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SAN DIEGO (KGTV) — The Food and Drug Administration has released new guidelines to vaccine makers with added safety measures that experts say will push back the timeline, making the release of a COVID-19 vaccine before the election highly unlikely.The guidelines lay out what it will take for companies to secure a fast-tracked authorization for a vaccine, known as an emergency use authorization or EUA.The new guidelines require vaccine makers to follow the volunteers in their clinical trials for a median of two months after their final dose.It’s an important step to see if anyone has a bad reaction, says Dr. Christian Ramers of Family Health Centers of San Diego.“Some of the safety issues that people like me are concerned about might take months actually to develop,” Dr. Ramers said. “My analysis of this is that it's the FDA standing up and saying, ‘We're going to adhere to our rigorous scientific process.’”The White House had resisted the new guidelines from the FDA for more than two weeks. After their release, President Trump described them as a “political hit job.”“New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!” the president wrote on Twitter Tuesday night.It’s hard to gauge exactly how the two-month buffer affect the vaccine timeline because clinical trials do not start all at once; volunteers are enrolled on a rolling basis. But Dr. Sydney Wolfe of the consumer group Public Citizen said the drug makers have offered clues.“The companies one-by-one are saying, ‘We can’t get anything in until the end of November or the end of December or the beginning of January,’ and that’s a relief,” he said.In a clinical trial, half of the volunteers get the vaccine and half get a fake drug called a placebo.The updated guidelines require companies to have an estimated effectiveness of at least 50 percent, meaning there are 50 percent fewer cases of infection in the group receiving the vaccine compared to the placebo group.The guidelines also instruct companies to have a plan to continue collecting data in their clinical trial even after they get an EUA and the vaccine hits the market.“The worst thing that could happen here is something meets that minimum bar of 50% efficacy, meaning it works pretty well, but then the bottom just falls out from these clinical trials and we don't get the information we need,” he said.Dr. Ramers was initially skeptical of fast-tracking a vaccine with an EUA rather than waiting for full approval since it’s only been done once before, but he’s supportive of the process under the updated guidelines.“I think that's the best way to balance speed and safety,” he said.Still, experts like Dr. Wolfe think going with an EUA over a full approval could backfire. He points out the new guidelines allow up to half of the people in the clinical trial to be tracked for less than two months after their final dose.“All things aren’t equal [between an EUA and full approval] because you don’t have all the information and B, people know that,” he said.Dr. Wolfe is concerned the public will be reluctant to roll up their sleeves and embrace the vaccine if it just has an emergency authorization. Now that the FDA has made the EUA guidelines more rigorous, he thinks waiting for full approval might take just a few more months.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.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.However, Dr. Wolfe said the possibility of the president overruling the FDA is unlikely to have an impact now because the vaccine developers themselves have indicated they will follow the FDA guidelines.Additional reporting by Justin Boggs 4090

SAN DIEGO (KGTV) — The holiday season is underway in San Diego, as locals prepare to jump into December this weekend.Outdoor ice skating can be found at Viejas Casino and Resort's massive outdoor ice rink, and Carlsbad welcomes the "big man" to town to help light their Christmas tree!Legoland also jumps into the season with Holidays at Legoland and several street festivals and art shows give you the chance to get a jump on holiday shopping for friends, family, and pets!Not interested in anything here? Check out the 10News?community events calendar for a look at even more things to do!But Thanksgiving is first on the list. The 72nd annual Mother Goose Parade in El Cajon will ring in the season for being together with family and friends, as local gather to watch floats, bands, and Santa glide through town.Here's a look at this weekend's big events:THURSDAYOutdoor ice skating at ViejasWhere: Viejas Casino & Resort; Cost: - (Runs Thursday - Sunday) Holiday lights and entertainment have arrived at Viejas! Get into the winter spirit with ice skating at one of the biggest Southern California rinks around. A 90-minute session for kids will run while adults and teens can skate for . Art of the Holiday?ShowWhere: Fallbrook Art Center; Cost: Free(Runs Thursday - Saturday) Explore handmade crafts and jewelry by talented artists at Fallbrook Art Center's free Art of the Holiday Show. Wearable art, glass and ceramics, ornaments, and more can be found as a unique and creative gift this season! FRIDAYTree Lighting & Santa ArrivalWhere: Carlsbad Premium Outlets; Cost: FreeWelcome in the holiday season with Santa as he helps light Carlsbad's outlet Christmas tree. Enjoy holiday performances by Samantha Robertson, Singers Company, and the Carlsbad Company Theatre as well, and get a start on your holiday shopping. Del Mar Antique Show & SaleWhere: Del Mar Fairgrounds; Cost: Free(Runs Friday - Sunday) Del Mar Fairgrounds will be packed with vintage collectibles and antiques spanning glass, pottery, jewelry, art, and much more at the Antique Show & Sale. Have your own treasure? Appraisal team members can take a look and see if you've struck vintage gold! SATURDAYPadres Pedal the CauseWhere: Petco Park; Cost: - 5Pedal the Cause rallies the San Diego community to raise awareness and funding for cancer research in San Diego. The challenge includes four cycling courses, spin classes, or a 5K run/walk ending in centerfield inside Petco Park! You choose! Holidays at LegolandWhere: Legoland California; Cost: (Runs Saturday - Sunday) Holiday magic kicks off at Legoland, where a 30-foot high Lego Christmas tree will play centerpiece to a park full of holiday cheer. Make sure to visit Lego Santa and a cast of characters at the new Holiday Village! 10th Annual Doggie Street FestivalWhere: Liberty Station; Cost: FreeLiberty Station's Doggies Street Festival brings together live entertainment, auctions, and, of course, everything cats and dogs for pet owners and those looking to adopt a furry friend. Visit with rescue societies and get tips from vets and pet services, and bring your own doggo to enjoy the festival too!  SUNDAY72nd annual Mother Goose ParadeWhere: El Cajon; Cost: FreeEl Cajon's Mother Goose parade is billed as the largest parade in San Diego County! Celebrate Thanksgiving as thousands line the streets to watch Santa, marching bands, and more as the parade begins on Main St. at El Cajon Blvd. marching toward First St. 28th annual Encinitas Holiday Street FairWhere: Downtown Encinitas; Cost: FreeHead out for free fun in Encinitas, including two stages of live entertainment, delicious food, children's rides and games, and more during the Encinitas Holiday Street Fair. Vendors will also be out giving guests the chance to get some holiday shopping done, offering handmade crafts, art, and more! Taco TKOWhere: Liberty Station; Cost: Help discover San Diego's best taco during an all-you-can-eat taco showdown at Liberty Station! Taco TKO pits local restaurants against each other for the title of "San Diego's Most Awesome Taco," as part of the San Diego Bay Wine + Food Festival. 4299

SAN DIEGO (KGTV) - The California Department of Alcohol Beverage Control (ABC) made changes making it easier for businesses to sell alcohol.This week, the agency made major changes allowing restaurants to sell beer, wine and pre-mixed drinks or cocktails for pick-up or delivery as long as it is sold with food and has a secured top.While the changes will help many business owners, some San Diego bar owners say the ABC needs to take a look at other parts of the law as well."I know my seven employees are hurting, and I am too," said Tony Raso of Bar Sin Nombre.Raso said when the statewide order came down to close, he did. He has bar food he can sell, but where his problem comes in is with the beer that's already on tap."My struggle has been with all of the draft beer," he said. "We're primarily a draft house, and most of my money is in draft inventory."According to the ABC's website, restaurants "selling beer, wine, and pre-mixed drinks or cocktails for consumption off the licensed premises may do so when sold in conjunction with meals prepared for pick-up or delivery. Any such alcoholic beverages must be packaged in a container with a secure lid or cap and in a manner designed to prevent consumption without removal of the lid or cap."Raso said while he appreciates the relaxed restrictions, he's still sitting on at least ,000 in kegs he can't sell."Allow us to repackage the beer from the taps," Raso said. "Allow us to drain the inventory that we already have tapped that's going to spoil and allow us to create some sort of revenue."In a statement to 10News, a spokesperson for the ABC wrote 1623

SAN DIEGO (KGTV) - The Department of Homeland Security is responding to the caravan of Central American immigrants prepared to enter the United States through the border with Mexico.At least 600 people from Guatemala, Honduras, El Salvador, and Nicaragua are traveling to Tijuana, according to freelance journalist Jorge Nieto. About 100 arrived last night. Eventually the group will enter the U.S. at the San Ysidro port of entry.Homeland Security Secretary Kirstjen Nielsen released a statement on the caravan.“DHS continues to monitor the remnants of the ‘caravan’ of individuals headed to our Southern border with the apparent intention of entering the United States illegally. A sovereign nation that cannot – or worse, chooses not – to defend its borders will soon cease to be a sovereign nation. The Trump Administration is committed to enforcing our immigration laws – whether persons are part of this ‘caravan’ or not.”DHS warned members of the caravan that they may be turned over for prosecution under illegal entry laws. Anyone seeking asylum may be detained while their claims are processed, DHS said.“Again, if you enter the United States illegally, let me be clear: you have broken the law. And we will enforce the law through prosecution of illegal border crossers,” Nielsen stated.The DHS statement encouraged those with asylum claims to seek protection in the first safe country they enter, naming Mexico as a possibility.“While we are committed to doing everything we can on the border to secure our nation, we need Congress to do their job as well.  I join the President in asking Congressional leadership to work with the Administration to pass legislation to close the legal loopholes that prevent us from securing our borders and protecting Americans. I stand ready to work with any member who in good faith seeks to support DHS’s mission and secure our country,” Nielsen wrote. 1914

SAN DIEGO (KGTV) — The King family, who launched "Chelsea's Light" after the rape and murder of their daughter Chelsea in 2009, has decided to end the popular "Finish Chelsea's Run" event after eight years.In an interview with 10News from the family's home near Chicago, Chelsea's father, Brent, said they are proud of the impact they have been able to have through "Finish Chelsea's Run," but that it was time to move on from the event."Our family wants to thank everybody that has ever come out to run in our race. It's spectacular. It's beautiful. It brings us a lot of joy. But at the same time, it reminds us how we lost our little girl," King said.Chelsea was a 17-year-old student at Poway High in 2010 when she went for a run at Rancho Bernardo Community Park. A registered sex offender, John Gardner, later pleaded guilty to dragging King into a secluded area near Lake Hodges, raping her, and strangling her to death. He buried the body nearby.Shortly after his arrest, Gardner also admitted to the murder of an Escondido teen, Amber DuBois, who had disappeared a year earlier.The King family began the "Chelsea's Light" Foundation, through which it carried out "Finish Chelsea's Run" and a companion baseball tournament. King says "Chelsea's Light" will continue to exist and raise money. However, he has launched a new nationwide organization called "Protect the Joy."King says he will use the experience he gained helping pass "Chelsea's Law" legislation in several states to protect youth from sex offenders to help build a bigger, stronger organization dedicated to issues of defending children."I've built an organization that mirrors the Sierra Club, or the Surfrider Foundation, or Greenpeace. But instead of protecting the trees, or the coastline, or the whales, I'm going to protect our children," King said.For more information on King's new organization, visit the website: ProtecttheJoy.org. 1952