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SAN DIEGO (KGTV) — The Food and Drug Administration has released new guidelines to vaccine makers with added safety measures that experts say will push back the timeline, making the release of a COVID-19 vaccine before the election highly unlikely.The guidelines lay out what it will take for companies to secure a fast-tracked authorization for a vaccine, known as an emergency use authorization or EUA.The new guidelines require vaccine makers to follow the volunteers in their clinical trials for a median of two months after their final dose.It’s an important step to see if anyone has a bad reaction, says Dr. Christian Ramers of Family Health Centers of San Diego.“Some of the safety issues that people like me are concerned about might take months actually to develop,” Dr. Ramers said. “My analysis of this is that it's the FDA standing up and saying, ‘We're going to adhere to our rigorous scientific process.’”The White House had resisted the new guidelines from the FDA for more than two weeks. After their release, President Trump described them as a “political hit job.”“New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!” the president wrote on Twitter Tuesday night.It’s hard to gauge exactly how the two-month buffer affect the vaccine timeline because clinical trials do not start all at once; volunteers are enrolled on a rolling basis. But Dr. Sydney Wolfe of the consumer group Public Citizen said the drug makers have offered clues.“The companies one-by-one are saying, ‘We can’t get anything in until the end of November or the end of December or the beginning of January,’ and that’s a relief,” he said.In a clinical trial, half of the volunteers get the vaccine and half get a fake drug called a placebo.The updated guidelines require companies to have an estimated effectiveness of at least 50 percent, meaning there are 50 percent fewer cases of infection in the group receiving the vaccine compared to the placebo group.The guidelines also instruct companies to have a plan to continue collecting data in their clinical trial even after they get an EUA and the vaccine hits the market.“The worst thing that could happen here is something meets that minimum bar of 50% efficacy, meaning it works pretty well, but then the bottom just falls out from these clinical trials and we don't get the information we need,” he said.Dr. Ramers was initially skeptical of fast-tracking a vaccine with an EUA rather than waiting for full approval since it’s only been done once before, but he’s supportive of the process under the updated guidelines.“I think that's the best way to balance speed and safety,” he said.Still, experts like Dr. Wolfe think going with an EUA over a full approval could backfire. He points out the new guidelines allow up to half of the people in the clinical trial to be tracked for less than two months after their final dose.“All things aren’t equal [between an EUA and full approval] because you don’t have all the information and B, people know that,” he said.Dr. Wolfe is concerned the public will be reluctant to roll up their sleeves and embrace the vaccine if it just has an emergency authorization. Now that the FDA has made the EUA guidelines more rigorous, he thinks waiting for full approval might take just a few more months.The FDA’s new guidance notes that an Oct. 22 meeting of its Vaccines and Related Biological Products Advisory Committee will not be to discuss specific vaccine candidates.Trump previously said he would consider overruling the FDA on its vaccine guidelines in hopes of speeding up the process. There is both health and economic pressure for a vaccine to be developed as the coronavirus continues to claim an average of 800 US lives a day, according to Johns Hopkins University data.However, Dr. Wolfe said the possibility of the president overruling the FDA is unlikely to have an impact now because the vaccine developers themselves have indicated they will follow the FDA guidelines.Additional reporting by Justin Boggs 4090

SAN DIEGO (KGTV) - The City of San Diego is rolling out the second phase of the polystyrene foam and single-use plastics ordinance as the Memorial Day weekend kicks off. Starting May 24, a ban on the sale and distribution of egg cartons, food service ware and food trays made from polystyrene foam begins. The ban includes bowls, plates, trays, cups, lids and other similar items designed for single-use. According to the city, polystyrene foam doesn’t biodegrade and can be mistaken for food by marine life and other animals. Acceptable alternatives include recyclable plastic, aluminum and recyclable paper products, the city says. Some businesses that make less than 0,000 are exempt until 2020. “The City’s goal is to achieve zero waste by 2040,” said the City’s Environmental Services Department Director, Mario X. Sierra. “This ordinance not only helps in achieving that goal, but also improves water quality, reduces pollution and keeps our environment healthy.” 980

SAN DIEGO (KGTV) - Sweetwater Union High School District officials say their revised budget will not have a major impact on students, but some parents are getting notices from schools informing them of cuts to some afterschool programs, tutoring and summer school.The discovery of an accounting miscalculation over the summer led to a million budget shortfall that the district rushed to fix. On Oct. 8, the district’s board unanimously approved a revised and balanced 2018-19 budget. The San Diego County Office of Education has until Nov. 8 to approve it.Changes to the budget include furlough days for numerous district employees, elimination of paid training days for teachers and cuts to the adult education program. Other cost-saving measures in the budget include energy conservation strategies and a reduction in travel expenses.RELATED: Sweetwater Union High School District passes revised budgetIn a statement, district officials said: “Throughout this budget challenge, we believe that we have remained pragmatic, honest, and transparent in our efforts. This process has also enabled us to implement new practices and protocols that will help prevent this situation in the future.”CLICK HERE TO READ REVISED BUDGETDistrict spokesman Manny Rubio said the revisions would not have an impact on district students. He also said schools in the district would not see major changes or reductions in staffing or programs.“There will be no major changes, and student impact will be minimized as we go forward with the plan,” Rubio told 10News.However, last week, officials at Rancho Del Rey Middle School sent a letter to families informing them of “cutbacks that may affect some parents as they plan for their students outside of school activities.”In the letter, Rancho Del Rey officials said a tutoring program at the school would no longer be offered “due to a district-wide budget shortfall.” The letter went on to say summer school in June 2019 would not be offered. 1987

SAN DIEGO (KGTV) - The brand new Continental Apartment complex in Little Italy isn't like its upscale neighbors.It's made up of studios, some smaller than 400 square feet, and offers very little parking. That's why the starting rent is "just" ,550 a month, about 35 percent below market for the trendy area. "The rent is high in San Diego because of simple math - supply and demand," said Jonathan Segal, the architect who designed The Continental.Segal says costly approval delays and fees are contributing to that very supply crunch. The Continental, no exception, was delayed for two years. Segal says he paid almost million in fees for the building. But he's specifically perplexed by how the city charges what are called Developer Impact Fees. The money goes to uses like parks, fire, library and transportation.The city charges as much as ,000 per unit, depending on location, not size. That's why the city fee on developers could be disproportionately impacting rent prices for smaller units. In other words, if a developer takes a building and creates 40 apartments, that developer would have to pay that fee 40 times. Alternatively, if that same developers takes that same building and does just one large unit, that developer only pays the fee once. Now, there's a growing push at City Hall to change how the city calculates the impact fee. This week, a city council committee held a preliminary discussion on the fee's future. One option, endorsed by City Councilman Scott Sherman, is to do it by square foot. That way, building more, smaller units won't increase costs on developers - and ultimately renters or buyers. "If you were to do it by a square foot process, then a developer would come in and say, 'you know what? I can build two units at 0,000, instead of one at 0,000,'" Sherman said. A 2016 report from the housing commission said flat fees create a disincentive for developers to create more, smaller units that could help ease the housing crunch. Segal says changing how the fee is calculated could give him more latitude to offer lower rents. "I may be able to reduce my rent because I want to be more aggressive," he said. Segal paid about ,500 per unit in developer impact fees for the Continental, totaling 0,000 to the city. The developer impact fees range from ,500 in San Pasqual to more than ,000 in Tierrasanta. 2378

SAN DIEGO (KGTV) - Summer vacation. A time for kids to cut loose and enjoy weeks of freedom. And as studies have shown, to forget chunks of what they learned the year before. Even shorter breaks can erase some lessons.A special program at San Diego Unified is helping keep kids stay sharp and excited about learning all year round, even during breaks. It's about making learning a fun, family affair.In a classroom at Rosa Parks Elementary School in City Heights, 7-year-old students Melody and Isabella are getting some one-on-one attention with their lessons. The teachers in this case are Melody's grandmother and Isabella's mom."Everyday they have to read. Everyday they have homework to do," said Anna Gonzalez. She and Maria Theresa Jaume are among a growing number of parents and guardians getting more involved with their kid's education through the "Family Engagement Department" at San Diego Unified."So, I now know how to ask her questions," says Gonzalez, "How to engage her with the reading and things like that.""It solidifies the bond right," says Family Engagement Program manager Pamela King, "It shows kids that education is important." King says the program was established in 2016, inviting families to become partners in their kid's education with tips on how to do it."You're reading a fiction book. You're learning about the characters but what are characters thinking? What's motivating the character? So, going a little deeper."Organizers say it's about connecting with a child's curious nature. Making reading as fun as playtime, or as close as possible.You can find out more about the family engagement program here. 1651