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SAN DIEGO (KGTV) — Governor Gavin Newsom’s vaccine safety task force will have to work quickly once the FDA announces a decision on Pfizer’s COVID-19 vaccine candidate.The 11-member panel, officially called the Scientific Safety Review Workgroup, has been tasked with reviewing the safety and efficacy of vaccine trials and rendering a recommendation on their use in California.The workgroup has a difficult mission: review the data thoroughly enough to offer a recommendation independent from the FDA, but do it fast enough to avoid delaying distribution of the vaccine.Pfizer’s emergency use authorization application spans thousands of pages.The workgroup has already reviewed Pfizer’s early-stage clinical trial data from phases 1 and 2 and found no cause for concern, Governor Gavin Newsom said. They’re still waiting to get their hands on the all-important Phase 3 data, which included thousands of participants.Panel member Dr. Rodney Hood, the president of the Multicultural Health Foundation, acknowledged the task force will have to complete its review of the Phase 3 data “very, very quickly.” Dr. Hood is one of two members from the San Diego region, along with Dr. Mark Sawyer of Rady Children’s Hospital.“We certainly don't want to introduce any unnecessary delay in the vaccine being available to Californians,” Dr. Sawyer said.The FDA has scheduled a meeting of its vaccine advisory committee, known by its acronym VRBPAC (pronounced verb-pack), on Dec. 10. The agency said it will make Pfizer’s Phase 3 data available at least two days before that meeting.At the end of that meeting, a group of about 20 experts on the advisory committee will vote on whether to recommend emergency authorization of the vaccine. The FDA is expected to issue a decision shortly after, although the agency does not have to abide by the advisory committee’s recommendation.“The California committee is on notice to be ready for a meeting either later in the day on the 10th or on December 11,” said Dr. Sawyer.Dr. Sawyer was recently added to VRBPAC, so he will cast a vote on whether to recommend approval of the vaccine at the national level before participating in California’s process.“It is going to take a few days for the vaccine to really start flowing,” he said. “I don't think the [California] committee is going to introduce extra delay.”The California committee has promised to issue its decision within 24 hours of the FDA’s to avoid slowing down distribution, but that means the members may have as few as three days to review the safety and efficacy data.Federal regulators will spend about three weeks reviewing the thousands of pages of data submitted as part of Pfizer’s application. VRBPAC and the California Scientific Safety Review Workgroup will render decisions based on summaries prepared by the FDA, Dr. Sawyer said.Both doctors say they have confidence in the FDA’s process and acknowledge it would be very unlikely for the California workgroup to break with the agency’s recommendation. They said the mission of their review is to add an extra layer of verification after complaints the Trump administration was exercising political pressure on the FDA.“I think the governor foresaw that it was going to be very important that the general community accept these vaccines, assuming they're approved and are safe and effective, because otherwise we're not going to get out of this pandemic,” Dr. Sawyer said.The doctors say they want to make sure that community acceptance extends across all demographics, so they’ll be looking closely at the numbers to see if various ethnic or racial groups had different responses to the vaccine.Based on research on past vaccines, a differential response is not expected, Dr. Hood said. However, COVID-19 does strike Latinos and African-Americans more severely, making vaccine acceptance among minority communities all the more critical.“I want to look at the data, get an assessment of risk-benefit and the question I ask is, would I take it? Number one. Number two, if I would take it, would I recommend it to my family?” he said.The doctors said they will also closely examine reports of side effects.Early data suggests both Pfizer and Moderna’s candidates have somewhat harder-hitting side effects than the typical flu vaccine. Dr. Sawyer compared the side effects to the recent shingles vaccine.“Your arm hurts for a day or two. You may not feel well. You may feel a little bit under the weather for the first 24 hours. You could even have a mild fever or headache,” he said, noting those symptoms typically resolve within 24 to 48 hours based on the data available so far.“That's actually a good sign. You want that to happen,” he added.Those sorts of short-term side effects are signs the body is building a strong immune response. They’re evidence the vaccines work as well as advertised, but the doctors say they won’t know for certain until they review the final numbers. 4949
SAN DIEGO (KGTV) — Gusty offshore winds and high temperatures will work their way back into San Diego County this week.San Diego Fire-Rescue is expected to beef of staffing Sunday through Monday in anticipation of the Santa Ana wind event forecasted to start Sunday night.Sunday, winds will turn offshore and become gusty along coastal slopes, according to the National Weather Service. High pressure will add to the warming, increasing the risk for wildfires.NWS forecasts a high of 76 degrees and low of 58 degrees, Sunday.WEATHER: Check updated conditions across San Diego County Those temps rise Monday, with a forecasted high of 85 degrees and low 62 degrees. Monday will see winds shift east, as winds shifts through the coastal slopes and into San Diego County mountains and foothills. Wind speeds may sit at 15-25 mph, with gusts up to 30-40 mph. Humidity levels will hover near 10%, elevating the fire danger.Breezy conditions are expected to continue into Tuesday morning, before weakening that afternoon. Low humidity and warm temperatures, with periods of easterly winds, will be common throughout the week, NWS says. 1138
SAN DIEGO (KGTV) — Holiday light displays are one of the best aspects of the holiday season.Thousands upon thousands of lights in some cases dress up homes and businesses throughout San Diego County, bringing out families and friends to enjoy the sights and sounds of the season.Throughout the county, San Diegans have numerous displays to drive to and admire. Some are snuggled in cul-de-sacs around town, others, larger events that continue the fun throughout the end of the year.Here's where you can catch San Diego's best light displays this season:(Links for display locations can be found by clicking the location in the map above.)Displays"Carlsbad Christmas House" can be found on Romeria Street in Carlsbad. Lights are on display from Dec. 2 to Dec. 31, from 5 p.m. to 10 p.m. (closed rain days.) "Christmas on Knob Hill" is located at Knob Hill Road in San Marcos. Lights are displayed from Nov. 22 to Dec. 30, from 5 p.m. to 9 p.m. Santa will make an appearance from Dec. 14 to Dec. 23, from 6:30 p.m. to 7:30 p.m. "Candy Cane Lane" covers Hickory Ct., Hickory St., Butterwood Ct., and Rockrose Ct. in Poway. "Christmas Card Lane" is located on Oviedo St. off Black Mountain Rd. in Rancho Penasquitos. "Belardo Lights" runs on Belardo Dr. through Dec. 27. Lights will be on from about 6 p.m. to 10 p.m. nightly. "Starlight Circle/Sunburst Santee" covers Tomel Ct. off Magnolia Ave. in Santee. Residents have their own schedule for how long lights will be up, but they’ll generally be on from about 5:30 p.m. to 10 p.m. "The Forward House" in Banker’s Hill is located at Ivy St. and 1st Ave. The house will be lit generally from 5 p.m. to 10 p.m. Events"December Nights" will hit Balboa Park on Dec. 7 and 8. The park will be decked out in lights as well as holiday music, vendors, and food. "Jungle Bells" welcomes the holidays to San Diego Zoo from Dec. 14 - Jan. 6. The park will run daily light shows and entertainment with zoo staff and animals. "San Diego Bay Parade of Lights" brings out boats dressed in hundreds of lights to the bay, as they parade on the water Dec. 9 and 16. "Garden of Lights" at San Diego Botanic Gardens showers the garden in more than 125,000 lights, and hosts marshmallow roasting, a musical light show, and more. "Christmas Celebration" at SeaWorld San Diego runs from Nov. 17 to Jan. 6, bringing a 40-foot Christmas tree, Santa’s village, and delicious foods to the theme park. 2429
SAN DIEGO (KGTV) - For six years a Camp Pendleton Recon Marine allowed filmmakers full access into his life, which at one point hit rock bottom. The GI Film Festival documentary, Homemade, aims to start a conversation on taking better care of our returning veterans. Staff Sgt. Adam Sorensen was injured in 2010 by an explosive device in Afghanistan; 100 pieces of shrapnel pierced his body, and he required two surgeries.He could no longer serve in a combat role and spent the next couple of years as an instructor. The documentary follows Sorensen as he navigates civilian life and the effects of Post Traumatic Stress, Traumatic Brain Injury, and addiction on his marriage, family, and work.Filmmakers Danielle Bernstein and Jason Maris included scenes that can be hard to watch. "For me, it ultimately is to help people, because that's the whole reason I really wanted to make something that looked at how is this affecting people, families," said Maris. The film premiered at the GI Film Festival in San Diego and will begin playing in select theaters nationwide on Veterans Day.You can learn more about the film here or watch the trailer. The GI Film Festival continues into the weekend and will feature stories with similar themes; healing through sports, post 9/11, post traumatic stress, and transitioning back to civilian life. Similar films include Island Soldier, Team River Runner - Beyond Paddling, and Finding Satan. 1440
SAN DIEGO (KGTV) — Eighty-five people linked to the Sinaloa Cartel were charged Thursday for their roles in a massive East County drug trafficking network.Eight indictments were unsealed in a San Diego federal court charging the alleged members with federal drug trafficking, money laundering, and firearms offenses, according to the Office of the United States Attorney Southern District of California.Investigators executed more than a dozen search warrants Thursday in a coordinated takedown of locations around the East County. Investigators discovered at least four pounds of methamphetamine and two firearms.The networks reportedly supplied a variety of controlled substances — like meth, heroin, and fentanyl — to distributors around Southern California, and then laundered tens of thousands of dollars in narcotics proceeds back to Sinaloa Cartel traffickers in Mexico.As of 1 p.m., 47 of the 85 charged were in federal or state custody. Some of the charges carry potential 20-year sentences and millions in fines.“Today we sent a message to drug traffickers in our community. If you sell drugs in San Diego, we will find you and prosecute you to the full extent of the law,” said U.S. Attorney Robert Brewer.Authorities used surveillance, wire taps on phones, and undercover agents to obtain evidence and track encrypted communication by members through services like WhatsApp and Signal.Through wiretaps, investigators seized about 175 pounds of methamphetamine, heroin, and fentanyl; about ,000 in cash, multiple firearms; and a 2020 Cadillac Escalade valued at 5,000.Defendants will start to be arraigned Friday. 1638