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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 celebration of the National Parks Service's 103rd birthday, locals can enjoy the country's spectacular national parks for free.On Sunday, Aug. 25, NPS will celebrate its birthday by granting free admission to park goers across the country. The promotion is one of five "fee-free" days throughout the year. The next free admission days at Sept. 28 for National Public Lands Day and Nov. 11 in honor of Veterans Day.In San Diego, residents can enjoy free entrance to Cabrillo National Monument at the tip of Point Loma. As an added bonus, living history re-enactors will be in attendance to walk guests through the Age of Exploration.Films are also shown daily at the monument covering Cabrillo, the lighthouse, and nearby aquatic life. Guests can explore Cabrillo monument, nearby Old Point Loma Lighthouse, check out native plants, or trek down a trail to tide pools along the coast. 914

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) -- If you're feeling a little behind on your sleep schedule, Wednesday is your day to catch up! February 28 is National Public Sleeping Day. Don't take it too far though, you might get in trouble if you nap at work! There are different types of naps, according to nationaldaycalendar.com. "The Power Nap is approximately 10 to 20 minutes long and can give a boost of energy to get us through the rest of the day," the website writes. "It also doesn’t leave us drowsy like some longer naps might and will also allow us to fall asleep at a decent time at night."Our Scripps Digital Producer created the above note for you to take to work or school. It probably won't work...but it least it will make you smile. Good luck catching up on zzz's!   802

SAN DIEGO (KGTV) - Mayor Kevin Faulconer, County Supervisor Ron Roberts and county health officials announced Tuesday a plan of "Vaccination, Sanitation & Education" to stop San Diego's hepatitis A outbreak."This is our community and we are working day and night to take care of it. It is going to require a sustained effort and everyone in San Diego County has a role to play," Mayor Faulconer said. The county's top medical professionals say there is no end in sight to the outbreak that began in March. RELATED: San Diego Hepatitis A death toll, those sickened rises"This outbreak could last another six months and unfortunately there are going to be more lives that are going to be at risk," said Dr. Nick Yphantides, the county's chief medical examiner at a news conference outside the county administration building. Officials gave critical updates about the outbreak, which has killed 16 people and sickened 444 others. While most of the cases involved the homeless or drug users, 25 percent of the patients were neither, health officials said.Hepatitis A is a highly contagious liver infection that is usually transmitted by fecal-oral or person-to-person contact, or consumption of contaminated food or water. The disease is spread when infected patients go to the bathroom and do not wash their hands properly.RELATED:  1376