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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) – Interstate 5 near UC San Diego will be closed from Sunday, September 17, through Thursday, September 21, 10:30 p.m. to 5 a.m. each night to accommodate construction of the Gilman Drive Bridge.The new bridge proposes to connect the east and west campus of UC San Diego between Gilman Drive and Medical Center Drive while spanning over Interstate 5.San Diego Association of Governments states: 428

SAN DIEGO (KGTV) — It’s an online service that brings groceries right to your doorstep, but some who work for Instacart told Team 10 they are being treated unfairly.Instacart entered the San Diego market in 2016. It basically works like Uber, where people can sign up to be “shoppers” and fill orders for a fee.Jacquelyn Westby signed up for Instacart to make extra cash.“We shop for groceries and then deliver using our own vehicles, our own gas,” Westby said. She recently graduated from grad school and is looking for a job in the field of occupational therapy. Instacart helped keep her afloat as she dealt with growing bills.“This job was the difference between homeless and not. Being able to eat and not,” Westby said.Westby said Instacart changed its pay structure over the past couple months. A company spokesperson said changes were meant to improve the shopper experience, adding things like “pay per mile” and estimated earnings. Westby, however, said the new pay formula has made things worse.“Before I could easily work a four hour shift in the morning or the afternoon and make 0 [to] 0 and be done with my day,” Westby said. “Now, I’m working 12 hours a day and sometimes I’ll make upwards of . Sometimes, it’s .”She said tip is now factored into total earnings from Instacart. Westby also said while heavy pay is added for heavier items, it is not consistent.“I think it’s about the bottom dollar. What’s happening is not fair,” Westby said.In a statement to Team 10, an Instacart spokesperson wrote in part: 1545

SAN DIEGO (KGTV) - Lime is warning riders of a problem with their deckles scooters that can cause “sudden excessive braking during use.”The company issued a safety update on Saturday, saying they had recently discovered a bug in the firmware of their scooters.They determined in some circumstances, the brake on the front wheel would be suddenly and automatically applied often after hitting an obstacle while riding downhill at high speeds.“While this issue has affected less than 0.0045% of all Lime rides, some riders have been injured,” wrote Lime in the safety update.That includes Paul Grasso, who says he was riding a Lime scooter on December 18 on Ingraham Street near Vacation Road in Mission Bay.He said he had just gone down the bridge and was making his way up a sidewalk ramp when the scooter’s wheels tightened up, sending him flying face-first into the pavement.“I spent five days in the hospital,” he said with a “broken nose, fractured skull, traumatic brain injury, fractured eye socket, ten stitches in my forehead and stitches on my nose.”10News reached out to Lime about Grasso’s crash but they said they couldn’t comment on rider specific questions.Lime has launched a fleet-wide firmware update to fix the braking bug. It should reach all of their scooters in the next few days, according to the company’s safety update.Until they have confirmed that all of their scooters have been updated, they have issued a list of precautions for riders:Before starting your Lime trip, walk around the scooter and do a visual inspection of the hardware. Is the vehicle body in good condition? If not, don’t use that vehicle; report it to our customer service team and then select another vehicle.Once you start your Lime trip, give the brake a tight squeeze. If the brake does not engage properly and immediately stop the vehicle, dismount, end the trip and notify Lime customer service.Use extra caution in the next few days while we issue the final firmware update -- especially when riding downhill. Always stay in full control of your scooter and don’t go full speed while riding downhill.Comply with any scooter audible or visual warnings to slow or adjust your speed.Ride defensively: wear a helmet and reflective or bright clothing, respect the right of way and be cautious of other cars, trucks and pedestrians, don’t ever ride under the influence of alcohol or drugs, and always ride in bike lanes when available.Ride smart: follow the rules of the road, keep both hands on the handle bars, don’t use your mobile device while riding and avoid wearing headphones. 2591

SAN DIEGO (KGTV) — Longtime San Diego State football coach Rocky Long is stepping down after nine seasons.San Diego State officials announced Wednesday that Long will be replaced by Aztecs defensive line coach Brady Hoke.Hoke was SDSU's head coach in 2009 and 2010 before leaving to become head coach at Michigan. Long served as defensive coordinator under Hoke and replaced him when he left in 2010.RELATED: San Diego State basketball reaches top ten in polls for first time since 2014During his nine seasons as head coach, Long lead the team to a 81-38 record, three Mountain West Conference championships, and four 10-win seasons since 2015. Combined with previous head coach positions, he is 146-107 in his career."It's time. It's time," Long said. "I love coaching but I don't necessarily love all the things head coaches do."Long said it's time for a "new face" and "new voice.""It doesn't mean the message will be different it just means it will be presented in a different way ... as you grow older you know when it's time," Long said.RELATED: San Diego State's stadium effort gets -million donationLong never saw a losing season at the helm in San Diego, his team's best performances coming in 2015 and 2016 with back-to-back 11-3 records. He was named Mountain West Conference coach of the year in 2012 and 2015 and led SDSU to a bowl appearance all nine years, with four bowl wins.SDSU's most recent season saw the team end with a 10-3 record and dominant 48-11 win over Central Michigan University in the New Mexico Bowl.Since taking over as head coach, Long has led San Diego to rank 11th in rush defense and interceptions, 14th in total defense, 20th in scoring defense, 22nd in turnovers caused, and 26h in defensive pass efficiency, according to the school.It's unclear what Long intends to do next, but sources tell ESPN he spoke with Syracuse about a defensive coordinator position recently and intends to keep working. To that point, Long remained coy on those rumors, saying only that he's been contacted by programs and "as of this moment I'm retired. That doesn't mean I'm not going to listen to what they have to say.""I was smart enough to listen. And a couple of those places I visited," Long said. "I mentioned it before, I'm tired of being head coach but I love coaching."RELATED: Holiday Bowl kicks off amid uncertain futureHoke posted a 13-12 record during his first two seasons with San Diego, going 4-8 in his first year and turning the program around to a 9-4 record and Poinsettia Bowl win the next season. As head coach at Ball State, SDSU, Michigan, and Tennessee, he's recorded an overall record of 78-72. "When Brady decided to come back I told everybody he's the best defensive line coach around," Long said of his replacement. "He's a great guy and a great head coach."Hoke thanked Long and the program officials that looked to bring him back into the Aztec fold."It's great to be back," Hoke told reporters Wednesday. "You never get to do something twice that you really want to do in life ... I can assure you, we are going to keep going in the direction that we're going."Hoke said he'll next be looking at how he'll put together his coaching staff, saying "I think the guys here are a privilege to work with and are good men."In his time away from San Diego State, Hoke says he plans to continue the trends and successes already in place."I think philosophically, that hasn't changed much," Hoke said. "You always grow, if not, you won't get to where you want to go." 3521

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