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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 summer of 2020 has been one marred by civil unrest in the U.S. Since the death of George Floyd at the hands of police on Memorial Day weekend, thousands of protests have taken place across the country calling for police reform and an end to systemic racism.While some of those protests have resulted in burned buildings and looted businesses, a non-profit group reports that the overwhelming majority of Black Lives Matter protests in 2020 have been peaceful.According to a report from the Armed Conflict Location and Event Data Project (ACLED), there were nearly 8,000 demonstrations linked to the Black Lives Matter movement between May 26 and Aug. 22 — 93% of which were peaceful.The ACLED, which sources information via reports from the media, reports from government and non-government agencies as well as targeted social media reports, says that Black Lives Matter protests took place in more than 2,000 locations — including in all 50 states — between late May and August. Most places that saw protests that devolved into riots also saw several other peaceful demonstrations.The organization also notes that in places where riots were widespread, like Portland, that the vandalism was limited to the span of a few square blocks.The ACLED's findings contradict the findings of pollsters, who report that as many as 42% of Americans believe most Black Lives Matter activists are "trying to incite violence or destroy property." The ACLED believes that disparity comes from "biased media framing" stemming from "disproportionate coverage of violent demonstrations."And while BLM demonstrations have been largely peaceful, the ACLED reports that local governments have disproportionately responded with force. About 1 in 10 BLM protests were met with government intervention — a 6% increase when comparing government intervention in all other demonstrations. In half of those interventions, police used tear gas, rubber bullets, pepper spray or batons while attempting to force protesters to disperse.While not the case in every violent protest, the ACLED reports that some riots were instigated by "agents provocateurs," or outside infiltrators. For example, a man with an umbrella who committed early acts of vandalism in Minneapolis has since been linked to Hells Angels.The Black Lives Matter protests have also sparked a conversation about statues dedicated to Confederate leaders or those with colonialist or slave-owning pasts. The ACLED found 38 instances in which protesters toppled such statues, though local governments across the country have peacefully removed dozens of similar monuments on their own.The ACLED aggregates data from political conflicts around the world. According to the group's webpage, the non-profit organization receives some funding from the State Department. 2810

The Tampa Police Department is searching for a young man who was caught on camera doing a skateboard trick across a custom-painted car in Ybor City.A spokesperson for the police department said the case is being investigated as a felony criminal mischief. Detectives would like to speak with Dalton Newbury as a person of interest. According to those who have shared the video that's getting thousands of shares on Facebook, it was originally posted to Instagram by the skateboarder himself. The video has since been deleted from instagram. Tampa Police obtained the video and shared it on their YouTube page. Watch the video below:  661

The Russian lawyer who met last year with senior members of the Trump campaign said Donald Trump Jr. told her at the meeting that a Trump administration would be willing to review a 2012 sanctions law.Natalia Veselnitskaya, the lawyer who attended the meeting, made her comments from Moscow in an interview with Bloomberg published Monday.She said Trump Jr. told her: "Looking ahead, if we come to power, we can return to this issue and think what to do about it." 472

The State of Washington will soon have to rehab a lake that is overrun with an invasive species: Goldfish.The fish have filled West Medical Lake, along with Koi, and are crowding out other fish species.Pet owners likely dumped goldfish into the lake, and that may be the source of the problem, says the Division of Fish and Wildlife. Officials say while some believe it's a service to goldfish to release them into a lake, it is a disservice to the ecosystem.Goldfish are a domesticated version of a wild carp from East Asia and were developed due to artificial selection created by humans.Simply put, goldfish are mostly for visual effect.West Medical Lake, near Spokane, Washington, is known as one of the best producing opening day trout lakes in the state, according to the Washington Dept. of Fish and Wildlife. It gets stocked with thousands of native trout every year, but that trout is unable to flourish because of the goldfish, which is taking resources such as food and oxygen away. 1016