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发布时间: 2025-05-26 09:50:56北京青年报社官方账号
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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

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SAN DIEGO (KGTV) -- The Navy is trying to find the owner of a boat that washed ashore at the Naval Base Coronado.The boat washed up and came to a rest against the fence that separated Coronado’s dog beach from the base.The Navy is asking the owner to come forward immediately to have the boat removed. The problem can get costly for the Navy.Several boats have already washed ashore this year. If the Navy can’t locate the owner, they have to cover the removal cost.Anyone with information on the boat’s owner is asked to call the Navy legal office at 619-545-8141. 573

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SAN DIEGO (KGTV) - The City of San Diego may owe you some of its unclaimed .2 million.The funds come from checks that are returned if the addresses are invalid. Checks that remain uncashed after six months become unclaimed monies.Amounts range from to ,000.We want to refund every single dollar of unclaimed money,” said Cecilia San Pedro, Disbursements Manager for the Office of the City Comptroller. “A simple search is all it takes to verify if you have been issued a check that has gone unclaimed. There is no charge to search the data or to file a claim.”To see if the City owes you money, click HERE.You can submit a claim by printing and completing the Request for Unclaimed Monies form.Send to:City of San Diego, Office of the City ComptrollerUnclaimed Monies Claim Processing202 C St. – Mail Station 7ASan Diego, CA 92101The City will verify claims and send replacement checks in four to six weeks. Anyone who has questions about unclaimed money may call 619-236-6310 or email comptroller@sandiego.gov.    1045

  

SAN DIEGO (KGTV) — The community is coming together for the family of a San Diego mother of two who died this week while acting as a surrogate for another family.Michelle Reaves was helping a family have children of their own, according to a GoFundMe set up to help her family. It was her second surrogacy for the same family when complications arose and she died while giving birth, the campaign explained.The baby Reaves was carrying survived.Reaves leaves behind two children, Gage and Monroe, and her husband, Chris.The organizer of the GoFundMe campaign is hoping the community will "be there for Michelle’s family like they would for us.""I can’t even begin to imagine what her husband Chris and her two babies are going through so I want to start this page to help raise money for help with the kids, for Chris as they all adjust, funeral services, or anything at all to make it as easy as we can on them," wrote organizer Jaime Herwehe. "For those of you who didn’t have the pleasure of knowing Michelle, she will always be known for the love she had for her family. Michelle has the best, most sarcastic, funny personality and always had you laughing."You hear about these things happening all of the time but never in your life imagine it will happen to you." 1277

  

SAN DIEGO (KGTV) -- The Infinite Chemical Analysis Lab building in Miramar looks like any other chemical lab, but inside the products they are testing are all cannabis. InfiniteCal tests products for things like potency, pesticides, heavy metals and microbial analysis to make sure the products are safe for consumption and meet state standards. Josh Swider is the CEO and co-founder. Swider's company consists of roughly 45 employees, 30 of those are either chemists or biologists. The team tests products for licensed retailers to make sure their cannabis meets the standard for what is allowed by the state. When it comes to vaping, Swider says their analysis shows that what's making people sick is when the product is diluted, most recently with Vitamin E or Vitamin E acetate. According to the CDC, 33 people have died from lung related illnesses linked to e-ciggarettes or vaping products. Most of those samples tested by the FDA had THC. San Diego County has confirmed 22 vape related illnesses in the county. Although InfiniteCal doesn't just test products for vaping, Swider says the best thing a person can do is to do their research and make sure they are buying from a licensed retailer. He also recommends asking the business for their certificate of analysis to find out what's in the cannabis product they're consuming. InfiniteCal operates six days a week and also will tests an individual consumer's product if they show up to the lab. The company is expanding to a location four times it's current size by the end of the year. 1554

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