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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 holidays are approaching, giving San Diego plenty of things to do — in addition to any last-minute shopping — this weekend.San Diegans looking for holiday cheer can enjoy nightly snowfall in Eastlake, Jungle Bells fun at the San Diego Zoo, and ice skating around town.California County Christmas returns to Pacific Beach, packing Moonshine Beach with more than a dozen bands for a massive benefit concert and toy drive. A "Merry-Achi Christmas" comes to Balboa Theatre, where Mariachi Sol de México will serenade audiences with Christmas classics from Mexico and America.RELATED:10 special holiday events coming to San DiegoQuaint mountain towns near San Diego County to visit this holiday seasonHoliday parades: Festive San Diego parades to catch this seasonMap: Best Christmas lights to see in San DiegoSan Diego's annual Holiday Half Marathon returns to take runners down the Sr-56 bike path to Torrey Pines for a fun run before the holidays. And Ballast Point celebrates Victory at Sea Day with some pirate-themed fun around one of their most popular brews.THURSDAYA Merry-Achi ChristmasWhere: Historic Balboa Theatre; Cost: Tickets start at Celebrate the season with a special performance by three-time Grammy-Award nominee Mariachi Sol de México at the Balboa Theatre. The 13-piece ensemble brings the sounds of the season to the stage with Mexican and American Christmas songs and carols.6th annual California Country ChristmasWhere: Moonshine Beach; Cost: Free with donation of an unwrapped toy or donation at doorEnjoy an old fashioned, country-style holiday celebration in Pacific Beach at Moonshine Beach, where their annual Christmas toy drive and benefit concert will bring holiday cheer to the coast. More than a dozen bands will play throughout the night and guests will enjoy a silent raffle, line dancing and two-step competitions, and more.FRIDAYNightly snowfall at Village WalkWhere: Village Walk at Eastlake; Cost: Free(Thursday - Sunday) Village Walk at Eastlake turns into a winter wonderland this month with daily snowfall at 1 p.m., 2 p.m., and 3 p.m., then again at 6 p.m. and 7 p.m. from Dec. 7 - 24. From 12 p.m. to 3 p.m. everyday, kids can grab a photo with Santa and get a free coloring book.Jungle BellsWhere: San Diego Zoo; Cost: - (Thursday - Sunday) The San Diego Zoo's holidays are sure to be wild with Jungle Bells, with daily light shows, live entertainment, and an all new "aurora" light experience blends 3-D projections with music and lights into a dazzling show.SATURDAYSan Diego Holiday Half MarathonWhere: Rancho Pe?asquitos; Cost: -9Lace up your running shoes and hit the ground for San Diego's annual Holiday Half Marathon starting in Rancho Pe?asquitos, and leading runners along the State Route 56 bike path all the way to beautiful Torrey Pines State Beach. The race finishes with entertainment and awards and — hopefully — a new race record under your belt.Holiday Market at Societe Brewing CompanyWhere: Societe Brewing; Cost: Free to attendSpeaking of Societe Brewing, they'll be hosting a holiday market in their parking lot this month, with local vendors offering goods perfect for holiday shopping. Every dollar purchased at the market will also go towards every full pour inside their tasting room.Winter Wonder: Beachside at Belmont ParkWhere: Belmont Park; Cost: FreeSan Diego's 94-year-old theme park by the sea comes alive this month with Winter Wonder at Belmont Park. The event features a holiday toy drive, holiday sculptures, free photos with Santa, and other winter-themed activities and entertainment.SUNDAYLiberty Station Hanukkah and Menorah Lighting CelebrationWhere: Liberty Station Arts District; Cost: Free to attendTo ring in the Hanukkah festivities beginning on Dec. 22, Liberty Station will hold a public menorah lighting, featuring music and other holiday festivities for families. The lighting will take place near the Rady Children's ice rink, giving families another fun holiday option. More Hanukkah events around San Diego.Ballast Point: Victory at Sea DayWhere: Ballast Point Brewing Company; Cost: Fans of craft beer will surely enjoy Ballast Point's celebration of their Victory at Sea brew, and several of its variations, at the brewery's local tasting rooms this weekend. Victory at Sea Day gives drinkers the chance to sample the brewer's varieties of their popular stout, complete with a commemorative goblet, sticker, and eye patch. Pirate costumes "aarrrgh" highly encouraged.Skating by the SeaWhere: Hotel del Coronado; Cost: -Where else can you glide along the ice right next to the surf? This rink at the Hotel del Coronado’s Windsor Lawn is built every holiday season. Part of your admission supports San Diego’s Make-A-Wish Foundation. More places to ice skate in San Diego. 4830

SAN DIEGO (KGTV) - Summer vacation. A time for kids to cut loose and enjoy weeks of freedom. And as studies have shown, to forget chunks of what they learned the year before. Even shorter breaks can erase some lessons.A special program at San Diego Unified is helping keep kids stay sharp and excited about learning all year round, even during breaks. It's about making learning a fun, family affair.In a classroom at Rosa Parks Elementary School in City Heights, 7-year-old students Melody and Isabella are getting some one-on-one attention with their lessons. The teachers in this case are Melody's grandmother and Isabella's mom."Everyday they have to read. Everyday they have homework to do," said Anna Gonzalez. She and Maria Theresa Jaume are among a growing number of parents and guardians getting more involved with their kid's education through the "Family Engagement Department" at San Diego Unified."So, I now know how to ask her questions," says Gonzalez, "How to engage her with the reading and things like that.""It solidifies the bond right," says Family Engagement Program manager Pamela King, "It shows kids that education is important." King says the program was established in 2016, inviting families to become partners in their kid's education with tips on how to do it."You're reading a fiction book. You're learning about the characters but what are characters thinking? What's motivating the character? So, going a little deeper."Organizers say it's about connecting with a child's curious nature. Making reading as fun as playtime, or as close as possible.You can find out more about the family engagement program here. 1651

SAN DIEGO (KGTV) - The Florida school shooting is conjuring painful memories for an uncle who calls his nephew the "14th Columbine victim.""You get choked up and then you're mad," said Tim Barnes.It was a flood of different emotions, as Barnes watched coverage of the tragedy in Florida.April 19th, 1999, as news broke about the massacre at Columbine High through frantic 911 calls, the San Diegan had his nephew Greg on his mind: A Columbine High student and one of the top basketball players in Colorado.Greg did survive the shootings, but one of his best friends did not. Greg was among several students who tried to keep the girl's basketball coach alive."From my understanding, he was holding Coach Sanders when he bled to death," said Barnes.Two months later, Barnes sat down with his nephew.    "Everything's cool. I'm good. I'm fine. Don't really want to talk about it. And that scared me. You could tell not everything was okay," said Barnes.Less than a year later, Greg took his own life. Next to him was a CD, looped to play a song with the words, "I'm too depressed to go on.""Just complete shock. Unbelievable, still unbelievable," said Barnes.So many years later, the grief is now accompanied by a determination to prevent a repeat of his family's tragedy.  For survivors, victims and others deeply impacted by school violence, he has this message: don't be afraid to get help and feel your pain."Feel it. You're mad? Be mad. Vent. You're sad? Cry. Feel it. It hurts. You can't hang onto it, or you will be the next victim," said Barnes. 1599

SAN DIEGO (KGTV) — The new community plan for Kearny Mesa, given final approval by the City Council earlier this week, takes effect Friday. Several properties are being rezoned with 27,000 new housing units planned for those parcels.“My vision is that within five years, you’ll be able to live on Convoy, enjoy the restaurants and the shops that are on Convoy, and work in a job in Kearny Mesa, all in one community," City Councilmember Chris Cate, who represents the area, told ABC 10News ahead of the final vote.Cate says the city is trying to encourage a"live-work" village concept for many San Diego neighborhoods, especially those that are major job centers, such as Kearny Mesa. The idea is that by creating housing and recreational possibilities in the same communities where people work, they will have to commute less. That has numerous benefits across the city, including less traffic and car pollution.It is anticipated that many of the new projects will replace aging strip malls whose parking lots remain vacant much of the time. Cate hopes the areas around Convoy St., Clairemont Mesa Blvd., and Aero Dr. will become similar to the feel of Little Italy.Because parameters have already been set for how many homes will go onto each affected parcel, as well as other necessities such as pathways, street improvements, and parks, there will not be the same drawn-out approval process that has been seen with other recent attempts at development. Cate says that means developers who acquire the land will be able to move quickly, as long as their design stays within the parameters of the community plan. “They already have an understanding of what these projects will look like, what’s required of them, where different pathways or parks will go. All these things are already agreed to on the front end," Cate said.Cate says he anticipates that the first projects could break ground in 2021. 1910