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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 mother of two children killed in a Rancho Bernardo condo fire last month wants to meet the person who called 911, a family friend says.7-year-old Isabella Lopez and her 10-year-old brother Christos died in a fire at Bernardo Terrace, October 28.The children’s funeral is November 10 and the friend who has been helping plan it says the kids’ mom wants to thank the 911 caller for giving her a final moment with her dying son.RELATED: Two children dead, father in critical condition after Rancho Bernardo fire“She didn’t get it with her daughter, but she got it with her son and that means the world to her,“ said Sam Trink, “If they didn’t call when they did, she would not have gotten an extra three minutes with her son.”The funeral is being held at Grace Point church in Del Mar Heights. It begins at 8 AM and is open to the public. 871

SAN DIEGO (KGTV) - The California Highway Patrol has ruled out street racing and DUI as causes of a crash on Interstate 805 in Sorrento Valley that left a man with serious injuries. Traffic came to a standstill in the northbound lanes of the freeway about 2 p.m. when a silver Mercedes SUV hit the driver of a blue Nissan. Witnesses told the CHP the Nissan suddenly stopped in a lane and the driver got out of the car. CHP says the Nissan became disabled and the driver got out of the car after pulling off to the side of the road. The Nissan’s driver was struck and thrown 135 feet before landing on the pavement. The CHP said the man had severe head injuries. A total of four cars were involved in the resulting pileup. Three people were taken to the hospital, San Diego Fire-Rescue reported, but no one aside from the Nissan's driver was seriously hurt. The other drivers stopped and cooperated with the investigation. The affected lanes of the freeway reopened about four hours after the crash.The Nissan was recently purchased, according to the CHP. Investigators said the driver might be a member of the military. 1127

SAN DIEGO (KGTV) – Tens of thousands of jobs are on the line as Congress struggles to save the airline industry, but a new bill announced Friday is giving some aviation workers hope.For Dante Harris, it’s more than a job.“It's a career that I would never want to exchange for any other,” said Harris.In his 21 years as a flight attendant with United Airlines, he’s traveled to every corner of the world. Now, he’s among the tens of thousands laid off after Congress failed to pass a stimulus bill this weekHarris is the president of the Association of Flight Attendants-CWA Council 12 union stationed at LAX, which also serves San Diego and Seattle members.He says about 2,500 United Airlines workers on the west coast lost their income and health care.It comes as an incredibly hard blow for the first responders of the sky who already faced countless challenges due to COVID-19.“We provide service to make sure that doctors and nurses get to where they need to go, to make sure that Americans are safe,” said Harris.On Friday, House Speaker Nancy Pelosi said if a bipartisan agreement is not reached, she’ll push for a standalone bill to extend payroll protections for airline workers for another six months.Harris is calling on Washington to extend that crucial funding so airline workers can get their wings back.“We need that bridge to get us to the point where we can bounce back,” said Harris. “And we can fly America to all corners of the earth again.” 1468

SAN DIEGO (KGTV) - Surveillance cameras caught two people in a truck turning an alley in El Cerrito into a dumping ground.Just off Dayton Street is one unsightly mess. Maurizio Rios, who lives near the alley, can barely look at it."Feels terrible. It's actually disgusting," said Rios.Right next to a new home construction are two barbecues, two chairs, and parts of a several different tables. "The image is not a good image. It's trash. It's a dump," said Rios.The men who sullied that image were likely not aware that Rios' surveillance cameras were watching.Monday afternoon, just before 3:30 p.m., a pickup truck loaded with stuff was seen driving down Dayton Street and turning into an alley. From several other cameras, the truck is seen driving through the alley, before it finally stops. Two people then get out and begin unloading. More than four minutes later, the truck drives off."It's unbelievable. Why don't they just take it to the dump?" said Rios.Rios filed a police report and delivered a big clue: a clear image of the front license plate. Last year, the City of San Diego increased penalties for illegal dumping. Fines now range from 0 to ,000. 1178

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