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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) - Do you know how to survive a rip current? The common occurrence at San Diego beaches accounts for 80 percent of all rescues, the U.S. Lifesaving Association reports. Rip currents are currents of water that flow out from shore, potentially pulling swimmers and surfers away from land, according to the National Oceanic and Atmospheric Administration. 63 people in California died in rip currents between 1999 and 2013, second only to Florida in fatalities. You can greatly increase your chances of survival by swimming at a beach with lifeguards, the USLA says. The odds of drowning while swimming at a USLA-affiliated lifeguard protected beach is 1 in 18 million, the group claims.Anyone in the water - or thinking about getting into the water - should look for a gap of seemingly calm water between areas of breaking waves, a difference in water color, or a line of foam or debris moving out to sea. What to do if you’re caught in a rip current:*Don’t try to swim against the current*Swim parallel to the shoreline before trying to head back in to the beach*Float or tread water if the current circulates back toward the shore*If you can’t make it back to shore, yell and wave for helpLifeguards also encourage you to call 911 or get help from a professional. Many people have died trying to rescue rip current victims, NOAA experts say.Need more information? NOAA has an online training program called Break the Grip of the Rip. 1457
SAN DIEGO (KGTV) -- During this COVID-19 pandemic, many unsung heroes have stepped up to offer assistance in this critical time of need. And that includes a local pilot, who helping those workers, that help him to get off the ground. Anthony Oshinuga became interested in becoming a pilot when he was 5-years old, and now he's a veteran of the air. Anthony's need for speed and adrenaline led him to racing and performing aerobatics. But he calls his latest piloting adventure, his most rewarding. Flying his own biplane, he traveled across in the country for a campaign he calls, "Reach for the sky...we've got the ground"."Essentially, what that means, is for the support crew that is on the ground at each airport we visited. We delivered a COVID-19 relief package that had face masks, hand sanitizer, and then we gave them a mug to say thank you. We appreciate what you are doing."It was quite a trip for the Valley Center resident, as his flight included 44 stops in 22 locations."My sponsor, Epic Fuel,s, put together this campaign that covered six thousand nautical miles, in my biplane, traveling about 160 miles per hour, " says Anthony. His trip was about giving thanks to airport employees."We have people at the airport, like the guys who fuel the trucks, and those workers who greet people coming off private jets. There are interactions and contact with these people all the time, and we don't think about that."And along his journey, he was able to visit with young kids, and maybe inspire them to become pilots one day. "There were a few stops along the way where people got word of me stopping in. A bunch of kids came out that were S.T.E.M motivated. They were students going through the engineering program, and I got the opportunity to meet them and speak to them, and just to inspire them."It was definitely a trip of a lifetime."Flown six thousand miles with that message, and making it out pretty good right." 1942
SAN DIEGO (KGTV) – Homicide detectives are investigating after a man died in Hillcrest early Sunday morning. According to Lieutenant Anthony Dupree, a passerby was walking near Albert Street and Upas Street around 5:30 a.m. when he saw a man with trauma to his body and called police. The passerby performed life-saving efforts on the man before paramedics arrived, but the man was pronounced dead at the scene, Dupree said. According to police, the man was between the ages of 25 and 30, but his identity is unknown at this time. Dupree said detectives are going door-to-door in the area to find out if anyone heard anything. 635
SAN DIEGO (KGTV) -- Fernando Tatis Jr.’s strong start to the 2020 MLB season has earned him an award for National League Player of the Week.The San Diego Padres’ young shortstop garnered his first career NL POTW award, and he is the first Padre to earn the award since Manuel Margot in July 2017.Tatis Jr. is the first Padres infielder to earn Player of the Week honors since Chase Headley in August 2011.Over the last six games, Tatis Jr. has slugged six homers, drove in nine runs, scored seven runs, and is batting .435.Tatis Jr. leads the Padres with eight home runs; his 8 HRs are tied with New York Yankees slugger Aaron Judge for most in the majors entering Aug. 10 play.On Aug. 8, Tatis hit two home runs against the Arizona Diamondbacks.In addition to the POTW award, the 21-year-old is the subject of an in-depth ESPN profile titled "Bringing joy back to baseball." 883