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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 Republican nominee for a US House seat in Illinois has said the September 11 terrorist attacks were an inside job and that singer Beyonce Knowles has ties to the Illuminati.Bill Fawell is running against incumbent Democratic Rep. Cheri Bustos in Illinois' 17th District, where she won by 20 points in 2016 even though the district also voted narrowly for Donald Trump. Fawell won his uncontested primary in March. He has not reported any fundraising to the Federal Election Commission, per publicly available records.A KFile review reveals Fawell, a real estate broker, pushed conspiracy theories in blogs and his 2012 book, "New American Revolution."In his book, Fawell pushed a conspiracy theory that 7 World Trade Center collapsed as part of a controlled demolition and the attacks were a plot to destroy documents."Go to YouTube and punch in 'Building #7' It's the third building that went down with the twin towers on 9/11," Fawell wrote. "Nothing hit this building, not a thing, and it fell entirely upon its own. If it looks like a standard commercial implosion demolition, it's because that is exactly what it is.""It's interesting to note that the clandestine branch of the CIA was housed on the top floor," he added. "No personnel were lost, but any and all documents were destroyed, just like a giant shredder. The Pentagon was hit in a wing being remodeled (but few people), that held a mountain of paperwork regarding 1 trillion dollars which the Secretary of Defense, Donald Rumsfeld, was having trouble accounting for. That mountain of paperwork became a pile of ash."In a February 2013 post on the blog of a political action committee he established in 2012 called Elect a New Congress, Fawell said that Beyonce's husband, rapper Jay-Z, "has a long history of serving up the godless Illuminati" and shared a YouTube video that speculated that Beyonce's upcoming halftime performance at the Super Bowl would have Illuminati symbolism.The Illuminati is a secret society that serves as the basis for a popular conspiracy theory that alleges that many of the world's leaders and celebrities are masterminding world events.In the same blog post, Fawell said that the previous Super Bowl's halftime show, performed by Madonna, was satanic and influenced by the Illuminati. He also called Madonna a "narcissist skank with the crooked teeth."In an interview with CNN, Fawell stood by his blog posts and the theories he espoused on them. He said that Jay-Z and Beyonce expressed their support for the Illuminati in their videos, and that singer Taylor Swift had as well.In explaining his rationale that 7 World Trade Center didn't collapse on its own, he said, "There's no way that 1,500-degree jet fuel can melt steel that requires 2,500-degree temperatures to melt." He also acknowledged that he didn't expect any support from the national Republican Party apparatus.The Illinois Republican Party did not respond to a request for comment.Another Illinois Republican nominee for a House seat, neo-Nazi Arthur Jones, has been rejected by national Republicans and the state party for denying the Holocaust.In a 2014 post, Fawell speculated that New York City was going to be destroyed in a false flag attack by the deep state in either the year 2016 or 2017."New York City is going to be destroyed in the biggest, baddest false flag attack ever made by any organization upon the American People in a Pearl Harbor redux," Fawell wrote. (False flag attacks are acts designed by perpetrators to look like they were carried out by other individuals or groups.)He said that the attack would be made in an attempt to drag America into war, and that financial institutions were already withdrawing money from New York in preparation for the supposed attack.In another post in 2014, he wrote that then-President Barack Obama created false flag attacks to shore up support for his foreign policy intervention against ISIS.In addition to alleging conspiracies, Fawell used sexist and racist slurs against politicians.In one 2013 post he called former Secretary of State Colin Powell an "Uncle Tom" and called former Secretary of State Hillary Clinton a "bitch" as well as a witch.He also regularly called Obama "Barry Soetoro" and sometimes called him "Barry Goddamn Soetoro Barack Hussain (sic) Obama."When Obama lived in Indonesia as a child he sometimes was known as Barry Soetoro, as Soetoro was his stepfather's last name. Many conspiracy theorists allege that Soetoro is his real last name and use it to argue that he was not born in the United States.The-CNN-Wire 4578

The Trump administration plans to raise pending tariffs on 0 billion in Chinese goods to 25% from 10%, a source familiar with discussions confirmed to CNN.The news was first reported by Bloomberg.The move, which is not finalized and could change, according to the source, comes as the United States and China remain locked in a trade war. Talks between US and Chinese officials have done little to ease tensions.The United States has already imposed 25% tariffs on Chinese goods worth billion. China immediately responded with its own tariffs on US goods worth billion.A second round of tariffs on products worth billion could take effect as soon as this week.US Trade Representative Robert Lighthizer earlier this month ratcheted up tensions when he released a list of thousands of additional Chinese exports worth 0 billion that could face 10% tariffs after a public comment period. It included fruit and vegetables, handbags, refrigerators, rain jackets and baseball gloves.Those tariffs, which might now be steeper, could go into effect as soon as September. 1108

The unemployment rate has dipped below 4 percent for the first time since 2000.The United States added 164,000 jobs in April, the Labor Department reported Friday. That was slightly below what economists expected. Unemployment dropped to 3.9 percent, the lowest since December 2000."The employment situation continues to surprise everyone," said Robert Frick, chief economist with Navy Federal Credit Union. "Getting down to 3.9 is quite a marker."Wages grew 2.6 percent from a year earlier. That was also slightly below expectations.The report indicates another month of solid job growth for an economy that has been expanding for almost nine years — the second-longest streak on record.Hiring gains in April were broad. Professional and business services added 54,000 jobs, health care added 24,000, and manufacturing posted an increase of 24,000 jobs.The mining sector added 8,000 jobs, extending its gains. Employment in mining has risen by 86,000 since October 2016.The wage growth number seemed unlikely to alarm Wall Street, which has been worried in recent months about inflation. Stock futures were little changed after the report came out.Inflation is closing in on the Federal Reserve's 2% target, gasoline is heading toward a gallon, and companies are reporting cost pressures. Faster inflation could force the Federal Reserve to raise interest rates more quickly than planned.Frick believes unemployment will keep falling as businesses offer more attractive wages and benefits to fill openings."There's still hundreds of thousands of more people who will enter the workforce," he said. "I think we can get down to 3.5 percent."If unemployment falls much further, it will reach territory not seen in half a century. Unemployment fell as low as 3.8 percent in April 2000, in the waning days of the technology boom. The last time it was lower than that was 1969. 1898

The stockpiling frenzy that occurred in the spring during the first wave of COVID-19 may rear its ugly head again.Research from Inmar Intelligence shows that 57% of shoppers are planning to rebuild their stockpile as worldwide coronavirus cases surge in what experts call a second wave.In the months following the pandemic's beginning, cleaning supplies and toilet paper disappeared from store shelves as quickly as they were stocked.According to Inmar, 64% of shoppers said they took part in the spring stockpiling.By far, toilet paper (67%) and hand sanitizer (57%) are on top of the list when it comes to products that shoppers plan to hoard should they find it necessary to create another stockpile.Inmar Intelligence says it is now the responsibility of retailers to make sure supply meets demand as communities once again face possible shutdowns in the face of rising COVID-19 cases."Today's shoppers still have concerns around safety, availability, and convenience, and will continue to look to their local retailers to deliver consistency and seamless customer service across all touchpoints," said Inmar Chairman and CEO David Mounts in a press release. "As we enter one of the busiest shopping seasons, it will be important for retailers not only to prepare for this new surge in demand but also to deliver value to customers during this time of crisis to maintain heightened trust and customer loyalty."The firm stated that 27% of shoppers are considering a winter stockpile because they're concerned certain products won't be in stock when they need them.In comparison, another 27% are concerned about in-store shopping safety if a second wave were to happen.Other products that consumers have stocked up or plan to stock up on are paper towels (52%), disinfecting wipes (53%), and canned goods (54%).45% of shoppers said they plan to purchase new items such as frozen dinners, pasta, snacks, and cleaning products, which weren't in their first stockpile.This story was first reported by Jeff Tavss at KSTU in Salt Lake City, Utah. 2051

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