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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 future of warfare is in San Diego for the time being. The 21st Century Combined Arms Advanced Naval Technology Exercise is currently taking place at the Naval Information Warfare Center Pacific (NIWC Pacific). ANTX West 2019 is roughly two weeks long and features the brightest in the military, academia and industry demoing the latest advancements to see if they are ready for the battlefield. “This isn’t a trade show - this is ‘get people together let’s go do things and see how it goes,’” said Rear Admiral Donald Gabrielson, “this is innovation.” Much of technology of the the last several years has focused on human and machine interactions with virtual reality. “We can give feedback to the industry and say this is eligible for rapid prototyping or this needs some science and technology investment,” said Richard Byers, a systems engineer with the Navy. More than 80 developing products and systems are being tested at NIWC Pacific along with San Clemente island. “Being able to apply the technology in an operational a realistic environment is critically important,” said Brigadier General Christian Wortman, USMC.Congress has given the military the power to fast track products that perform well at ANTX for rapid prototyping and their discretion. 1290

SAN DIEGO (KGTV) - The City of San Diego is one step closer to approving the 6.5M purchase of two hotels to permanently house homeless people living in the convention center.When the pandemic hit in March, the Bridge Shelters and Golden Hall were cleared out and about a thousand people were brought into the convention center, according to the mayor's office.The emergency setup allowed for proper social distancing, and resources to request PPE and other supplies.The convention center will be emptied in December to prepare to open for events when it is safe.Since the pandemic, downtown has looked different according to Marshall Anderson, Vice President of Government Affairs with the Downtown San Diego Partnership."I would encourage all of you to walk around downtown so you can see just about how safe and livable it is at the moment ... For too long has downtown acted as the region's homeless shelter. It's nice to see another neighborhood bearing some of the responsibility for sheltering some of our most vulnerable," he said.The city plans to buy two Residence Inn hotels, one in Kearney Mesa, the other in Mission Valley. Together the hotels could house about 400 people and support tenants who are accessing services for mental health and substance abuse issues.During the city's Public Safety and Livable Communities Committee Meeting Wednesday, Mission Valley neighbors voiced their complaints."It's a bad idea, I am absolutely opposed to this project," a man who has lived in Mission Valley for 30 years said."My real concern is obviously the safety of my community but also the safety of the potential residents ... I am just opposed to this idea because it doesn't seem practical for the city and I feel like it opens the city up to a lot of liability in terms of motorist versus pedestrian accidents," a woman living in the same neighborhood added. She is concerned there is not enough transit or pedestrian infrastructure in the area.The people who would move into the hotels, according to the mayor's office, are stable and already accessing services for mental health and substance abuse. The office added there are already similar units in the area.The committee passed the plan to purchase the hotels and the item will go before the full city council on Oct. 13. 2299

SAN DIEGO (KGTV) - The holidays are creeping into San Diego County this weekend.El Cajon's annual Mother Goose parade will headline the weekend, marking a Thanksgiving tradition San Diegans have participated in for years.The weekend will also see a couple of holiday events get underway, including the Global Winter Wonderland set up at SDCCU Stadium and Encinitas Holiday Fair.Here's a look at what's happening this weekend:18th annual San Diego Asian Film Festival at San Diego Natural History Museum - Thursday - SaturdayMore information.Film buffs will experience more than 150 films from 20 countries in 30 languages spanning action, romance, comedy, drama, animation, documentaries, and family-friendly films. Q&As with filmmakers, opportunities to meet cast and crew and podcast panels will also be hosted. 835

SAN DIEGO (KGTV) — The 10-day Sturgis motorcycle rally held in August led to more than 266,000 new coronavirus cases, according to a new study from San Diego State University.The study, released this week, says upwards of 460,000 people converged on Sturgis, a South Dakota city of 7,000, causing a bump in Coronavirus infections across the US. "Large crowds, coupled with minimal mask-wearing and social distancing by attendees, raised concerns that this event could serve as a COVID-19 'super spreader,'" said the study, which did conclude that the rally was a super spreader event.Researchers from San Diego State's Center for Health Economics and Policy Study used anonymized cell phone data to track where attendees came from, then traced it back to their counties. They found that the counties that had the highest numbers of Sturgis attendees saw a 7% to 12% increase in coronavirus cases. The study also said that CDC data shows that cases in Meade County, South Dakota, where the rally is held, increased 6 to 7 cases per 1,000 population a month after the event started. Descriptive evidence suggests these effects may be muted in states with stricter mitigation policies (i.e., restrictions on bar/restaurant openings, mask-wearing mandates)," the study says.In all, the study says that led to more than 266,000 new COVID-19 cases nationwide.The study says these cases accounted for an additional .2 billion in health costs, enough to pay each attendee ,000 not to have attended the rally. South Dakota Governor Kristi Noem called the study fiction, noting it was not peer-reviewed and based on "incredibly faulty assumptions." Her statement did not elaborate on what those assumptions were and what she considered faulty."This report isn’t science; it’s fiction. Under the guise of academic research, this report is nothing short of an attack on those who exercised their personal freedom to attend Sturgis,” Noem's statement read in part. “Predictably, some in the media breathlessly report on this non-peer reviewed model, built on incredibly faulty assumptions that do not reflect the actual facts and data." 2137

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