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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) — Every Thursday afternoon in Logan Heights, people line up to get food.Angela Brannon-Baptiste is the woman who started the pantry and the organization that supplies it, called "It's All About the Kids".The non-profit has been serving local families since 2004, handing out more than 1.5 million meals and counting."They tell us that for many of them this is the only food they're receiving because there's just no money to buy food," said Baptiste.When the pandemic hit the group saw the need grow almost overnight."We saw hundreds of additional families come to see us each week and it was a bit frightening," Baptiste explained.Although they'd like to help everyone, they're restricted by their own means.Unlike some other food distribution programs that operate on a first come first serve basis, It's All About the Kids takes a more targeted approach."We decided we needed to narrow that down and really work with the schools to identify who was most in need, so that's who we help now," Baptiste said.At this point, that help is going to about 2,200 families currently on the program.Those who show up get boxes of not just something to eat, but something good to eat.Batiste says it's important they provide as much fresh food as possible, " I think that food is so important and that is our responsibility as successful adults to give back to those that are less fortunate and to help them, so that's just always been my mantra." 1463

SAN DIEGO (KGTV) — Hundreds of homeless individuals remain evacuated at SDCCU Stadium after heavy rains flooded an East Village shelter this week, forcing them to leave.Flooding Thursday night overturned portable restroom facilities at the Alpha Project facility, turning the ground into a swamp of feces and human waste and inundating tents meant to house the homeless from the storm.Saturday, those evacuated remained at the Mission Valley stadium. Mayor Kevin Faulconer planned to visit the stadium to meet with those evacuated.RELATED: Hundreds of homeless evacuated as rain floods downtown San Diego shelterHomeless individuals at the stadium were given food and a clean place to sleep, but Red Cross organizers say they need new clothing, blankets, and socks to help replace what was lost. Donations can be brought to SDCCU Stadium's Gate C.Hazmat crews still have to clean up the downtown site as of Saturday. There is no timeline on when the downtown shelter will be reopened or how long the emergency shelter would be in place. 1044

SAN DIEGO (KGTV) -- For over a decade, SDSU associate professor of chemistry Gregory Holland has been researching spiders and particularly black widow’s silk.They’ve come to the realization, through their research, that the properties of black widow silk are stronger than steel and tougher than the Kevlar in bulletproof vests.Gregory Holland, SDSU associate professor of analytical chemistry and Northwestern chemistry professor Nathan Gianneschi said their collaboration shows the organization of the molecules involved in silk production is more complex than previously thought.There are companies that use synthetic spider silk but its the specific black widow spider silk that has the top tier benefits.“The synthetic spider silk its not a bad material, its just not as good as the real thing," Holland said.Holland says the company that creates synthetic silk actually has partnerships with Adidas and Patagonia. "The most important thing is a spider does it low energy, environmentally friendly. It’s just protein water and salt”.Once they reach the point where they’re able to identically replicate the silk of a black widow spider, the artificial version could be used in building materials for bridges or environmentally friendly replacements for plastic.Black widows (Latrodectus hesperus) spin a lightweight thread much stronger than that of other spider species, with draglines that can stretch an extra 25 percent of their length before snapping.The composition of the spun silk fibers was previously identified, but the structure of the proteins involved in producing them has been more of a mystery, now one step closer. 1650

SAN DIEGO (KGTV) -- Dr. Scott Overcash and the staff at La Mesa-based laboratory eStudySite are preparing for what could be a history-making clinical study."I'm personally really excited about being in the effort to try to prevent people from getting the disease," said Overcash.In just days, Overcash will soon be overseeing a first-of-its-kind trial of a coronavirus vaccine created by the American biotech company Moderna.Starting as early as next week, the first of 350-500 local patients will begin receiving the vaccine.The same one has already been given to patients in phases one and two of the trial. This is the next and possibly final step before FDA approval."What's a little bit different about this particular situation is that the different phases have all been sort of compressed and are all ongoing at the same time," Overcash explained.Overall, 30,000 people around the country are expected to take part in this larger study.Unlike earlier phases, this round is targeting a more vulnerable part of the population.The patients taking part will belong to one of three groups: older than 65, younger but with underlying conditions or those at high risk of catching the virus because of their job.Moderna's vaccine uses what's called messenger RNA to trick the body's cells into producing the antibodies necessary to fight the virus.So far, this particular vaccine has shown promise, but only time will tell"There are multiple candidate vaccines that are going to be rolling out and we're just so hopeful that at least one will be effective enough to be rolled out for use," said Overcash.To learn how to participate in a clinical trial, visit https://coronaviruspreventionnetwork.org/. 1708

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