the drinks can’t be consumed until the buyer is in a safe location.The U.S. government hasn’t released preliminary drunk driving data for 2020. But Jonathan Adkins, the executive director of the Governors Highway Safety Association, said there’s no anecdotal evidence that drunk driving has spiked during the pandemic.Patrick Maroney, a former liquor control officer in Colorado who is now a consultant, said carryout beer and wine — which was allowed in around 15 states prior to the pandemic — are different from cocktails because the containers are sealed by the manufacturer and the alcohol content is lower. Cocktails are mixed at the bar, so the alcohol content can vary and they may not be properly sealed, he said.Maroney said states need to make sure police and health officials are consulted before changing laws that have worked for decades. He noted that California reported a spike in reports of alcohol delivery to minors in April.“Are law enforcement officials worried about an ‘open air’ type atmosphere?” he said. “Is the law restricted to at-home consumption? How do they enforce it?”Maroney received funding from the Center for Alcohol Policy — which is funded by beer wholesalers — for a recent research paper raising concerns about carryout cocktails.Even before the coronavirus hit, there was a push to modernize alcohol laws to reflect the growing popularity of food delivery, Lewis said. She thinks lawmakers will have a hard time reinstating bans on carryout cocktails once the pandemic eases.“Once you get the genie out of the bottle and there hasn’t been a problem, how do you get it back in?” she said.Still, restaurant and bar owners say they’re not worried that patrons will get so used to carryout that they’ll stop going out even after the coronavirus has passed.“I think that people are social. People enjoy the bar experience and like being waited on,” said Dave Kwiatkowski, who owns the Sugar House cocktail bar in Detroit, which closed March 15 but was able to reopen July 10 for carryout service.Kwiatkowski normally employs a staff of 16. For now, it’s just him at the door and a bartender making drinks.“It’s enough to pay the electricity and the insurance, and it’s nice to give at least a couple of people some jobs,” he said.Kwiatkowski does wonder how he’ll handle carryout demand once the pandemic has ended and there’s a crowd in the bar on a Saturday night. But that will be a good problem to have, he said. He wants carryout cocktails to be permanently legalized.“I think this is probably going to change how we do business forever,” he said. 6446

The demand for mail-in ballots is surging. Election workers need training. And polling booths might have to be outfitted with protective shields during the COVID-19 pandemic.As officials prepare for the Nov. 3 election, one certainty is clear: It’s coming with a big price tag.“Election officials don’t have nearly the resources to make the preparations and changes they need to make to run an election in a pandemic,” said Wendy Weiser, head of the democracy program at the Brennan Center for Justice. “We are seeing this all over the place.”The pandemic has sent state and local officials scrambling to prepare for an election like few others, an extraordinary endeavor during a presidential contest, as virus cases continue to rise across much of the U.S.COVID-related worries are bringing demands for steps to make sure elections that are just four months away are safe. But long-promised federal aid to help cash-starved states cope is stalled on Capitol Hill.The money would help pay for transforming the age-old voting process into a pandemic-ready system. Central to that is the costs for printing mail-in ballots and postage. There are also costs to ensure in-person voting is safe with personal protective equipment, or PPE, for poll workers, who tend to be older and more at risk of getting sick from the virus, and training for new workers. Pricey machines are needed to quickly count the vote.Complicating matters is President Donald Trump’s aversion to mail-in balloting. With worrisome regularity, he derides the process as rigged, even though there’s no evidence of fraud and his own reelection team is adapting to the new reality of widespread mail-in voting.“As cases of coronavirus in this country rise, it’s vital that all voters be able to cast their ballots from home, to cast their ballots by mail,” said Sen. Amy Klobuchar, D-Minn.A huge COVID response bill passed by the House in May contains a whopping .6 billion to help states with their elections, but the Senate won’t turn to the measure until late July. Republicans fought a 0 million installment of election aid this March before agreeing to it.But key Senate Republicans seem likely to support more election funding, despite Trump’s opposition, and are even offering to lower a requirement that states put up “matching” funds to qualify for the federal cash.“I’m prepared not only to look at more money for the states to use as they see fit for elections this year, but also to even consider whatever kind of matching requirement we have,” said Roy Blunt, R-Mo., chairman of the Senate panel with responsibility for the issue. “We can continue to work toward an election that produces a result that people have confidence in and done in a way that everybody that wants to vote, gets to vote.”The pandemic erupted this spring in the middle of state primaries, forcing many officials to delay their elections by days, weeks and even months. They had to deal with a wave of poll worker cancellations, polling place changes and an explosion of absentee ballots.Voting rights groups are particularly concerned with the consolidations of polling places that contributed to long lines in Milwaukee, Atlanta and Las Vegas. They fear a repeat in November.As negotiations on the next COVID relief bill begin on Capitol Hill, the final figure for elections is sure to end up much less than the .6 billion envisioned by the House. That figure followed the recommendations of the Brennan Center to prepare for an influx of absentee ballots while providing more early voting options and protecting neighborhood polling places.Even before the pandemic, election offices typically work under tight budgets. Iowa Secretary of State Paul D. Pate, who serves as president of the National Association of Secretaries of State, said the group has been calling on the federal government to provide a steady source of funds, particularly to help address ongoing costs of protecting the nation’s election systems from cyberthreats.For Georgia’s primary last month, election officials spent .1 million of the roughly .9 million the state has received in federal funds. The money was used to send absentee ballot applications to 6.9 million active registered voters and print absentee ballots for county election offices. Some of it also was used to purchase PPE and secure drop-off boxes for counties.Meanwhile, the state elections division has seen a ,000 reduction for the current budget year as Georgia — like the rest of the nation — deals with a decline in revenues due to the pandemic.The state’s remaining federal funds will be used to help cover the costs of developing an online system for voters to request absentee ballots, a less expensive option than sending ballot applications to every voter, and exploring whether installing plexiglass dividers around voting machines could allow more voters in a polling place at one time.In Colorado, which is already a universal vote-by-mail state, the Denver election office has had to reduce its budget by 7.5%, which amounts to nearly 0,000. Jocelyn Bucaro, Denver’s elections director, said the federal funds sent earlier this year helped with purchasing PPE and other pandemic-related supplies.Iowa similarly spent its federal dollars on mail-in ballots and pandemic supplies, Pate said.Vote-by-mail veterans and vendors of the equipment, software, ballots and envelopes that will be needed in November say the window to buy them is quickly closing.“Right now, what I’m seeing in most places is just this kind of indecision. What are we supposed to be planning? Vote by mail or in-person or combination?” said Jeff Ellington, president of Runbeck Election Services, which prints ballots and the special envelopes used to mail them and also supplies high-volume envelope sorters.“Decisions just need to be made so people can start to put a plan into place,” he said.BlueCrest, a Pitney Bowes spinoff, sells high-volume sorting machines that handle up to 50,000 ballot envelopes per hour. That’s the kind of crunch big counties can expect to face on Nov. 3 in states including Wisconsin and Pennsylvania, where Rick Becerra, a vice president at the company, said he’s been talking to officials. The machines average 5,000 each.“I tell them the time is now,” he said.___Cassidy reported from Atlanta. Associated Press writer Frank Bajak in Boston contributed to this report. 6414

The Dallas Police Department said on Tuesday evening that two of its officers and a civilian loss prevention officer were shot at a Dallas Home Depot. The Dallas Police confirmed earlier in the evening that the two officer were in critical condition. Dallas Police Chief Renee Hall said late Tuesday evening that all three victims are out of surgery in a Dallas hospital. "We're asking for your continued prayers for them and their families," Hall said. The shooting reportedly took place around 4:11 p.m. local time.  In a press conference, police identified Armando Juarez, 29, as a person of interest. He is believed to have left the incident driving a white pickup truck. Around 9 p.m. local time, Juarez was arrested after a car pursuit involving Dallas Police and a white pickup truck.Hall said that Juarez will be charged with multiple counts of aggravated assault on a police officer, and also had an outstanding warrant for his arrest. A female passenger in Juarez's truck was also detained after the chase, Hall said. In 2016, Dallas experienced one of the deadliest ambushes on law enforcement in recent US history, as five officers were shot and killed while patrolling a Black Lives Matter protest.  1285

The English city of Manchester came together Tuesday to mark the first anniversary of the terror attack that killed 22 people attending an Ariana Grande concert.Families of the victims, the injured, emergency services and local and national leaders were joined by UK Prime Minister Theresa May and Prince William, the Duke of Cambridge, for a memorial service at Manchester Cathedral.Those inside the cathedral were joined by thousands more across the country in a minute's silence to remember those killed in the suicide bombing as they left the Manchester Arena.Prince William read from Corinthians during a service full of song and tribute to the victims and their families. 685

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