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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
Attorney General William Barr took aim at his own Justice Department on Wednesday, criticizing prosecutors for behaving as “headhunters” in their pursuit of prominent targets and politically charged cases.The comments at a speech at Hillsdale College in Michigan amount to a striking and unusual rebuke of the thousands of prosecutors who do the daily work of assembling criminal cases across the country.Barr described the prosecutors as part of the “permanent bureaucracy” and said they were in need of supervision from “detached,” politically appointed leaders who are accountable to the president and Congress.“The men and women who have ultimate authority in the Justice Department are thus the ones on whom our elected officials have conferred that responsibility — by presidential appointment and Senate confirmation,” Barr said, according to his prepared remarks. “That blessing by the two political branches of government gives these officials democratic legitimacy that career officials simply do not possess.”As Attorney General, Barr has been aggressive in pursuing certain categories of prosecution himself, including seeking federal charges against those arrested in protests following the death of George Floyd. In fact, later on Wednesday, Barr said wants prosecutors to be aggressive in charging demonstrators who cause violence.So far, more than 300 people have been charged with federal crimes in the protests that erupted following the death of George Floyd.An Associated Press analysis shows that many are accused of serious crimes like hurling Molotov cocktails, burning police cars and seriously injuring law enforcement. Others are not accused of serious crimes, prompting criticism that the effort is a politically motivated effort to stymie demonstrations. 1790

As millions of Americans avoid routine doctor’s appointments right now for fear of catching COVID-19, a decades-old practice is suddenly gaining new attention: the house call.“The notion of a house call means the care provider can get a more comprehensive view of you as a person,” explained Stacey Chang, who serves as the executive director for the Design Institute for Health.Chang says a reinvention of the house call could be a viable solution to America’s evolving post-coronavirus healthcare system. New portable technology means doctors can do more than just check your temperature.Health officials across the country are also worried that Americans in isolation are avoiding routine check-ups, which could lead to more long-term issues once the pandemic ends.“The care that didn’t happen, the routine care for managing chronic diseases, we may end up having greater mortality from those missed interventions than what COVID itself caused,” Chang added.Aside from keeping people away from hospitals where COVID-19 might be lurking, the house call gives physicians a chance to get to know their patients. Spending more than 10 minutes with someone in an office would give doctors a better chance to treat chronic diseases.“It’s really a relationship between the person that’s caring for you and the person you’re caring for,” Chang said. 1352
As the end of an incredibly contentious and the heated 2020 election season ends, new research suggests that Americans are more susceptible to falling prey to disinformation depending on which state they call home.For months, Bhaskar Chakravorti and his team at the Global Business School at Tufts University have been analyzing how misinformation has been spreading during this election cycle. Where a person lives often makes them a higher target to everything from fake Facebook accounts to fake Twitter accounts and even fake headlines."We are in extremely more dangerous territory now than we were two years ago," Chakravorti explained.Bad actors, the analysis found, are more likely to target people in states that are either facing hotly contested Presidential or Senate races. Chakravorti says in places like Florida, South Carolina, Kentucky, Montana and Arkansas, voters are more vulnerable to being hit with misinformation. In places like Georgia, Illinois, New Jersey and Minnesota, residents are less likely to be bombarded by false or misleading posts and stories.A person's age, education level and media consumption all weigh into the findings.Chakravorti also says that misinformation is more likely to spread and gain traction on social media."The misinformation is asymmetric in its power,” he explained. “It travels further and faster than truth and facts."Most troublesome right now, the amount of misinformation spreading about voting, from fake stories claiming people can vote after Nov. 3 to false information about mail-in ballot deadlines. Experts also say the spread of misinformation will likely continue long after Election Day.The non-profit Common Cause has also been studying the issue closely."It can result in more uncertainty when there’s already a decrease in the institutional trust and authority that many people feel with their government," said Jesse Littlewood, who works with the group.So, what's the best way to combat misinformation?Do it on the local level. People are more likely to trust information that comes directly from their city or state officials, especially about voting."It’s a real challenge for voters to stay abreast with all that changing information," Littlewood said. 2239
As mixed messages continue regarding face coverings, Mississippi became the first state to lift a statewide mask mandate. Cities and towns can now put their own rules in place.The governor said the facts and data still show masks work, and the state is still requiring them at certain events, including the state fair that starts this week.“I suspect Mississippi will see an increase in cases if people stop wearing face coverings,” said Dr. Amesh Adalja with the Johns Hopkins University Center for Health Security.Infectious disease experts remind people just because an order may be lifted, doesn't mean they should stop wearing masks.“We have to have an effective vaccine to prevent people from getting infected as well as prevent them from getting severe disease, that we had adequate testing capacity so people could know their status and wouldn't go out into public if they were positive,” said Adalja. “I think short of that, masks are going to be one tool that we have to continue to use and many people are going to get accustomed to masks and they're going to realize that masks also likely have some impact on other respiratory viruses, so we may see mask wearing much more common in the United States, similar to what it is in other Asian countries, because of the value people are gaining from them.”New research on homemade cloth masks found they expel invisible cotton fibers into the air. It’s unknown if those fibers can carry infectious viral particles, which drives home the point of washing any cloth facial coverings. Make sure you do that regularly. 1580
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