威海癫痫病专科医院哪个好(江苏中医怎样治疗儿童羊癫疯) (今日更新中)

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 addition of 536 new homes on a former golf course in Rancho Penasquitos won't clog the one road leading out of the neighborhood in the event of an emergency evacuation, according to a new city study. The city released the environmental impact reporter for Lennar's Juniper proposal on Wednesday. Lennar is proposing to turn the languishing course behind the old Hotel Karlan on Penasquitos Drive into 536 housing units for senior citizens, including 81 affordable. The project also includes a nearly three acre public park, a three-mile trail. The environmental document analyzes impacts such as noise and traffic. It also looked at how the additional homes would impact evacuations in the northeast portion of Rancho Penasquitos, a neighborhood with only one road in and out. The document said there would be a less than significant impact on getting out fast for two reasons - first, a wildfire that starts in the Black Mountain Open Space park to the west would be blown away from the site by Santa Ana winds. Secondly, the site is not prone to wildfire because it is protected by developed terrain. "As part of the EIR, a fire risk analysis determined potential impacts related to wildfire hazards from implementation of the project would be less than significant and the project’s Wildland Fire Evacuation Plan demonstrates that timely evacuation of the site is feasible and would be improved by the additional roadway and emergency egress connections provided by the project," said city spokesman Anthony Santacroce. Additionally, plans call for adding a road into and out of the Juniper complex from Carmel Mountain Road, with emergency access. It would add a traffic light and roundabout to Penasquitos Drive, and improve an emergency access road on the opposite side of the neighborhood. Still, a group of residents is raising concerns that the Juniper project, combined with another potential 350 on the hotel site, would clog the one road leaving the area. Junaid Razvi, who heads the Penasquitos Northeast Action Group, noted Santa Ana winds are unpredictable and has had to evacuate three times in the last 15 years. "To put it mildly, I don't think we're getting the whole picture here," said Razvi. "We are not nimbys. I think the development has to be sensible terms of density, the access, ingress and egress points."Razvi's group said it plans to meet with Councilman Mark Kersey in the next few weeks to air their concerns. In a statement, the councilman said he understands where they are coming from. "Given our region's history, I understand and share residents' concerns about wildfire preparedness," he said. "Nothing is more important to me than public safety, especially when it comes to fire risk, and fire safety will be a primary concern when I evaluate any development proposal that comes before the City Council for approval."San Diegans have until April 6 to submit their comments on the EIR. 2957

SAN DIEGO (KGTV) — The City of Poway Friday honored the memory of Lori Lynn Gilbert-Kaye, who was killed last April in a shooting at a local synagogue, by renaming a street after her.Many gathered Friday for the unveiling of Lori Lynn Lane (formerly Eva Drive). It's located in the Green Valley Neighborhood, off Stone Canyon Drive. Lori Kaye lived at that intersection. “To be able to dedicate this street to her memory means a lot to us in Poway,” says Poway Mayor Steve Vaus.RELATED: Family discovers synagogue shooting victim's random act of kindnessNeighbors and friends came together and petitioned for the change. Vaus says it's rare for the city to rename a street after someone. The last one dates back to the 1980s. But Vaus says the city had no hesitation with this renaming. The Poway City Council unanimously approved the honor in November. Gilbert-Kaye lost her life in that tragic synagogue shooting back in April. Many say she was a light in this community. RELATED: Chabad of Poway to dedicate Torah scroll to memory of synagogue shooting victim“It’s so appropriate that we do this on the cusp of Hanukkah. Hanukkah is the Festival of Lights, and Lori was a bright and shining light,” says Vaus. “I think the one word that people would use to describe her, she was a giver.”Vaus says as they are a few months away from the first anniversary of the shooting, the City of Poway will continue to stand strong, and lift up Gilbert-Kaye’s family. The trial date for the man accused of opening fire in the Chabad of Poway has been set for June. 1564

SAN DIEGO (KGTV) - The gloves are coming off in the race for San Diego County District Attorney, with a unlikely person taking shots at Genevieve Jones-Wright Friday.Rebecca Harrison, who said she’s the victim of a Balboa Park rapist, backed candidate Summer Stephan.At a news conference in front of the courthouse, Harrison said Jones-Wright, who was the public defender in the case, treated Harrison as if she was the one on trial.“Several weeks ago I found out that Genevieve was running for D.A. and it literally made me sick to my stomach. It felt like someone had kicked me because she was professing that she gives dignity and a voice to victims when that is not what I experienced whatsover,” Harrison said.Jones-Wright told Team 10 investigator Adam Racusin she gave Harrison an extreme level of compassion and that the press conference was all political posturing. She also said the 6th amendment of the constitution guarantees everyone the right to competent representation, and that everyone should read the full transcript of the cross examination.Stephan did not make a public statement at the news conference. 1132

SAN DIEGO (KGTV) -- The magic of the holiday classic "The Nutcracker" couldn't be stopped, even by a pandemic, as the San Diego Civic Youth Ballet has figured out a way for the show to go on.We're used to seeing this ballet with its lavish sets on an indoor stage with dancers close together, but this season things will look different because the virtual show will be outside with dancers wearing masks and distancing.Lucia del Rio stars as Clara and says, "I'm just really excited to be doing it at all. It's like in the beginning it was kind of hard to see how it was going to work especially since we were on Zoom. The most exciting part for me is being around everyone even if we have our masks on."The 9th grader from Academy of Our Lady of Peace says while they have had two in-person rehearsals following safety precautions, most rehearsals have been from home alone via Zoom."It's just very tough.. My floor is not good, my floor is very slippery." San Diego Civic Youth Ballet Artistic Director Danika Pramik-Holdaway has been on the other end of those Zoom rehearsals and says they've all had to overcome a few obstacles."Knowing who they stand next to, who they go behind, how they go in their direct order, when you're on Zoom at home by yourself that's very very challenging," says Pramik-Holdaway.But the students were up to the task and with hard work, Lucia and the other dancers have been able to turn lonely Zoom rehearsals into something special. The small group performance outside the Casa del Prado Theater will be recorded so people can watch online. It will be a simplified, shorter version of The Nutcracker, but the beloved scenes will still be there. Lucia says, "It's really really special. It's kind of a gift to be able to dance with people in the holiday season, so I'm really excited about that."Not to mention a virtual trip to see the Sugar Plum Fairy could yield a sweet reward --- more viewers than usual. Pramik-Holdaway says, "I'm sure we'll have definitely a lot of grandparents, who don't live here in San Diego, get to see their grandkids dance."They both agree that holding onto cherished traditions like this one, even if they have to be adapted, is something we need right now."Since we're in Balboa Park we have people walking through the park and everyone stops by and says, 'Oh, the Nutcracker!' They hear the music and I think it makes everyone feel like things are going to be okay again," says Pramik-Holdaway.SDCYB is celebrating its 75th anniversary this year and ticket sales help keep this nonprofit going. Access to this performance is only and tickets are on sale now. "The Nutcracker" debuts online on December 19 and goes through January 1. You can get tickets here at https://www.sdcyb.org/. 2762

来源：资阳报