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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 February, we spoke to Jelynn Malone from Mostra Coffee after her coffee shop won best roaster in the U.S. by Roast Magazine. Since then, things for small businesses like hers have been touch and loyal customers including high school juniors, Siya and Anoushka, wanted to help."A lot of businesses were closing. We both brainstormed about how we could help local businesses who have helped us in the past," said Anoushka." So they created a campaign called Loving the Locals. "We started a GoFund Me page and reached out to friends and family who were able to donate. With that money, we were able to donate to Mostra Coffee."And when Malone was ready to meet her donors she said, "I'm looking for adults, they didn't give me their names or tell me how much and I see these two young high school girls and they're like 'Are you Jelynn?'" To describe Malone as surprised was an understatement. "Then they hand over this large check to me and it says a thousand dollars and I'm completely shocked. I'm emotional, touched," Malone described. Malone's no stranger to giving back. A portion of her profits goes to farmers in the Phillippines, where she sources a lot of her product from. When the pandemic began, she donated gratitude boxes to frontline workers. All of her efforts never went unnoticed, even by young customers. "They [Mostra Coffee] continue to give back to community even during these difficult times and we felt that quality was important to us and it's what we were going for. We shared similar values and they were a great fit for us," Siya said. Mostra Coffee is the first business Loving the Locals has donated to. They have a GoFund Me and all profits will go to another small business once their goal is met. 1760

SAN DIEGO (KGTV) — Lime is rolling its dockless scooters and bikes out of San Diego, a month after a hearing officer ruled the company could keep its operating permit.Lime announced Thursday they would not be renewing their permit to operate in San Diego but would monitor the opportunity to return in the future.“As part of our path to profitability, Lime has made the difficult decision to exit San Diego and focus our resources on markets that allow us to meet our ambitious goals for 2020," a statement from Lime said. "We’re grateful to our team members, riders, Juicers and communities who supported us throughout this journey. We appreciate the partnership we’ve enjoyed with San Diego and remain hopeful we can reintroduce Lime back into the community when the time is right."RELATED: City Council committee OKs changes to dockless scooter, bike lawThe company said it tried to work with city leaders on compliance and safety concerns, but was instead forced to defend its permit — which it did successfully. Lime added that the city's most recent regulations have led to a decrease in ridership and that the city has not been transparent when it comes to towing by city-contracted and private towing companies.In December, city council leaders voted to ban electric scooters from the city's boardwalks at Mission Beach, Pacific Beach, Mission Bay Park Bayside Walk, and La Jolla Shores. A month before, city leaders passed new regulations for e-scooters and bicycles, including a speed limit drop from 15 to 8 miles per hour on boardwalks, a ban on parking scooters in certain areas, and permitting fees.RELATED: San Diego scooter ridership drops off dramaticallyLime said it is also ending operations in Atlanta, Phoenix, and San Antonio as part of its "path to profitability."In September 2019, Uber also made the call to pull its dockless scooters and bikes out of San Diego. The company said at that time that, “we agree with local elected officials in San Diego who’ve said current micromobility regulations foster an unsustainable operating environment."Data released in October 2019 showed 222,076 people rode the dockless vehicles in the two week period ending Oct. 15, down from 441,830 rides from July 15 to July 30. 2243
SAN DIEGO (KGTV) -- Many doctors across San Diego County have seen a recent surge in positive COVID-19 cases. Five hundred one new cases were reported Thursday.But, most people don’t require hospitalization and can isolate at home.“We just do video visits with patients and talk to them about their symptoms,” said Dr. Michele Ritter, an infectious disease specialist at UC San Diego Health and an associate professor of medicine.“At the end of April, May, we were getting maybe four or five new referrals a day to be seen, and then it went up to about 40 a day.”Ritter is also the medical director of the COVID-19 clinic. She said many of her patients live with other people.“There are times there are three of four generations of a family living in a house together and sometimes very close quarters, so that’s a challenge,” she explained.If someone in your household has COVID-19 the Centers for Disease Control and Prevention recommends they stay in a separate room and use a different bathroom if possible, avoid contact with other members of the household and pets, don’t share personal household items, and wear a cloth face covering when around others“The absolute ideal situation is your own room, your own bathroom. Not everybody has that, we have patients who live in two-bedroom apartments with six other people and a single bathroom.,” said Ritter.While isolation is critical, Ritter said if you must use a shared space, like a bathroom, it’s essential to disinfect after every use. That includes using a shower, toilet, or sink.“When you’re done if you’re able to have something like a Clorox wipe, or a washcloth with some Clorox bleach on it wipe down the surfaces that you’ve used and wash your hands,” she said. “In terms of laundering clothing, it’s probably fine to launder them together if you’re using high temperatures to wash your clothes.”She said to wash all dishes and utensils used by someone with COVID-19 in hot water and soap or run them through a dishwasher.“A lot of patients have their family members bring meals to them and set it outside their door so they can eat,” she said.Another challenge is parents who test positive for COVID-19 and have mild symptoms, but still, have to take care of their kids.“I find that most parents do well wearing a mask; the kids get used to it,” she said. “You can still be around your kids; just do the best you can.”Ritter said many of her patients have been able to keep the virus from spreading to their loved ones at home by following simple steps.“Wearing masks, washing hands, cleaning frequently touched surfaces is the best you can do,” she said. “We don’t always have perfect situations, so we do the best we can with what we have.” 2720
SAN DIEGO (KGTV) — Local Regal Cinemas are offering an affordable day at the movies all summer long.Regal Cinemas' "2019 Summer Movie Express" series offers movie tickets to select kid-friendly films at 10 a.m. on Tuesdays and Wednesdays at participating theaters.In San Diego, participating theaters include Regal Edwards San Marcos, Regal Escondido, Regal Mira Mesa, Regal Edwards Rancho San Diego in El Cajon, and Regal Partway Plaza in El Cajon.RELATED: Summer Movies in the Park return to San DiegoMoving seats, weather effects come to Mira Mesa theaterAnd movie-goers will be able to enjoy a variety of kid-favorite films like "The LEGO Movie 2," "Secret Life of Pets," "Kung Fu Panda 3," "How to Train Your Dragon," and several more.For a full list of movies and participating locations, visit Regal's website here. 833
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