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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) — Gusty offshore winds and high temperatures will work their way back into San Diego County this week.San Diego Fire-Rescue is expected to beef of staffing Sunday through Monday in anticipation of the Santa Ana wind event forecasted to start Sunday night.Sunday, winds will turn offshore and become gusty along coastal slopes, according to the National Weather Service. High pressure will add to the warming, increasing the risk for wildfires.NWS forecasts a high of 76 degrees and low of 58 degrees, Sunday.WEATHER: Check updated conditions across San Diego County Those temps rise Monday, with a forecasted high of 85 degrees and low 62 degrees. Monday will see winds shift east, as winds shifts through the coastal slopes and into San Diego County mountains and foothills. Wind speeds may sit at 15-25 mph, with gusts up to 30-40 mph. Humidity levels will hover near 10%, elevating the fire danger.Breezy conditions are expected to continue into Tuesday morning, before weakening that afternoon. Low humidity and warm temperatures, with periods of easterly winds, will be common throughout the week, NWS says. 1138
SAN DIEGO (KGTV) — Four San Diego businesses, including two restaurants and two gyms, have filed a lawsuit seeking an emergency injunction to stop the latest shutdown orders.Under the red tier, both sectors were open for indoor operations as limited capacities. Restaurants were allowed to serve people inside at 25 percent of the normal capacity, and gyms at only 10%.On Saturday, purple tier restrictions will go into effect, meaning businesses like restaurants and gyms must shutdown indoor services completely and move outside.Cowboy Star Restaurant & Butcher Shop, Home & Away Encinitas, Fit Athletic Club, and Bear Republic filed the lawsuit against California Gov. Gavin Newson and the County of San Diego, as well as other state and county officials arguing that the closures go against their rights.The lawsuit states that Newsom and the California Department of Public Health (CDPH) lack the authority to impose the continuing restrictions on California businesses.All four businesses detail the numerous health and safety measures they’ve added to provide a safe environment for staff and customers during this pandemic.“I think it’s pretty clear that the law is on the side of governmental authority to try to get this under control,” said Jan Ronis, an attorney with the Law Offices of Ronis & Ronis. “Why they continue to file lawsuits… it’s beyond me.”Ronis is not involved in this case, but said when the pandemic began, he reviewed emergency legislation available to the government at both state and federal levels.“These laws have been in the book for decades, and governments have used them sparingly, and quite frankly think they’re valid as surprised as I was by the breadth and scope of government authority once these emergency declarations are declared,” said Ronis.He said he had seen similar lawsuits filed across the state during the last several months, and most don’t hold up in court.“I really feel sorry for the businesses, but the fact is this is a monumental health crisis,” said Ronis.Dr. Wilma Wooten, San Diego County’s public health officer, recently asked for the CDPH to allow the county to stay in the red tier. She explained that businesses that would be impacted the most by purple tier restrictions, like restaurants and gyms, are not the cause for the local increase in COVID-19 cases.The lawsuit said despite the data provided by Dr. Wooten, the CDPH still denied the request without any justification based on science or data.Both the law firm that filed the lawsuit and the County of San Diego refused to comment on this matter, stating they do not comment on pending litigation. 2646
SAN DIEGO (KGTV) - Homeowners in La Mesa are being warned their houses could be at risk of a destructive pest: Formosan subterranean termites.San Diego-based company Thrasher Termite & Pest Control made the unfortunate discovery this month in a La Mesa home."Unlike native subterranean termites, the termites we observed were extremely active, didn't flee when disturbed, and the soldiers went into attack mode. They had hollowed out large areas of structural wood, always staying just beneath the exterior paint and unnoticed by the homeowner," said Garrett Thrasher.They're deemed "super-termites" due to enormous colonies up to two million strong. The pests can cause significant structural damage within six months unlike traditional dry-wood termites, which take 10-15 years to do similar damage.RELATED: Heat and humidity creating perfect conditions for bugsThe invasive species of termites was first discovered in La Mesa in 1992. Efforts to eradicate the population were thought to be successful, but pest control experts say that's no longer the case. Years after the discovery, monitoring efforts eventually stopped due to a lack of funding."They can't fly very far, but there's so many of them that they've continued to survive since the last sighting," said Thrasher.About 60 homeowners have received letters from San Diego County officials warning of potential risk.Thrasher says it's hard to say how large the problem is but he believes the pests have a strong foothold in the area.According to the University of California Agriculture and Natural Resources, the 1992 Formosan subterranean termite infestation was estimated to be about ten years old. This age corresponds to a time that a family living at the epicenter of the affected area brought wood and potted plants with them when they moved to La Mesa from Hawaii. Formosan subterranean termite is common in Hawaii; the species was misidentified for several years after its introduction in San Diego.RELATED: San Diegans report increase in mosquitoes during heat waveAs with virtually all species of termites, researchers say the hidden nature of young Formosan colonies make them especially difficult to detect and identify. Damage by young colonies is often localized and may go unnoticed for years.HOW CAN YOU TELL IF YOU HAVE FORMOSAN TERMITES?Check for what may look like paint chips around your windows or any wood area of your home. These may be hollowed-out areas created by termites.You can also check trees on your property for any obvious signs of termite; wood often appears to have been eaten away along the grain pattern.Another red flag is seeing swarmers; this is how they reproduce.WHAT CAN YOU DO IF YOU HAVE AN INFESTATION?Calling a pest control company is the first step. A professional will need to treat your home and create a chemical barrier. 2860
SAN DIEGO (KGTV) - For the first April 20 in California, marijuana use is legal in the state.California’s new recreational marijuana laws took effect Jan. 1, 2018, as the passage of Proposition 64 in November 2016 opened up the state to regulate cannabis. For local users, however, it's not a matter of simply heading outside and smoking freely.Several state laws are in place to make sure smokers celebrate "4/20' legally - and safely - will be in effect Friday. Here's what they need to know:RELATED: 536