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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) - Members of a newly formed Guardian Angels chapter in Pacific Beach went on patrol for the first time Saturday night.Members of the Sacramento Chapter traveled to San Diego to train the new volunteers. Administrator Sarah Bonesteel joined after a neighborhood crime walk, saying "crime is getting out of control, we've lost our parks, and our library and things like that."RELATED: Guardian Angels look to start street patrols in Pacific BeachThe Guardian Angels are a national crime prevention nonprofit organization that started in New York in 1979. The group said it created chapters in over 130 cities in 13 countries.While the group has several programs to prevent crime, the most visible are its street patrols. The Pacific Beach Chapter hopes to provide a safe environment after the bars close.Guardian Angels patrol in groups of at least two while wearing red berets and uniforms, and say the patrols are meant to serve as a visual deterrent and aim to avoid violent confrontations.Angels on patrols are unarmed but trained in self-defense to protect themselves in case a situation becomes physical. They hope they do not have to use their training.The organization conducts background checks on new members to ensure everyone's safety. 1270

SAN DIEGO (KGTV) -- In 2014, the Whittingtons shared their story about their first-born child in a video that went viral.Ryland was born a girl. “As soon as Ryland could speak, she would scream, ‘I am a boy!’” the video explained. As Ryland got older, the feelings got stronger.After consulting professionals and experts, parents Jeff and Hillary Whittington came to the conclusion Ryland was transgender. For their child’s well-being, they decided to allow him to transition as soon as possible.Today, the YouTube video about Ryland's journey has more than 8 million views.In a 2016 interview with 10News, Jeff Whittington explained some of the criticism his family received. “They think that this is something that just happened overnight. We just made this split-second decision and our son said, ‘I feel like a boy.’ And we said great. And that wasn’t the case,” he said.Hillary Whittington wrote a book about their journey, Raising Ryland."I think people are definitely opening their minds a lot more,” Hillary Whittington said, as she reflected on their family’s journey over the past several years.Jeff explained how they try to deal with those who do not agree with their family’s decision. “We recognize that a lot of that comes from background, stories, and experiences they’ve had. We tend to take that negativity and try and understand what the source of that may be and try and find empathy for those that are critical,” he said.Ryland, now 12-years-old, said he is comfortable with his story being so public. “I know it helps a lot of people,” he said.Last year, his family hosted a “coming out party” to share with loved ones. Ryland gave a speech in front of his friends and others close to him. “It’s not a secret, but for many years I’ve kept it private because I was afraid you might treat me differently or not look at me the same if you knew,” he said. “When I was born, the doctors told me that I was a girl. But they were wrong. In my head and in my heart, I’ve always been a boy.”Ryland is about to enter seventh grade. He loves math and sports—his favorites are ice hockey and lacrosse.He shared what Pride month means to him. “Pride month is just a month of showing who you are and showing that you support who people want to be,” Ryland said.“We’re grateful for who our kids are. They’ve taught us so much about life and I wouldn’t a thing about them,” Hillary said.For those who still have negative things to say about their family, Ryland’s 8-year-old sister shared her thoughts. “I would want to say to them that I don’t care what they think and that I am happy to be who I am and who my family is,” Bryn said.“She took the words right out of my mouth!” Ryland echoed. 2706

SAN DIEGO (KGTV) - Mayor Kevin Faulconer detailed his plan to bolster San Diego's infrastructure in a proposed budget Tuesday.The plan calls for a total of about 3 million in investments into the city's streets, parks, and water system — among other improvements. The investment in infrastructure is the largest in San Diego's history, according to the mayor's office.The investments are part of the mayor's proposed .8 billion budget, which City Council leaders are set to adopt at a June 11 meeting.RELATED: San Diego Mayor Kevin Faulconer unveils 2019 budget"After decades of neglect, we have a lot more to do, which is why I’m focused on fixing more streets, building more parks and making more neighborhood upgrades than ever before," Faulconer said in a release. "We also need to invest in aging buildings like those in Balboa Park so they stand the test of time and that’s exactly what this budget will do."Here's a look at some of the financial commitments the mayor's plan proposes:Pure Water: Among the commitments is a 1 million investment into Pure Water San Diego to create an independent, drought-proof local water supply for San Diego. That project is expected to break ground in 2019.RELATED: San Diego is tops for walkable parks, study showsBalboa Park & fire stations: Also on the docket are 1 million in repairs for local libraries, fire stations, lifeguard stations, and recreation centers. The funds will also see new roofing installed for Balboa Park's Mingei International Museum and Air & Space Museum.Transportation: The plan puts 8 million toward transportation projects which consist of road paving, traffic signals, sidewalk improvements, and bridges. This includes funding to fix about 390 miles of streets.Parks & Rec: Mission Bay Park, Chollas Lake, Hickman Field Athletic Area, and Skyline Hills Community Park will see .5 million in park upgrades, including new lighting, trail realignments, and ADA improvements.Water system: Faulconer's proposal also includes .6 million for stormwater upgrades to channels, pumps, storm drain pipes, and watersheds.Faulconer's entire proposed budget can be viewed on the city's website. 2230

SAN DIEGO (KGTV) -- Looking around Barrio Logan, you can't miss the shopping carts, tents and camps belonging to the homeless. Residents of the San Diego neighborhood say the city is turning their community into a "homeless ghetto" - and it's time for it to stop. Tuesday night a group gathered outside the Our Lady of Guadalupe Church, calling on the city to provide "fair distribution of homeless services across San Diego.""It's unbelievable what the mayor and the City Council are doing to this area," said Father John Auther. The priest pointed to a map, asking why a nearly 370 square mile city is putting most of the homeless services in a one-quarter square mile. Father Auther says the concentration of services goes beyond the residents of Barrio Logan. It's bad for the homeless community, too. The area was hit hard by the hepatitis A outbreak.RELATED: Health officials reminding San Diegans about hepatitis A shot "Many of the homeless as we know suffer from addiction problems, alcoholism, mental illness, and what the city has decided to do is put all of them together," Father Auther said. "How will anyone get well?"Right now, city crews are working on a transitional homeless facility in the neighborhood. The facility is going up just 15 feet away from a school playground. A playground closed because of the homeless issue. "We can no longer feel comfortable, feel safe with our students down here on this playground," said Noel Bishop, principal of Our Lady's School San Diego.10News asked a few people in the homeless community two questions: 1. Will the new facility help you? All said yes. 1651

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