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SAN DIEGO (KGTV) — It’s a term we’ve heard a lot during the pandemic: emergency use authorization.From ventilators to diagnostic tests to experimental drugs like remdesivir, the Food and Drug Administration has issued at least 616 emergency use authorizations, or EUAs, since the pandemic began.“That’s such a powerful term: emergency use authorization,” said President Donald Trump on Aug. 23 when announcing an EUA for convalescent plasma.Top officials at the FDA are now floating the idea of using an EUA to speed up distribution of a vaccine against COVID-19, writing that it “may be appropriate” under certain circumstances. Critics contend it would be a dangerous move.The mechanism was put into law back in 2004, and EUAs have been used in several health emergencies since, including the 2009 H1N1 pandemic.An EUA allows the FDA to temporarily authorize a drug or device for use during an emergency under certain conditions. There must be no formally approved alternatives to the product, and the available evidence must suggest the potential benefits outweigh the potential risks.“Because in some emergencies, we just cannot wait for all the evidence needed for full FDA approval,” the agency says in a video explaining the rationale for an EUA.While EUAs are relatively common for diagnostic tests and experimental drugs, there has only been one EUA issued for a vaccine. In 2005, the FDA authorized a vaccine intended to protect U.S. soldiers from an anthrax chemical attack. It was the first time the FDA ever used the EUA process. In that case, the product, Anthrax Vaccine Absorbed, had been formally licensed in 1970 as safe and effective against anthrax on the skin, but was not formally approved to counteract inhaled anthrax.In a letter to pharmaceutical companies, the FDA said it “may be appropriate” to issue an EUA for a COVID-19 vaccine “once studies have demonstrated the safety and effectiveness” of the product, but before other steps in the traditional submission process, like detailed information on how the vaccine was made and tested.“It is extremely rigorous,” Dr. Christian Ramers of Family Health Centers of San Diego said of the typical FDA approval process. “People have to submit thousands of pages of documents. They have to open their books, essentially, and show all of the detail on how these things have been tested.”An EUA could allow for the release of a vaccine before the election, something President Trump has suggested but other members of his administration have said is unlikely.The prospect of an EUA for a vaccine alarms consumer advocates like Dr. Sidney Wolfe of Public Citizen, who sent a letter to the agency urging it to avoid the expedited process.“The amount of information on how effective it is, the amount of information on how safe it is is less than would be required for full approval,” Wolfe said. “And full approval could arguably come in three or four months.”Wolfe thinks an EUA could backfire.“The loss of confidence by people will contribute to a much decreased willingness to be vaccinated,” he said, citing a survey during the 2009 H1N1 pandemic that showed people were reluctant to volunteer for inoculation if the vaccine only had emergency authorization.Critics say there’s already shaky public confidence after reports of political pressure from the president in the EUAs for convalescent plasma and for hydroxychloroquine.In the latter case, the FDA revoked the EUA for the anti-malaria drug June 15 after more studies showed it wasn’t effective and could have serious side effects.Dr. Ramers at Family Health Centers of San Diego says there is a big ethical difference between authorizing an experimental drug with limited data and authorizing a vaccine.Fundamentally, doctors give drugs to patients who are already sick, and they're more willing to try something untested in a last-ditch effort. “In somebody who has been through two or three or four rounds of [chemotherapy] and nothing has worked, the risks and benefits are tilted in a different way,” he said.“But a vaccine is a really special situation because we’re giving it to healthy people. We’re giving it to the general population before they become ill. So historically, the safety threshold for a vaccine has been way, way, way higher,” Ramers added. 4302

SAN DIEGO (KGTV) - Members of Congress are responding to a Team 10 investigation that uncovered allegations the government is not providing adequate medical care to some U.S. citizens in its custody.Two recently filed lawsuits allege that dozens of individuals’ medical needs were deliberately ignored by Department of Homeland Security (DHS) agents, and Americans were forced to undergo life-threatening and torturous detox in temporary holding cells at the border.In a statement to 10News U.S. Congressman Bennie Thompson, Chairman of the Committee on Homeland Security wrote, “The allegations made in these lawsuits are extremely troubling. Anyone in CBP custody who is in medical distress should receive urgent medical care if they require it. Across the board, it’s clear that CBP has work to do to ensure safe and humane conditions for all detainees.”San Diego area Congressman Scott Peters also responded saying, “Everyone in federal custody deserves access to basic care. Ignoring a detainee’s pleas for help runs counter to CBP’s own national policies, which say detainees are entitled to medical care if they report an illness or appear to need help. Officers at the border may be overwhelmed, but if CBP is going to detain people, they have a duty to provide proper medical care to the people in their custody.”10News also heard from ACLU of San Diego & Imperial Counties. A spokesperson wrote, "Unfortunately, horrible detention conditions at U.S. Customs and Border Protection facilities, including inadequate medical care, is nothing new – though they are violations of the agency’s own internal standards for treatment of people in its custody. As a result of recent federal policy decisions, far more people are being unnecessarily held in CBP custody, for longer, under these deplorable conditions. These decisions are greatly exacerbating CBP’s longstanding failure to meet the basic humanitarian needs of the people it insists on detaining.”When asked for a comment on the allegation in the lawsuits a spokesperson for Customs and Border Protection said the agency cannot comment on matters that are currently under litigation. 2159

SAN DIEGO (KGTV) — Kick off the new year with some sports, some laughs, and some winter fun in San Diego!If you're looking for a night out, Stand Up Science will have you laughing and learning at American Comedy Company.Winter fun can still be found in Poway, during the two-day Winter Festival, packing snow, sledding, and delicious food into Poway Community Park.Don't see anything in this week's rundown? Check out the 10News Community Calendar for even more fun around town this weekendPadres season is right around the corner and the team is giving San Diego access to autographs, a gear garage sale, and interactive fun at Petco Park during Fan Fest.Plus, fans of the local craft beer scene can test the latest in brews during San Diego Brew Fest at Liberty Station. Here's more of what's happening this weekend around town:THURSDAYStand Up ScienceWhere: The American Comedy Company; Cost: Learn, laugh, and enjoy a drink with comedian and science podcast host Shane Mauss during an thought-provoking evening filled with brainy topics, special guests, and Q&A discussions with the audience!San Diego Metal YogaWhere: The Kensington Club; Cost: Combine the relaxing activity of yoga with your favorite heavy metal tunes during Metal Yoga! This all skill levels yoga class is led by a certified yoga instructor who has a love for metal music, so be ready to mountain pose to Slayer, Sabbath, and other bands.FRIDAYWinter FestivalWhere: Poway Community Park; Cost: Free(Friday - Saturday) Winter isn't over yet! For two days, enjoy delicious foods and all your favorite winter activities, like building a snowman, sledding, and roasting marshmallows over a campfire, during Poway's Winter Festival!Hops on Harbor with Fall BrewingWhere: Flagship Cruises & Events; Cost: -Enjoy an evening of perfectly paired beers from Fall Brewing and eats along with San Diego's most scenic views on the water during Hops on Harbor this weekend. Cruise guests also get to meet and greet with brewers and have the chance to win prizes and giveaways. Kids area welcomed aboard too!SATURDAYHello Kitty Cafe TruckWhere: The Shoppes in Carlsbad; Cost: FreeFor the first time, the Hello Kitty Cafe Truck hits Carlsbad, bringing fans a bite of tasty goodies, including a giant Hello Kitty cookie, macaroon set, and lunchbox with confetti popcorn, and an array of merchandise, including exclusive thermal bottles, bow headbands, t-shirts for kids and adults, toys, and more.Padres Fan FestWhere: Petco Park; Cost: FreeGet ready for the next season of Padres baseball during Fan Fest! Fans can claim their free ticket online and get access player autographs, kids activities, Q&A sessions, interactive experiences, the Padres Foundation Garage Sale and more!9th annual San Diego Brew FestWhere: Liberty Station; Cost: -Dozens of San Diego breweries will be at Liberty Station for a day filled with brews, foods, and live music during San Diego Brew Fest! Experience tastes of local brewers' latest creations and even international craft beers.SUNDAYSan Diego Resolution 5K/10K/Half MarathonWhere: Mission Bay; Cost: -Have a fitness resolution? Get 2019 off to the right start and shed some holiday pounds during the San Diego Resolution 5K/10K/Half Marathon! The event that benefits Wild Willow Farm & Education Center, an eco-friendly organization supporting a healthier SoCal food system.Jurassic TourWhere: The San Diego Concourse; Cost: -(Saturday - Sunday) Tour the era of dinosaurs in San Diego at Jurassic Tour! Kids admission gets youngsters unlimited access to fossil digging, bounce houses, basketball, and a dino theater and band.Gem FaireWhere: Del Mar Fairgrounds; Cost: (Friday - Sunday) Clean out that jewelry box! More than 70 vendors will be at the Del Mar Fairgrounds showcasing some of the most beautiful gems around, as well as providing jewelry cleanings, ring sizing, and other gem services! 3949

SAN DIEGO (KGTV) -- Many families throughout San Diego County are struggling due to the coronavirus pandemic, making the otherwise cheery holiday season less than ideal.Despite hard economic times, many throughout the region are finding ways to give back in 2020.Although volunteering may look different this year, there are plenty of opportunities to help out, from donating to food banks to fostering an animal.Feeding San DiegoNot only can you donate to help feed families, students, and seniors in need through Feeding San Diego, but your help also keeps the group's food distributions running and supports mobile pantries.And with ABC 10News, you can help us provide millions of meals to San Diegans during our Month of a Million Meals through Dec. 31. Last year, the campaign raised more than 5.1 million meals. Learn how you can help here.San Diego Food BankThe San Diego Food Bank has more than doubled the number of people it’s providing food assistance to during COVID-19. From mid-March through October, the organization distributed more than 37 million pounds of food. The food bank says all volunteer shifts have been booked through the fall, but you can still sign up to volunteer at a later date here. You can also donate money. The organization says for every given, 5 meals can be provided.Father Joe's VillagesHelp support Father Joe's Villages and provide aid to individuals battling homelessness in San Diego. Donations can help provide housing, meals, health care, and education to those in need locally. Anyone interested can donate money, goods, a vehicle, or their time to help. Learn more about how to help.The Salvation ArmyIt wouldn’t be Christmas without the famous Red Kettles. However, this year, the organization is taking its campaign online. With a few mouse clicks, you can help the Salvation Army support bill assistance, homeless shelters, and food pantries across San Diego. To donate to the Red Kettle Campaign online here.And despite the pandemic, The Salvation Army is asking volunteers to answer the call and become a Christmas Kettle Bell Ringer. Click here to sign up.San Diego Humane SocietyThe Humane Society has temporarily suspended its volunteer recruitment and onboarding due to the coronavirus, but that doesn’t mean you can’t give back. The organization is still accepting donations. Donations will help the group provide medical care, shelter, and food to homeless animals. Of course, pet adoptions are still running this season as well. You can also sign up to foster a pet. Visit the humane society's website to learn how to adopt or foster a pet, or donate.Red Cross San DiegoYou can also help the Red Cross San Diego's humanitarian and disaster relief efforts for those in need. Donations with help support safe shelters, hot meals, care, and comfort for people who have lost everything to a disaster.The Red Cross is also supporting the critical need for blood during this time. Click here to learn how you can donate blood.San Diego Blood BankThe San Diego Blood Bank is in need of volunteers to donate blood, especially during the holiday season. The bank aims to collect more than 350 units of blood each day in order to meet the needs of local patients who are battling life-threatening conditions. One pint of blood can save up to three lives. You can sign up for an appointment here. 3357

SAN DIEGO (KGTV) — In a departure from recent years, Warner Bros. will be a no-show at San Diego Comic-Con's revered Hall H this year.A WB spokesperson confirmed to 10News that the studio and DC Comics will forgo any Hall H panel. In recent years, Warner Bros. has been pivitol for Hall H panels, especially in 2018 when Marvel and HBO elected not to take the stage.The decision was made all the more surprising — for fans, disappointing — considering the studio's upcoming slate of comic book movies, including "Joker" (Oct. 4, 2019), "Birds of Prey and the Fantabulous Emancipation of One Harley Quinn" (Feb. 7, 2020), "Wonder Woman 1984" (June 5, 2020), and "The Batman" (June 25, 2021).MORE COMIC-CON 2019 NEWSLast year, the studio used Hall H to preview "Wonder Woman 1984," "Aquaman," "Shazam!," "Fantastic Beasts: The Crimes of Grindelwald," "Godzilla: King of the Monsters," and "The Lego Movie 2: The Second Part.""Wonder Woman" director Patty Jenkins confirmed the news on Twitter this week, saying, "By now you’ve heard: WB isn’t going to Hall H this year. We’re so sad to miss you there! And waiting until Dec. to start our official #WW84 campaign in full-- But the truth is… we can just… barely… wait…" 1224