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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 County health officials are focusing their efforts to reduce COVID-19 cases in hard-hit disadvantaged communities.Since the state released its tiered reopening system, County officials have closely monitored case rates and positivity rates, the two metrics that move counties between restrictive and less restrictive tiers.Now, the state has added a new metric relating to equity. It focuses on disadvantaged communities. The state looked at several factors that influence health in communities, including economics, education, transportation, social, neighborhood/environment, and housing conditions. The metric is meant to focus on those communities and their risk to COVID-19.At a news conference Wednesday, County officials say they are working to create a plan to address equity and submit to the state next Thursday. They also say the state will release additional guidelines on Monday.The county's health equity rate is at 6.2, which falls under the red tier. That number needs to drop below 5.2 to meet the orange tier criteria.San Diego County is currently already operating in the red tier based on the other two metrics. The county's positivity rate is at 3.5, Which meets the criteria for the orange tier. But the county's state calculated adjusted case rate is 6.5 new daily infections per 100-thousand people, which falls in the red tier. The red tier allows many businesses to reopen their indoor operations, though at a limited capacity.County officials said the new health equity metric does not play a factor in moving San Diego back into a restrictive tier. But it does play a role in moving to a less restrictive tier.County health officials have been working to reduce COVID-19 cases in disadvantaged communities through outreach and education, testing, and contact tracing, but feel more could be done."Undoubtedly, there's more we can do," Supervisor Nathan Fletcher said. "So even though we've done all of those things and continue to do those things, we will continue to search out more opportunities to address the inequity issues in trying to help those communities who are most impacted." 2153

SAN DIEGO (KGTV) -- San Diego County Fire is offering some residents key safe boxes that allow first responders to gain access to homes in emergency situations, County News Center reports.The boxes, called KnoxBoxes, are installed on or near the front door and can only be opened by local firefighters responding to life-threatening emergencies, the county says.County Supervisor Dianne Jacob says the program fulfills an urgent need.“For older folks with chronic health conditions or in need of help with basic activities, KnoxBoxes can be a lifesaver,” said Jacob. “These devices can also provide some peace of mind in a region where wildfire is a year-round threat.”County Fire received a federal grant to help purchase 200 boxes. The county plans to loan the boxes to residents in rural communities.So far, the county says it has received 70 applications. Over 25 boxes have been installed.County officials released a list of qualifications for those interested in participating in the program:Live in San Diego County Fire, Ramona Municipal Water District, or Deer Springs Fire Protection District coverage areas.Be any of the following:At least 62 years oldHave a disabilityNeed assistance with one or more Major Life ActivityAnyone interested in applying is asked to call San Diego County Fire at 858-974-5744 or email FireCRR@sdcounty.ca.gov.You can also click here to download an application or read more about the program. 1440
SAN DIEGO (KGTV) - San Diego County is nearing a move into the state's most restrictive tier of COVID-19 regulations.California launched a tier system in late August to measure COVID-19 risk within a county. San Diego County is now moving into the so-called purple tier, or widespread tier. Moving into that level would trigger stricter regulations, including the indoor closure of several businesses like restaurants and gyms.Some restaurant owners say if San Diego County moves into that tier and they are ordered to close their indoor dining areas, they will not follow the orders."We really want to push against it. There's no other way of making it nowadays," said Nick Kacha, the manager of Rudford's Restaurant in North Park.On Thursday, they put up a sign outside the restaurant that says, "Stand Up Small Business. #Defy""We're hoping other businesses will stand up with us and join the wave," Kacha said. He says nearly a dozen other businesses have said they will also stay open.Restaurant owner, Todd Brown, says he's still deciding what to do. He owns several restaurants, but the one is focused on is Bub's at the Beach in Pacific Beach. Brown says he is worried if they have to close again, they might close for good.Both businesses have followed the public health orders since the pandemic started. But for Brown, he says this time he is thinking it through."If we decide to stay open, it's not because we're trying to make a political statement. It's because we're trying to survive," he said. "You have the option of defying an order and staying open. How does that work? I have no idea, and it's not something I'm really interested in doing. But the other option is your doors are closed forever." 1724
SAN DIEGO (KGTV) — San Diego Police have released officer bodycam footage of a fatal shooting involving a man in Mountain View earlier this month.San Diego Police say 39-year-old Jose Alfredo Castro-Gutierrez was shot and killed after officers responded to the 300 block of South Pardee Street just before 5 a.m. on Oct. 19 over reports of a violent disturbance involving a weapon.According to police, Castro-Gutierrez was staying at a home as a guest when the residents were woken up by him. He had reportedly been acting paranoid and ripped a metal curtain rod from a window and began breaking windows and other objects in the home.Video shows Castro-Gutierrez crawl through a window in the front of the home and run toward police, before officers fired their weapons and fatally struck him. A metal pole was found near him.Three officers fired at Castro-Gutierrez: One officer fired a bean bag round, another officer fired a Taser, and a third officer fired several rounds from his service pistol, SDPD says.Officers started first aid at the scene, but Castro-Gutierrez was pronounced dead at the hospital. The officer who fired his service pistol was identified as Isai Castillo, a two-year veteran of SDPD assigned to Southeastern Division.Gene Iredale, the attorney who represents Castro’s family, says they are planning to file a wrongful death action. He says the lethal force was not warranted.“This was a tragic combination of negligence and callousness that led to a needless death,” Iredale said.Iredale says his client leaves behind a wife and a one-year-old child. He says Castro is a Mexican citizen and a legal resident of the U.S. His wife lives in Mexicali, but Castro has been working and renting locally.He says Castro also has a history of mental illness.“This was a person in a mental health crisis and was paranoid,” Iredale said. “His last word as he rushed towards the officers was ‘ayuda,’ ‘help me’”In a recorded video statement provided to ABC 10News by Iredale, Castro’s wife was emotional, saying the family is shocked at what happened, calling her husband’s death an injustice. She described him as a hardworking and responsible man, that many people loved.RELATED: San Diego Police identify man killed in officer-involved shooting in Mountain ViewSDPD's homicide unit is currently investigating the shooting, after which the San Diego County District Attorney's Office will review the case to determine if the officers bear any criminal liability. Internal Affairs, Community Review Board on Police Practice, and the Shooting Review Board will also review the incident.Anyone with information about the shooting is asked to call SDPD at 619-531-2293 or Crime Stoppers at 888-580-8477. 2724
来源:资阳报