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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 late '80s Gary Cheatham founded Auntie Helen's in a one-car garage in North Park in 1988.Gary did fluff-and-fold laundry first for one, then for a handful of friends who were sick with AIDS."Everybody could do it. But nobody would do it. And I think that makes him a superhero in my eyes," says Auntie Helen's current Executive Director, Rod Legg.Fear and stigma at the time hurt the LGBT community as much as the disease, but word spread quickly about Gary's services, and Auntie Helen's grew. Sadly, so did the disease.HIV and AIDS claimed more than 100,000 lives in the U.S. in the 1980s. Many of Gary's clients and friends who died willed their estates to Auntie Helen's.Their belongings accumulated in Gary's garage, which was also where he did laundry. Eventually, with help from a few high-powered friends and other activists, Gary opened Auntie Helen's thrift store in 1989.The laundry service and the thrift store are still located in North Park."We also do COVID-19 [laundry], which is our frontline medical workers. That's a tie in to the past, we had to do that. We had to offer that," Legg says.They're expanding the store, and their outreach, giving out free groceries to their regular clients (about 25-35 individuals) and now also to frontline workers.With COVID-19 leaving so many more people on hard times, they started delivering groceries — no questions asked, no referral needed. At one point, to more than 300 people.Legg explains, "this is everybody's HIV in a sense... We don't know where we're at. We're all wondering what's going to happen the next day, but most importantly is neighbor to neighbor we need to make sure we're taking care of each other."All in keeping with the legacy of Gary Cheatham, about whom, Legg says, "this man was way before his time... Can you imagine the faces of the people that got the hugs, and the clothes? We should all be our heroes, for each other." 1943

SAN DIEGO (KGTV) - In a downtown courtroom on Friday afternoon, attorneys battled over a request to halt the shutdown orders for San Diego bars, restaurants, and gyms.Attorney Bruno Katz is representing a group of local businesses like Cowboy Star restaurant and Bear Republic Crossfit gym, which are seeking an emergency injunction. He told the judge, “What I do want to say, your Honor, is that the temporary restraining order is based on data. It’s based on facts. It’s based on science and it's based on the state not showing why it has targeted these industries when the science and data doesn't support it.”The state argued that the damage to businesses pales in comparison to the damage on human life. “There's nearly a thousand dead San Diegans and the numbers are getting dramatically worse and have been for the last couple of weeks,” said state Deputy Attorney General Jonathan Eisenberg.Restaurants and gyms were open for indoor operations with limited capacities under the red tier. However, last Saturday’s move to the purple tier forced them to shutdown indoor services completely and move outside. They're suing Governor Newsom and San Diego County, arguing that the closures go against their rights and are causing financial devastation.The suit was filed on behalf of all restaurants and gyms.Local owner of The Studio SD fitness studio Rachel Racz spoke to ABC10 News before Friday’s hearing. She told ABC10 News in part, “It's been rough to shut down business again when people were feeling normal and then we see the County of San Diego's Department of Health say that gyms are only point .4% of cases in San Diego and it's really frustrating as a business owner where we have these ebbs and flows- where we can be open and then we can’t.”Superior Court Judge Kenneth J. Medel stated that he would have a ruling by 5 p.m. on Friday. If not, he said he would issue his decision on Monday. 1916

SAN DIEGO (KGTV) -- Mayor Kevin Faulconer responded Friday after Governor Gavin Newsom issued new stay-at-home orders for the region.Faulconer said in a statement on Twitter that local businesses aren’t being treated fairly under the new guidance.“Restaurants made good faith efforts to comply with COVID rules. Now the rules are changing once again,” Faulconer said.“If the Governor shuts restaurants down, it’s only right the state compensates them for the costs incurred moving outdoors,” he continued.RELATED STORIESCalifornia's latest stay-at-home order to take effect in San Diego County on SaturdaySan Diego businesses hope to spike business ahead of more closuresThe statement comes after Newsom said Thursday he was pulling the “emergency brake” to stop the spread of coronavirus.The new orders shut down businesses such as hair salons and barbershops, zoos, movie theaters, wineries and breweries, and outdoor playgrounds, among other sectors. 961

SAN DIEGO (KGTV) -- It should be no surprise at this point that home prices are still on the rise in San Diego this April. A new report from Zillow shows that, year-to-year, home values in San Diego have risen more than eight percent. According to Zillow, the median home value in San Diego currently sits at just over 5,000. That change marks an increase of 8.4 percent since last April.Meanwhile, rent is also on the rise at a median of just over ,500, or an increase of 3.6 percent since last April.Click on the charts below for more information:  The high cost of housing in San Diego is in stark contrast with national home values.The median home value nationally is 5,600. If there's one thing San Diego and the rest of the nation have in common in this report it's that both saw home values increase by more than eight percent.“Home values are rising faster than we’ve seen in a very long time: The spring home shopping season has been a perfect storm of strong demand and tight supply,” said Zillow senior economist Aaron Terrazas.Nationally, the number of new homes being built is also seeing a decrease. “Sluggish new construction has exacerbated the supply situation and homes that are hitting the market, are moving very quickly once they do. Americans are also in a spending mood, boosted by recent tax cuts and rising wages. Millennials who long delayed becoming homeowners, are out in force – a shift we’re also seeing in softer rent appreciation," said Terrazas. Zillow adds that nationally, home values are rising at their fastest pace in 12 years. RELATED: SD woman climbs out of 3,000 debt hole | This is how much space 0K will buy you in SD | How much you need to earn to buy a home in SD 1790