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SAN DIEGO (KGTV) — It’s a term we’ve heard a lot during the pandemic: emergency use authorization.From ventilators to diagnostic tests to experimental drugs like remdesivir, the Food and Drug Administration has issued at least 616 emergency use authorizations, or EUAs, since the pandemic began.“That’s such a powerful term: emergency use authorization,” said President Donald Trump on Aug. 23 when announcing an EUA for convalescent plasma.Top officials at the FDA are now floating the idea of using an EUA to speed up distribution of a vaccine against COVID-19, writing that it “may be appropriate” under certain circumstances. Critics contend it would be a dangerous move.The mechanism was put into law back in 2004, and EUAs have been used in several health emergencies since, including the 2009 H1N1 pandemic.An EUA allows the FDA to temporarily authorize a drug or device for use during an emergency under certain conditions. There must be no formally approved alternatives to the product, and the available evidence must suggest the potential benefits outweigh the potential risks.“Because in some emergencies, we just cannot wait for all the evidence needed for full FDA approval,” the agency says in a video explaining the rationale for an EUA.While EUAs are relatively common for diagnostic tests and experimental drugs, there has only been one EUA issued for a vaccine. In 2005, the FDA authorized a vaccine intended to protect U.S. soldiers from an anthrax chemical attack. It was the first time the FDA ever used the EUA process. In that case, the product, Anthrax Vaccine Absorbed, had been formally licensed in 1970 as safe and effective against anthrax on the skin, but was not formally approved to counteract inhaled anthrax.In a letter to pharmaceutical companies, the FDA said it “may be appropriate” to issue an EUA for a COVID-19 vaccine “once studies have demonstrated the safety and effectiveness” of the product, but before other steps in the traditional submission process, like detailed information on how the vaccine was made and tested.“It is extremely rigorous,” Dr. Christian Ramers of Family Health Centers of San Diego said of the typical FDA approval process. “People have to submit thousands of pages of documents. They have to open their books, essentially, and show all of the detail on how these things have been tested.”An EUA could allow for the release of a vaccine before the election, something President Trump has suggested but other members of his administration have said is unlikely.The prospect of an EUA for a vaccine alarms consumer advocates like Dr. Sidney Wolfe of Public Citizen, who sent a letter to the agency urging it to avoid the expedited process.“The amount of information on how effective it is, the amount of information on how safe it is is less than would be required for full approval,” Wolfe said. “And full approval could arguably come in three or four months.”Wolfe thinks an EUA could backfire.“The loss of confidence by people will contribute to a much decreased willingness to be vaccinated,” he said, citing a survey during the 2009 H1N1 pandemic that showed people were reluctant to volunteer for inoculation if the vaccine only had emergency authorization.Critics say there’s already shaky public confidence after reports of political pressure from the president in the EUAs for convalescent plasma and for hydroxychloroquine.In the latter case, the FDA revoked the EUA for the anti-malaria drug June 15 after more studies showed it wasn’t effective and could have serious side effects.Dr. Ramers at Family Health Centers of San Diego says there is a big ethical difference between authorizing an experimental drug with limited data and authorizing a vaccine.Fundamentally, doctors give drugs to patients who are already sick, and they're more willing to try something untested in a last-ditch effort. “In somebody who has been through two or three or four rounds of [chemotherapy] and nothing has worked, the risks and benefits are tilted in a different way,” he said.“But a vaccine is a really special situation because we’re giving it to healthy people. We’re giving it to the general population before they become ill. So historically, the safety threshold for a vaccine has been way, way, way higher,” Ramers added. 4302
SAN DIEGO (KGTV) - It's been 13 years since Filirican Torres died after being hit by a car on the 94 Freeway, and her family says every passing holiday and anniversary brings the pain back to the forefront."It feels like someone is stabbing you in the heart over and over again," says sister Edy Torres.Friday is the anniversary of the death, which is still unsolved. Now the Torres family is asking anyone with information to come forward and help them get closure."Maybe they heard something in the last 13 years," says Torres. "Maybe they heard her name or something came up. Help us out."The family says Torres was thrown from a car on the freeway on January 10, 2007, and then hit by several other cars on the road. It happened on the Eastbound lanes of the 94 in between Euclid Avenue and Kelton. At the time, San Diego Police called the death "suspicious." In 2009, Crime Stoppers released a photo of a white Geo Metro as a suspect vehicle, but they never made any arrests."She was a loving person," Torres says of her sister. "When you met her she would put a smile on your face. She had this aura where you would just gravitate to her."As they have for years, the family is putting up posters around the area where the crash took place."It's been 13 years," says Edy. "Time hasn't healed anything. We just learn to cope with the pain."Anyone with information is asked to call Crime Stoppers at 888-580-8477. 1424
SAN DIEGO (KGTV) - It is Tax Day, and if you’re like most Californians, you’re probably wondering what happened to the nice refund you’re used to getting. Or worse, you owe the government this year. So how do you Make it in San Diego on Tax Day? We found an expert who can help.It's the worst sticker shock imaginable. You're used to a little something back from the government every year in the form of a refund, but suddenly you find yourself with a hefty bill. And the feds don't look kindly on late payments."I always tell people: if you owe money, the first step is don't panic," says Ariel Jurow-Kleiman an Assistant Professor of Law at the University of San Diego. Jurow-Kleiman should know. She's helped people in this situation many times before as a tax attorney and now teaches tax law at USD. Here's the problem."The Federal tax laws were changed in a way that will dramatically affect California residents," explains Professor Kleiman.And that's probably what hit you, too. Many itemized deductions you used to get were either tossed out or capped. "It used to be you could deduct all of your state income taxes," adds Jurow-Kleiman.Now those California income taxes are capped at ,000. And your house, the interest on the mortgage was capped too - double whammy. So, if you owe, here's the first step: do not put off filing. "Absolutely, it is so important to file your taxes on time even if you think you're going to owe," says Professor Kleiman, emphasizing the point. There are penalties for filing late: 5% of your tax liability and up to a maximum of 25%. So, let's say you owe 00 and didn't file for a month, that alone will cost you at least an extra . So, file right away, and pay what you can now."There is interest, it fluctuates, right now it's 6%. It compounds daily so every day, every week that you owe there is a little bit more interest that's added on," warns Jurow-Kleiman.That compound interest can accrue quickly but Professor Kleiman says there are options. You could file for an extension and pay the full amount later. Or you could work out an installment agreement but know some fees could be tacked on. In some cases, paying off your taxes with a credit card could be cheaper than the interest from the government."If you're considering owing money to the government versus owing money to a private lender,” adds Professor Kleiman, “It's very often better to borrow money from a private lender and pay your taxes."However, Professor Kleiman adds that’s not always the case. She advises avoiding payday lenders or someone who charges very high-interest rates. And there is help, especially for those with low incomes, the elderly and the disabled.We have provided links to the Volunteer Income Tax Assistance Program and the local Taxpayer Advocate. For local low income clinics you can call the University of San Diego LITC at (619) 260-7470 or Legal Aid Society of San Diego LITC at (877) 534-2524.Finally, make sure you don’t fall into this situation again next year by checking that you have the proper withholding in your paycheck. You can discuss that with your Human Resources representative at work or a tax expert. 3181
SAN DIEGO (KGTV) — Lego fans will have more to look forward to in 2019, as Legoland California plans new attractions in celebration of its 20th birthday.Among one of the park's 2019 offerings: Free admission for kids 12 and under on their birthday, starting in January."Having a chance to reflect on the last 20 years ahead of next year’s birthday celebration, it’s incredible to think about all we’ve accomplished during that time and the amount of kids we positively impacted through their experiences at the Resort," said park General Manager Peter Ronchetti.RELATED: Southern California theme parks ring in the holiday seasonAmong the new additions for 2019, Legoland said it plans to add new attractions and live shows for visitors to experience.One new addition will be a new attraction inspired by "The Lego Movie." The park will host special "Lego Movie" festivities from Feb. 16 - 17 and 23 - 24 around the park ahead of the attraction's opening.The park's resort is also getting a special zone geared toward toddlers modeled after Duplo. The play town will add an express train in the park and kids will be able to ride, slide, and hide in the interactive area.Also being added is a "Lego 4D-Officer in Pursuit" film that will play at the park's theater and new live character shows at the Miniland Stage.It's not exactly clear when the new additions would be opened to guests in 2019. 1458
SAN DIEGO (KGTV) - It appears traffic along parts of Normal Street in Hillcrest will disappear for good, giving way to the Normal Street Promenade.City Councilmember Chris Ward says the city has signed on for the project as part of the Uptown Bikeways Project with SANDAG.The east side traffic lanes would stay but the lanes on the west side will be replaced by dedicated bike lanes and a pedestrian walkway along a two-block stretch from the Hillcrest Pride Flag to Lincoln Avenue."I'm excited. Hillcrest is a close-knit community, and this will make it even more social," said Hillcrest resident Madison Layo."A great gathering space for everyone that people can rally around ... show a little pride," said Alex Craig, another Hillcrest resident.Ward says the public space can host events like the weekly farmer's market and Pride gatherings, along with events such as street fairs, movies and concerts. The proposal also includes 70 extra parking spaces from Lincoln Avenue to Washington Street. Supporters believe the project could also attract business activity to the area.The Uptown Community Parking District has allocated .8 million for the project. Community outreach for the project will begin in early 2019 with construction expected to start in 2020. 1307