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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 Cruise Lines International Association announced Tuesday that any cruise ship worldwide carrying more than 250 people must test everyone, passengers and crew members, for COVID-19 before embarking.They must also test negative for the virus if they are to board the ship, CLIA said in a press statement posted to their social media account."CLIA ocean-going cruise line members have agreed to conduct 100% testing of passengers and crew before embarkation - a travel industry first," CLIA tweeted. 508

The doors to Interior Secretary Ryan Zinke's office are getting a nearly 9,000 upgrade.The Interior Department confirmed the project Thursday, saying it is both necessary to replace old doors that are in "disrepair" and attributing the high cost to the historical nature of the building.News of the 8,670 contract comes as several agencies are facing scrutiny over excessive spending. Last month, Housing and Urban Development Secretary Ben Carson withdrew an order for pricey dining room furniture, including a ,000 table. Zinke is also under fire for questionable travel habits.Zinke was unaware of the expense for the doors, Interior spokeswoman Heather Swift said, saying the project was driven by "career facilities and security officials" as part of a decade-long modernization of the 1930s building."The secretary was not aware of this contract but agrees that this is a lot of money for demo, install, materials, and labor," Swift said in a statement. "Between regulations that require historic preservation and outdated government procurement rules, the costs for everything from pencils to printing to doors is astronomical. This is a perfect example of why the secretary believes we need to reform procurement processes."The new doors will be made of fiberglass. The previous sets of doors have been damaged for years, according to an Interior official, to the point where wind and water come into the office during inclement weather, which in turn damaged the historic hardwood floors. Damage has caused bottom panels to fall out and be "replaced with cardboard and duct tape," the official said.The Associated Press previously reported on the door contract Thursday."What a waste. Just think how many dining sets you could have bought or private jets you could have chartered with that money," Rep. Adam Schiff, D-California, joked on Twitter. 1898

The current spike in COVID-19 cases is stressing the testing system across the country.As the virus spreads at unprecedented rates, more Americans are seeking COVID-19 tests. But in recent days, companies that make the tests and the supplies needed for them are struggling to keep up with demand."Those companies were operating on an allocation basis, and that just means that basically everything they make is going out the door," said Kelly Wroblewski, the Director of Infectious Disease Programs at the Association of Public Health Laboratories. "There is no reserve, so there's an increased demand in a lab for testing. There's no more reagent to be had, so to meet that demand, that lab has to use a different manufacturer's test."Wroblewski adds that along with issues in getting supplies, officials are also short on human resources — there is only so much lab capacity and only so many trained people to conduct the tests.The American Clinical Laboratory Association says the surge in demand for testing means some labs could reach or exceed their current testing capacities soon — meaning it could take longer for patients to get PCR test results back.Wroblewski says that it can take currently take anywhere from 24 hours to a week to get PCR test results back.With antigen tests, patients can get results back in less than 30 minutes. There is currently enough of a supply for antigen tests, but not all facilities offer them.Both lab groups stress that COVID-19 testing is important, but patients should be strategic."There's been a lot of emphasis put on testing, but testing is only one piece of the puzzle," Wroblewski said. "It gives you some information, and if you're not going to do anything with that information — whether it be targeted closures. whether it be staying home and isolating — we're not going to stop the spread of disease."As far as getting more tests, it's going to take a while. Wroblewski says it could take up to six months or more to increase production capacity significantly. Labs don't expect to see a ramp-up in supplies until early 2021. 2090