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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 Guinness Book of World Records' largest-ever bounce house will visit 27 U.S. cities this year, including two weekend stints in San Diego.The Big Bounce America tour will bring "The World's Largest Bounce House" to San Diego for two weekends Oct. 18-20 and 25-27. The massive inflatable castle stands 32-feet tall and covers 10,000-square-feet of space.Guests can hop into several different "zones " within the puffy castle walls, including an obstacle course, ball pit, basketball hoops, a giant slide, and more. There's also a VIP section that includes a DJ booth, dance floor, and VIP dome with nightclub lights and sounds.RELATED: Mission Beach Plunge pool reopening after years of vacancyGrahame Ferguson, co-founder of The Big Bounce America, told 10News in 2017 that the bounce house took 18 months to create.Tickets range from to and welcome family and adult-only sessions. San Diegans can sign up for alerts now for when tickets are available. 990

SAN DIEGO (KGTV) — The brother of the man accused of fatally shooting a Good Samaritan on Interstate 15 in October has been arrested and will also be charged in connection with the murder.Edson Acuna, 24, was taken into custody in Mexico and turned over to U.S. authorities Tuesday, according to San Diego Police. Acuna's brother, Brandon, was arrested shortly after 21-year-old Curtis Adams was shot and killed on I-15 during the early hours of Oct. 27.Adams, a San Diego Navy sailor, and his girlfriend had stopped their vehicle on southbound I-15 just before 2:30 a.m. to check on an apparent stranded vehicle near the Mountain View area, said San Diego police homicide Lt. Anthony Dupree. RELATED: Good Samaritan shot to death on freewaySuspect in shooting of Navy sailor on San Diego freeway has criminal historyNavy sailor remembered in vigilAdams exited his vehicle and approached the other car when someone in the vehicle opened fire on him and fled the scene. He was taken to UCSD Medical Center where he died of his injuries.Police said Tuesday a warrant was issued for Acuna's arrest after his brother's arrest, but authorities believed he had fled to Mexico.Both Acuna brothers are suspected in another shooting that happened about 10 minutes prior to Adams' murder. In that shooting, a victim interrupted his vehicle being broken into and was shot at, but survived. 1386

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

SAN DIEGO (KGTV) — The family of 19-year-old Dylan Hernandez, the San Diego State University (SDSU) freshman who died after falling off a bunk bed last November, say they are concerned about the investigation conducted by Campus Police and the University. The family believes the University Police Department is not pursuing certain angles, including a possible cover-up.Last November, Dylan Hernandez died after attending a Phi Gamma Delta fraternity party. In police reports obtained by the San Diego Union-Tribune, the freshman made it back to his dorm room around midnight. On the morning of Nov. 7, 2019, he fell off the top bunk bed and hit his head. An autopsy concluded that Hernandez had fractured his skull, suffering from a brain bleed that ultimately led to his accidental death. Reports also state that his blood-alcohol level was about 0.23, nearly three times the legal limit. RELATED: San Diego State suspends 14 fraternities after student is hospitalizedIn a newly released statement to 10News, the Florida native's family said they are disturbed at how poorly Campus Police and San Diego State are handling the investigation. "The Hernandez family is concerned because witnesses they provided to SDSU and UPD still have not been questioned," George Kindley, Hernandez family lawyer, said. The same University Police reports state that UPD never interviewed anybody from the Phi Gamma Delta fraternity. They also never sought out search warrants for Snapchat videos or phone records, despite knowing that some fraternity brothers instructed others to delete possibly incriminating videos and messages. According to the report, one of those messages read, "Remember, silence is golden."This was a shocking revelation to the family. In a statement to 10News, the Hernandez family said, they hope:RELATED: Cause determined after San Diego State University student dies"SDSU and UPD will quickly live up to their promises and complete the investigation without further delay. The Hernandez family wants SDSU and UPD to take action now to prevent future tragedies like this one from occurring." (George Kindley, Hernandez family lawyer)Sunday, UPD responded to a 10News inquiry regarding the Hernandez family. They said:"The preliminary, incomplete police report was provided to a representative of the Hernandez family in an effort to be as supportive and transparent with the family as possible during a difficult time for them as they are mourning the tragic loss of their loved one. Details of the incomplete report, released late last year, was not meant to be shared with the public as it compromises our ongoing investigation and can hinder witnesses from sharing information. "The Hernandez family also told 10News they are questioning the SDSU's bunk bed safety enforcement. They said:RELATED: SDSU launches two task forces in wake of student's death"SDSU needs to provide all students in school issued bunk beds with a safety rail that actually meets minimum safety standards, not a pseudo safety rail that SDSU knows failed and caused other students injuries in the past." (George Kindley, Hernandez family lawyer)In response, SDSU said in the last five years, they have only had two known incidents regarding bunk beds. However, they did not reveal specifics. They said: "All lofted beds and bunk beds located within SDSU residence halls are produced by national manufacturers and meet California State Fire Marshal requirements. Colleges and universities are not required to follow U.S. Consumer Product Safety Commission guidelines defining requirements for childrens' beds." (Cory Marshall, San Diego State University)The U.S. Consumer Product Safety Commission guidelines state the height from the railing from the top of the mattress must be no lower than five inches. College dorms, jails and military barracks are not held to the same standards. 3885