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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 State of Utah sent face masks showing a handgun and controversial political image to a Salt Lake City family.The free masks are part of the “A Mask For Every Utahn” campaign, where federal COVID-19 money purchased more than two million masks to stop the spread of the virus.“I was just shocked,” said Chrstine Passey-Spencer outside her Rose Park home.Two masks delivered to the family show an American flag with a handgun printed across them with “Don't Tread on Me” written below a coiled rattlesnake.“I think the thing that bothered me most is that I knew my tax dollars paid for this and this is very politically charged speech,” Passey-Spencer said.The “Don't Tread on Me” image stems from the Revolutionary War but has become controversial in recent years. The Gadsden Flag has been used by the Tea Party, anti-gun control activists and white supremacists.In 2016, it was deemed to have “racially-tinged” messaging in some contexts by the federal government.More recently, the image has been used by people believing COVID-19 health restrictions take away their constitutional rights.“We hope this is an isolated incident that we just missed these couple of masks,” said Governor’s Office of Economic Development’s Ben Hart, who oversees the state’s mask program.Since April, the state purchased millions of masks from local and international manufacturers.Hart admits about 100 of the “Don't Tread on Me” masks were included in a shipment last month. Hart says the staff deemed them “inappropriate” and attempted to set all of them aside.“We will not be using taxpayer dollars to pay for these masks. We will be working with the manufacturer and ensuring we do not pay for them,” said Hart.The governor’s office replaced the masks for Passey-Spencer on Tuesday.KSTU's Hailey Higgins first reported this story. 1828

The Trump administration is planning to expand an operation that would send federal law enforcement agents to Detroit, Cleveland and Milwaukee in the coming weeks, the White House announced Wednesday night.According to a recap of the day's events on the White House website, President Donald Trump and the Department of Justice plan to expand the program into the three Midwestern cities in the next three weeks.Trump and Attorney General William Barr announced Wednesday that they would send federal agents to Chicago and Albuquerque to combat rising crime under the "law and order" push.“In recent weeks there has been a radical movement to defund, dismantle and dissolve our police department,” Trump said Wednesday at a White House event, blaming the movement for “a shocking explosion of shootings, killings, murders and heinous crimes of violence.”“This bloodshed must end,” he said. “This bloodshed will end.”Detroit Mayor Mike Duggan, Police Chief James Craig and Michigan Gov. Gretchen Whitmer spoke out earlier this week after Trump said they were looking into the plan to bring agents to Detroit."There could be no possible justification for such an action. The Detroit Police Department has had the support of the Detroit community in making sure our City did not have a single store looted or a single fire started during the protests," Duggan and Craig said in a joint statement. "Unlike nearly every other major city in the country, the Detroit Police Department never requested assistance from the National Guard - we handled our issues as a community. We definitely have no need for any federal presence being sent in now.""It is deeply disturbing that President Trump is once again choosing to spread hateful rhetoric and attempting to suppress the voices of those he doesn't agree with," Whitmer said. "Quite frankly, the president doesn't know the first thing about Detroit. If he did, he would know that for nearly two months now, Detroiters have gathered to peacefully protest the systemic racism and discrimination that Black Americans face every day. There is no reason for the president to send federal troops into a city where people are demanding change peacefully and respectfully."Federal officers are already in Portland, Oregon and have clashed with protesters over the previous few days."Portland is a very different place than Chicago, but Chicago should be calling us, and so should Philadelphia and Detroit and others to go in and really help them," he said. "Because when you're losing many people a weekend... you see the same numbers as I do. When you're losing these people they should call us and they should say come on in. It's incredible to me, but they're not doing it. At some point they will; at some point we may have no other choice but to go in."This story was originally published by Max White at WXYZ. 2860

The US asked China to close Consulate General in Houston in 72 hours. This is a crazy move.— Hu Xijin 胡锡进 (@HuXijin_GT) July 22, 2020 141

The true power of @ChadwickBoseman was bigger than anything we saw on screen. From the Black Panther to Jackie Robinson, he inspired generations and showed them they can be anything they want — even super heroes. Jill and I are praying for his loved ones at this difficult time.— Joe Biden (@JoeBiden) August 29, 2020 325

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