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SAN DIEGO (KGTV) -- Residents in an Allied Gardens neighborhood say they woke up to guns drawn and shouts from FBI agents."I literally have goosebumps right now. It's sad," said Shiva Eftekhari.Around 6 a.m., agents executed a search warrant at a home in the 7100 block of Glenroy Street.  Throughout the morning and into the afternoon, agents collected bags and bags of evidence, including a computer. At one point, they were spotted trying to hammer open a safe in the driveway. 498

SAN DIEGO (KGTV) — Regulators at the Food and Drug Administration said they found no red flags that would stand in the way of authorizing Pfizer’s COVID-19 vaccine on an emergency basis.FDA scientists independently confirmed Pfizer’s claim that its vaccine is 95 percent effective after two doses and said they found no serious safety concerns, according to documents released Tuesday.The FDA released the 53-page review ahead of a meeting this week by an outside group of vaccine experts that will advise the agency and vote on whether to recommend an emergency use authorization for the drug in people 16 and older. A San Diego doctor will be among the 30 voting members.Government regulators examined the vaccine’s efficacy in subgroups and found it remained highly effective regardless of age, gender, race and risk factors. The vaccine scored 91 percent or better in nearly every way the agency sliced the data.“The news is really outstandingly good in terms of efficacy,” said Dr. Christian Ramers of Family Health Centers of San Diego. “It’s kind of almost a dream come true to have something that's 90 percent efficacious. If you recall, the FDA was shooting for better than 50 percent.”Among adults who were aged 65 or older and obese, one of the highest risk groups for severe COVID-19, the vaccine was 100 percent effective. That means no one who got the vaccine got sick, only volunteers in the placebo arm who got salt water.Dr. Peter Chin-Hong, an infectious disease expert at UC San Francisco, noted that most influenza vaccines are between 40 and 60 percent effective. “So getting 90 percent and above in some groups is just staggering,” he said.Pfizer’s vaccine is administered in two doses staggered three weeks apart. The FDA’s review began providing protection after 10 days, and just one dose reduced cases by 52 percent.That could spark discussion about how to allocate scarce doses in countries with limited access; however, Dr. Chin-Hong said there are too many unknowns to skip the second shot.“We don't know how long that protection would last,” he said. “Given the history and experience with other vaccines, we know that you get a more durable level of antibodies after a second shot.”The FDA also examined side effects in detail. Regulators found the majority of people who got the vaccine experienced some kind of mild to moderate side effect that resolved within a few days. A moderate side effect interferes with, but does not prevent, daily activity.According to the data, 84 percent of recipients had a reaction at the injection site, 63 percent felt fatigue, 55 percent had a headache, 38 percent experienced muscle pain, 32 percent had chills, 23 percent had joint pain and 14 percent had a fever.“These are things you expect from a vaccine. It actually means that it's working,” Dr. Ramers said. “That’s your immune system learning from that vaccine how to fight that bad virus.”Because of the mechanics of how Pfizer’s mRNA vaccine trains the body to build an immune response, there is no way the vaccine can cause COVID-19, he noted. The vaccine does not contain actual virus or viral particles.The FDA also looked for signs of any serious side effects in the trial of 44,000 volunteers. The agency noted there were four cases of temporary facial paralysis called Bell’s palsy in the vaccine group and none in the placebo group.Despite the apparent imbalance, the FDA scientists noted the numbers were so small the cases could have been caused by something other than the vaccine. In a large group of people, a certain number of cases of Bell’s palsy are expected to occur because the disorder can be caused by several pathogens.The number of cases in the vaccine group did not exceed what regulators call the background rate, meaning the number of cases that would be expected to occur in the general public.Bell’s palsy is temporary and treatable. Actress Angelina Jolie announced in 2017 she experienced a bout of Bell’s palsy and fully recovered. 3997

SAN DIEGO (KGTV) - San Diego cyber security expert Ted Harrington with Independent Security Evaluators invited us to his Downtown office to see how quickly and easily he and his colleagues demonstrate successful hacks of modern medical devices. Medical devices like pacemakers and patient monitors are some of the newest vulnerabilities to cyber attack in the healthcare industry.  The threat hits home. According to the California Life Sciences Association, the state has more medical device jobs that anywhere in the nation, with 74,000 employees. A total of 7,700 of them are based in San Diego.  San Diego is a city that's no stranger to malicious software or "malware" assaults on the medical sector. Last year, the 306-bed Alvarado Medical Center had its computer system affected by what it called a "malware disruption". The hospital briefly considered doing an on-camera interview with us about the security changes that have been implemented since the incident, but then it backed out.The hospital spokesperson cited in part, "A careless slip during an interview can reveal possible [vulnerabilities] in our 'armor' that a hacker can take advantage of." Also last year, nearby Hollywood Presbyterian Medical Center made headlines when it paid a ,000 ransom to the hacker who froze its computer system for several days."Healthcare is attacked more than any other industry because that's where the money is," writes prominent cybersecurity company Sophos in its SophosLabs 2018 Malware Forecast report. A records check on the U.S. Department of Health and Human Services' Office of Civil Rights website shows a total of thirteen California healthcare facilities that are currently under investigation for reported hacks.  Now, the threat to patient privacy could be challenged by a threat to patient safety. Harrington and his team connected my finger to a sensor that was attached to a patient monitor. My healthy vitals were displayed on the patient monitor screen and on the screen representing a nurse's computer. In a real-world setting, that nurse's computer would be in a different room from the patient and his or her monitor. 10News Reporter Jennifer Kastner was asked to remove my finger from the sensor, to make it look like she was flat-lining, but Harrington and his team hacked the nurse's computer in seconds to make the nurse's computer show that she was still healthy.He and his team also showed us they could hack a patient's displayed blood type."If the physician thinks the patient is a certain blood type and orders a transfusion of a different blood type, that directly hurts the patient. It would most likely result in a fatality," says Harrington. In October, the FBI put out a warning about the growing concern over cyber criminals targeting unsecured "Internet of Things (IoT)" devices, including medical devices like wireless heart monitors and insulin dispensers. Years ago, it was reported that former Vice President Dick Cheney had his pacemaker altered to prevent an assassination attempt. "We can't bury our heads in the sand anymore. These types of medical cybersecurity vulnerabilities are going to become commonplace," says Dr. Christian Dameff with UC San Diego Emergency Medicine. Dameff is also a self-described hacker. Despite the FDA's claim that there aren't any known cases of patients' devices getting hacked, Dameff believes attacks have happened and they were likely accidental, but never got reported."These devices in our systems are not well equipped to even discover these types of attacks," he said. "It's essentially like asking a toaster to figure out if your house has been hacked. They're just not designed to find out."The experts we spoke to want to make it clear that while there's a threat of cyber attacks on medical devices, the likelihood of it happening to the average patient is low. They urge people to stay mindful of the risks and talk to their healthcare providers about solutions.   4453

SAN DIEGO (KGTV) -- Residents in San Ysidro and Tijuana are fearful of what will come next after hundreds of migrants rushed the border Sunday in a show of force.Commuters told 10News they fear that they won’t be able to get across a bridge in San Ysidro to work or cross over to see family.In Mexico, residents say they’re fed up with the flood of migrants. “Deport them back to where they are, let them over here. They need to get out of Tijuana because it's just crazy for us,” said Candace Sanchez, a Tijuana resident.On the US side, those with family south of the border are concerned with what the future holds. “It worries me that the border might get closed. I mean it's like uh what's going on? We've never really seen this before,” said Victor Juarez.Employees who depend on their jobs in the US are also frightened. “Kinda scary because you know, I mean, every day we just know that we have to do what we have to do every day just to survive,” said Dana Aviles.Many people missed a day of work due to Sunday’s border closure, taking a toll with the holiday gift-giving season approaching. “I just hope they get out of here in Tijuana and let our lives be normal again, you know,” added Sanchez. 1213

SAN DIEGO (KGTV) -- San Diego local and federal law enforcement keeps finding huge, hidden pot farms being grown illegally on public lands. 10News Investigative Reporter Jennifer Kastner and Photojournalist Dave Pickering came to an undisclosed spot on Palomar Mountain for exclusive access to a high-risk operation, led by the Drug Enforcement Administration. Agents and officers say Mexican cartels are responsible for most of these remote grows. 456

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