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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) -- Family and friends of Sabrina Rosario gathered Saturday night for a memorial service to honor her and her four boys. Rosario and her boys were killed by her estranged husband, the children's father, last month. The boys: Enzi, 3, Zuriel, 5, Ezekiel, 9 and Zeth, 11. Rosario was 29-years-old. RELATED: Fourth boy dies following murder-suicide in Paradise HillsRosario's mother, Gloria Collins, said the night was meant to be a celebration for her daughter and grandchildren. Collins says her daughter was brave and beautiful and she finds comfort in knowing she's in a better place. Roughly 400 people filled the church in Paradise Hills for the memorial. Pictures and flowers filled the front of the room. The service included prayer, singing and stories of Rosario and the boys. Rosario had been granted a restraining order from her estranged husband just hours before she was killed, but that order was never served. 947
SAN DIEGO (KGTV) - Hundreds are getting tested for coronavirus before Thanksgiving hoping to keep their family safe. Medical experts say it's not necessarily going to work.The lines were hours long in front of a Linda Vista testing site, just as long at sites around the county Sunday."There's a worrisome reason for that, people are planning to go visit their older relatives and they think they're going to be 100% safe," Dr. Davey Smith, Chief of Infectious Diseases at UC San Diego said getting tested Sunday or any day leading up to Thanksgiving could give you a false negative."If I get tested now, it doesn't mean that I'm not infected, it just means that I'm not actively shedding the virus," Smith said.According to the CDC the incubation period for the virus is 2-14 days."I thought Halloween was going to be the scary part of the year but November, December, January are just going to be really tough I think. We've got Thanksgiving coming up, then we have Christmas coming up and then New Year's and everybody is tired of being on lock down, it breaks my heart," Dr. Smith said leaning back in his chair.Data shows after each holiday this year, we've seen a spike in cases.The CDC and Dr. Smith urge everyone to gather virtually, or in small groups outside, socially distance and wash your hands often.We all know 2020 has been the year of sacrifices and Dr. Smith feels it too, "I'm really grateful for my niece who I have not met yet, because of the pandemic, I am so excited, I get pictures every day, so I'm pretty happy."All of us hopeful next year we can all be with our loved ones."If we can just get through the winter, I promise these vaccines and treatments are really going to change everything and that just means there will be more of us to celebrate next year," Dr. Smith said. 1811
SAN DIEGO (KGTV) - Family members are offering a reward for information that leads to an arrest in the shooting death of Victor Vega.On May 28, 2016, San Diego Police officers responding to a shooting in the 8300 block of Brookhaven Road in the Skyline area found Vega lying on the street with gunshot wounds. Officers and medics began life-saving measures, but Vega died at the scene. 398
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