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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

As the saying goes, beauty is in the eye of the beholder. And when it comes to appreciating art, that may be more true than ever. It's so subjective and comes down to true appreciation. One woman understands that more than most.To Myrna Hayutin the photos on her gallery wall are more than pictures of the past. She points out some of the art on display.  "This is a limited edition signed by Carl Mydans," Hayutin said. "This is Babe Ruth the last time he put on his uniform."These are works of art."It is history," Hayutin said. "It's just knowledge."And for the last 35 years she's been selling fine art like these pieces, despite the fact that she's legally blind."I anticipate doing this for at least another 10 years," Hayutin said. "As long as my eyesight holds."Hayutin started losing her eyesight when she was eight due to retinitis pigmentosa. And over the years, it's gotten progressively worse."It's like an island," Hayutin said. "As the disease progresses the island gets smaller and smaller now I see through two straws. So you may be standing right here but I am not seeing you. Or if were talking and you move I'll lose you."Still it hasn't affected her love for art or her determination to purse it as a career."It never occurred to me to stop me from doing anything that I really wanted to do," Hayutin said.Hayutin runs a successful international fine art gallery, Gallery M, and recently became an art appraiser."I'm looking at the artwork but honestly thank goodness with my devices I can really zoom in and see them much, much better," Hayutin said.Hayutin said her dog, Gouda, helps her navigate the changes in her eyesight, but what helps most is not focusing on what could happen."I would never have opened the gallery if I was fearful of what would be instead of what was at that time," Hayutin said. "I try to live in today and use the eyesight that I have today."Hayutin said every day is what you make it."There are some days where I'm not as positive as I should be, but I try it," Hauytin said. "I try to get back on that positive I mean because I'm surrounded by all of this gorgeous art and that's very uplifting."  2212

ATLANTA (AP) — A federal judge is permanently blocking Georgia’s 2019 “heartbeat" abortion law, finding that it violates the U.S. Constitution.U.S. District Judge Steve Jones ruled against the state Monday in a lawsuit filed by abortion providers and an advocacy group.Jones had temporarily blocked the law in October, and it never went into effect.The new ruling permanently enjoins the state from ever enforcing House Bill 481.The measure sought to ban abortions once a “detectable human heartbeat” was present, with some limited exceptions.Cardiac activity can be detected by ultrasound as early as six weeks into a pregnancy.Jones found the law violated the 14th Amendment. 685

Authorities have intercepted bombs intended for former President Barack Obama and Hillary Clinton, and several other top political figures were targeted in what authorities are investigating as a connected series of incidents.Also, CNN's New York bureau in the Time Warner Center was evacuated after a package containing a bomb, addressed to former CIA Director John Brennan, was discovered, city and local law enforcement officials said.In addition, sources told CNN that a suspicious package intended for California Democratic Rep. Maxine Waters was intercepted at a congressional mail screening facility in Maryland; New York Gov. Andrew Cuomo received what he said was a device at his Manhattan office; and the San Diego Union-Tribune evacuated?its building after "suspicious looking packages" were spotted outside.The developments, which unfolded rapidly and continued steadily into the afternoon, touched off fear and confusion and immediately invited questions about the motives of those responsible. The recipients of the packages are all prominent targets of right-wing criticism and, in many cases, of President Donald Trump himself."This clearly is an act of terror attempting to undermine our free press and leaders of this country through acts of violence," New York Mayor Bill de Blasio said at an afternoon news conference.CNN, citing a law enforcement official, was initially told a suspicious package containing a pipe bomb that was addressed to the White House was intercepted at Joint Base Bolling in Washington, DC. The Secret Service, however, later said it had only intercepted the two packages intended for Obama and Clinton and called reports of a package headed for the White House "incorrect." 1742

Back in theatres for a LIMITED TIME, watch Chadwick Boseman as Jackie Robinson in 42. Tickets: https://t.co/xw3qukokfp pic.twitter.com/jYiU4VVfLv— Cinemark Theatres (@Cinemark) September 2, 2020 202

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