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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 Downtown San Diego Partnership is relaunching a program to help businesses impacted by the COVID-19 pandemic.A new round of the organization's Downtown Loyalty program launches at noon on Tuesday. It allows people to buy discounted gift cards to some of downtown's most recognizable restaurants, coffee shops, retail, and services."It's a digital gift card sale," said Sarah Brothers, marketing and communications director for the Downtown San Diego Partnership. "So you're able to buy a gift card to your favorite downtown locations. And for every purchase, you get a free funded by philanthropy."It allows the customer to get more than what they paid for, and it's extra revenue for the business at the receiving end.The program is made possible through fundraising and donations.The first round of the Downtown Loyalty program's gift card sale sold out in four days when it launched in July. It provided nearly ,000 in direct revenue to struggling businesses in downtown San Diego. There is hope the second round of gift card sales will have even more significant impact, with nearly ,000 to support businesses. 1163

SAN DIEGO (KGTV) — The former home of San Diego Padres icon Tony Gwynn has finally found a buyer."Mr. Padre's" Poway home, that had since been foreclosed, was sold on Dec. 13 for ,429,500, according to Realtor.com. The two-acre residence was placed on the auction block in June starting at .2 million. The posted legal notice said that .5 million was still owed on the home.After the auction failed to find a new owner, the lender took control of the property.RELATED: Family of MLB legend Tony Gwynn settles tobacco lawsuitWhen the home remained empty, suspicious activity and reported squatters took up residence inside the estate. In January, the San Diego County Sheriff's Department said they had received nearly half a dozen reports about trespassers at the address over the past few weeks.Realtor celebrity reporter Erik Gunther said the steady price cuts on the property encouraged the new buyer to "take a swing" at the home."After a drawn-out debacle involving squatters and foreclosure, the former home of Hall of Famer Tony Gwynn finally has a new owner," Gunther wrote. "The bank whiffed with their initial price of .12 million, but a steady number of price cuts over the past few months finally encouraged a buyer to take a swing at rehabbing the baseball legend's home."The 7,370-square-foot home features seven bedrooms, 5.5 baths, living room with fireplace, a spacious kitchen and dining room, and its grounds include a basketball court and a pool with a spa. Bad investments by Gwynn caused the MLB legend to file for bankruptcy in 1987, which may have played a role in difficulties holding on to the property after his death from cancer in 2014. The Gwynn family had owned the residence since 1991 for the bank took ownership, according to Realtor. 1784

SAN DIEGO (KGTV) - The first thing Whitney Dickerson does when she gets home from work each evening is make a cup of her favorite tea.It's because her job as a veterinary technician can be stressful. "Everyday I go in and I don't know what's going to go through those doors," she said. "It could be a really emaciated animal with severe mange, it could be a really happy lab coming through."But Dickerson's angst doesn't end when her shift is over. She's living paycheck to paycheck, and has moved seven times in her six years in San Diego just to find a rent she can afford.COMPLETE COVERAGE: Making it in San DiegoShe's now splitting a two-bedroom apartment in Talmadge, which goes for ,874 a month. She's not sure how much more she'll be able to afford. "I feel like the city's slowly pushing me out," she said.Now, the rent's getting so high that it's near a tipping point for thousands of San Diegans. More than half of those who responded to a recent 10News Union-Tribune scientific poll said they'd seriously considered leaving California in the last year.  </p><p> The average rent is now ,887 a month, up 8 percent from a year earlier, according to Marketpointe Realty Advisors. And CoreLogic reports the median home price in the county is now about 0,000. "That's a problem for everybody, and I think everybody feels that," said Rick Gentry, who heads the San Diego Housing Commission, which oversees affordable housing in the city. </p><p><strong>HOW DID WE GET HERE?Gentry describes something of a perfect storm when it comes to housing in San Diego -1) There's not enough housing for the middle class.2) There aren't enough resources for low-income individuals.3) The current market has already swallowed up the glut of homes built during the housing bubble before the market crashed in 2008. "And that means the marketplace has gotten that much more expensive and that much tighter," Gentry said. "There's no place to move to."Gentry added turnover has declined drastically at the 3,400 affordable apartments the commission manages, and the section 8 voucher waiting list has ballooned to 80,000. Plus, San Diego County continues to grow with more jobs - employers added 27,000 new payroll positions in the last 12 months. Meanwhile, developers in the county only pulled permits for 10,000 new homes. "It takes a long, long time to get approvals for buildings to put new product online," said Mark Goldman, a real estate lecturer at San Diego State University. "There are more and more impact fees that makes it more expensive, there's a limited amount of land to do it."Goldman said it's a very complicated, risky business to start with a piece of vacant land and try to put a lot of housing on it.He said the amount of time that it takes given environmental review, regulations, and delays raises the cost of projects - to the point that some developers just drop it. WHAT WILL SOLVE THE CRISIS?There is movement in the works to spur development, including a region-wide plan to encourage development along transit routes. The city of San Diego also recently approved streamlining complexes with microunits and fewer parking requirements in these areas.The state also has a new law that allows the Housing Commission to make loans for the development of multifamily complexes that are affordable to middle income earners. 10News will dive deeper into solutions for Making it in San Diego on Friday.But until the prices come down, renters like Dickerson will be bracing for when their leases end. "If they go another 0-0 like a lot of places are doing," she said, "I'm probably going to have to move again."How are you dealing with the housing crunch? Email us at tips@10news.com. 3836

SAN DIEGO (KGTV) -- The man accused of assaulting a Pacific Beach woman while she slept in her own home was in court for the first time on Monday. Jeffrey Hanze pleaded not guilty to the charges, which include sexual assault during a burglary. The 55-year-old was arrested in L.A. County on October 29th for the crime. Police say Hanze broke into a home in Pacific Beach on October 1st, getting in through an open window, then assaulting a woman while she slept. The woman woke up to the assault and Hanze got away.On Monday, the judge agreed to increase his bail from 0,000 to a million dollars and issued a protective order for the victim. A background check shows Hanze has a criminal record, including two felonies in San Diego County and several sex crimes dating back to 2011 in Arizona. Hanze is due in court again on November 15th.    913

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