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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 took just three months for Tyler Walter to turn from a happy and healthy toddler into a dead one while in the care of the County of San Diego, according to a recent lawsuit."Defendants literally ignored Tyler to death."Those are just two of the claims in the lawsuit filed by Tyler's mother, Lisa Walter, against the County of San Diego and several social workers.Tyler Walter died shortly after being placed with a foster parent. The cause of death listed on his autopsy is blunt head trauma. His body after death, not returned to his mother for burial but cremated, the lawsuit claims.County social workers failed multiple times in their duty to monitor Tyler's living condition and update his mother, and the Juvenile Court, regarding the dramatic change in living conditions of his county-approved caregiver, according to the lawsuit.Tyler was taken from his mother after sheriff's deputies found drugs at the house where she was staying.Tyler's mother was charged with child abuse, possession of a controlled substance, and possession of paraphernalia used for narcotics. According to the San Diego County District Attorney's Office, Walter pled guilty to all charges and is currently going through a drug court program.After Walter's arrest, a social worker told her, "Tyler would be out of Lisa's care for a minimum of six months," the lawsuit stated. The lawsuit explained the social worker said that no matter the circumstances, she never returns any child earlier than six months and voiced only contempt for Walter.Shortly after Tyler's mother was arrested, his 19-year-old cousin became his foster mother in July 2018, the investigators report in Tyler's autopsy stated. 10News is not identifying the family member because she hasn't been accused of anything.Tyler's cousin lived in a home 100 miles away in Long Beach."The placement they put him in was a home daycare center with a 19-year-old and her partner," said Walter's attorney Shawn McMillan.RELATED: Mother claims San Diego County was negligent in death of her child while in Foster CareMcMillan said Walter requested that her son be placed with his grandmother, but social workers didn't let that happen.McMillan explained Walter was trying to reunite with her son and comply with her reunification plan, which included having to participate in regular visitation with him.According to the lawsuit, "Even the Juvenile Court judge, upon learning of the placement, questioned the defendants' decision and expressed concern that Tyler was placed outside of the County of San Diego."The lawsuit states, the defendants used Tyler's "remote placement as a punishment tool – to impose a huge burden on Lisa in order for her to see her own child. Their intent was to make visitation so extremely difficult and burdensome on Lisa, that she would either fail or give up."The lawsuit also accused the county and social workers of failing to provide any means for Tyler to receive or pay for medical care while in his cousin's care.According to Tyler's autopsy, he was in and out of the hospital in the weeks leading up to his death. He was vomiting and wouldn't eat.The lawsuit stated when his caregiver took him to one of his appointments, she was turned away because social workers failed to provide her with, or set up Tyler's medical insurance program. It also claimed his caregiver repeatedly attempted to contact social workers but received no response. "As a matter of law, regulation, procedure, and policy Tyler’s medical insurance was required to be in place and fully functional before Defendants, and each of them, dumped Tyler into nineteen-year-old's care. But defendants failed to do so," the lawsuit stated.Tyler Walter's DeathAccording to the lawsuit, Tyler's cousin and her girlfriend were kicked out of the home where they were living about a week before he died.The lawsuit stated they were homeless and living out of a car in a park in Long Beach."I am not clear under what set of circumstances in what universe that would be an appropriate placement," McMillan said.Tyler Walter died on Sept. 22, 2018.According to his autopsy report, Tyler was fussy and didn't eat much the day he died.Tyler's foster mother and another adult drove Tyler to a park not far from where they were staying. They parked, unbuckled Tyler from his car seat, and one of the adults smoked marijuana, the autopsy stated.The report stated that a short time later, they noticed Tyler was, "slumped completely over with his entire top half folded in half. His back seemed splotchy. [One of the adults] got him out and noticed he was not breathing. She took him to the table and began screaming for help. CPR was performed and when the decedent was turned over, dark fluid and mucus came out of the decedent."The report stated paramedics arrived at the scene and transported Tyler, but he was pronounced dead at the hospital.The official cause of death listed on his autopsy report is blunt head trauma.The autopsy report showed Tyler had a skull fracture, bruises on the left and right side of his forehead, discoloration behind his ear, a bruise on his cheek, and a cut under his chin.The medical examiner listed the manner of death as undetermined.The Long Beach Police Department told 10News the investigation into Tyler's death is ongoing. According to the lawsuit, Tyler's mother was in shock following news of his death. It stated, "Adding further trauma, Lisa was barred from retrieving Tyler’s remains in October of 2018. Importantly, at no point were Lisa's parental rights ever terminated. But the County refused to relinquish Tyler’s body to Lisa. In spite of Lisa's protest, the County gave the body to others."Tyler's funeral was arranged by the very people whose actions led to his death, the lawsuit claimed. "He was promptly cremated. But, Lisa had wanted Tyler to be buried. Lisa was not even consulted by the County as to the disposition of her son's remains," the lawsuit stated.The County of San Diego did not respond to our request for a comment on this story.In a previous story about Tyler Walter's death, a spokesperson wrote, "The safety of children in the County's care is our number one priority. We join in the grieving for this child's passing. This complicated case remains under investigation and we are limited in offering further comment."10News is not naming the social workers named in the lawsuit.Tyler’s foster parent also did not respond to requests for a comment on this story. 6501

SAN DIEGO (KGTV) -- In response to growing community outrage over a man who was released on bail a day after being arrested on attempted kidnapping charges, the San Diego County Sheriff's Department has released surveillance video of the incident in hopes of alleviating concern.The incident happened Sunday just before 3 p.m. in the parking lot of Costco Warehouse located at 1755 Hacienda Drive in Vista.A couple and their two small children were backing out of a parking stall when the suspect opened the rear vehicle door. The suspect attempted to remove the 2-year-old child from the car.Adam Glavinic, 37, was arrested for attempted kidnapping and being under the influence of a controlled substance and was booked into the Vista Detention Facility.Outrage ensued following reports that Glavinic was released from jail on a 0,000 bail the next day.WATCH: Growing outrage over attempt kidnapping suspect's release on bail"The Sheriff's Department in partnership with the D.A.'s Office are now releasing the video due to understandable concern from community members," said Lt. Ricardo Lopez, Media Relations Director for the San Diego County Sheriff's Department."It is understandable that anytime an incident involves a child in the vicinity of an event, it can produce fear and anxiety on the part of parents and community. This is why law enforcement prioritizes these cases and focuses on the evidence," said Lopez.The surveillance video the sheriff released Thursday night shows Glavinic walk up the driver's side of the family's white SUV. The SUV begins slowly backing out of the stall, and that is when Glavnic reaches for the rear passenger door handle. 1678

SAN DIEGO (KGTV) -- If you've ever gone out in the Gaslamp, you know how busy it can get. Nothing will ruin your night more than finding out your car's been towed.That's exactly what's happened more than 1,000 times since the city converted Fifth Avenue to a three-minute passenger loading zone after 8 p.m. on Friday and Saturday nights in September 2016. "They really don't ask questions around here," said Vanessa Figueroa, who hands out fliers for Gaslamp BBQ on the corner of 5th and Island every Friday and Saturday nights. "If you're parked here, your car's gone."The city made the change to reduce gridlock, boost emergency response times, and make passenger drop-offs safer. But that's also meant a lot of towing. In the first year, the city towed about 1,200 cars - drivers either missing the warning signs or getting confused by different ones next to each other.RELATED:  906

SAN DIEGO (KGTV) - It's one of San Diego's crown jewels. The Hotel Del Coronado has been a landmark of America's Finest City since 1888.While its walls are steeped in history, recently, rumors swirled that a face-changing paint job to the hotel's lobby was coming.Facebook users on the "Coronado Happenings" page voiced worries that the iconic hotel planned to paint its wood-finished lobby white.Do you have a fact or fiction question? Submit your question to 10News here.Those rumors, however, are just that, according to the hotel.Hotel Del Coronado's Public Relations Director Sara Baumann told 10News there were discussions of possible upgrades to retail shops on the hotel's lower level, but nothing regarding painting planned for the lobby. Nothing has been set in stone for any upgrades in any space, as well, Baumann added.Could that change even be made to a National Historic Landmark? According to the National Parks Service, "property owners are free to make whatever changes they wish if Federal funding, licensing, or permits are not involved." 1086

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