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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) - If you couldn't work, how far could you go without a paycheck? No one is immune to an unexpected injury or illness, and the financial hit can be devastating. The Social Security Administration (SSA) reports that one in four of today's 20-year-olds will become disabled for 90 days or more before retirement age. Having a plan for the long term can relieve a lot of stress if the unexpected does happen.One option is disability insurance; there's short-term and long-term. Disability insurance pays a portion of your income if you are suddenly unable to work because of illness, injury, or accident.You can get coverage through an employer or buy it from an insurer. According to State Farm, long-term disability insurance:Pays monthly income directly to you when you're unable to work because of a covered total disability.You choose the length of time you must be disabled before you start receiving benefits (Elimination Period) and the length of time you would receive benefits.Options include a five-year benefit period or a "to age 67" benefit option.Maximum monthly benefit amounts range from 0 to ,000, based on your income and occupation. You can customize your coverage with different riders.While different factors affect the cost, the annual price for a long-term disability insurance policy generally ranges from 1% to 3% of your annual income.According to the Council for Disability Awareness, 34.6 months is the duration of the average long-term disability claim.The nonprofit helps prepare people for unexpected injury through its five-step financial plan to give you a clearer understanding of your financial "big picture," including:Your sources of income, monthly expenses, and lifestyleThe impact a long-term disability could have on themPreparing a plan of action to address the crisisResources after life-changing disabilityMost people never expect a life-changing disability will happen to them, including San Diego resident Kat Blue. Blue was rear-ended at a red light on Feb. 1, 2018, and had previous head injuries before that."This one resulted in a concussion that just never went away," said Blue.A few weeks after the accident, Blue realized she could barely complete simple tasks like writing an email or talking on the phone. She suffered a traumatic brain injury (TBI), which would change her life forever. She constantly deals with nausea, dizziness, tetanus, and migraines. Blue has struggled to navigate the healthcare system and because she cannot work is constantly seeking resources so she can remain in San Diego."You have to advocate for yourself because there's no one within the system who is going to do it for you," said Blue. Blue says she does not have the resources to relocate and says San Diego offers a lot of support for TBI survivors. She's relied on Medicaid for medical care, which has helped with resources like a nurse care manager, but she says there are holes in the system."I'm still fighting to get a TBI specialist, I'm still trying to get a lot of the treatments and specialists and therapies that I believe could help me," said Blue. The San Diego County Health & Human Services Agency is ready to help San Diegans whose incomes have been impacted by an unexpected disability:CalFresh: Food assistance:Medi-Cal: Free or low-cost health coverage for children and adults with limited income and resources. If you qualify, you can enroll in Medi-Cal year-round.CalWORKS: Public assistance program that provides cash aid and services to eligible families that have a child(ren) in the home."You may not need our benefits today, but in the future, if you do we're here, and we encourage everyone to apply," said Rick Wanne, Director of Eligibility for the County of San Diego Health & Human Services Agency.Wanne says the County also has a close relationship with 211. "211 is a great resource for a number of reasons, they can provide general information over the phone about a whole variety of resources here in San Diego, additional food assistance, housing resources, where to find a local medical provider," said Wanne. Wanne said in addition to what the County offers many local nonprofits and other entities provide help.Blue says she's found the following resources helpful when advocating for herself:Legal AidCalifornia Department of Rehabilitation (DOR)Disability Rights CaliforniaBlue says she's also taken advantage of recreation opportunities through Sharp, some of which are free. Sharp also offers support groups for people with various disabilities. Another program that's been instrumental in Blue's recovery is Love Your Brain Yoga, a free program for TBI survivors. "A good part of my day is spent just trying to feel better, just trying to get well enough to do what I need to do that day," said Blue.Blue remains hopeful she'll get the care needed for her healing and says she'll continue to do everything possible to stay in the city she calls home. 4971

SAN DIEGO (KGTV) - Local groups including the Local Initiatives Support Corporation, are pushing for the City of San Diego to draft up and pass an ordinance that excludes certain zoning policies. "We're not asking to spend billions of dollars and build something, we're saying change the zoning. They have the prerogative, it's under their jurisdiction, we're reminding them there are issues at stake and those issues are communities to this day that are segregated," said Ricardo Flores, executive director of LISC.Flores says the same areas that were identified back in 1930 by San Diego banks as low-income areas are still falling under that category today. Additionally, areas outside of those remain zoned for single-family homes, keeping the lower income families from moving in. "So, what we’re effectively saying is, if you can't buy a single-family home in Kensington, then you can't live in Kensington. But, that’s not the truth; the truth is Kensington is zoned one thing, single family, and we need to expand that zoning." A representative at the rally from Chicano Federation says, "We are tired of the continuation of policies masked as zoning when in reality they are policies of segregation." Meantime, Borre Winkle, CEO and president of the Building Industry Association of San Diego told 10News, "The American dream is not to live in an apartment, the American dream is still to live in a single-family dwelling unit no matter how big it is".Winkle says getting rid of single family zoning isn't the solution. "For us, were totally on board with having multi family in a single-family zone, but we think it's going to run into a lot of neighborhood opposition." 1688

SAN DIEGO (KGTV) - IKEA is recalling a type of candy sold at certain stores in California, including the San Diego location in Mission Valley.The Godis P?skkyckling marshmallow candy may be contaminated. The chain did not immediately release the source of the possible contamination but said the health risk is low.IKEA said the candy is a seasonal product and only 400 bags have been sold since it became available in February.If you bought the candy, you may return it to the nearest IKEA store for a full refund. 523

SAN DIEGO (KGTV) -- Maintenance crews were hard at work at UC San Diego Tuesday fortifying campus buildings ahead of the rainstorms expected this week, all while several dorms continued to dry out from the last one.Workers shored up roofs and deployed straw wattles and 200 sandbags near the Marshall Lower Apartments. The university said 12 to 15 dorms flooded last week during torrential rain.UC San Diego said drains near the apartment complex were overwhelmed by the water and debris.RELATED: UC San Diego students reeling from flooded dorms after storm“We conducted additional drain and area inspections of the Lower apartments in advance of the rain,” the university said in a message to residents. “[Housing, Dining and Hospitality] maintenance staff will be on standby to ensure that everything holds and storm drains remain clear.”The National Weather Service said a flash flood warning will be in effect Wednesday morning through Thursday evening in coastal areas and the inland valleys.The bulk of the rain is expected to hit Wednesday evening through Thursday morning. Rainfall totals through Friday could reach 1.5 to 2 inches in coastal areas and up to 3 inches in the San Diego County mountains, NWS meteorologist Miguel Miller said.UC San Diego maintenance crews were still trying to dry out some of the dorms that flooded with fans Tuesday, meaning some students have to contend with the hum of dehumidifiers while studying for midterms.RELATED: What you need to know about San Diego's Thanksgiving holiday storm“The dehumidifiers were kind of loud, but it was a constant sound so I got used to it,” said one student.Another student, Jason Rose, said not only did his apartment building flood, his car did too. The vehicle was parked in the Hopkins Parking Structure.“I was studying all night for a week, so I didn’t go to my car until four days after. When I opened my car door, it smelled terrible and when I looked inside it was just full of water,” he said.“It’s totalled probably,” he added.Rose said the university did offer to help with his insurance claim.Check 10News Pinpoint Weather conditionsStudents said maintenance crews have been quick to respond to issues, but with this week’s storms will be a test.“I’m pretty concerned,” said one student. “Especially because it seems like there’s not any long term changes right now. I know that takes longer to do, but I don’t think 10 sandbags are going to save all of our apartments.” 2466

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