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Johnson & Johnson announced it has paused its coronavirus vaccine trials on Monday following an “unexplained illness” among one of its participants.Johnson & Johnson stressed that adverse events during trials are expected, and a pause gives researchers an opportunity to review all of the medical information before moving forward with the trial. Johnson & Johnson added that it’s not always immediately known if the affected person received a placebo or a study treatment.Among the trials paused was Johnson & Johnson’s multi-country “ENSEMBLE” vaccine, which entered Phase 3 testing in September. Johnson & Johnson said last month that its goal was to seek an emergency use authorization approval in early 2021.The FDA noted that a vaccine candidate must be at least 50% effective to receive emergency use authorization. Vaccine candidates should include a median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s risk-benefit.According to the FDA, a typical Phase 3 trial would take one to three years.“NIH is committed to supporting several Phase 3 vaccine trials to increase the odds that one or more will be effective in preventing COVID-19 and put us on the road to recovery from this devastating pandemic,” said NIH Director Francis S. Collins, M.D., Ph.D. “We also know that preventing this disease could require multiple vaccines and we’re investing in those that we believe have the greatest potential for success.” 1554

Jared Kushner told a software developer who worked at his newspaper, the New York Observer, to delete several "critical" stories in 2012, according to Austin Smith, the developer who said he "complied."Smith now has regrets about his involvement.Kushner was seeking to erase Observer stories that were "critical of his commercial real estate colleagues," Smith said in a Hacker News message board post.Back then, Kushner was the publisher of the Observer. Now he is a senior adviser to President Donald Trump.Smith said he was inspired to speak out by a recent Hacker News discussion about unethical behavior, plus the president's usage of extreme "enemy of the people" rhetoric to attack journalists."I didn't know any better then, but I do now," Smith said in a series of tweets on Monday.He said he is sorry for deleting stories by Observer staff members.BuzzFeed highlighted the deletions on Monday. A "handful of articles" were affected. The White House press office did not respond to requests for comment.According to emails seen by BuzzFeed's Steven Perlberg, Kushner went around the paper's editors "to mandate the removal of a handful of articles from the website."BuzzFeed noted that "the secret removal of stories due to outside pressure is widely regarded as an unethical practice in journalism."The editor at the time, Elizabeth Spiers, said on Twitter that she found out about this action "a few months ago." Her reaction: "I don't have enough choice expletives describe my feelings about that."How could Kushner pull this off without the newsroom knowing?"When you publish some 50 odd stories a week, you don't notice two or three missing here and there weeks after fact," Spiers told CNNMoney."We also had a couple of site redesigns and site search was abysmal," she added. "So if you didn't immediately find something in search there were more likely (at the time) explanations."Spiers has been critical of Kushner and other Trump White House officials.Kushner resigned from the Observer when he joined the Trump administration in January 2017. He transferred the paper into a family trust. 2116

Joe Biden is poised to unveil his vision for the modern Democratic Party in the first presidential nominating convention of the coronavirus era, an all-virtual affair that will test the former vice president’s ability to overcome unprecedented logistical challenges in an urgent mission to energize a winning coalition.The Democratic National Convention, which formally begins Monday, is not a convention in the traditional sense. There will be no physical gathering place, no cheering audience, no balloons. The program will consist instead of a series of online video addresses — half of which will be pre-recorded — that play out for two hours each night until Biden formally accepts the Democratic presidential nomination in a mostly empty Delaware ballroom on Thursday.Along the way, Biden’s party will make history by unveiling the nation’s first Black vice presidential nominee, Kamala Harris. The speaking program also features two former presidents, two past presidential nominees, one former first lady, a former Republican governor, a New York ultra-billionaire and various working-class Americans.“Nothing about 2020 has been normal. So I don’t think anyone expected that this convention would be normal either,” said Atlanta Mayor Keisha Lance Bottoms, who was under consideration to serve as Biden’s running mate and will speak at the convention. “I hope wherever people are that they’re excited about the moment and the opportunity that lies before us.”The online gathering comes as Democratic officials work to energize supporters behind Biden’s candidacy — not simply against President Donald Trump’s. While Trump is a huge motivator for many Democrats, there is some concern within the party that lower-information voters who lean Democrat and swing voters aren’t locks to cast ballots for Biden this fall, especially as the pandemic creates barriers to voting.At the same time, Trump and his allies are fighting to scare away would-be Biden-Harris backers by describing the Democrats’ 2020 ticket as the most ideologically extreme in American history. While widely considered a political moderate — at least compared with the likes of Vermont Sen. Bernie Sanders and Massachusetts Sen. Elizabeth Warren — Biden’s plans to implement a Medicare-like system for those who want it, sweeping environmental protections and higher taxes on the rich would represent a major shift to the left.Still, Biden attracted the support of former Ohio Gov. John Kasich, a Republican, who is scheduled to speak Monday. The Biden campaign hinted that Kasich would not be the only high-profile Republican featured at the convention, but refused to say more.The inclusion of Kasich, who opposed abortion rights and fought labor unions while in office, rankled some progressives. One of the far-left’s champions, New York Rep. Alexandria Ocasio-Cortez, is scheduled to speak for just 60 seconds to help introduce Sanders on the same night as Kasich. Prominent liberal activist Ady Barkan, who previously backed Sanders, is scheduled to deliver remarks the next day.“I’m glad that John and other moderate-type Republicans understand that it is wrong to be supporting Trump,” Sanders told The Associated Press. “But what John says has nothing to do with what I will say. My speech has everything to do with the need to defeat Trump, elect Biden and move the country into a government that works for all of us and not just the 1%.”There appears to be far less tension among the Democrats’ often-competing factions heading into the 2020 convention than many predicted earlier in the year. Just six months ago, political operatives were openly contemplating the prospect of a so-called contested convention in which none of the Democratic candidates had a clear delegate majority going into the convention.That possibility quickly faded in early March. After Biden’s commanding South Carolina primary victory, several competitors suddenly rallied behind him as the pandemic began to explode.Even if there was leftover resentment among wings of the party, the convention’s online forum doesn’t provide any opportunities for public infighting. Key votes on the party platform already will have taken place by mail ballot. The details, which are expected to be approved overwhelmingly, were hammered out in Zoom meetings.Progressives got their say when they extended party rules through 2024 that ban so-called “superdelegates” from voting for the party’s presidential nominee on the first nominating ballot.But without the opportunity for the approximately 4,800 Democratic delegates from across the country to gather on the same convention hall floor, as is tradition, the opportunity for a genuine convention debate over the direction of the party has been eliminated.Larry Cohen, a prominent Rules Committee member and Sanders’ confidant, lamented the loss of an in-person convention, but not because it limits debate.“The key of a convention, really, is the party building that comes with 57 different delegations,” he said, noting the in-person daily meetings that would occur in hotels across a host city. “You shape the party in those breakfast meetings, where you argue over what it means to be a Democrat in Wyoming, what does it mean in Georgia.”With less focus on policy debates, convention officials are highlighting the historic racial diversity on the ticket as the nation experiences a national awakening on race. Harris, who is also of Asian descent, is scheduled to address the nation Wednesday night as the first woman of color on a major party’s presidential ticket.The high-profile Black speakers also on the program include former first lady Michelle Obama, former President Barack Obama, New Jersey Sen. Cory Booker and Lance Bottoms, who will introduce a video tribute to the late Georgia Congressman John Lewis on Thursday night ahead of Biden’s speech.“For so many people of color in this country, race is always at the forefront,” Lance Bottoms said. “To be able to have this collective conversation in so many ways is cathartic, especially as we’re going into an election year, because there won’t be any secrets about what people across this country expect from the next administration.”Despite the focus on racial justice, Rev. Al Sharpton, a civil rights activist, predicted next week’s convention would “lack excitement.” He said it likely doesn’t matter, however, especially as Trump and his party prepare for their convention the following week.“As excited as I am about Kamala Harris, the best weapon Democrats have is Donald Trump,” Sharpton said. “He will do himself in. Just don’t get in his way. He will beat himself.”___Barrow reported from Atlanta. AP writer Will Weissert in Wilmington, Delaware, contributed. 6747

JCPenney is in serious trouble. There's no sugarcoating it.The department store chain, famous for its Christmas catalogs, is losing money — and customers. It has a lot of debt. And not much cash.A dismal earnings report on Thursday only reinforced that time is running out. JCPenney reported an adjusted loss of million in the first quarter, even worse than Wall Street was expecting, and lowered its projections for the year. Sales fell 4 percent, also missing estimates.Much like floundering rival Sears, JCPenney is struggling to adapt to the changing retail landscape as people increasingly shop on their phones. 628

JAPATUL VALLEY (CNS) - A fire that has blackened 17,665 acres in rural eastern San Diego County remains at 87% containment Sunday, authorities said."Fire activity was minimal overnight as firefighters continue to mop up hot spots and secure the fire perimeter," according to a U.S. Forest Service news statement. "Structure defense remains a priority for values at risk. Every day the fire stays within its current perimeter, the threat to the adjacent communities continues to diminish. High pressure over Southern California will result in a warming trend into the middle of the week."The Valley fire, southeast of Alpine, has destroyed 30 residences and 31 outbuildings, damaged 11 other structures and injured three firefighters.RELATED: Resource event gets Valley Fire victims back on their feetFire activity was limited Saturday as firefighters continued to mop up hot spots and secure the fire perimeter, officials said. A high-pressure system was expected to keep temperatures high through the rest of the weekend.At noon Friday, Cal Fire announced that all evacuations and road closures necessitated by the conflagration, dubbed the Valley Fire, had been lifted.Saturday morning, the county announced the reopening of the Lake Morena and Potrero campgrounds that had been closed during the evacuation orders. Campsites were available to book at http://reservations.sdparks.org.However, the Cleveland National Forest remained closed to the public until further notice "to protect natural resources and provide for the safety of the public and firefighters," Cal Fire advised.RELATED: Valley Fire claims Jamul woman's home, beloved animals"This closure will stay in place until conditions improve and we are confident that national forest visitors can recreate safely," officials with the state agency said.The blaze erupted for unknown reasons early Sept. 5 off Spirit Trail and Carveacre Road and spread rapidly through tinder-dry vegetation amid sweltering heat and high winds, Cal Fire officials said.The agency cautioned those returning to the fire-ravaged area to "use extreme caution around trees, power poles and other tall objects or structures that may have been weakened" by the blaze.The San Diego County Sheriff's Department was increasing its patrols in the area to ensure public safety and prevent looting.Officials advised that motorists in the area could face traffic disruptions due to the continued presence of firefighters, law enforcement personnel and utility workers still in the area.Non-residents were asked to avoid locales in and around the burn zone if possible.About 140 San Diego Gas & Electric customers in Alpine, Barrett Lake, Dehesa, Lyons Valley and Rancho Palo Verde lost power during the fire fight.Due to smoke drifting over much of the San Diego region, the county Pollution Control District advised that the air quality might be unhealthy in some local communities and advised people to limit outdoor activities until conditions improve.Gov. Gavin Newsom declared a state of emergency for San Diego County on Sunday Sept. 6 due to the Valley Fire, a move intended to free up federal relief funds.County officials encouraged people who have lost their homes or other property to the wildfire to call for assistance at 858-715-2200 or email valleyfirerecovery.@sdcounty@ca.gov.Additionally, a county assistance center for victims of the blaze will be in operation at Rancho San Diego Library, 11555 Via Rancho San Diego, on Saturdays and Sundays from 10 a.m. to 6 p.m. and Mondays from 11 a.m. to 7 p.m. until further notice.Those who would like to help victims of the fire can make donations to a disaster-relief fund implemented by the San Diego Foundation, which can be accessed online at sdcountyrecovery.com. 3770