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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

ATLANTA (AP) — Two more Atlanta police officers have been fired over an incident in which two college students were pulled from a car during a protest against police brutality.Atlanta police confirmed Wednesday that Sgt. Lonnie Hood and Officer Armon Jones were fired as a result of their involvement in the May 30 incident.Atlanta Mayor Keisha Lance Bottoms and police Chief Erika Shields previously announced the firing of two other officers who were involved in the incident.Hood and Jones were among the officers caught on camera shouting at a young couple in a car in downtown traffic during the Black Lives Matter protests. The cops then proceeded to fire Tasers at the pair and dragged them from the vehicle.Throughout the incident, the man and woman can be heard screaming and asking what they did wrong.The four officers who have been fired and two other cops are facing criminal charges in connection with the altercation.Hood is charged with aggravated assault against both Young and Pilgrim for using a Taser against both of them, according to an arrest warrant obtained by The Associated Press. He is also charged with simple battery for violently pulling Pilgrim from the car and throwing her down on to the street, the warrant says.Jones is charged with aggravated battery for hurting Young’s left arm when he dragged him from the car and slammed him onto the street, the warrant says. He also is charged with pointing a gun at Young. Young suffered a fractured arm and a gash requiring two dozen stitches. 1529

ATLANTA (AP) — Rapper and actor T.I. has settled civil charges with the U.S. Securities and Exchange Commission that he helped promote a fraudulent cryptocurrency. T.I., whose real name is Clifford Harris, agreed to a civil settlement with the SEC that was announced Friday. He's paying a ,000 fine and agreeing not to sell or market similar securities for at least five years. A representative for T.I. did not immediately respond to an email seeking comment on Monday. The charges against Harris were part of a larger enforcement action against others including film producer Ryan Felton, who faces wire fraud and other charges in a 28-count indictment unsealed Wednesday. 685

At least one person is dead and hundreds of thousands of homes are without power as Hurricane Michael moves inland from Florida to Georgia.Michael made landfall Wednesday around 2 p.m. ET as a Category 4 storm near Mexico Beach, Florida. The strongest storm to hit the continental US since Hurricane Andrew in 1992, Michael dashed homes into pieces, swallowed marinas and left piles of rubble where shopping centers once stood.Now a Category?1 storm with winds up to 75 mph, the storm is moving across southwestern Georgia about about 17 mph near Albany. Meanwhile, flooding continues along the Gulf Coast, where downed trees and utility polls are making precarious rescue efforts even harder. 721

As more businesses open up, along with schools and colleges, there are still some hurdles many people need to get over when it comes to fears associated with COVID-19.Fox 17 spoke with Psychologist Dr. Lyndsay Volpe-Bertram from Spectrum Health about these fears."I don't think six or seven months ago any of us thought we'd be still in this current state," Dr. Volpe-Bertram explained, adding that the differences in the way people are handling the precautions is adding another layer of stress. "I think that range of reaction and behavior is also contributing to our overall stress because everybody is kind of taking a different approach to it."To address a balance, Dr. Volpe-Bertram recommends what's called "Ongoing Calculated Risk Assessment", similar to what many call risk vs. reward."We are looking at it as, 'Is this worth it to me?' Is what I'm going to get as a benefit back from having this experience or putting myself out there in some way, is that worth the possible exposure?", asked Dr. Volpe-Bertram.Essentially she recommends we be efficient and choosy in everything we do, even in socializing or explaining."Rather than saying, 'We have to say yes to everything'. Help us identify what are the most important events for us to be attending? Who are the most important people that we want to spend our time with?"Dr. Volpe-Bertram reminds, as the weather turns and flu season fast approaches, not to stress about it, but instead prepare for more mental well-being."It's important for us to start thinking about what our coping strategies are going to be in the Winter and how are we going to keep ourselves busy. Because we don't want people to stay holed-up in their houses, fearful of going out to places. But we want them to move and feel more comfortable in ways that are safe," said Dr. Volpe-Bertram.This story was first reported by Derek Francis at WXMI in Grand Rapids, Michigan. 1916

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