天津武清区龙济泌尿男科好不好(天津武清龙济前列腺炎) (今日更新中)

The U.S. regulators who will decide the fate of COVID-19 vaccines are taking an unusual step: Asking outside scientists if their standards are high enough.The Food and Drug Administration may have to decide by year’s end whether to allow use of the first vaccines against the virus. Thursday, a federal advisory committee pulls back the curtain on that decision process, debating whether the guidelines FDA has set for vaccine developers are rigorous enough.“We will not cut corners, and we will only use science and data to make that determination,” FDA Commissioner Stephen Hahn pledged at a meeting of the Milken Institute Wednesday.Exactly how much data his agency needs to be sure a vaccine is safe and effective is a key question for the advisers. An even bigger one: If the FDA allows emergency use of a vaccine before final testing is finished, will that destroy chances of ever learning just how well that shot -- and maybe competitors still being studied -- really work?“We can’t lose sight of the fact that it is in our societal interest to see these trials to completion,” said Dr. Luciana Borio, a former FDA acting chief scientist who will be watching the advisers’ debate.Plus, multiple vaccines are being studied -- shots made with different technologies that each have pros and cons.“The first vaccine is not necessarily the best vaccine,” cautioned Dr. M. Miles Braun, a former FDA scientist now with Georgetown University School of Medicine. If the trials aren’t allowed to finish, it may be difficult or impossible to ever know for sure.It’s a critical moment in FDA’s 114-year history. The government has spent billions to race a vaccine through a research process that usually takes years, and FDA faces unprecedented pressure from the Trump administration, fueling public skepticism that politics could overrule science.Interest is so high, FDA is airing the meeting on YouTube. Here are some key issues the committee will discuss:HOW MUCH EVIDENCE IS NEEDED?FDA is requiring manufacturers to do studies of at least 30,000 people to prove if a vaccine protects and how safe it is. Those studies must include adequate numbers of people at highest risk from COVID-19 -- older adults, minorities and anyone with underlying health problems.FDA has made clear that any vaccine must be at least 50% effective. And while the studies are designed to run for two years, companies may get enough evidence the shots are protective -- in at least some people -- to stop the trials early and seek what’s called an “emergency use authorization” for wider vaccinations.Despite White House objections, the FDA told vaccine makers earlier this month not to seek that speedier review until they’ve tracked at least half their trial participants for two months. With other vaccines, that’s about the amount of time when major side effects crop up.That’s not long enough, said the head of the non-profit ECRI Institute, which reviews medical technology for hospitals and insurers. In comments submitted to the advisory committee, ECRI’s Dr. Marcus Schabacker said FDA should require six months of follow-up.“Doing any less would simply risk too much, and the consequences may be severe,” he wrote. “A weak vaccine that loses public trust could poison the well for epidemic control for many years.”WOULD EMERGENCY USE DERAIL FULL ANSWERS ABOUT VACCINES?Normally when a study ends because of evidence that a vaccine is working, the participants who got dummy shots are offered the real thing.But if FDA allows emergency use of a COVID-19 vaccine, that’s not the same as having full proof the shot works, Borio cautioned.And if the participants in the placebo group are immediately offered the real shot, researchers may not be able to get answers about all the high-risk groups in the study — or tell how long the vaccine’s protection lasts, a process expected to take many more months.But Pfizer Inc., which with Germany’s BioNTech is developing one of the leading candidates, told FDA that if it’s granted emergency use authorization, it “would have an ethical obligation” to alert study participants who got a placebo and allow them vaccine access. The company wants FDA to look into “other scientifically and statistically sound methods” to determine long-term safety and effectiveness.Pfizer’s stance is likely to face pushback. The Infectious Diseases Society of America states that FDA’s panelists “should insist” that vaccine developers “present a compelling case” for how they will complete their trials if FDA grants early authorization of their vaccine.Clearing a vaccine based on premature or faulty data “could cause more harm” by “further eroding public confidence in all vaccines,” the group said.It’s an unprecedented dilemma. The FDA has previously allowed emergency use of only one vaccine, a decades-old shot that in 2005 was authorized to prevent anthrax poisoning.This time around, multiple COVID-19 vaccines are in the pipeline. Pfizer competitor Johnson & Johnson cautioned that early FDA clearance of one vaccine could “jeopardize integrity” of other ongoing trials if patients decide to drop out to seek the first cleared shot instead.The company asked regulators to explain what options are available to ensure completion of all ongoing COVID-19 vaccine trials.WHAT ABOUT LONG-TERM SAFETY MONITORING?Even a study of 30,000 people cannot spot a side effect that only strikes 1 in 100,000. So the government is planning extra scrutiny of every COVID-19 vaccine to hit the market.At first there will be limited doses given to just certain high-risk people -- and those early recipients are to get text messages daily for the first week after vaccination, and then weekly out to six weeks, asking how they’re feeling.FDA also will be checking databases of electronic health records and insurance claims, looking for any red flags.“There’s a kind of tracking that has to take place here on a massive basis that hasn’t taken place before,” said Dr. Jesse Goodman of Georgetown University, a former director of the FDA’s vaccine and biologics center.___The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content. 6274

The subject of the hit podcast “Serial” could be days away from hearing whether he’ll receive a new trial.On Saturday, Adnan Syed's defense attorney Justin Brown tweeted that he's expecting a ruling from the Maryland Court of Special Appeals in the coming week.I expect a ruling from the appeals court this coming week. #FreeAdnan https://t.co/0eQmLaaxFn— Justin Brown (@CJBrownLaw) February 25, 2018 408

The rescue of 11 hungry children in Amalia, New Mexico, on Friday began with a mysterious tip delivered to a detective across the country, in Clayton County, Georgia, from where young Abdul-Ghani Wahhaj vanished in November."We are starving and need food and water," read the message that provided the impetus for the raid on the rural compound near the Colorado border.New York imam linked to caseThere, authorities found the emaciated children -- the youngest 1, the oldest 15 -- in a squalid underground trailer, along with three women in their 30s, apparently the youths' mothers.After a standoff, police also took into custody two armed-to-the-hilt men -- one of them Siraj Wahhaj, 40, Abdul-Ghani's father.But they didn't find Abdul-Ghani that day. On Monday, investigators returned and found the remains of a young boy whose identity is awaiting confirmation, Taos County Sheriff Jerry Hogrefe said.Here's what we know of the youngster whose disappearance ultimately set the New Mexico raid into motion: 1018

The University of Iowa ticket office says they are suspending ticket sales for the upcoming football season.In a statement on their ticket website, school officials said that those who renewed their season tickets and paid their per-seat contributions by June 30 would be included in any potential seating plans for Kinnick Stadium.The university also announced that the Hawkeye Express would not operate for the upcoming season because of the potential of reduced capacity.“Hawkeye fans are excited about the upcoming season, and we appreciate their continued enthusiasm and support,” said Henry B. and Patricia B. Tippie, Director of Athletics Chair Gary Barta. “With the current information available, we need to pause additional sales and focus on reduced-capacity seating models based on our season ticket holders. We anticipate finalizing this by late July and will share it with our fans. The option of having the ability to accommodate as many Hawkeye fans who are comfortable attending a game in Kinnick Stadium is still one of the scenarios.”New sales of the digital season pass, mini-plans, and single-game ticket sales were also put on hold. 1161

The Royal Oak Police Department has completed our internal investigation into the August 13 incident involving an African American man and the Royal Oak police.On behalf of the police department, I would like to apologize to Mr. Myers for how he was treated. What should have been a very short encounter was extended when the officer involved insisted on getting Mr. Myers' identification. The officer had no legal right to demand the identification and should have simply advised Mr. Myers why we were there and allowed him to go on his way. The officer involved is a new, probationary officer and he made a mistake. This officer will be provided with remedial training to address this issue.Early in this encounter, Mr. Myers requested a supervisor make the scene. Although the first officer did not call for a supervisor, the second officer on scene did.The responding supervisor did not handle this situation in a manner I expect Royal Oak supervisors to conduct themselves. He did quickly advise Mr. Myers that he was free to go; however, he did not effectively look into the situation or allow those present the opportunity to express their concerns.This is not the practice of the Royal Oak Police Department and it is not acceptable. The supervisor has been disciplined and every Royal Oak police supervisor has received additional training in procedural justice.This incident stemmed from a 911 call in which the caller reported she was uncomfortable because a male subject was circling her vehicle, staring at her from across the street, and was possibly taking pictures of her and her son. In total, Mr. Myers was verbally detained for approximately 19 minutes. A supervisor was called to the scene, per Mr. Myers request, about 6 minutes into the encounter and the supervisor arrived approximately 11 minutes later (17 minutes into the encounter). Mr. Myers was advised he was free to go 2 minutes after that.This is an unfortunate incident where the ROPD did not live up to our own standards.Corrective action has been taken and we will continue to hold all members of the ROPD to the highest standards. 2124

来源：资阳报