成都治静脉曲张要花多少钱(成都市小腿血管炎专科医院) (今日更新中)

SAN DIEGO (KGTV) — It’s a term we’ve heard a lot during the pandemic: emergency use authorization.From ventilators to diagnostic tests to experimental drugs like remdesivir, the Food and Drug Administration has issued at least 616 emergency use authorizations, or EUAs, since the pandemic began.“That’s such a powerful term: emergency use authorization,” said President Donald Trump on Aug. 23 when announcing an EUA for convalescent plasma.Top officials at the FDA are now floating the idea of using an EUA to speed up distribution of a vaccine against COVID-19, writing that it “may be appropriate” under certain circumstances. Critics contend it would be a dangerous move.The mechanism was put into law back in 2004, and EUAs have been used in several health emergencies since, including the 2009 H1N1 pandemic.An EUA allows the FDA to temporarily authorize a drug or device for use during an emergency under certain conditions. There must be no formally approved alternatives to the product, and the available evidence must suggest the potential benefits outweigh the potential risks.“Because in some emergencies, we just cannot wait for all the evidence needed for full FDA approval,” the agency says in a video explaining the rationale for an EUA.While EUAs are relatively common for diagnostic tests and experimental drugs, there has only been one EUA issued for a vaccine. In 2005, the FDA authorized a vaccine intended to protect U.S. soldiers from an anthrax chemical attack. It was the first time the FDA ever used the EUA process. In that case, the product, Anthrax Vaccine Absorbed, had been formally licensed in 1970 as safe and effective against anthrax on the skin, but was not formally approved to counteract inhaled anthrax.In a letter to pharmaceutical companies, the FDA said it “may be appropriate” to issue an EUA for a COVID-19 vaccine “once studies have demonstrated the safety and effectiveness” of the product, but before other steps in the traditional submission process, like detailed information on how the vaccine was made and tested.“It is extremely rigorous,” Dr. Christian Ramers of Family Health Centers of San Diego said of the typical FDA approval process. “People have to submit thousands of pages of documents. They have to open their books, essentially, and show all of the detail on how these things have been tested.”An EUA could allow for the release of a vaccine before the election, something President Trump has suggested but other members of his administration have said is unlikely.The prospect of an EUA for a vaccine alarms consumer advocates like Dr. Sidney Wolfe of Public Citizen, who sent a letter to the agency urging it to avoid the expedited process.“The amount of information on how effective it is, the amount of information on how safe it is is less than would be required for full approval,” Wolfe said. “And full approval could arguably come in three or four months.”Wolfe thinks an EUA could backfire.“The loss of confidence by people will contribute to a much decreased willingness to be vaccinated,” he said, citing a survey during the 2009 H1N1 pandemic that showed people were reluctant to volunteer for inoculation if the vaccine only had emergency authorization.Critics say there’s already shaky public confidence after reports of political pressure from the president in the EUAs for convalescent plasma and for hydroxychloroquine.In the latter case, the FDA revoked the EUA for the anti-malaria drug June 15 after more studies showed it wasn’t effective and could have serious side effects.Dr. Ramers at Family Health Centers of San Diego says there is a big ethical difference between authorizing an experimental drug with limited data and authorizing a vaccine.Fundamentally, doctors give drugs to patients who are already sick, and they're more willing to try something untested in a last-ditch effort. “In somebody who has been through two or three or four rounds of [chemotherapy] and nothing has worked, the risks and benefits are tilted in a different way,” he said.“But a vaccine is a really special situation because we’re giving it to healthy people. We’re giving it to the general population before they become ill. So historically, the safety threshold for a vaccine has been way, way, way higher,” Ramers added. 4302

SAN DIEGO (KGTV) -- Keep an eye out for two new residents at the San Diego Zoo - two penguin chicks named Lucas and Dot. The three-month-old penguin chicks will reside in the Cape Fynbos habitat with a colony of 29 adult penguins. After weeks of careful planning—including providing the chicks with a private pool, where they learned how to swim the hand raised penguins got to see their new home. The two juveniles immediately started swimming and climbing rocks, while keepers vigilantly monitored their progress. Animal care staff said the initial introduction went very smoothly and the birds behaved exactly as keepers had hoped, but they plan to allow only closely monitored interactions for the next few days.“We will be pulling [Lucas and Dot] back at night,” said Debbie Denton, keeper. “We don’t want to leave them out unsupervised yet. We just want to give them a few days out here with the rest of the colony, and make sure that they are comfortable enough to do OK on their own overnight.”Lucas and Dot were hatched in San Diego from eggs supplied though a breeding loan by the Minnesota Zoo, which has successfully hatched more than 24 eggs since opening its African penguin habitat in 2011.    Guests can visit Lucas and Dot at their home in the Cape Fynbos habitat, inside Africa Rocks at the Zoo.    1379

SAN DIEGO (KGTV) - Marine Corps Air Station Miramar broke ground Friday on its first hangar to house the F-35, the most advanced fighter jet in the world.While the plane may be controversial, the hope is to replace aging aircraft. The new project will also include a flightline expansion."We're building new F-35 joint strike fighters and we're going to send them right here to Miramar,” President Trump said in his visit to the base Tuesday.Congressman Scott Peters and other military leaders were in attendance at the groundbreaking, thrilled about finally moving these projects forward."We're really taking care of the nation's defense," said Rep. Peters, representing the 52nd District. "One of the things when I went to the Armed Services Committee was to make sure that this facility was high on the list of priorities," he said. Harper Construction won the bid and will employ about 2000 workers.  The 160,000 square foot hangar is designed to hold up to 12 F-35s."We need to upgrade the infrastructure, the connections, the systems inside the hangers," said Col. Jason Woodworth, the Commanding Officer at MCAS Miramar.While critics have pointed to design flaws and skyrocketing costs on the new planes, the military says aging aircraft like the F/A-18 hornets are becoming tougher to maintain."Older airplanes are like that telephone on your wall you had when you were a kid with the rotary dial on it," Woodworth said. "[The] cell phone in your pocket, that's the F-35 that does it all.""3rd Marine Aircraft Wing was more excited than anybody here," said Asst. Wing Commander Michael Borgschulte with the 3rd Marine Aircraft Wing.The Marine Corps plans to replace its entire fleet of Harriers, Hornets, and Prowlers with new F-35s."The more flight hours, the more times our pilots can get in the aircraft an actually execute their mission, the more proficient they are," Borgschulte said.The Pentagon admits budget shortfalls have hurt military training, but it stopped short of blaming cutbacks for this week's F/A-18 crash in Florida that killed two navy pilots.The hangar should be done by January 2020, about the same time the F-35s are set to arrive. This groundbreaking kicks off just two of nine projects scheduled over the next 13 years.MCAS Miramar expects to have at least 70 F-35s by 2031. 2333

SAN DIEGO (KGTV) — Lifeguards say two people were rescued from a trail in the Blacks Beach area on Sunday in separate incidents.The first involved a woman who injured her ankle, according to San Diego Fire-Rescue. The woman was about half-way down before being injured. Lifeguards put her on a stretcher and used ropes to lower her down to the beach. She was taken by lifeguards to meet paramedics.The second occurred on the same trail, involving a woman suffering from heat exhaustion. She was unable to make it down the rest of the trail, requiring lifeguards to hoist her to the beach below to get her to paramedics.Lifeguards said with Labor Day weekend approaching and a heatwave expected next weekend, they are reminding visitors to local trails to know their limits, wear proper footwear for uneven beach terrain, and make sure they have plenty of water.Beach lifeguards say they don't expect to see crowds slow down anytime soon. 945

SAN DIEGO (KGTV) — Infectious disease experts say it may take months before the first doses of a COVID-19 vaccine reach an important population: kids.Some doctors worry it may already be too late to get a vaccine authorized for younger kids before the start of the next school year because of the time it takes to recruit children and conduct a new round of clinical trials.“Our children under 12 years of age are almost certainly going into next school year without a vaccine option available for them,” said Dr. Evan Anderson, a pediatrician at Children’s Healthcare of Atlanta and associate professor at Emory University.Dr. Anderson said such a delay could further impact school reopenings and have resulting consequences on children’s mental health, among other concerns. He said the window is rapidly closing to get a vaccine authorized in time for children older than 12 unless more trials begin immediately.In October, Pfizer tested its vaccine candidate for the first time in 100 kids aged 12 to 15. Moderna is expected to begin testing in that age group in January, according to Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases. However, neither company has announced plans to begin testing their candidates in children under 12.That’s concerning to the American Academy of Pediatrics, which has been calling on vaccine-makers to include children in clinical trials since September. The AAP argues immunization is critical to stemming the pandemic.“We know that children can be infected with COVID-19 and can transmit it to others. To reduce the spread of this virus and control the pandemic as well as for their own safety, it’s crucial that children be included in the national vaccination program, and that vaccines are made available to children as soon as possible,” said Dr. Yvonne Maldonado, chair of the AAP Committee on Infectious Diseases, in another push last month.Although COVID-19 takes a more severe toll on older adults, children make up about 12 percent of the infections in the U.S. and recent studies have shown kids over 10 years old can transmit disease as efficiently as adults, the AAP noted.More than 1.3 million kids had been infected with COVID-19 as of Nov. 26.Experts say it’s important that drug companies test COVID-19 vaccines in children separately from adults.“Kids' immune systems are really different than adults. As any pediatrician will tell you, kids are not just small adults, their immune systems behave really differently,” said Dr. Christian Ramers of Family Health Centers of San Diego.Dr. Ramers said testing is needed to find the right vaccine dose for kids and see if there are any unexpected side effects.But there are challenging logistics in any pediatric trial. Since children’s immune systems change as they grow, vaccine-makers have to separate their trials into several age groups. That means more child volunteers are needed.“I mean it's more challenging, as an investigator myself for research, to enroll a kid into a study because you have to get permission [from parents],” said UC San Francisco infectious disease expert Dr. Peter Chin-Hong.Because parents have to sign off, experts say it can take much longer to enroll enough kids for a study.In a statement to ABC 10News, Pfizer said it is “working actively with regulators on a potential pediatric study plan.”“As we do with all vaccines which are initially studied in adult populations, we are following a careful, stepwise approach as we move down to younger age groups,” said Jerica Pitts, Pfizer’s director of global media relations.“Global regulatory agencies require evaluation of the candidate vaccine in pediatric populations. Moving below 12 years of age will require a new study and potentially a modified formulation or dosing schedule,” she added.Could a vaccine become mandatory at schools?Once a vaccine is approved for kids, a lot of parents are wondering if and when it might become mandatory at California schools.The California Department of Public Health told ABC 10News several things would need to be in place before it would consider making a vaccine mandatory at either schools or child care facilities.The vaccine would need to reviewed and approved by the FDA and recommended for use in children by the federal Advisory Committee on Immunization Practices. The state would also look for a recommendation by the American Academy of Pediatrics, and there would need to be "sufficient vaccine supply to enable access for all children."READ MORE: Will California make the COVID vaccine mandatory at schools? 4602

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