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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 approaching one year since a San Diego Navy Sailor was hurt in an explosion while on deployment, leaving him paralyzed.Saturday, community members rallied together to support wounded sailor, Kenton Stacy, on his journey to recovery. Hundreds of people gathered in Liberty Station for the Stacy Strong 5k.“We feel very blessed,” says Kenton Stacy’s wife, Lindsey. “All the love and support we’ve seen over the last year just has been amazing.”The event had live music, a silent auction, and awards for race winners. During this time last year, the Navy EOD tech was deployed in Afghanistan when an IED exploded while he was clearing out a hospital. The explosion left him paralyzed from the neck down.“It’s definitely been a very hard year… There’s been highs, there’s been lows,” says Lindsey Stacy. Her husband has not made it home from the hospital just yet but, today he was transported and joined family and friends at the event.“I just think he feels so blessed," she added.The funds for the event will go to the EOD warrior foundation. The organization provides financial assistance and resources to wounded active duty service members and veterans. Stacy’s “Alive Day” anniversary is November 9.  1270

SAN DIEGO (KGTV) — It's been 25 years since President Bill Clinton approved Operation Gatekeeper, the measure focused on the issue of immigrants crossing the border illegally — specifically the San Diego sector.Two key parts of Operation Gatekeeper were surveillance equipment and enforcement infrastructure, like walls and fences. Twenty-five years later, Border Patrol Agent Theron Francisco tells 10News, "Before Gatekeeper this area was in utter chaos, agents were apprehending 1,000 per shift. We had hundred of thousands of apprehensions a year." It's a measure that Francisco says paved the way for Border Patrol today."It's absolutely night and day from where we were back then," Francisco said.Tuesday, those against Operation Gatekeeper held a rally. Former Border Patrol agent Jenn Budd tells 10News, "That was the whole purpose, to push them out here to make it more difficult and dangerous for them to cross. I didn't want to be a part of it but its something I have to admit I was a part of."Budd tells 10News, it's partly why she left Border Patrol, "I left because I felt the policies we were enacting were killing people and what we were representing to the public wasn't the truth." Meantime, Border Patrol agents say it's only helped increase San Diego safety."The days are gone where illegal aliens are running through people's backyards trying to hide from Border Patrol," Francisco added. Budd says, "We need them to work for us, we need them to protect our borders we need them to keep drug smugglers out, but we don't need children dying in their custody and all sorts of things they're doing right now." 1637

SAN DIEGO (KGTV) - Kids and teens struggling with their mental health during the Coronavirus Pandemic and weeks of protests over racial injustice have a new way to cope.BlueShield CA has expanded its Blue Sky program, increasing funding to local mental health organizations and giving kids a platform to share tips on dealing with anxiety and depression."There's a greater need now than ever," says Blue Sky Program Manager Amanda Lasik. "There's a greater need to speak to youth voices and listen and learn from what's going on."According to the CDC, 7.1% of kids age 3-17 have been diagnosed with anxiety, and 3.2% of kids in the same age group have been diagnosed with depression. Experts believe those numbers will rise because of the pandemic and protests.As part of the expansion, Blue Sky partnered with DoSomething.org to launch the "New State of Mind" campaign. Kids send tips for coping to the website, which get published through emails, texts, and social media."The response has been overwhelming," says Lasik. "When we were originally planning this campaign, we thought it'd be great if we got about 17,000 tips. We've already received over 60,000."In addition to the "New State of Mind" effort, Blue Sky has provided 0,000 to 18 youth organizations in San Diego and Alameda county. The money has helped them adapt their services to the challenges of the past few months."It's been a quick transition, but these groups are now offering counseling online, doing arts programming online, and engaging young people online in different ways," says Lasik."We've also heard from the nonprofit community that they just need a little bit of operating support."The money is in addition to the million that BlueShield pledged as part of the Blue Sky initiative last December.RELATED: South Bay schools partner with insurance company to address student mental health challengesFor high school student Joel Castro, connecting with these programs has been empowering."It gives me hope," says Castro. "It's great to see other young people get very passionate about issues and wanting to fix them." 2111

SAN DIEGO (KGTV) — If there's one thing Californians know, it's that guacamole is always extra.Expect this weekend! National Chip and Dip Day comes on Saturday, but the fun starts Friday. Rubio's is giving away free chips and guacamole with any purchase on Friday and Saturday in celebration of the delicious event. Just present this coupon with any purchase and dip into some delicious freebies.At the very least, break open a bag at home and kick back with a handful of chips and side of dip. 502