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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 leader of a San Diego motorcycle gang pleaded guilty Tuesday to participating in a scheme to seal dozens of Jeep Wranglers in San Diego County. Jimmy Josue Martinez, a leader of the Hooligans motorcycle gang, pleaded guilty Tuesday, admitting to participating in the scheme. According to court records, the gang is responsible for the theft of more than 150 of the vehicles since 2014, totaling about .5 million. Records show that the Hooligans used high-tech methods to disable security systems and steal the Jeeps before taking them to Tijuana to be sold or stripped for parts. RELATED: Three arrested, 6 sought in San Diego Jeep Wrangler theft ringAs part of the plea agreement, Martinez admitted to stealing the Jeeps in Pacific Beach, Serra Mesa, Chula Vista, Mission Valley, Ocean Beach, Hillcrest and North Park. Martinez and members of his crew would obtain the vehicle identification number in advance before getting secret key codes which allowed them to create a duplicate key for a particular Jeep. “The joy ride is over for Mr. Martinez,” said U.S. Attorney Robert Brewer. “These thefts were audacious and sophisticated and created hassle and heartache for scores of Jeep owners. I congratulate prosecutors Andrew Galvin and Joseph S. Green, the FBI and members of the Regional Auto Theft Task Force for putting together a strong case against a gang that, unfortunately, has lived up to its name.”Along with Martinez, eight other members of the gang were charged in a grand jury indictment in 2017. Of the nine charged, six have pleaded guilty and three are fugitives. 1616

SAN DIEGO (KGTV) -- The COVID-19 pandemic has brought uncertainty to school districts across the state. With health conditions changing daily, so does the look of your child's education in the fall.This week an announcement of 100% distance learning from the state's two largest school districts sent some parents into an immediate panic."I was very taken aback," said San Diego mom Leona Smith.How long will classes be virtual? At this point, there's not a clear-cut answer. Parents are left with a lot of questions about how virtual and hybrid programs will impact their kids' education and their family."What are the resources going to be? How is it going to be laid out? What is the time spent? Is it going to be more structured through the distance learning than I felt it had been?" Smith said.Los Angeles Unified and San Diego Unified school districts made their course public, while other districts are still determining what the first day of school will look like, and some already have students back on campus.Statewide, there is no one-size-fits-all answer, but there are requirements districts need to follow."Most parents don't know there is a minutes requirement for each day," said Kevin Gordon with Capitol Advisors Group. "There's actually an annual minutes requirement that we have to hit for kids, and then there's actually a minimum number of days per year that we have to hit – 180 days, generally, and 180 minutes, generally."Gordon said a school day requires a minimum of 180 minutes or three hours of education at lower grade levels and 240 minutes or four hours for high school students.Gordon said those are minimum time standards and most districts exceed that.Reporter Adam Racusin asked him about class sizes."While they are lower than they used to be, they aren't the 20 to 1 that we would like them to be. And in all the upper grades they are absolutely exceeding 30 to 1 in most California classrooms," Gordon said.Imagine the challenge for districts that are bringing students back onto campus while following social distancing guidelines."It's not about cutting class sizes in half, it's like cutting class sizes into thirds," Gordon said.Another area of concern surrounds students who may need more support and instruction than they can get through typical distance learning.In California, once a child is found eligible for special education, the family will participate in the process by attending an individualized education program or IEP. It's both a process and a written document."It becomes almost like a contract and it says here's what the school district is going to do for the student" said special education attorney Timothy Adams."Parents really need the school district to help them, especially in circumstances where the student has really complex needs and requires a variety of in-person, therapeutic services that are delivered usually through their IEP. We need the school districts to implement those services," he explained.Many parents will have to wait for answers, while districts work to make plans flexible enough to adapt to changing community conditions.We reached out to the California Department of Education about guidance for districts regarding hours of learning a day, class sizes, and special education and did not hear back. 3304

SAN DIEGO (KGTV) -- Sunday is expected to be the busiest travel day of the Thanksgiving holiday weekend, but it will still be light in comparison to holiday travel before the pandemic. Four million Southern Californians were expected to travel over Thanksgiving, despite warnings against travel because of the pandemic. The CDC advised people not to travel, asking them to stay home, to avoid further spread of COVID-19. Doctors worry about the effects of this weekend's travel will be seen in a few weeks from now, with a surge of cases. RELATED: Fauci: US may see 'surge upon surge' of virus in weeks aheadThroughout the weekend, the San Diego International Airport remained relatively empty, there were no long lines for pick-up or drop-off of passengers, and the lines for flight check-ins were only a few people long.If you are traveling, health officials recommend following all health guidelines currently in place, like wearing a mask at all times and social distancing. 987

SAN DIEGO (KGTV) - The Medical Board of California (MBC) has filed an order to revoke the license of Dr. Jeffrey Lovin, a San Diego County radiologist who’s facing charges related to prowling and peeking.ABC 10News first reported on Dr. Lovin last year after his ex-girlfriend shared home security video of a man lurking in her North County backyard while she and her fiancé were inside. She said the man in the video is Dr. Lovin.He’s been charged with multiple counts related to prowling and peeking and violating a protective order. He’s pleaded not guilty and will stand trial next March.Dr. Lovin was already on probation with the MBC for other criminal activity.The Board has now issued an order to revoke his license on Dec. 18 for mental or physical impairment and unprofessional conduct by failing to comply with the terms of his probation.“We never know if we're safe,” his ex-girlfriend told ABC 10News on Tuesday. We’re not using her name or showing her face. She said that she and her fiancé Frank Zeigler still live in fear. “I hear any noise at night and I'm out front seeing what's going on at my home,” he said and added, “We lock all our doors and keep all our blinds closed around the clock.”“We want him to lose his license so he doesn’t do this to anybody else and we feel like this is the first step toward a little justice,” Zeigler later added.On Tuesday, ABC 10News spoke to someone at the law office that has represented Dr. Lovin. She declined to connect us to with him to see if he wanted to offer any comment.On Tuesday, a spokesperson for the Board wrote to ABC 10News, “Dr. Jeffrey Lovin may practice medicine under the terms of his current probation until the revocation of his license takes effect on Dec. 18, 2020. Dr. Lovin may petition the Board for a stay and reconsideration of the decision to revoke his license or file a writ in superior court to challenge the decision before it comes effective.” 1945