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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 family of Rebecca Zahau said they are filing a new lawsuit against the San Diego County Sheriff's Office for refusing to provide access to records regarding the sheriff's investigation into her death.The family is also petitioning on the San Diego County Medical Examiner - both current and former - to change her cause of death to homicide or undetermined from suicide.On July 13, 2011, Rebecca Zahau’s nude body was reportedly found hanging from a balcony at the Spreckels Mansion in Coronado. Investigators said her hands and feet were bound with red rope. The same red rope was discovered hanging over the balcony.Authorities said Adam Shacknai called 911 to report her death. Shacknai was staying at the mansion that was owned then by his brother Jonah Shacknai, Zahau's boyfriend.Zahau, 32, had been babysitting her boyfriend’s 6-year-old son Max when he suffered serious injuries in a fall down a staircase at the home. The boy died from his injuries five days later.The San Diego County Sheriff’s Department and Medical Examiner’s Office ruled Zahau’s death a suicide. Authorities have suggested she took her own life out of remorse and sorrow over the boy’s injuries.The Zahau family rejected the suicide conclusion, and for many years, they have believed she was murdered by Adam Shacknai. Shacknai failed a polygraph exam in 2011.The family filed a wrongful death lawsuit against him in 2013.In April 2018, jurors found Adam Shacknai liable for Zahau's death, and he was ordered to pay million to Zahau’s family despite her death being ruled a suicide.Eight months later, the sheriff’s department announced that they would not reopen the Zahau death case following a review saying they found no evidence she "died at the hands of another."In a statement, the sheriff's department says they do not comment on pending litigation, calling the Zahau investigation "objective and thorough."RELATED:-- Settlement reached in civil case; Shacknai speaks to 10News-- Coronado mansion death case won't be reopened-- Jury finds Adam Shacknai responsible in Zahau wrongful death case-- PHOTOS: Zahau death investigation-- TIMELINE: The Rebecca Zahau case 2188

SAN DIEGO (KGTV) - The family of a man reported missing from a Spring Valley care facility two weeks ago told 10News Friday he was found safe in North Park.Aldofo Otanez, who has schizophrenia, lived at Mi Casa es Su Casa. His family said he was planning to visit his brother on February 16 but never arrived.Otanez’ brother said the family passed out flyers and posted pictures on social media.RELATED: Schizophrenic man still missing after two weeksOn Friday, a 10News viewer called the family to say Otanez had been sleeping on the sidewalk on El Cajon Blvd. in North Park.People at Dave’s Flower Box had given him a bottle of water, money to buy coffee, and a burrito.The family says he was hungry but is doing well. 738

SAN DIEGO (KGTV) — The mother who reported her 3-year-old son missing in Linda Vista Tuesday morning has been arrested. According to police, Maria Flores was arrested for filing a false police report. Flores reported her son, Kevin Serrano, missing from a home in the 2500 block of Ulrich St. just after 10 a.m., according to San Diego Police.At 3:00 p.m., police reported the boy was found unharmed in the 7500 block of Mesa College Drive. Officers said the child's caregiver called them and said he had been dropped off in the morning.Flores told police that Kevin was last seen at home. Police deployed officers on foot, patrolling on motorcycles, and air resources to help search for Serrano.“This is highly unusual. We’re taking this extremely seriously," police said during a press conference. "The door was unlocked and closed, according to the mom ... The clock is ticking for us, we’re extremely worried." 952

SAN DIEGO (KGTV) — Summer is right around the corner, San Diego.For younger San Diegans, that means week of adventure and learning at summer camp! And there's something for every interest around San Diego County. Whether it's a traditional day camp with fun activities or something specific (did someone say Circus Camp?)RELATED: Events to enjoy with your toddler in San DiegoHere's a look at a variety of camps — specialty or traditional — around the county this summer:Summer Critter CampWhere: Helen Woodward Animal Center; When: June 10 - Aug. 30Kids will get to experience animal encounters and summer camp activities, animal-themed games, crafts, songs, and get a free Critter Camp t-shirt.YMCA Overnight and Day CampsWhere: Various locations; When: June - AugustYMCA branches across San Diego County offer up a variety of day and overnight camps, from traditional to specialty, and camps just for sports, leadership, adventure, and more.Mesa Rim Climbing CampWhere: Mesa Rim locations; When: March - AugustKids can hit the ropes at Mesa Rim's two San Diego locations, learning yoga, top roping and bouldering skills, or enjoying non-climbing activities like a ninja obstacle course, scavenger hunts, and more.San Diego Zoo and Safari Park Summer CampWhere: San Diego Zoo and Safari Park; When: June - AugustCampers will get to enjoy a wide variety of animal adventures at the San Diego Zoo or Safari Park, with options for various grade levels and featuring a variety of exhibits, tours, games, crafts, and more.Girl Scout CampsWhere: Various locations; When: Various datesWhether or not your child is a Girl Scout yet, they can jump into summer day camps, resident camps, weekend camp outs and more, all featuring educational activities and leadership building fun. Circus CampWhere: San Diego Circus Center; When: June 17 - Aug. 9Kids will learn the fundamentals of circus arts at the San Diego Circus Center's summer camp. Everything from aerial tricks, tumbling, juggling, and clowning to help build strength, teamwork, and focus.Wildlife Day CampWhere: Living Coast Discovery Center; When: June 10 - July 26Campers will experience animal encounters, games, arts and crafts, outdoor exploring, and more while learning about wildlife, conservation, and science.Outside the LensWhere: Liberty Station; When: June 21 - Aug. 23Interested in photography? Kids can jump into a variety of digital media camps throughout San Diego County, designed to build photography and filmmaking skills, promote creativity, and encourage collaboration.Science Summer CampWhere: Fleet Science Center; When: June - AugustA variety of science-themed activities await covering STEAM topics, wildlife, energy and physics, coding, space, and much more through experiments and hands-on learning.Youth Programs at La Jolla PlayhouseWhere: La Jolla Playhouse; When: June - JulyChildren will take part in a series of interactive theatre training programs that cover acting, musical theater, stage movement, improvisation, or behind-the-scenes tasks like costumes and props, set design, and technician support. 3098