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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 US stock market sank deeper into the red following sluggish economic reports on Monday and bad news from a couple of blue-chip giants.The Dow fell 600 points by late afternoon, or 2.6%. The S&P 500 lost 2.6% and retreated to its lowest level of the year. And the Nasdaq joined the Dow & S&P 500 in negative territory for 2018. All three indexes have plunged about 7% so far this December.The Dow closed down 507 points for the day.And the Russell 2000 index of small-cap stocks tumbled into a bear market, marking a 20% decline from the record highs notched in late August.A weaker reading from the New York Federal Reserve about manufacturing in the Empire State and a drop in confidence from the nation's homebuilders weighed on the markets."Investors are zeroing in on this idea of slower growth for 2019," said Michael Arone, chief investment strategist at State Street Global Advisors. "More people are worried about a recession in late 2019 or 2020."The political noise in Washington isn't helping either. President Trump, in a tweet Monday morning, repeated his criticism of the Federal Reserve for its recent rate hikes. The Fed meets Wednesday and is widely expected to raise rates again.But Trump tweeted that "it is incredible that with a very strong dollar and virtually no inflation, the outside world blowing up around us, Paris is burning and China way down, the Fed is even considering yet another interest rate hike. Take the Victory!"The Fed is supposed to be politically independent. Any evidence that it might be swayed by attacks from Trump could unnerve the markets."If the Fed doesn't raise rates it will look like it's succumbing to the bullying of Trump's tweets," Arone said.But Nancy Perez, managing director at Boston Private, said the Fed is likely to slow down its pace of rate hikes in 2019 simply because the economy is slowing, not because of pressure from Trump.Perez added that the recent market turmoil is justified because investors are readjusting to this fact."We have been getting a bump in profit margins due to lower taxes but the earnings growth itself is not sustainable," Perez said. "Projections will come down and volatility will continue." 2247

The US Food and Drug Administration has again expanded the list of recalled medications that contain valsartan, used as a component in a set of drugs to treat heart failure and blood pressure.The expanded list was posted Monday.The FDA announced an initial recall in July after lab tests revealed that some drugs could have been tainted with a substance that may lead to a higher risk of cancer. The drug had been recalled in 22 other countries.The expanded recall includes some drugs that contain valsartan and hydrochlorothisazide, but not all drugs containing valsartan are affected. 594

The Supreme Court decided on Monday that they will not reexamine a doctrine that protects law enforcement and government officials from being sued over their actions while on the job.The doctrine, which the justices created nearly 50 years ago, gives "qualified immunity" for law enforcement officers, which protects them from frivolous lawsuits CNN reported.The decision comes amid protests over the death of George Floyd, who died while in police custody in Minneapolis.According to CBS News, the courts were to hear one case about a man in Tennessee that was bitten by a police dog, although he was sitting on the ground with his hands raised.NPR reports that two justices, Sonia Sotomayor and Clarence Thomas, have both been skeptical of the doctrine. 763

The Time Warner building in New York City, where CNN has a studio, is one of several places to receive a potentially explosive device this week. It is being investigated as an act of terrorism.The package was located in the building's mailroom, CNN reported on air today. Employees said authorities told them it looked like a pipe bomb and had wires attached.Police believe it is a very serious incident and a real explosive that was delivered. The Time Warner building's other businesses were evacuated and folks moved farther away from the location at what is a busy time of day in metro New York City. 617

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