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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 been more than a month since the big ship fire in San Diego Bay.The flames are out but the boat is still there.It's become a sort of "morbid tourist attraction." Tourists and locals stopping to take photos of the charred Norton Sound bobbing up and down in the bay.RELATED: Multi-alarm fire erupts on fishing vessel docked in San Diego BayRestaurateur Melissa Moore was working just feet away when the ship mysteriously turned into a giant oven on Sept. 29. The smoke hung over Seaport Village sickening those nearby."As workers, we all started having headaches. We had to just leave," Moore recalled.Now it's early November and many are wondering why the boat is still parked in front of the Greek Islands Cafe - which Moore's family owns.RELATED: Questions remain after investigation into boat fire at San Diego HarborThe Port of San Diego told 10News they were working with the U.S. Coast Guard to move the ship as soon as possible. Contractors were disposing of chemicals on board.The Coast Guard cautioned there was no immediate leak or threat to the environment.Where did the ship come from?...10News learned the Norton Sound - which now has gaping holes in it - was originally owned by an American company in Seattle. It sailed into our bay in March.A San Diego shipping agent found it a place to dock. And then it was sold to a company in Mexico.Since the fire, a company employee has met with the Port and the Coast Guard at least once."I never did hear what was exactly in there," Moore said.No cargo was listed on the paperwork. San Diego Fire-Rescue said the cause of the fire was still under investigation, but there is currently no reason to suspect arson.So what now?...For now, the pier is locked off - which frustrates Moore."That is something people like to walk down," Moore said.RELATED: Mystery surrounds fishing boat that erupted in fire on San Diego BayStructural engineers must inspect it, according to the Coast Guard, and said the owner may not be able to afford to pay for the Norton Sound's removal.The Coast Guard is planning to use money from a special clean-up fund - paid for by a tax on oil refineries - to remove the ship. However, that may not happen for a few more weeks."The only positive thing is that people are still coming down here taking pictures. (laughs) other than that, they can take it away," Moore said. 2431

SAN DIEGO (KGTV) -- Marty Coyne snags the same prime spot at Campland on the Bay every Fourth of July weekend.He parks his massive RV right across from the water."Wouldn't trade it in for any other place to stay in the summer," he said Friday. "It's beautiful here, safe here, the grandkids can run free and have a great time."This year - however - the celebration is quite a bit different - due the outbreak of Covid 19.Campland on the Bay, on Mission Bay's north end, is like many hotels along San Diego's coastline. It's not totally booked.Elvin Lai, who owns the Ocean Park Inn in Pacific Beach, said he was booked in the high 60 percents at a time when the hotel is usually full. "It doesn't mean that I won't get last minute bookings but we're used to being sold out for the month of July months in advance, so it's different."On Friday at the campland, the mood was festive, but the activities were limited - the skate park and basketball courts were taped off. There won't be any bands for outdoor entertainment, and indoor dining is disallowed.Campland on the Bay also placed yellow cones on the beach to give people a clear path to the water. It's also requiring all tents to be spaced out by eight feet. Masks are required in public areas, and rangers are carrying around extra.Still, not every visitor was wearing a mask."Everybody doesn't follow it," said Barry Homer, who is staying on the grounds with his wife Cindy. "It'a always a problem everywhere in the world, for lots of reasons."Hotels and Campland are still open to last minute reservations."We anticipate it's going to be be like this no more than today and tomorrow, and then it'll go down to quiet as people go back to their normal lives," said Ahmed Aitlahcen, the campland's general manafger.The Auto Club predicts 107 million residents of the Pacific Coastal states will take trips this summer. That's down 17 percent from 2019. 1916
SAN DIEGO (KGTV) — In some of the most severe cases of COVID-19, doctors are finding it’s not the coronavirus making people critically ill.It’s their own immune system, and a San Diego-based biotech company thinks it has an answer.La Jolla-based INmune Bio announced Tuesday it has FDA approval to begin a Phase 2 clinical trial on its inflammation fighting drug, Quellor.In many of the sickest COVID patients, doctors have noticed their blood is filled with high levels of immune proteins called cytokines. Cytokines act as messengers between cells and the virus can cause them to go haywire, setting off what’s known as a cytokine storm.In a cytokine storm, the body’s immune system starts to attack its own cells and tissues rather than the virus. During the Spanish Flu of 1918, many of the deaths were caused by cytokine storms.“You need to control the cytokine storm to keep patients from getting sick,” said INmune Bio’s CEO Dr. R.J. Tesi.There are several different types of cytokines. A drug undergoing testing in a federal trial with remdesivir targets a cytokine called beta interferon.The San Diego biotech’s drug Quellor suppresses a very specific cytokine called soluble tumor necrosis factor, which Dr. Tesi calls “the master cytokine” because of its role in triggering other immune proteins.Dr. Tesi said this particular cytokine may contribute to another troubling issue with COVID-19: blood clotting.“When they write the history of COVID-19, the clots are going to be the bad guy,” Dr. Tesi said. “These blood clots go off everywhere and they gum up the works. They make it so the lungs can't work. They make it so the kidneys can't work. They make it so the heart is screwed up. Make it so you have strokes.”INmune Bio, which is publicly traded but has just six full-time employees, is hoping its drug can address both the blood clots and the inflammation.The company plans to enroll 366 hospitalized COVID-19 patients for a Phase 2 trial to see if intervention with Quellor can keep people off ventilators and out of the ICU. 2053
SAN DIEGO (KGTV) — Local law enforcement made the holidays a little brighter for hundreds of deserving kids. The 26th annual "Shop with a Cop" event brought 300 kids out to go on a shopping spree with local officers, from San Diego Police to California Highway Patrol to San Diego County Sheriff's deputies.The shopping spree was just the tip of the iceberg for kids Saturday morning. Their day started at SeaWorld San Diego, where they had breakfast with officers and enjoyed a Christmas-themed dolphin show. RELATED:East County family's Santa treehouse helps families in needMAP: San Diego's best holiday light displays to see this yearMore than 300 officers then escorted the kids to the Sports Arena Target location via police motorcade, where the holiday fun began.Each child was given 0 for their own shopping spree, which they spent of everything from board games to action figures to even gifts back to officers.The goal is to not only provide kids with a happier holiday season, but to encourage positive interaction with law enforcement. 1059
来源:资阳报