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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 San Diego is planning on expand its designated scooter parking zones to Ocean Beach. The Mayor’s staff recently sent a list and map of 106 prospective locations to the Ocean Beach planning board. The scooter corrals are similar to the on-street parking the city has already installed downtown. The ‘Micro Mobility Parking Corrals’ - as the city calls them - are installed at red curb spaces that do not block traffic, fire hydrants or impede visibility. The Mayor’s office says it is working with community groups to find suitable locations in OB and they plan to have feedback by June 10th. 630
SAN DIEGO (KGTV) - The largest employer in the country is waving away a long standing tradition. Walmart is planning to phase out its greeters at more than 1,000 stores across the country. The retail giant says it is moving forward with a new role called “customer host” that is more physically demanding. The hosts will still greet people but must also be able to pass physical exams including lifting a 25-pound box and climbing ladders. Critics say the move targets their elderly and disabled employees, which make up a significant portion of the company’s greeters. “I can’t do that,” said Adam Catlin, who has cerebral palsy and has worked as a Walmart greeter for a decade. Walmart says it is striving to place greeters in other jobs at the company and the title of greeter will be officially eliminated April 26. “I want to keep my job past April 26 because I have made a lot of good friends and a lot of good memories over the years,” added Catlin. Walmart has not said how many greeters will lose their jobs but adds it is, “extending the current 60-day greeter transition period for associates with disabilities while we explore the circumstances and potential accommodations, for each individual, that can be made within each store.” 1252
SAN DIEGO (KGTV) — The Fourth of July is traditionally a fun-filled weekend for locals to enjoy delicious food and take in a fireworks show. And while the pandemic has put some limits on that, there are still ways to have fun safely.El Cajon and Poway are hosting fireworks displays and encouraging residents to practice social distancing by staying in their car or watching the show from a distance.The Del Mar Fairgrounds also continues to host delicious fair food weekends with Chicken Charlies, Roxy's, and many more delectable treats — all from the comfort of your car drive-thru style.Balboa Park is also reopening several museums with guidelines in place to keep visitors safe.(As a reminder, residents are encouraged to stay home if they feel ill and avoid large gatherings with people not from the same household. The county also requires residents to practice social distancing and wear a facial covering when within six feet of those not from the same household.)Balboa Park museum reopenings (Friday): Starting Friday, several Balboa Park museums will reopen with new sanitation and distancing guidelines in place. The Fleet Science Center, San Diego Natural History Museum, San Diego History Center, and more will welcome visitors back this weekend for months-long closures. More infoEl Cajon July 4 fireworks (Saturday): Locals in El Cajon will be able to catch fireworks over John F. Kennedy Park at 9 p.m. on July 4, though the park itself will be closed. The show will be visible over a wide area and city officials encourage residents to look up and enjoy the show from home safely. More infoPoway's July 4 fireworks (Saturday): Fireworks will launch from both Poway High School and Sportsplex in South Poway Business Park at 9 p.m. on July 4. The two locations will allow for a nearly 360-degree view of fireworks from the Sportsplex while allowing those who traditionally view the show near the high school to continue doing so. Tickets must be purchased to watch the show from Lake Poway's parking lot. More infoSan Diego County Fair food fun (Friday-Sunday): What's the July 4 weekend without some fair food? The Del Mar Fairgrounds is offering delicious bites from fair vendors Friday through Sunday from now until Sept. 7. Grab a bit from vendors like Chicken Charlies, Roxy's, Sugar Bear, and more! The fair is also hosting virtual exhibits showcasing student artwork, photography, and livestock shows. More info 2445
SAN DIEGO (KGTV) - The mother of Rebecca Zahau testified Thursday in the second day of the civil lawsuit surrounding the Coronado mansion death.Rebecca Zahau died in July 2011. Her nude, bound body was found hanging from the balcony of the Spreckels mansion.The death was officially declared a suicide but Zahau's family disagreed. They filed a wrongful death civil lawsuit against Adam Shacknai, the brother of Zahau's boyfriend.Shacknai’s lawyers argue there is no physical, eyewitness, or scientific evidence linking him to Zahau’s death.Zahau's mother, Pari Zahau, took the witness stand Thursday morning and gave an emotional testimony as she was asked questions about her daughter.She remembered her as a sweet, loving and religious woman. The jury has three days off and will hear testimony again Monday.The family’s attorney Keith Greer handed Pari Zahau a piece of evidence and asked her to describe what it was.It was an envelope full of cash from Rebecca Zahau addressed to Pari Zahau and her late husband.Pari Zahau explained to the jury her daughter would support her financially by sending cash every month. That envelope was never sent, although one of the final times Pari Zahau talked to her daughter, she was told it would be on the way soon.Pari Zahau had to take a break from testifying when lawyer Keith Greer asked, “Did you ever think Rebecca would kill herself?”She gave a tearful response saying, “No. No, never. Never. My daughter? No. She is very sweet girl and she is very strong. No no, not suicide, they killed her.”After Pari Zahau broke down in tears, the lawyer asked for a brief break.The trial is expected to last a month. The Zahau’s family’s goal is to get the Sheriff’s Department to reopen a criminal investigation. 1802