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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 City of Poway Friday honored the memory of Lori Lynn Gilbert-Kaye, who was killed last April in a shooting at a local synagogue, by renaming a street after her.Many gathered Friday for the unveiling of Lori Lynn Lane (formerly Eva Drive). It's located in the Green Valley Neighborhood, off Stone Canyon Drive. Lori Kaye lived at that intersection. “To be able to dedicate this street to her memory means a lot to us in Poway,” says Poway Mayor Steve Vaus.RELATED: Family discovers synagogue shooting victim's random act of kindnessNeighbors and friends came together and petitioned for the change. Vaus says it's rare for the city to rename a street after someone. The last one dates back to the 1980s. But Vaus says the city had no hesitation with this renaming. The Poway City Council unanimously approved the honor in November. Gilbert-Kaye lost her life in that tragic synagogue shooting back in April. Many say she was a light in this community. RELATED: Chabad of Poway to dedicate Torah scroll to memory of synagogue shooting victim“It’s so appropriate that we do this on the cusp of Hanukkah. Hanukkah is the Festival of Lights, and Lori was a bright and shining light,” says Vaus. “I think the one word that people would use to describe her, she was a giver.”Vaus says as they are a few months away from the first anniversary of the shooting, the City of Poway will continue to stand strong, and lift up Gilbert-Kaye’s family. The trial date for the man accused of opening fire in the Chabad of Poway has been set for June. 1564

SAN DIEGO (KGTV) -- The family of a murdered San Diego Army Veteran is setting up a scholarship in her memory. Julia Jacobson's sister, Casey Jacobson, spoke to 10News from her home in North Dakota Tuesday. The family had bracelets made in honor of Julia and her beloved dog, Boogie. RELATED:  321

SAN DIEGO (KGTV) -- Summer of '85, the community of Normal Heights was devastated by a fire that claimed 69 homes but no lives. October, 2003, the Cedar Fire broke out in the Cleveland National Forest and exploded across San Diego County. The largest wildfire in California history to that point, it killed 15 people and destroyed thousands of homes. Hardest hit were Scripps Ranch and Tierrasanta.Four years later, another firestorm raced through the north county, killing two and featuring wind gusts of over 100 miles per hour. The Witch Fire forced the evacuations of half a million people in San Diego County.Our sister TV station in Denver asked for help in covering a wildfire that burned for almost a month in Colorado. I provided live reports for KMGH, there, and KGTV, here in San Diego. Much more rugged terrain and restricted access than here in California.December of last year, the Lilac Fire ignited near Bonsall and strong winds pushed it toward the coast, wiping out 72 residences in Rancho Monserate Mobile Home Park.. An enormous earthquake shook Mexico City in September, 1985. Tremors measured 8.0 and aftershocks almost as strong. 10News hopped onto a flight the next morning and we covered the destruction and rescue efforts. We had just paused after a full day of shooting; our batteries depleted and being re-charged when another aftershock rumbled through. Everyone in the hotel where we had set up base, emptied into the street at a dead run. A many as 10,000 people were believed to have died in those quakes. A year later we returned to report on recovery efforts.We drove to the Northridge quake, which hit in January, 1994; magnitude of 6.7, killing 57 and injuring 8700. In the midst of driving snow in Julian. Battered by a winter storm on the Oceanside Pier.A giant boulder crashed onto a house in Rancho San Diego in 2000. Fortunately, no one was home when the 140-ton house guest dropped in.Rainbow Creek was the site of a desperate search for a 5 year old boy who'd been swept away in flood waters early last year.We just observed the 10 year anniversary of an FA-18 jet crash into two homes in University City. Four were killed in that tragedy.PSA Flight 182 will never be forgotten. A Cessna collided in mid-air with the jetliner over North Park, claiming 144 lives and and 22 homes. It was in 1978. There've been many tributes. 2375

SAN DIEGO (KGTV) - The City of San Diego and the San Diego Housing Commission announced details about a planned purchase of two hotels to convert into permanent housing for the homeless.After a six-month search, city officials announced the purchase of the Residence Inns in Mission Valley and Kearny Mesa. The price tag: 6.5 million.Scott Marshall of the San Diego Housing Commission says the project draws upon city, county and state funds to turn hotel rooms into 332 affordable apartments for the homeless, many of them currently staying at the convention center as part of the program, Operation Shelter To Home."This is not temporary shelter. They are permanent homes that will provide them a path out of the shelter and off the streets," said Marshall.Marshall says of the 29 sites considered, the two Residence Inns stood out."They were operating as hotels and in good condition. They didn't require a lot of work for people to move in," said Marshall.Federal housing vouchers will help residents with part of the rent. They'll also receive a host of wraparound services."Things like health care, Life skills training and employment assistance to help them get back on their feet and to a more stabile life," said Marshall.The hotels turned apartments reside in commercial areas, with many other motels and hotels as neighbors. SDSU marketing professor Miro Copic says any issues at the sites could turn into pubic relations problems."Tourists and travel agents could see it as a negative, and it may turn away people from the area. The city has to manage this effectively. If it does so, it may not have much of an impact on nearby hotels," said Copic.If the city council approves the purchase in October, the apartments could be ready by December. 1768

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