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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 coronavirus outbreak is filling many with fear, anxiety and depression. To cope with these feelings, 10News spoke with licensed psychologist Dr. Michelle Carcel on strategies to get through the chaos."Evolutionarily we are not built for quick adaptation." Carcel said, that's why the reptilian part of our brain is freaking out. "One of my favorite sayings, it's not mine but I use it all the time, is relax nothing is in our control."READ RELATED: San Diego County libraries go digital to fight spread of coronavirusCarcel said mindfulness activities like yoga and meditation bring you into the moment and activate the parasympathetic nervous system, to calm the brain.Her first piece of advice for coping with all these changes to your daily life is to set a schedule. A schedule for you and any kids will bring back a sense of normalcy, and comfort.If you're feeling down, or isolated, find a furry friend. Adoptions and fostering is up in San Diego.RELATED: Where to get help amid coronavirus"Take time to walk your dog, play with your cat. They relieve stress quite a bit, so that's good," Carcel said smiling.Checking on a friend during this time of isolation is also important. "That is actually one of the worst times for folks who are specifically suffering from domestic violence concerns. We must take this incredibly seriously," Carcel added. She urges anyone who needs help to call the Crisis Line at 888-724-7240.Another serious issue we're facing is financial stress, many losing their job from the shut down. Carcel says while these are unprecedented times, we will endure, "here's the thing, humans are resilient. We have made it through a bunch of different, terrible things in our evolutionary process and we must remember that."She advises enjoying the time we have inside, by indulging in a book, playing a board game, or calling someone you love."Just surf the wave, we're going to make it through," she said.OPTUM has a free 24/7 helpline for anyone who needs emotional support, you can call 866-342-6892. 2060

SAN DIEGO (KGTV) -- The Carte Hotel in the heart of Little Italy is not nearly as full as it could be.It had been open just a few months before the pandemic hit, "We had a great start until March and the virus started showing up," said general manager Henri Birmele.Like many other hotels in California, The Carte is only allowed to book rooms for essential workers.But staff is preparing for when the Governor says they can fully reopen. "We have sanitizers on every floor, every piece of equipment that's available we have throughout the building to take care of team members and hotel guests," Birmele said Common areas will be sanitized every hour, the restaurant and rooftop bar will be spaced out to make it easier to social distance, valet service won't be available, there will be at least 12 hours and a deep clean between when one person checks out and another checks in and room service will leave orders at the door instead of bringing them in. The Carte is hoping to ease people back into hotels by encouraging "staycations" and planning to offer locals discounts and deals. "How people react, I don't know. I think time will tell. I think we have all the precautions in place to make sure that everyone is safe during their stay," said Birmele. 1270

SAN DIEGO (KGTV) — The man suspected of killing his stepmother and burying her body in a Tijuana backyard has been arrested on probation violations.Aaron Seth Juarez, 20, was taken into custody in San Diego Thursday. He was also wanted by the Deputy Attorney General of Justice in Tijuana on suspicion of killing Fernanda González Serrano in February.San Diego Police are currently working to return Juarez back to Mexico.González was last heard from on Feb. 2. Shortly after her disappearance, her husband was treated for a gunshot wound in San Diego, but was reportedly unable to answer any questions.RELATED:Family: Arrest warrant issued for stepson of woman found buried in Tijuana backyardMan suspected of killing, burying stepmother in Tijuana backyard may be in U.S.Woman discovers her sister's body buried in Tijuana backyardAfter social media posts searching for González, her sister, Erika, received a call not to keep searching, and that González, "was already dead and in the back of her yard."Erika and her father went to González’ Tijuana home and started digging in the backyard, where they discovered González’ body.Mexican police believed Juarez may have returned to the U.S. on Feb. 23. 1213

SAN DIEGO (KGTV) — Target is rolling out more locations for customers to take advantage of drive-up shopping.Target's Drive Up service is expanding to more customers who place orders through the Target mobile app. The free service then delivers a customer's order to their car in under two minutes.Currently, the service is available in more than 1,100 Target locations, including in San Diego County:South Park (3030 Grape St., San Diego)Mission Valley (1288 Camino Del Rio N., San Diego)Lemon Grove (3424 College Ave., San Diego)National City Plaza Bonita (3060 Plaza Bonita Rd., National City)Grossmont (5500 Grossmont Center Dr., La Mesa)Chula Vista East (910 Eastlake Pkwy, Chula Vista)Rancho San Diego (2911 Jamacha Rd., El Cajon)El Cajon (250 Broadway, El Cajon)Mira Mesa (8251 Mira Mesa Blvd., San Diego)Santee (9846 Mission Gorge Rd., Santee)Poway (14823 Pomerado Rd., Poway)San Diego Del Sur (17170 Camino Del Sur, San Diego)Escondido South (280 E Via Rancho Pkwy, Escondido)Escondido (1280 Auto Park Way, Escondido)Vista South (3150 Business Park Dr., Vista)Vista (1751 University Dr., Vista)Oceanside (2255 S El Camino Real, Oceanside)Rancho California(29676 Rancho California Rd., Temecula)San Clemente (990 Avenida Vista Hermosa, San Clemente)Murrieta (41040 California Oaks Rd., Murrieta)“With this expansion of Drive Up, we’re continuing the momentum from our coast-to-coast roll out last year to bring even more guests their fastest Target Run yet,” Dawn Block, Target's senior vice president of digital, said in a release. “Guests love the ease and convenience of these parking lot pickups—in fact, it’s our top-rated fulfillment service.”Target's move comes as more retailers opt to offer curbside pick-up for orders, including the company's competitor Walmart, which also offers drive-up delivery for orders made the same day. 1854