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SAN DIEGO (KGTV) — Low-lying parts of San Diego are dealing with the possibility of more coastal flooding Saturday and Sunday morning because of "King Tides." The high tide event is expected to occur the mornings of December 22 and 23, according to tidal charts. King tides occur when there is an alignment of the gravitational pull of the sun and the moon. RELATED: Sandbags available in San Diego CountySome parts of Imperial Beach already experienced tidal flooding Friday morning as several homeowners reported water entered their homes. Wow! Really high tide here in Imperial beach. Water soaking the area. @10News pic.twitter.com/F3P6dNr7HS— Mimi Elkalla (@10NewsMimi) December 21, 2018 700

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) -- Many doctors across San Diego County have seen a recent surge in positive COVID-19 cases. Five hundred one new cases were reported Thursday.But, most people don’t require hospitalization and can isolate at home.“We just do video visits with patients and talk to them about their symptoms,” said Dr. Michele Ritter, an infectious disease specialist at UC San Diego Health and an associate professor of medicine.“At the end of April, May, we were getting maybe four or five new referrals a day to be seen, and then it went up to about 40 a day.”Ritter is also the medical director of the COVID-19 clinic. She said many of her patients live with other people.“There are times there are three of four generations of a family living in a house together and sometimes very close quarters, so that’s a challenge,” she explained.If someone in your household has COVID-19 the Centers for Disease Control and Prevention recommends they stay in a separate room and use a different bathroom if possible, avoid contact with other members of the household and pets, don’t share personal household items, and wear a cloth face covering when around others“The absolute ideal situation is your own room, your own bathroom. Not everybody has that, we have patients who live in two-bedroom apartments with six other people and a single bathroom.,” said Ritter.While isolation is critical, Ritter said if you must use a shared space, like a bathroom, it’s essential to disinfect after every use. That includes using a shower, toilet, or sink.“When you’re done if you’re able to have something like a Clorox wipe, or a washcloth with some Clorox bleach on it wipe down the surfaces that you’ve used and wash your hands,” she said. “In terms of laundering clothing, it’s probably fine to launder them together if you’re using high temperatures to wash your clothes.”She said to wash all dishes and utensils used by someone with COVID-19 in hot water and soap or run them through a dishwasher.“A lot of patients have their family members bring meals to them and set it outside their door so they can eat,” she said.Another challenge is parents who test positive for COVID-19 and have mild symptoms, but still, have to take care of their kids.“I find that most parents do well wearing a mask; the kids get used to it,” she said. “You can still be around your kids; just do the best you can.”Ritter said many of her patients have been able to keep the virus from spreading to their loved ones at home by following simple steps.“Wearing masks, washing hands, cleaning frequently touched surfaces is the best you can do,” she said. “We don’t always have perfect situations, so we do the best we can with what we have.” 2720

SAN DIEGO (KGTV) — In just days, Pfizer’s COVID-19 vaccine will go before a key group of scientific advisers to the Food and Drug Administration, and a San Diego doctor will be part of the process to cast an important vote.Dr. Mark Sawyer, an infectious disease specialist at Rady Children’s Hospital, will serve as a voting member of the Vaccines and Related Biological Products Advisory Committee or VRBPAC when the body meets Dec. 10 to publicly vet Pfizer’s COVID-19 candidate.Dr. Sawyer is also a professor of clinical pediatrics at UC San Diego. He has served before on this outside advisory committee to the FDA, but the stakes have never been so high.“I mean this is a tough decision,” he said in an interview Friday. “We're weighing the benefit of a vaccine against the risks. And with any new product, we don't know the risks and we have to estimate based on the data we have.”Dr. Sawyer said he received Pfizer’s full Phase 3 data Friday morning, making him one of the first Americans outside the FDA to see the full details of the company’s large-scale clinical trial. The FDA is expected to release the data to the general public by Tuesday, two days before the public meeting.Sawyer will be one of about 20 outside vaccine experts from around the country on VRBPAC. The FDA hasn’t yet released a full roster of the doctors and scientists who will take part. The independent advisory committee will hear comments from Pfizer and the FDA and listen to public input before voting on whether to recommend emergency authorization.The marathon meeting is expected to last up to nine hours.“The FDA counts on this advisory committee to be an independent group of people who are looking at the same information they looked at and asking us what our concerns are, or whether we reached the same conclusion that their staff have reached,” he said.The meeting comes on the heels of a study by Pew Research that found lingering skepticism of the vaccine. Just 60% of Americans planned to get vaccinated as of the survey released Monday.“I do think that's going to change once this committee meets and the data is made public and we can all talk together as a community about what we know about the safety, and what we don't know, frankly,” he said.Dr. Sawyer was a member of VRBPAC for four years and briefly served as the acting chair in 2017.The committee meets a few times each year to make recommendations on the annual flu vaccine and other drugs.The committee’s vote is not binding. The job of the outside advisers is to issue a recommendation and the FDA can overrule them, but the agency rarely does. From 2003 to 2019, VRBPAC made 105 recommendations. The agency fully implemented 84% of VRBPAC’s recommendations and partially implemented 10%, according to Union of Concerned Scientists.That means when the committee votes Thursday, it’ll carry a lot of weight. The FDA is expected to announce its final decision shortly after the vote, possibly within hours.Dr. Sawyer said the advisers will make a decision following the process they traditionally do, based on all the knowns and unknowns. “And we’re going to weigh that against what we're going through right now,” he said. “Our hospitals are getting overwhelmed. Our ICUs are getting full.”“We really need to do something to intervene and the vaccine is the best thing we've got going,” he added. 3369

SAN DIEGO (KGTV) — It's going to be a great weekend to get outside and enjoy the fall season in San Diego!Believe it or not, the Christmas season has already begun as the Old Globe Theatre brings "Dr. Suess's How the Grinch Stole Christmas" back to the stage. Tickets are on sale for show times throughout the month!Also, SnowJam takes over Del Mar this weekend, packing heavily discounted and new gear and clothing, lift tickets, and more into the Del Mar Fairgrounds just before snow hits the slopes.Not interested in anything here? Check out the 10News?community events calendar for a look at even more things to do!Beer and food fans get their fill as well, with San Diego Beer Week continuing, Stone's DRK Festival, and the San Diego Bay Wine and Food Festival!Plus, Veteran's Day festivities hit town in celebration of our armed forces! Here's a look at what's happening this weekend:THURSDAYDr. Suess's How the Grinch Stole ChristmasWhere: Old Globe Theater; Cost: - (Runs Thursday - Sunday) That's right. The Grinch is back in San Diego! The Old Globe's production of "How the Grinch Stole Christmas" returns, bringing the classic Christmas tale of the Grinch's plan to ruin Whoville's holiday fun to the stage. San Diego Asian Film FestivalWhere: Various locations; Cost: - (Runs Thursday - Sunday) Enjoy San Diego's showcase of Asian American and international works of cinema as the San Diego Asian Film Festival this weekend! The festival brings an opening night party on Thursday followed by short film screening and special presentations! FRIDAYStone DRK FestivalWhere: Stone Brewery, Escondido; Cost: Fan on the dark brews? Stone, while known for its IPAs, is celebrating its darker pours during Stone DRK Festival. A ticket gets beer fans tasters, a commemorative glass, and tastes of some of the breweries favorite and rare beers! SnowJam?Ski & Snowboard ExpoWhere: Del Mar Fairgrounds; Cost: - (Runs Friday - Sunday) The latest and greatest in snow gear is waiting at Del Mar this weekend, as SnowJam comes to town. Check out heavily discounted, brand new equipment and clothing and lift tickets, and check out live demonstrations or talk with industry reps. Just in time for ski season!  SATURDAYSan Diego Veteran's Day ParadeWhere: San Diego Embarcadero; Cost: FreeCelebrate our nation's veterans and active-duty military members during San Diego's annual Veteran's Day parade! Service members will travel down Pacific Highway, past the USS Midway, in celebration of our nation's heroes. San Diego Beer WeekWhere: Various locations; Cost: Varies(Runs Friday - Sunday) Local craft beer fans can visit participating restaurants, bars, and breweries for special beer releases and events highlighting why San Diego is considered the capital of craft beer. 6th annual Ride the Point 2018Where: Oggi's Pizza and Brewing, San Diego; Cost: - Pedal for a cause along Point Loma in support of pancreatic cancer research! The annual Jim Krause Memorial Charity Bicycle Ride starts at Liberty Station and takes riders on a scenic path through Point Loma. The public is also invited to the race's free healthy lifestyle expo at the event!  SUNDAYSilver Strand Half Marathon & Veteran's Day 5KWhere: Sunset Park, Coronado; Cost: - Show your support for our nation's military during the Silver Strand Half Marathon! The run starts and finishes at Imperial Beach Pier Plaza, and treats runners and walkers to a post-race beach party and beer garden at the end! BOOmont Park and Fall FestWhere: Belmont Park; Cost: Free - Halloween may be over but Fall fun is still here! Belmont Park will continue its Boomont Park and Fall Fest this weekend, with free trick-or-treating, costume contests, entertainment, pumpkin painting, and much more. San Diego Bay Wine and Food FestivalWhere: Embarcadero Marina Park North; Cost: 5 - 5Treat your taste buds to bites from more than 60 celebrity chefs and restaurants, and sips from hundreds of wines and spirits during San Diego Bay Wine and Food Fest! San Diego's top chefs will be churning out delicious creations over the course of an entire week. 4261

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