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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) — In the midst of a housing supply crunch, San Diego is seeing apartments taken off market and reserved for short-term vacationers. The units would add to the estimated 16,000 vacation rentals now available in the City of San Diego, according to a recent audit.Now, a company called Sonder has signed master leases at apartment complexes and towers in locations including downtown, North Park, Little Italy, and Point Loma. Instead of renting them full time, the company leases them to visitors, charging more than 0 per unit on an average night. "Every San Diego resident needs to be afraid of that," said Brian Curry, whose group Save San Diego Neighborhoods is tracking Sonder. "It's a huge crisis, drives up rents, drives up housing prices."Curry's group estimates Sonder has leased more than 70 units and counting, including entire buildings in some locations. A spokesman for Sonder declined comment Thursday. In the past, the company has stated it pays all local taxes and that it has the right to sublease to short-term renters. Additionally, it has noted that developers have used increased revenue from Sonder to build even more market rate units. Still, City Councilwoman Barbara Bry said she was appalled at the practice and says the city should be ensuring developers deliver on the units the city approves. "Private developers tell us, 'let us build more units, let the market take care of our housing problem,' and then they artificially remove units and turn them into short-term vacation rentals," she said. "That's not fair."Meanwhile, the city code enforcement division is continuing to investigate The Louisiana complex on University Avenue. The city approved the complex as a 13-unit mixed-use apartment complex, but Sonder has the master lease for each of the market-rate units. The only confirmation so far is that the two low-income units on the property are leased to San Diegans who qualified. 1947

SAN DIEGO (KGTV) — Jurors were again deadlocked in the retrial of the man accused of shooting two people outside of a Metallica concert in downtown San Diego in 2017.In July, 37-year-old Ray Pitoau had his first trial and was found guilty of three firearm charges, including felon in possession of a gun. But jurors were deadlocked when it came to charging him with three counts of assault with a deadly weapon.On Friday a jury, again, could not reach a verdict on the assault charges against Pitoau.RELATED: 526

SAN DIEGO (KGTV) – Major developments came late Tuesday to create countywide policy changes related to policing reforms. After several hours of testimony and public comments, all three parts of a policy package were voted on and passed by the San Diego County Board of Supervisors during a special meeting.It was introduced by Supervisor Nathan Fletcher who said it was designed to create more transparency and to start to change systemic and structural racism that has caused pain and harm to generations of African American people.The three proposals that passed include launching mobile crisis response teams made of social workers and clinicians instead of law enforcement for some mental health and homeless services and emergency calls, increasing independence and strengthening oversight of the Citizen’s Law Enforcement Review Board and establishing an Office of Equity and Racial Justice.ABC10 News listened in as callers weighed in on both sides of the debate over the creation of an Office of Equity and Racial Justice. Many callers were in favor of its creation. Others argued that the County should consider a bolstered version brought forth by civil rights activist Rev. Shane Harris who recommended that the County increase the number of staffers assigned to the Office and increase its budget to million.The Board of Supervisors decided that the passed proposal for the Office of Equity and Racial Justice will need to be reviewed by an independent consultant and the Human Relations Commission will need to provide guidance on the Office’s mission.Late Tuesday, the Office of Supervisor Nathan Fletcher sent ABC10 News the following statement:“The Board of Supervisors today voted to support the entire Racial Justice and Law Enforcement Realignment Policy Package authored by Supervisor Nathan Fletcher and crafted in partnership with respected leaders from the Black community. The three policies will strengthen the Citizen’s Law Enforcement Review Board Authority and Independence, create an Office of Equity and Racial Justice for the County of San Diego and launch countywide Mobile Crisis Response Teams (MCRT) to allow trained mental health clinicians, not law enforcement, to respond to non-violent service needs. The group released the following statement after the vote:‘The community called for change, and today’s action is a step forward. Tackling deep seeded issues of systemic and structural racism is not going to be easy and at times it will be uncomfortable, but, we will be a better organization and a better people because of the actions we take to support racial justice and realigning law enforcement. We are thankful for the considerable community input we received to shape these policies and tremendous support that helped ensure their passage. The most important days of this work are in front of us and we look forward to a continued partnership with Black community leaders as we put these policies into practice.’” 2972

SAN DIEGO (KGTV) - It's one of San Diego's crown jewels. The Hotel Del Coronado has been a landmark of America's Finest City since 1888.While its walls are steeped in history, recently, rumors swirled that a face-changing paint job to the hotel's lobby was coming.Facebook users on the "Coronado Happenings" page voiced worries that the iconic hotel planned to paint its wood-finished lobby white.Do you have a fact or fiction question? Submit your question to 10News here.Those rumors, however, are just that, according to the hotel.Hotel Del Coronado's Public Relations Director Sara Baumann told 10News there were discussions of possible upgrades to retail shops on the hotel's lower level, but nothing regarding painting planned for the lobby. Nothing has been set in stone for any upgrades in any space, as well, Baumann added.Could that change even be made to a National Historic Landmark? According to the National Parks Service, "property owners are free to make whatever changes they wish if Federal funding, licensing, or permits are not involved." 1086