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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) — For many San Diego children, having a bed is a luxury. Instead, they sleep on couches, with siblings, or even the floor.When 13-year-old Lilia Montiel learned about the problem, she wanted to help fix it. Montiel's dad is a speech and language pathologist who works at several schools, including Empower Charter School. While working there one day, he learned his student had suffered rat bites due to sleeping on the floor.“That really struck a chord in my heart and made me really sad," remembers Lilia. "I thought of a way I could maybe fix that problem and do it for a few different families.”She started ZZZs 4 Kidz and is now raising money to provide 1,000 beds to San Diego kids in need.On Wednesday Lilia got some help from Jerome's Furniture, which donated ten bunk and twin beds with mattresses.“Even though you're small or young, you don’t have to be big or an adult to make a difference in someone’s life," said Lilia.To donate to ZZZs 4 Kidz, click here. 1004

SAN DIEGO (KGTV) — For several months, San Diegans were invited to weigh in on the Port Master Plan proposal. It's the Port of San Diego's first comprehensive update in nearly 40 years, aiming to reflect changes in the needs and priorities of the region. The Port manages 34 miles of San Diego Bay and Waterfront along Chula Vista, Coronado, Imperial Beach, National City, and San Diego. When the Port published the proposed master plan in April, several communities voiced major concerns; two of the most vocal being Coronado and Point Loma residents. "We have this little slice of history, and I think it's our obligation to preserve, so it's enjoyed generations to come," said Cameron Lilley, a multi-generational Point Loma native.For months, Lilley has been garnering community support in opposition to some of the proposals impacting Shelter Island. "We started digging into it and quickly realized that there were so many points that really didn't consider the locals in the restructure of our community," said Lilley. Some of their primary concerns:Up to 1600 new hotel rooms70,000 square feet of retail and restaurant spaceRemoving private and historic docksThe Port received nearly 3,000 comment letters in response to its initial proposal. On Monday Port commissioners listened to public comment and made recommendations to staff.Direction to staff for the Shelter Island Planning District:No new hotel rooms on Shelter Island, move them to Harbor Island 30-foot height limit, consistent with City of San Diego height limitKeep Marlin Club at current location La Playa Piers - keep piers the way they are; open to the public with gangways and floating docks to remain privateLa Playa Yacht Club - no perimeter walkway, pursue other methods to provide public access to the areaScott Street - no reconfigurationAdd clarifying language:While it was never the Port’s intent to build a restroom on the La Playa Trail or at the trailhead, add language to clarify that no restrooms will be built Clarify the Port’s intent for the La Playa Trail to maintain it in its natural stateClarify the Port’s intent to maintain and protect current maritime usesPort staff will bring a revised proposal back to the table in six months, giving the public another opportunity to weigh in. 2289

SAN DIEGO (KGTV) - For decades Veterans Village of San Diego has been committed to serving homeless veterans, aiding in transitional housing and rehabilitation. In recent years, however, they've been struggling to fill vacant beds."Over the last several years, we've just seen a change in the environment. There's a lot of resources here in San Diego for homeless veterans. The number of veterans who've wanted to come through our programs has decreased," said Kim Mitchell, President and CEO of Veterans Village. "Some just aren't ready, as you know there's are a lot of homeless here in San Diego, not only veterans but non-veterans, people are in various stages of where they are in life."Now the nonprofit hopes to welcome non-veterans into two of their programs: County-funded Drug Medi-Cal and the transitional housing program. "There is a lot of people that want to get off the street and want to go through a program to get clean and sober, and so if we have beds in this program that can help them do that we want to do that," said Mitchell.Mitchell says they have full support from the Housing Commission and the U.S. Department of Veteran Affairs.Leaders will ask City Council on Tuesday to approve the request. If approved, the nonprofit could serve non-veterans within weeks. 1297

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