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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) - Mayor Kevin Faulconer detailed his plan to bolster San Diego's infrastructure in a proposed budget Tuesday.The plan calls for a total of about 3 million in investments into the city's streets, parks, and water system — among other improvements. The investment in infrastructure is the largest in San Diego's history, according to the mayor's office.The investments are part of the mayor's proposed .8 billion budget, which City Council leaders are set to adopt at a June 11 meeting.RELATED: San Diego Mayor Kevin Faulconer unveils 2019 budget"After decades of neglect, we have a lot more to do, which is why I’m focused on fixing more streets, building more parks and making more neighborhood upgrades than ever before," Faulconer said in a release. "We also need to invest in aging buildings like those in Balboa Park so they stand the test of time and that’s exactly what this budget will do."Here's a look at some of the financial commitments the mayor's plan proposes:Pure Water: Among the commitments is a 1 million investment into Pure Water San Diego to create an independent, drought-proof local water supply for San Diego. That project is expected to break ground in 2019.RELATED: San Diego is tops for walkable parks, study showsBalboa Park & fire stations: Also on the docket are 1 million in repairs for local libraries, fire stations, lifeguard stations, and recreation centers. The funds will also see new roofing installed for Balboa Park's Mingei International Museum and Air & Space Museum.Transportation: The plan puts 8 million toward transportation projects which consist of road paving, traffic signals, sidewalk improvements, and bridges. This includes funding to fix about 390 miles of streets.Parks & Rec: Mission Bay Park, Chollas Lake, Hickman Field Athletic Area, and Skyline Hills Community Park will see .5 million in park upgrades, including new lighting, trail realignments, and ADA improvements.Water system: Faulconer's proposal also includes .6 million for stormwater upgrades to channels, pumps, storm drain pipes, and watersheds.Faulconer's entire proposed budget can be viewed on the city's website. 2230

SAN DIEGO (KGTV) - It was more than a decade after two-year-old Jahi Turner disappeared.His mother, Tameka, had been posted on deployment with the U.S. Navy in 2002. Step-dad Tieray Jones claimed the boy vanished while playing with other kids at a park in Golden Hill, while Jones was buying a drink at a vending machine.Police thought otherwise, suspicious that Jones had severely punished the boy for bed-wetting and he died. The body never to be found.RELATED: Stepfather facing trial in Jahi Turner murderTameka called Tieray with detectives listening in."The accident ... is something that's an accident, ya know. Anything else what happened would have to be supposedly my fault," Tameka said.Tameka explained that she no longer trusted Tieray, saying, "I'm learning all this information that had I known years ago ... I'm sorry."RELATED: Trial begins for stepfather accused in disappearance, death of Jahi TurnerThe trial will resume o February 20. 977

SAN DIEGO (KGTV) -- Major decisions that could boost - or deal a real blow - to Republican candidates running for state offices about to be made in San Diego.It's because the California G.O.P. Convention kicks off Friday at the Sheraton Harbor Island. About 1,000 Republican delegates will be voting on a variety of endorsements for this year's ballot.G.O.P. gubernatorial candidates like Travis Allen and John Cox will attend, hoping to earn enough delegate votes for the party's endorsement for this year's election.The party is focussed only on state offices and initiatives - such as repealing the gas tax, said Cynthia Bryant, the state party's executive director.This is San Diego's second major political convention leading up to the June primary. The Democrats held their statewide convention here in February - with a who's who of national politicians.It was also the site of major news when the party declined to endorse Sen. Dianne Feinstein in her bid for re-election.The big difference for Republicans is that the party will not be taking up major federal issues like gun rights and immigration, Bryant said. The state party also won't be adopting a platform. Instead, Republicans will be focussing on the big decisions in the state - like repealing the recent 12 cent per gallon gas tax hike.They'll also be endorsing candidates for Governor, Lt. Governor, and attorney general. Still, Thad Kousser, who chairs the political science department at UC San Diego, says a lot of the decisions made could shape whether the Republicans can recruit new members. "Is this going to be a red meat crowd that really responds only to the visceral issues of immigrations? Or is it going to be a more strategic party that responds to issues that could help Republicans expand their base?" Kousser said. There are some closely watched congressional elections in San Diego County, including who will replace Republican Congressman Darrell Issa in the 49th district, and whether G.O.P Rep. Duncan Hunter can defend his seat in the 50th. Those endorsements could come later on. The convention runs through Sunday. 2157

SAN DIEGO (KGTV) — Local officials say the county has been cleared to reopen more businesses ahead of the state, including gyms, hotels, bars, day camps, and museums.According to the county, the following businesses would be allowed to reopen no earlier than June 12, pending approval by local health officials:GymsHotelsBars/wineriesZoos and indoor museumsFamily entertainment facilities (bowling alleys, batting cages, etc.)Day campsCampgroundsPro sports without fansFilm and TV productionCard roomsSan Diego Supervisors sent a letter to Gov. Gavin Newsom last week requested the expanded reopenings.Friday, the state released new guidance on reopening sectors of the economy including the businesses listed above for variance counties, of which San Diego is included. The state's criteria for sectors can be found here."The following guidance should be implemented only with county health officer approval following their review of local epidemiological data including cases per 100,000 population, rate of test positivity, and local preparedness to support a health care surge, vulnerable populations, contact tracing and testing," the state's website reads.RELATED:California to let schools, gyms, bars reopen next weekSan Diego to reopen several shoreline parks, piers, boardwalksSan Diego Supervisors request state allow gyms, pools, theme parks to reopenThis week, San Diego County allowed sitting and relaxing on beaches to resume and announced that beach parking lots would reopen and beach activities will resume within household units on June 9.The City of San Diego also announced this week that several popular piers, boardwalks, and beach parks would reopen this month.As of Friday, San Diego County had reported 8,180 coronavirus cases and 294 deaths. About 1,397 people have been hospitalized with the virus. 1833