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SAN DIEGO (KGTV) -- In just hours, Rady Children's Hospital is expected to get their first shipment of the Pfizer COVID-19 vaccine. It is unclear how many doses the hospital will receive, but once they arrive they will be stored in ultra low temperature freezers, until they are given to hospital staff. FedEx is in charge of making the historic delivery.The hospital's chief operating officer, Dr. Nicholas Holmes, says most of the hospital's staff wants to get the vaccine. It will not be mandated, since it's only approved for emergency use. The first to get the vaccine at the hospital will be front-line healthcare workers in the 1-A category. The category includes physicians, respiratory therapists, nurses, and other staff who have high chances of exposure to the virus. Dr. Holmes says a team at the hospital spent the last four days planning the logistics for distribution. Staff working in the same departments will get the vaccines on a rolling basis, just in case they experience side effects and to prevent an entire department from having to miss work at once. Once the staff receives it's first dose, they'll get a second dose 21 days later. 1166

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) — Local health officials said Thursday a new case of vaping-related lung injury has been reported, as county leaders prepare to consider new vaping regulations.So far in San Diego, there have been 43 confirmed cases of vaping-associated lung injury with three cases under investigation. There haven't been any local deaths, but all patients have had to be hospitalized. Those affected range in age from 17 to 70 years old, according to the county.The CDC has said that vitamin E acetate and tetrahydrocannabinol (THC) are closely linked with e-cigarette, or vaping, associated lung injury. CDC recommends people avoid using THC-containing e-cigarettes or vaping products.RELATED: San Diego woman hospitalized with vaping illness warns others“Vaping-related lung injuries continue to be reported in the region and that’s concerning,” said Wilma Wooten, county public health officer.As of Jan. 7, the CDC has reported 2,602 hospitalizations or deaths from sudden and severe lung injuries associated with vaping.The San Diego County Board of Supervisors is set to discuss several potential local actions on regulating e-cigarette devices during a Jan. 14 meeting. Those ordinances include a ban on flavored tobacco sale and distribution, device moratorium, and restricting e-cigarette smoking to outdoor areas at restaurant. The ordinances would apply to unincorporated parts of the county.“As stewards of public health; we have a responsibility to raise awareness and act in the best interest of the public to protect them,” said Supervisor Fletcher. “Right now we simply do not know enough about the chemicals being consumed and their impacts. We are acting in a similar fashion to other jurisdictions in California, we are acting with an abundance of caution.” A second meeting on the ordinances will be held on Jan. 28. If the ordinances pass, they will go into effect July 1. 1902

SAN DIEGO (KGTV) -- It’s been nearly one year since the deadly University City poolside shooting. Kion Gould was hosting his 48th birthday party at his apartment complex. Right before the shooting began, Gould said he saw a man lying on a lounge chair by himself, so he invited him to join the festivities.That’s when the man, later identified as Peter Selis, pulled out his gun.The only thing Gould could do is raise his arm. His bone was miraculously able to stop the bullet.RELATED: Body camera footage captured during University City shooting released“I didn’t think it was a real threat until he basically raised the gun toward my head, that was the moment I realized I should have done something right before that, that’s the biggest thing that bothers me and bothers me to this day," said Gould.Police eventually shot and killed Selis after a shootout. In total, seven people were shot, including Monique Clark who died.Kion, who still lives in the La Jolla Crossroads Apartments, went back to the area where the shooting took place during an interview with 10News. RELATED: University City mass shootingWatch the full story Sunday night on 10News at 11 p.m. 1193

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