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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) - Following a heated battle over new regulations for short-term vacation rentals Wednesday, the San Diego City Council approved new regulations in a 6-2 vote.The new rules will go into effect July 2019.The rules, which were based on a plan by Mayor Kevin Faulconer, adopt the city’s first license-based system to manage the rentals, charge cost-recoverable fees to administer licenses and enforce code violations, establish a “Good Neighbor” policy to preserve neighborhood quality of life, hire additional staff to respond to complaints about nuisance properties, and implement a per-night fee that would generate funding for affordable housing projects.RELATED: San Diego City Council approves new rules on short-term rentalsAlthough the plan initially called for homeowners to be allowed two licenses for a primary and secondary home, the council later amended the provision before the plan passed its first vote in July.Faulconer’s proposal was changed to allow a host to be issued a license for a primary residence and a dwelling on the same land as the primary residence.Faulconer also had a provision in his plan allowing no limitations on the number of licenses available to hosts within Mission Beach when it was introduced in June. The mayor later amended his plan by allowing only existing operators of short-term rentals in Mission Beach.After the first vote, the revised plan was praised by Council members Lorie Zapf, Barbara Bry, and Chris Ward.RELATED: City Council members to make push for short-term vacation rental regulations in San Diego 1583
SAN DIEGO (KGTV) — Dinner tables across San Diego will be set with all the trimmings this Thanksgiving, but that doesn't mean everyone is eating in.Many local restaurants will also offer special dinners, complete with turkey, stuffing, and traditional dishes. Perfect for those who prefer to skip the mess at home or would rather head out for dinner.Reservations are recommended any diners choose to go.RELATED: Other restaurants open for Thanksgiving dinnerHere are a few ways to give back this ThanksgivingBut no matter where dinner is served at these restaurants, diners will without a doubt be satisfied with what chefs are cooking:20|Twenty (Carlsbad): Enjoy a buffet of traditional Thanksgiving dishes like mashed potatoes, carved turkey, stuffing, and sweet potatoes for breakfast and dinner times. Reservations for adult buffets can be purchased for and children's buffets for .International Smoke (Del Mar): International Smoke is cooking up a delicious menu featuring smoked turkey, coffee-rubbed prime rib, grilled verlasso salmon, mac and cheese, coconut curry cornbread, and more for Thanksgiving. Reserve a spot for the buffet at per person.George's at the Cove (La Jolla): A three-course Thanksgiving is on the menu at George's at the Cove, featuring beef carpaccio, turkey with mushroom stuffing, roasted pork chop, locally-caught yellowtail and swordfish, and more. Dinners begin at per person.JRDN Restaurant (Pacific Beach): JRDN is prepping up three-course meals featuring braised short ribs, crab toast, a turkey dinner, risotto, stuffing, sweet potato, and more. Dinners range from - per person and for children 12 and under.Bleu Bohème (Kensington): Enjoy french cuisine this Thanksgiving at Bleu Bohème, where chefs are serving crab croquette, roasted turkey, King salmon, short ribs, fresh beats and more on their menu. Dinners are per person and .95 for children 12 and under.Louisiana Purchase (North Park): Louisiana Purchase is open on Thanksgiving from 5 p.m. to 10 p.m. for dinner, where you can enjoy dishes like shrimp sliders, crab fingers, gumbo, fried chicken, and more.Mister A's (Downtown): Mister A's is serving up a magnificent view of downtown San Diego along with three-course dinners featuring roasted turkey, lamb, scallops, beet salad, lobster bisque, mac and cheese, and more. Dinners are .50 per person.ALBACA (Coronado): Coronado's ALBACA will treat guests to Thanksgiving dinners featuring butternut squash, jalapeno chimichurri, prime rib, slow-cooked turkey, mashed potatoes, cranberry sauce, and more. Dinners are for adults and for children 12 and under. 2660
SAN DIEGO (KGTV) - Gusty Santa Ana winds and dry conditions prompted the National Weather Service to declare a Red Flag Warning for parts of San Diego County.A Fire Weather Watch was initially set to take effect Thursday, but NWS officials -- citing Santa Ana winds and low humidity -- updated the declaration into a Red Flag Warning.The warning is scheduled to take effect Thursday at 10 a.m. and will expire at 10 p.m. Friday. As a result, Cal Fire is increasing staffing this week. LATEST WEATHER FORECASTNWS officials said, “Santa Ana winds will develop Thursday with peak winds arriving Thursday night into Friday morning before gradually decreasing Friday afternoon and evening. A very dry air mass will spread into southern California on Thursday with lowest daytime humidity on Friday around 5 percent.”According to NWS officials, the Red Flag Warning will impact the San Diego region’s mountain and inland valleys.“Any fires that develop will likely spread rapidly with extreme fire behavior possible. Outdoor burning is not recommended,” according to the NWS.Cal Fire ads that there are some things you can do to help prevent fires. Check out the list below: 1181
SAN DIEGO (KGTV) — Get ready for sunny days at SeaWorld this summer, as the cast of a television favorite comes to San Diego.SeaWorld will host Sesame Street favorites including Elmo, Cookie Monster, and others with themed floats, music, and two performances along the parade route during the Sesame Street Party Parade.The parade will feature 10 massive floats depicting the areas kids know and love, like Mr. Hooper's Store and the Count's Castle.More than 20 dancers will jump and jive alongside Elmo down the parade route, along with a cast of furry friends.During the two mid-parade shows, performers will jump rope, hula hoop, and groove to guests' delight. One show will star Rosita, a Sesame Street favorite known for her guitar skills. The parade can be seen on weekends running from May 25 - Sept. 1 at the park. 830