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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 preparation for high heat expected this month, the county will close six parks.Officials close the parks every August as a safety measure for the typically high temperatures recorded at the sites.The following parks will be closed through Aug. 31:El Capitan Preserve, LakesideHellhole Canyon Preserve, Valley Center Mount Gower Preserve, Ramona Wilderness Gardens, PalaIn addition to the four parks, two more parks will continue to be closed throughout the summer until Labor Day weekend:Agua Caliente Regional Park, Anza BorregoVallecito County Park, JulianThe closures also give Department of Parks and Recreation staff time to perform much needed maintenance at the parks.There are still more than 100 other trails throughout the county to explore during the summer. Officials, however, warn hikers to be smart wherever they hike this summer. Here are some tips to keep in mind:Let someone know where you'll be and when you'll returnNever hike aloneLeave your dog at homeTake plenty of waterWear sunscreen, a hat and sunglassesTake breaks in shady areas, if possibleHave a fully charged phone or map on handWear lightweight, light-colored, ventilated clothingBring along a jacket if hiking after duskWear sturdy shoesFollow all posted safety rulesBring enough food, sunscreen to reapply, a flashlight, first aid kit, multi-purpose tool and a whistleKnow your limitations 1403

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) -- Jury duty service in San Diego County resumed Friday after a lengthy stoppage caused by the coronavirus pandemic.Courtrooms across San Diego County shut down about seven months ago amid state-mandated restrictions. Now, jurors are able to report once again, with a slew of health and safety precautions in place.Because of the virus, courts have had to change the way they operate, and some lawyers believe this will also affect the process of picking a fair jury.Many aspects of the courts have changed, from added safety precautions to transitioning to virtual court.Prior to the pandemic, there were usually 350-400 people that are summoned to serve as jurors at the Central Courthouse in downtown San Diego. Now, that number has been reduced to 18%-20% of the usual capacity to allow for proper social distancing.Just as before, jurors do have the option to delay their service based on a number of factors including financial reasons, being a caretaker, or having a physical or mental condition.Defense attorney Jan Ronis told ABC 10News, “The kinds of options that were previously available now have new options, in respect to vulnerable conditions and age groups, things of that nature … it’s a whole new world.”Ronis said he believes COVID-19 concerns could impact the jury pool that’s available, with more people opting to postpone their service.“A jury of your peers, which represents a cross-section of society, racially, ethnic, gender-wise, diversify, as far as age and demographic, these are hugely important,” said Ronis.It’s just one of the main challenges the courts will have to deal with as they’re already facing a backlog of cases.Ronis added, “Everyone’s been in limbo; people need to get things resolved, criminal and civil litigants and family courts, things of that nature. It’s really created a horrific situation for so many people.”Jurors that have been called in to report will do so next Tuesday, which is when jury trials are scheduled to begin.Court officials say of the jurors that were summoned this week, nearly 40% have either postponed their service or have been excused from jury duty. 2151

SAN DIEGO (KGTV) — It's always a good time to check on supplies and make sure you and your family are prepared for an earthquake.The County of San Diego recommends seven simple steps for earthquake safety:Fix potential hazards, like areas of your home that could pose a danger during an earthquake;Create a disaster plan with your family. The county's tips on how to handle a disaster here;Create a disaster supplies kit. The county also has tips on what to pack here;Fix your building's potential weaknesses;During earthquakes and aftershocks: Drop, Cover, and Hold-On;After the earthquake, check for injuries and damage; andWhen safe, continue to follow your disaster planSan Diego County recommends packing enough water, food, and supplies to last each member of the family at least three days. They also recommend that families practice their disaster plan so they're ready when an emergency happens.When an earthquake does happen, families should drop, find cover under something sturdy, and hold on to that cover. If there isn't anything sturdy, find an interior wall that is not near any heavy furniture or glass, scoot down and cover your head.If outside, find an open area away from buildings, trees, or anything overhead such as utility wires, sit down, and cover your head.While San Diego County has sparse earthquake activity compared to the rest of the state, one big enough can send tremors into our region.Residents can also sing up for AlertSanDiego mobile alerts from the county. Residents can also dial 2-1-1 for emergency updates. 1557

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