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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) — How safe do you feel eating at Petco Park? Or if you've chosen to support the Chargers, StubHub Center?A newly published analysis by ESPN's Outside the Lines investigated thousands of food-safety inspection reports from health departments that monitor professional sports venues across the U.S.The analysis looks at routine inspection reports from 2016 to 2017.According to ESPN, about 28 percent of the venues registered high-level violation in half or more of their food service outlets. The violations cover temperature, pests or bugs, poor condition of food, equipment failures, employee-related issues, and more.The study's worst is in Charlotte, N.C., where Spectrum Center — home of the NBA's Charlotte Hornets — posted a 92 percent violation rate, followed by Michigan's now-closed Palace of Auburn Hills (86.11 percent), and Texas' American Airlines Center (83.08 percent.)The highest rated stadium was Oakland's Oracle Arena — home of the NBA's Golden State Warriors— with a 1.12 percent violation rate.Petco ParkSan Diego's downtown ballpark ranked fifth among MLB venues and 24th among all venues analyzed by ESPN.Of the park's 168 outlets inspected, 28 recorded high-level violations, according to ESPN's study. The study found the park registered on average 0.09 high-level violations per inspections.Some of those violations, for example, including pest-related issues— two of which occurred in 2016 inspections. On Aug. 18, 2016, an inspector found bird droppings on top of an ice bin and on Sept. 20, 2016, rodent droppings were discovered on the floor and top of a concession stand's ice machine. That ice machine was taken out of service for the rest of the season, according to the study.The San Diego Padres told 10News they are "confident that our ballpark will continue to be one of the safest" in baseball:“We strive for excellence with our food and beverage service at Petco Park. Violations are unacceptable; and, it is our policy to immediately address any issues directly with our concessionaire to ensure they are corrected and do not occur again. We are confident that our ballpark will continue to be one of the safest in all of baseball, as evidenced by ESPN’s published rankings today," the statement read.StubHub CenterThe home of the Los Angeles Chargers came in seventh in the NFL and 22 among all venues in ESPN's study.Of the venue's 39 outlets inspected, 6 recorded high-level violations, the study says, and 0.06 violations per inspection, on average.Some of the violations recorded included employees not properly wearing hair restraints on July 15, 2017, and food not properly protected from contamination on April 29, 2017, the study says.In a statement to 10News from Levy, hospitality partner at StubHub Center, the company noted their violations compare "highly favorably" to the average number of violations at any restaurant:“We welcome the local Los Angeles County health department and employ third-party sanitation experts to ensure a safe environment for our guests. Any time a concern is identified, we immediately correct it and welcome the health department to return to confirm that we are in full compliance. While we take every violation seriously and strive for perfection in our scores, we are pleased to note that the number of violations per inspection at the stadium compare highly favorably to the average number of violations found at other dining establishment areas in the county.”To read ESPN's full study, click here. 3514

SAN DIEGO (KGTV) – Gov. Gavin Newsom said Wednesday that a rise in coronavirus cases is worrying, and warned counties to heed statewide precautions and enforce them.He doubled down on his warning, saying if individual counties did not enforce the state's guidance, they can lose funding."We cannot support bad behaviors, but we want to encourage and support good behavior," Newsom said. "And if counties simply are going to (flout) the rules and regulations that they attested to, the information that they put online and said, `We agreed to this criteria.' ... If they decide, `well, you know what, even though the numbers are going up, we're done, we've got this, we're just going to ... dismiss these new rules and regulations' -- we're going to attach some considerations, some consequences to that. There's .5 billion in this budget that simply will not flow to those counties that do that."Newsom added that while he doesn't anticipate having to take such actions since the majority of counties have been cooperative, funding will be issued monthly — not annually — to ensure counties continue to adhere to health restrictions.RELATED: California requiring face coverings for most indoor areasHow San Diego County officials monitor coronavirus trendsSan Diego County pauses future reopenings after hitting community outbreak triggerNewsom went on to plead with residents to continue to practice good hygiene and wash their hands, wear facial coverings when around others, avoid large gatherings, and stay home when sick to halt the spread of COVID-19."Washing your hands isn't just putting your damn hands, forgive my language, under the faucet for two seconds and calling it a day," Newsom said. "We've all seen that. Many have done that ... but in this pandemic, come on. We can do a little more and a little bit better."Monday, Newsom warned that the state was prepared to "revert back" to COVID-19 restrictions if needed, as the state sees a rise in cases. The governor added, "we don't intend to do that, we don't want to do that, but I want to make this clear - we are prepared to do that if we must."Last week, Newsom issued a statewide facial covering order for residents in high-risk settings, with exceptions, to address a rise in cases throughout the state. He said Wendesday that the most recent 14-day average of people testing positive for the virus in California overall is 5.1%, up from 4.6% earlier this month. He added that the number of people hospitalized due to COVID-19 increased by 29% over the last two weeks, and the number of ICU patients went up 18%.Tuesday, California reported 183,073 coronavirus cases and 5,580 deaths from the virus.City News Service contributed to this report. 2725
SAN DIEGO (KGTV) - Doctors across San Diego shared mixed emotions of despair and hope this week, as San Diego's COVID-19 cases surge while front line workers get the first doses of a vaccine."This is actually a really difficult time right now," says Dr. Holly Yang, the President of the San Diego County Medical Society. "Our hospitals are getting quite full and staff is getting really stretched.""It's tiring," says Dr. William Tseng, an Internist at Kaiser Permanente Hospitals. "But, as health professionals, we're here to take care of patients."They say this week has been particularly hard, as an influx of people who contracted the virus during the Thanksgiving holiday threatens to overwhelm the system."It gets tough," says Dr. Karrar Ali, an Emergency Room Physician at Sharp Chula Vista. "Now we're starting to make decisions based upon capacity... That's tough, when your resources start dwindling to the point where it's not just beds, but we're having staffing issues as well."Dr. Yang says, even as bad as things look right now, with the Southern California all but out of ICU beds, doctors in the SDCMS take hope from the vaccine."There's a light at the end of the tunnel," she says. "But that tunnel is long and dark. We're going to get there, but the challenge of getting us to there through this very difficult time is going to be a hard one." 1370
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
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