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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) - It's a great weekend to get out and enjoy San Diego's springtime with music, brews, and some heavy machinery.Del Mar's Goodguys 18th Meguiar's Del Mar Nationals roars into town, giving car heads the ultimate opportunity to see hot rods, muscle cars, and more.On the music scene, Snoop Dogg and Warren G will kick off the weekend with a show at The Observatory, and American Mariachi will debut at the Old Globe Theatre.RELATED: Springtime festivals in San DiegoFor locals looking for a festival, you can't go wrong with Julian's Gold Rush Days or the San Marcos Spring Festival and Street Fair.Here's a look at some of the things happening around San Diego this weekend:THURSDAY 710

SAN DIEGO (KGTV) -- Local leaders, including Mayor Kevin Faulconer, gathered at a Menorah lighting at San Diego City Hall. Rabbi Zalman Carlebach says with so many recent events of anti-Semitism, it’s important for communities like San Diego to come together in the spirit of peace. "In light of the current events that are happening around the country, that this world could use some more light. America could use some more light."There are several Hanukkah events scheduled around San Diego. For a list of events click here. 535
SAN DIEGO (KGTV) — It's called "cuffing season" and San Diego is the place to be for participating singles.According to Match, cuffing season is defined as "when daters find someone to settle down within the colder months … and may or may not be a relationship that lasts until the spring."Essentially handcuffing yourself to someone for the winter, before parting ways in the spring.RELATED: The San Diego single scene doesn't offer much, study saysUsing data from its Singles in America study, which Match calls the nation's largest study of singles' dating habits, the site based its rankings on more than 5,000 singles of all ages in the U.S. That study says nationwide, 70 percent of Gen Z and 63 percent of Millennials are searching for love, with about 14 percent of singles saying pressure from family or friends is the key reason they seek out a long-term relationship. The survey adds that only 9 percent of singles are looking to date casually.With that in mind, San Diego ranked as the second best city for cuffing, behind only Indianapolis. Although cuffing season occurs in the winter months, many of the best cities are located in more temperate climates:1. Indianapolis, Ind.2. San Diego, Calif.3. Denver, Colo.4. Chicago, Ill.5. Memphis, Tenn.6. Charlotte, N.C.7. San Antonio, Texas8. Columbus, Ohio9. Houston, Texas10. Los Angeles, Calif.RELATED: Dinner with a view: 9 San Diego restaurants named most scenic in AmericaBut for those looking for a temporary date to help make the end of the year less lonely, many other big cities are actually the worst place to be, according to Match:1. El Paso, Texas2. Washington, D.C.3. Detroit, Mich.4. Philadelphia, Penn.5. Fort Worth, Texas6. New York, N.Y.7. Baltimore, Md.8. Boston, Mass.9. Dallas, Texas10. Seattle, Wash.When it comes to San Diego's dating scene, the climate itself can also be called temperate.According to a previous study by Apartment List, San Diego ranked 73 overall for best cities for singles. In that analysis, only about 22 percent of respondents were satisfied with the dating scene in San Diego. Between women and men, about 17 percent of women and 35 percent of men were satisfied with dating here.Another recent study also offered clues as to San Diego's iffy state for singles. That survey, also compiled by Match, found that the average price of a date in California ran singles about 6, one of the highest in the country. Those figures were based on a dinner for two, two movie tickets, and bottle of wine. 2511
SAN DIEGO (KGTV) — Jessica Mattly was all smiles Thursday, ironically, thanks to the state Employment Development Department.“For the first time they called me,” she said. “I didn't call them. It was great.”A representative from the EDD, which issues unemployment insurance payments, called Mattly to tell her that they finally processed her application for jobless benefits. They’d begin by sending her four weeks of backpay.Mattly’s had been trying to get through to the EDD since she lost her job at a San Diego resort in late March, when Coronavirus restrictions went into effect. She filed for unemployment immediately, but like thousands of other San Diegans, got a request from the EDD for identity verification.She submitted the necessary documents, but never heard anything back.“I would just keep dialing, and keep dialing, and keep dialing, and I understand the definition of insanity. I do. And it felt like that was my only option,” she said.Mattly kept running into walls, until she turned to State Sen. Ben Hueso’s office, which contacted the EDD on her behalf.That lead to Thursday's phone call.Others, like Audee Kammer - just wouldn't take no for an answer.The EDD denied her identity documentation twice. She called hundreds of times - finally appealing the denials and getting a telephone hearing with a judge, who authorized payments.“I could see how some people, it could just throw them into deep depression and despair,” she said. “I feel for a lot of people out there that are in my same situation that I was and don't have the drive to keep knocking on that door.”Meanwhile, the latest state numbers show more than 230,000 San Diego County residents are unemployed.The EDD says its funding has increased drastically since the pandemic began and is now undertaking a massive hiring effort.It has filled 900 new positions to process an unprecedented amount of claims - with an additional 1,900 openings.Sen. Hueso represents the 40th Senate District, which includes portions of the County of San Diego and all of Imperial County. If you don't reside in District 40, you should contact your elected representatives for your area. To find your representative, click here. 2201
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