宜宾韩式双眼皮要拆线吗(宜宾瑞蓝二号玻尿酸) (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 romaine lettuce outbreak has many consumers thinking about where their crops are grown.One rooftop greenhouse company in Chicago says their lettuce is safer and longer-lasting.Jenn Frymark, the chief agriculture officer and manager of Gotham Greens, pulls out a head of lettuce and immediately starts to eat it."No, you don't need to wash it,” Frymark says. “We don't have that on our package, but there's no reason for me to wash it. I never wash any of our lettuce at home. It's amazing; nothing touches it; it’s so clean.”Here at Gotham Greens, lettuce is grown differently.  They do it hydroponically. That means it’s grown without soil, but in a nutrient-rich water. Instead of a traditional farm field, this lettuce is grown on rooftop greenhouses.Their space on Chicago's south side is the largest rooftop greenhouse in the country.  Because of the controlled environment, crops can grow in a third of the time of a traditional field.“We're giving this plant everything it wants: the right day temp, the right night temp, the nutrients, CO2 levels, air circulation, the water,” Frymark explains. “I mean, these are very coddled plants and they have everything they need, and they can just grow in this perfect environment and reach maturity very quickly.”Gotham Greens sells to grocery stores in the Chicago and New York metro areas, as well as select Whole Foods stores. The product goes from the greenhouse directly to grocery shelves in a day and a half.The company’s lettuce also lasts longer than the traditional grocery lettuce out here. Frymark says their product can last up to two to three weeks in the fridge. Additionally, Gotham Greens prices are comparable to other organic produce.Frymark also says their method dramatically lowers the risk for foodborne illness.“There [are] no manures, there’s no water sources that could be contaminants,” she says. “We don't have birds and animals getting into the field.”She says the company is expanding and plans to open more rooftop greenhouses in the near future. 2053

The United States Consumer Product Safety Commission (CPSC) is recalling nearly half a million Kidde smoke detectors, saying they could fail to work in the event of a fire.According to the CPSC, anyone with a Kidde smoke alarm should remove their alarm from the ceiling or wall and look for a yellow cap on the inside of the alarm (see photo above). Those who find a yellow cap should contact Kidde for a replacement, and should not try and remove the yellow cap.Those who do not find a yellow cap in their smoke alarm can continue using the device normally.The alarms were sold at Menards, The Home Depot, Walmart, Amazon and Kidde's website between September 2016 and this January.The following models are covered in the recall:PI9010 (DC/battery powered)Date code: 2016 Sep. 10 through 2017 Oct. 13PI2010 (AC/hardwired)Date code: 2016 Sep. 10 through 2017 Oct. 13If you are covered by the recall, contact Kidde toll-free at 833-551-7739 from 8:30 a.m. to 5 p.m. ET Monday through Friday, or from 9 a.m.to 3 p.m. on Saturday and Sunday. You can also visit online at www.kidde.com and click on “Product Safety Recall” for more information. 1168

The Trump administration is extending a ban on green cards issued outside the United States until the end of the year and adding many temporary work visas to the freeze, including those used heavily by technology companies and multinational corporations. The administration is casting the effort as a way to free up jobs in an economy reeling from the coronavirus. A senior official who spoke to reporters on condition of anonymity estimated the restrictions will free up to 525,000 jobs for Americans. Through the first 60 days of the program, the senior administration official said the White House projects that the visa ban saved around 50,000 American jobs, but could not specify the type of jobs. The ban does not impact refugees or people already in the United States, a senior official said. The ban, while temporary, would amount to major restructuring of legal immigration if made permanent. 909

The U.S. economy added 250,000 jobs in October, significantly exceeding expectations, the government announced Friday.The unemployment rate remained at 3.7 percent, a 49-year low. Wages grew 3.1 percent, strong growth after years of stagnant paychecks.The number will likely serve as a talking point for President Donald Trump and Congressional Republicans as they make closing arguments before the midterm elections next Tuesday.The year-over-year percentage growth in average hourly earnings looks larger than it actually is because wages declined last October as low-wage workers returned to their jobs following a particularly strong hurricane season. Month to month, hourly earnings increased by only five cents, a modest increase. 744

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