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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) -- Drove footage captured off the coast of San Diego shows orcas happily making their way through crystal clear water. The footage was captured by Domenic Biagini Photography roughly 20 miles off the coast.Biagini told 10News that the water was perfectly calm and the skies clear, allowing for some incredible footage to be captured.Watch the full video in the player below: 409
SAN DIEGO (KGTV) - Hundreds of men in high heels strutted through downtown San Diego on Saturday morning to support victims of domestic violence.The 11th annual “Walk a Mile in Her Shoes” event started with the mile walk and ended with a family festival featuring face painting, live music and more.“It is a lighthearted way to bring awareness to domestic violence,” said Heather Frinlay, the Chief Operating Officer of the YWCA of San Diego County. The morning of family fun raised money for programs that provide victims of domestic violence resources like housing, counseling, and legal aid.“This is not a private issue; this is a community issue,” said Frinlay. “We still have one in four women, and now one in seven men experiencing domestic violence in their lifetimes.”San Diego County reported more than 17,000 incidents of domestic violence in 2017. 871
SAN DIEGO (KGTV) — Hundreds of residents at “The Cliffs” mobile home park in Allied Gardens are fed up after living without running water since Thursday. The community consists solely of 55+ senior citizens, and many of them live alone or have limited mobility. "It's really kind of a pain in the neck,” 85-year-old resident William Shakespeare said. Like many of his neighbors living in the lower portion of the Cliffs, Shakespeare lost water since early Thursday. Luckily for him, his longtime girlfriend Suiko Paul is quite mobile. She became the go-to person for water supply for the entire street. "Elderly people live here. They don't drive. Somebody has to help them,” Paul said. She was been swamped. "She hauls water like crazy,” laughed Shakespeare. 10News met the on-site property manager as he and two others were digging a hole in the asphalt. He stepped away from the camera to tell us two old pipes burst on opposite ends of the mobile home park Thursday morning. Since then, he said he had been doing everything he can to fix the problem. But residents like Shakespeare and Paul did not want to see three people trying to fix a major water leak problem affecting more than 200 residents. "He's been here since Thursday, and they've been digging, but they're not sure where they're digging,” Shakespeare said. Many residents appreciated that the manager was trying to handle the problem himself, but they said it had gotten out of control. Like many of her neighbors, Paul said she had not taken a shower for four days, and she had gone to a friend’s house to wash dishes.The Red Cross began mobilizing at the clubhouse and doing door to door well-fare checks. But for many of the seniors, patience is running out."It seems like forever…. Not having water, I don't know what could be worse. Not having air, I guess,” Shakespeare said. The city is aware of the problem. But because the pipes are under private property, the owner of the entire mobile home park must have them fixed themselves before the city can turn the water back on. 2059
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