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As questions arise over when a coronavirus vaccine should be granted FDA approval, the leaders of several major pharmaceutical companies announced they have signed a pledge not to rush the development of a vaccine.The companies, AstraZeneca, BioNTech, GlaxoSmithKline, Johnson, Merck, Moderna, Novavax, Pfizer and Sanofi, released a joint statement on Tuesday confirming the pledge.The pledge includes the following points:Always make the safety and well-being of vaccinated individuals our top priority.Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes.Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.There has been pressure on both the FDA and manufactures to develop and approve a vaccine for the coronavirus. There have been more than 190,000 coronavirus-related deaths in the US since March, and the economic impact of the virus has cost millions of jobs.While most developed countries have not had the same public health pain as the US, the economic impact of the virus has been felt worldwide. The International Monetary Fund estimates a nearly 5% loss in global GDP in 2020.In Russia, the country claimed to begin distributing a coronavirus vaccine despite US-based vaccine candidates likely being months away from being able to demonstrate efficacy.The pressure domestically has also ratcheted up as President Donald Trump has suggested a vaccine could be ready by this fall’s presidential election."We're going to have a vaccine very soon... maybe even before a very special date, you know what date I'm talking about,” Trump said on Monday.In late August, the CDC told states to begin to prepare distributing a vaccine by Nov. 1. But Surgeon General Jerome Adams said that just because states will be ready to help distribute a vaccine on Nov. 1 does not mean a vaccine will be ready by then."We've always said that we're hopeful for a vaccine by the end of this year or the beginning of next year,” Adams told Good Morning America."We want to make sure states are available to distribute it," he added.The companies signing on the pledge said that the FDA has strict protocols for vaccine candidates. A typical vaccine trial takes one to three years, but the companies believe only a safe and effective vaccine will be granted approval.“FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US,” the companies wrote in the pledge. “FDA’s guidance and criteria are based on the scientific and medical principles necessary to clearly demonstrate the safety and efficacy of potential COVID-19 vaccines. More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.” 3296
Authorities in Texas say a partially-dressed woman who was captured on a home surveillance system ringing a doorbell early one morning is safe after officials discovered her boyfriend died of a self-inflicted gunshot wound.According to ABC News, five days after the 32-year-old woman was recorded on a Ring doorbell’s surveillance camera, the woman was located and is reportedly safe, police said.The Montgomery County Sheriff's Office said on Wednesday they responded to a home in the Sunrise Ranch subdivision after receiving reports of a 49-year-old man threatening to kill himself.Deputies attempted to knock on the door multiple times before making forced entry into the home, officials said. When they made their way inside, they discovered the man lying dead of a single gunshot wound.Authorities tell local news outlets they believe his death is a suicide.The man left a note and mentioned his girlfriend but police say she was not at the scene by the time officers arrived. The woman was later identified as the person ringing a stranger's doorbell early in the morning.Last Friday, the woman was seen ringing a doorbell in the neighborhood north of Houston around 3:20 a.m., the MCSO said. The woman left the home before the resident answered the door.The eerie video of the woman was widely shared on the Internet as people on social media feared the woman — who was seen only wearing a T-shirt and broken hand restraints — was in danger. Authorities aren’t releasing any information about the woman because she is a victim of domestic violence. However, local media outlets report that she is from the Dallas area and is staying with family.Officials say they'll be meeting with the woman as the investigation continues.SEE VIDEO BELOW: 1776

At a small store off a two-lane road in rural South Carolina, "lightning struck," the excited mayor of Simpsonville said Wednesday.Mayor Janice Curtis said she found out from a reporter that the winning ticket in the .537 billion Mega Millions drawing had been sold in her town.According to the mayor, the journalist asked, "How do you feel about this happening in little ol' Simpsonville?' And I about fell out. I had no idea. Can you believe it? One ticket! Here!"Simpsonville is the kind of town where farm fields are giving way to housing developers. The city grew from 18,000 to 22,000 people as the Greenville suburbs encroached over the past seven years. 671
At Monday’s NASCAR event at Talladega Superspeedway, drivers and crew members stood in solidarity with Bubba Wallace, a Black NASCAR driver who said he found a noose in his stall on Sunday.The drivers pushed Wallace’s car to the front of the field moments before the race got underway. 293
At a contentious meeting on Monday, the Department of Justice's antitrust chief gave AT&T a choice: to get your purchase of Time Warner done, either sell off CNN's parent unit or DirecTV, or we'll see you in court.The government is holding up AT&T's pending acquisition of Time Warner, stirring speculation that the Trump administration is trying to retaliate against CNN for its coverage of the president.According to two sources with knowledge of the meeting, the DOJ is demanding that AT&T divest all of Turner, the unit of Time Warner that includes CNN as well as TNT and TBS."Threatening Turner is a fig leaf for threatening CNN," one of the sources said.AT&T is said to be reluctant to sell assets, especially Turner, which represents a significant portion of Time Warner's profits.Earlier on Wednesday AT&T said the timing of the deal's closing is now "uncertain.""We are in active discussions with the DOJ," John J. Stephens, chief financial officer for AT&T, said at a Wells Fargo conference.The stock of Time Warner, which owns CNN, fell more than 6.5% by Wednesday afternoon. AT&T was flat.The New York Times and the Financial Times also reported Wednesday afternoon that the DOJ was demanding the sale of CNN or Turner as a condition of approving the deal.The wireless giant previously said that it expected the acquisition to take effect by the end of this year. The deal was announced more than a year ago.The U.S. government is causing the delay. Stephens' comments effectively confirmed last week's Wall Street Journal report that the government is "actively considering" an antitrust lawsuit to block the impending acquisition.While the Justice Department declined to comment, sources had told the Journal that the department will sue if it can't reach an agreement on so-called "conditions" that are attached to the deal.The Journal story was an unwelcome surprise for AT&T executives. Transactions like Comcast's acquisition of NBCUniversal in 2011 are routinely approved with conditions attached."For over 40 years, vertical mergers like this one have always been approved because they benefit consumers without removing any competitors from the market," AT&T said last week. "While we won't comment on our discussions with DOJ, we see no reason in the law or the facts why this transaction should be an exception."The Justice Department's hardline approach to AT&T -- belying the business-friendly image of the Trump administration -- has spurred questions about Trump's personal interest in the deal.Time Warner's portfolio also includes Warner Bros., HBO, TNT and TBS.As a candidate, President Trump publicly vowed to block the deal. As president, he frequently criticizes CNN. Over the summer The New York Times reported that Trump aides discussed using the pending deal as a powerful form of leverage over CNN's coverage."You have to wonder" about the behind-the-scenes machinations "given that Trump has a vendetta against CNN and has openly talked about using these types of deals to punish them," Trevor Timm, the executive director of the Freedom of the Press Foundation, told CNN last week.On last Sunday's "Reliable Sources" on CNN, when asked whether Trump has had any involvement, counselor to the president Kellyanne Conway said "we're not going to interfere with that here."When asked whether the president still personally opposes the AT&T-Time Warner deal, Conway said, "I haven't discussed that with him lately."Trump was quoted criticizing the DOJ several times last week. He said he wants the department to investigate his political rivals, including Hillary Clinton.AT&T has declined to directly comment on concerns about political interference.But Stephens reiterated confidence in the deal at Wednesday's Wells Fargo conference, saying "these types of mergers bring great benefit to customers and have very routinely been approved by the DOJ and the federal government."AT&T and Time Warner agreed to the billion deal last fall.The-CNN-Wire 4047
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