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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) — For the first time in 40 days, San Diego County has fallen below the state's County Monitoring List threshold for coronavirus case rate.San Diego County was placed on the list on July 3 after it crossed the state metric of 100 cases per 100,000 people over 14 days. Wednesday, the county reported a case rate of 94.1.The county will have to remain off the watch list for another three days to get off California's watch list and an additional 14 days in order for local schools grades 7th through 12th can return to in-person instruction.No other businesses are slated to be allowed to reopen after that 17-day window unless the state provides more guidance for business reopenings, according to the county.San Diego County reported 236 new COVID-19 cases on Wednesday, a 3% positive rate out of 7,339 reported tests. Six new deaths were also reported, including five women and one man who died between July 28 and Aug. 11. All of the victims had underlying conditions, county officials said.The county also reported two new community outbreaks, one in a grocery setting and one in a manufacturing setting.While the county's case rate has fallen, it continues to be high above its community outbreak threshold of seven in seven days. Currently, the county has 26 community outbreaks in a week. A community outbreak is three or more coronavirus cases in the same setting in people of different households in the past two weeks.Supervisor Nathan Fletcher said of the drop in the county's case rate: "San Diegans should be proud of the progress we have made, but we have to recognize the goal is not just to get our cases down, it is to keep them down. We’ve seen progress because of a renewed focus and vigilance, and we need that same focus going forward." 1782
SAN DIEGO (KGTV) -- For students in the 3D printing club at Westview High in Poway whose goal was never to hit the 'print' button, they've come a long way."It feels really amazing to know the 3D printing club is helping those who are in need."Victor Ku is president for Westview High's 3D printing club that started up this past year.When the club started, their mission was purely educational. They wanted to create a curriculum and teach people the basics of 3D printing because they didn't have the money to actually print anything."It can be very expensive and super confusing at first which is why we believe all these limitations shouldn’t restrict one from getting the opportunity to learn its such an amazing tool."Then when March came around, Victor said "we were back to square one. We didn’t really know what to do and we realized we need to quickly pivot towards the communities needs and in this case it was face shields or personal protective equipment."That's when the team of young and aspiring engineers got to work and finally hit 'print'."We took a small break and waited for all the design and the actual professional engineers to perfect the design before we started mass producing these face shields," Victor said.They've donated about 400 face shields to five different organizations, and are some of the youngest people to make a difference."We’ve distributed them to hospitals, hair salons and post offices to name a few. That little bit could definitely help save any lives."With things easing up, Victor said they want to widen their distribution list. They're also accepting donations to help buy supplies to create more face shields. 1671
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 of veterans who bravely served our country reunited this week in San Diego.It was the first Midway Class Reunion, also known as the Three Sisters Reunion.Veterans who served on the USS Midway, USS Coral Sea, and USS Franklin D. Roosevelt were invited to attend. In addition to touring the ship veterans were able to look at commemorative books from their deployments. “They get to meet others, they get to swap sea stories as we say in the Navy, get to swap sea stories with their friends and anyone willing to listen!” said a USS Midway Museum volunteer. Organizers say they hope to do another reunion in the future. 654