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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

At a quick glance through her office, you might think Laura Packard was working on the campaign trail. But this small business owner is fighting to keep her own title: cancer survivor.“A little over three years ago, I walked into a doctor's office with a nagging cough and walked out with a stage four cancer diagnosis. Everything changed for me all at once,” said Packard.She underwent chemotherapy and radiation over a six-month period. “I lost all my hair. Some days, I wouldn't be able to get out of bed, and there was a lot of pain,” she recalled.After multiple surgeries and hospitalizations, she said her bills were really piling up. “I think it was near a million dollars,” said Packard of her medical bills.She says, thankfully, her insurance through the Affordable Care Act saved her in more ways than one.“I've been self-employed off and on for over a decade, and I used to have junk insurance, and if I still had that insurance today, I would be bankrupt or dead,” said Packard.However, she’s worried this level of insurance coverage won’t last with the recent Supreme Court confirmation and once the election results become final.“The day after my first chemotherapy was when Republicans in the House voted to dismantle the Affordable Care Act, which was keeping me alive,” she said.As talks of repealing the ACA gained ground, she moved hundreds of miles away from family to live in Colorado.“Colorado has pretty good state-level protections, but nobody should have to live like this. Nobody should have to be a health care refugee in their own country just to get care, and state-level protections can only go so far. What you need is a federal law to protect everybody.”She, like so many Americans, is wondering how she will pay for her coverage if her costs go up. Packard is fearful her health will suffer if she can’t afford her premiums.“My life is in the balance, but millions of Americans are in the balance, too.”She is worried those with pre-existing conditions won’t be able to get the care they need at a price they can afford.She is also concerned the individual mandate for health insurance will be taken away. With fewer healthy people paying into the healthcare system, the system cannot help cover costs for people who are sick.“My fear is that the rest of the affordable care act will tumble because we won’t be able to sustain it in its totality,” said Michele Lueck, president of Colorado Health Institute.Packard is just one of millions being helped by the subsidies the Affordable Care Act is founded on, and while she knows the Affordable Care Act could be improved, she hopes it will be the building block for even better care, instead of waiting years for a new solution.“I don't even know how many people will die if they succeed in destroying the Affordable Care Act, because people will lose their insurance and people will die,” said Packard.The struggle is something all Americans have endured this year. This cancer survivor is just hoping this election will bring a confirmation that her health is valued.“In a pandemic, it's more clear than ever that we're all in this together and we need candidates and elected officials that work for the greater good,” said Packard. 3224

AUSTIN, Texas (AP) — Texas Lt. Gov Dan Patrick says he's offering up to million in defense of President Donald Trump’s unsupported claims of irregularities in the U.S. presidential election. The Republican said Tuesday he would pay out rewards for information that leads to voter fraud arrests and convictions. A former chief Texas ethics regulator suggested that paying reward money, which would come from Patrick’s political campaign, could run afoul of federal campaign finance laws. There's no evidence of widespread fraud in the 2020 election. 559

As screen time becomes a bigger part of students’ lives, preserving their vision is something to keep an eye on.Dr. Lauren Schneider, an ophthalmologist who has been treating patients in New York and Connecticut for six years warned screen time can cause a number of symptoms, including squinting and eye-crossing.“We do know that prolonged near work can place some children at risk for progressive myopia, which is worsening nearsightedness,” Dr. Schneider said.Doctors say tips on preserving your kids' vision during remote learning include making sure they keep a safe distance from their devices — at least 15 inches away from the screen is recommended — having them take screen breaks every 20 minutes and investing in a blue light blocker, which can be put on devices or glasses.“Some of our data suggests blue light emitted from our electronic devices may potentially be harmful long term to the center of the retina,” said Schneider Sunday.As school districts in the tri-state area continue to reopen this fall with full remote or hybrid learning models that include screen-based instruction, eye protection is another safety measure doctors say parents should have their sights on.“We want to make sure that while our students are hard at work which is going to require a lot of time in front of the computer that we’re avoiding unnecessary eye strain," Schneider said.According to medical experts, the full long term impacts on the eyes from remote learning are still being looked at, regular eye exams are highly recommended.For more tips and resources:www.visiontolearn.orgwww.childrenseyefoundation.orgwww.kidshealth.orgThis story was first reported by Jennifer Bisram at PIX11 in New York City, New York. 1726

At age 106, Sen. John McCain's Roberta McCain mother will be in attendance at the late senator's funeral this Saturday in Washington, D.C., and his burial service in Maryland, the Associated Press reported. Roberta McCain has outlived the son she called "Johnny," as the U.S. Senator from Arizona died on Saturday at the age of 81. Sen. McCain will be lain in state at the U.S. Capitol on Friday before his final services on Saturday. Roberta McCain, at age 96, was active on the campaign trail for her son during his presidential bid. She also made a number of appearances on television, including one controversial spot on MSNBC's Hardball, where she went after fellow GOP presidential hopeful Mitt Romney. Roberta McCain had an identical twin sister, Rowena Wright, who died at the age of 99 in 2011.  842

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