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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) - Each year around this time, we marvel as gray whales make their way from Alaska down to Baja, Mexico, to give birth. However, this year's migration started late. "This year, with the migration being so late, a lot of the moms aren't actually making it to the lagoon before they give birth. So we're seeing a lot of these pregnant females giving birth on the migration this year," said Captain Domenic Biagini, founder of Gone Whale Watching San Diego.While the migration is late, Biagini says the whales look much healthier than last year, when many died. "Likely these whales spent a little longer feeding this year to make up for what they didn't get last year, and with less sea ice than normal, they're able to actually go further north looking for food, which then also makes the migration longer," said Captain Dom. Biagini says the calves aren't strong enough to dive, so he's already seen close calls with private boaters speeding by. "The problem is a lot of these grays, especially the moms with babies, are intentionally trying to keep a low profile and people aren't realizing that they're there as they're flying through thee areas. So it's really crucial to be conscious of your speed and surroundings during gray whale season," said Biagini.He says while the newborns are more vulnerable, the moms do a good job keeping a low-profile.They should arrive at their destination in a week or two. 1433
SAN DIEGO (KGTV) — Hoover High School Friday celebrated the topping off of one of its newest additions to campus.The campus set the final beam of its new 500-seat theater into place, with students and staff signing the steel beam before a crane lifted it into place. The event marked the latest completion in the school's massive renovation project, which has already seen the return of the school's once iconic tower. The tower, which was topped off in January 2019, could once be seen from El Cajon Blvd., before it was taken down in 1976 due to seismic safety standards.Once the renovations are completed, Hoover High will have not only its Spanish-style tower back but also a new theater with theater support and instructional space, and a three-story building accommodating counselors, support staff, and students.The new classroom building will feature 20 classrooms to replace outdated modular classrooms elsewhere on campus.The project will also see a reconfiguration of the main parking lot, courtyard improvements, and a student drop-off area. 1062
SAN DIEGO (KGTV) - Father of three boys, Ben Walrath, was excited when he heard baseball practice was starting up again."There's only so much Fortnite they can play," Walrath said, his son Austin, 10, chiming in, "before I get bored." "Before we have to do something different," Walrath continued.He had a talk with his boys about how practice is going to be different to protect them from coronavirus.When quizzed, his sons answered correctly, "no dugout during practice," Austin said. "Stay six feet away." Walrath reminded them, "we're not going to be doing high fives and stuff like that... and no games right away."While Austin wasn't enthused about the new protocol, he was excited to see his friends for the first time in months at practice Monday.President of Sweetwater Valley Little League Arturo Maldonado said they are rolling out practice in three phases. Monday was the beginning of phase one with kids ages 10-15. This weekend phase two will start for kids ages 7-10 and as soon as June 26 the youngest ball players ages 4-7 will get to come back to practice."Everybody's learning how things are going to be done out in the field and that's why we're doing it in three different phases so that we can make adjustments," Maldonado said.He said managers and coaches will be wearing masks, but the kids don't have to. He said the kids will be encouraged to socially distance.There won't be any hugging, high-fives, or sunflower seeds and hand sanitizer is always close by. The dugout will be expanded to the stands, Maldonado said, to accommodate for social distancing.Parents aren't allowed at practice yet and sick players are encouraged to stay home.Monday Walrath said the boys played wiffleball, just as they would any other day."We're not going to change the game of baseball. We're changing how we're watching the game of baseball," Maldonado said.Walrath said safety is a priority for every family. "There's always health concerns in sports, whether that's normal injury concerns. Coronavirus adds a new twist to health concerns and just like with anything else I think this is a personal risk decision for each and every one of our families," Walrath said.Sweetwater Valley Little League has a history of big wins, making it to the Little League World Series in 2015, and Regionals in 2019.Families hope to get their kids some social interaction after months of staying at home and keep them safe. 2426
SAN DIEGO (KGTV) -- Forbes has released its list of America’s best employers of 2018 and two San Diego employers made the list.Both Qualcomm and the County of San Diego made the list coming in at 111 and 268.According to Forbes, Qualcomm employs more than 30,000 people and the County of San Diego employs over 20,000 people.Qualcomm made headlines recently after news that President Trump blocked Broadcom’s 7 billion bid to buy the company citing national security concerns. The company also recently laid off more than 1,000 people.RELATED: After Trump's block, Qualcomm facing post-Broadcom uncertainties To make the list, Forbes surveyed 30,000 Americans working for businesses with at least 1,000 employees.The U.S. economy is marking its 90th consecutive month of job gains as the unemployment rate continues to hover at a very low 4.1 percent. 868