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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, Ga. -- Musicians across the country performed for voters to bring unity and hope in a divisive time."Music is therapeutic," said professional saxophonist Christopher King. "It's like that one time that we can all come together whether we're Democrat or Republican."After months of divisive politics, King and other musicians came together through Play For The Vote. Their mission: lift worries and burdens from voters' shoulders and create a different feeling at the polls this Election Day."With everything we've been through since the beginning of this year, you can turn a negative into a positive," said King of this moment in history.Poll workers across Atlanta expected crowds of voters lined up around the building, but the day was quiet. The average wait was under five minutes. For musicians Ally Jenkins and Brian Raddock, performing on Election Day, even to a small crowd, was a moment of triumph, especially in a time where their life’s work has been slipping through their fingers."It's been a nightmare," said Jenkins, a violinist. "Everything was canceled within like three days of each other, and this is tens of thousands of dollars of income and also our purpose for living."Her longtime friend and fellow musician, Brian Raddock, feels her pain. "Devastating is putting it lightly, and in a lot of ways, and it's just because we're both freelancers. It's really show to show," he said.These two have played on Broadway and across New York City until COVID-19 shut their livelihoods down."I feel the most alive when I'm playing music, and to not have that with other people, it's it just kind of makes you feel a little bit lost when you're having to do it by yourself," said Raddock.But Election Day brought back a glimpse of normalcy. "To see some people smile while we're playing music and to use art to really help bring some more beauty into the world, I can't really even describe what it means. It's just wonderful," said Raddock.Their audience, mostly poll workers, agreed. "It was fun. It lifted your spirits to hear them. They're so talented, they're so good, and then to hear their plight, that's just something you hadn't even thought about," said Pattie Harris, an election volunteer.Thousands of musicians across the country are experiencing the same struggle. That’s why so many came together for Play for the Vote. Hundreds of artists volunteered across 48 states to play for voters, but also to start a movement lasting far beyond this year’s election."Music is the one universal language. There's just really a power of connection, that we can communicate, yet not know each other. I just hope that they walk away with a reminder that art and music is something that is a connector between all of us through all of our differences," said Raddock.A connection needing just one smile, just one look for these musicians to know: their life’s work is worth the fight.If you'd like to help support musicians struggling during the pandemic, you can help through Play for the Vote or through the Music Workers Alliance. 3066

Attorneys for the suspect in a deadly shooting at a Kentucky grocery store entered not guilty pleas on his behalf during his arraignment Friday.Gregory Bush, a 51-year-old white man, is accused of fatally shooting two African-Americans in the Kroger grocery store in Jeffersontown, and in the parking lot. Authorities have said the shootings appear to be racially motivated.Bush has been charged with two counts of murder, one count of attempted murder, and two counts of wanton endangerment for the October 24 shooting."It's particularly in times of loss and tragedy that our Constitution and our laws can be particularly tested, so Mr. Bush, of course, has rights to due process and a fair trial that we all are honored to have," public defender Angie Ellerman told CNN affiliate WAVE. 795

As New Haven, Connecticut, Fire Chief John Alston Jr. spoke to reporters about a spate of drug overdoses on Wednesday, he heard shouting coming from behind him."We're getting another call of a person," Alston said.He quickly helped coordinate the response, and then returned to the microphone.That scene came on the same day that as many as 40 people in the area of New Haven Green were believed to have overdosed on some form of K2 that may have been laced with opioids, according to New Haven police spokesman Officer David Hartman.New Haven Green is a large park and recreation area in the city's downtown.The patients included people of various ages and demographics, Alston said."It's a nationwide problem. Let's address it that way," he said. "It's a nationwide problem that people are self-medicating for several different reasons, and every agency -- police, fire, medical hospitals -- all are strained at this time. This is a problem that's not going away."New Haven police said one person is in custody.Director of Emergency Operations for New Haven Rick Fontana said the patients had symptoms of increased heart rates, decreased respiratory rates and a lot of vomiting. Some people were unconscious, others were semi-conscious.No one has died, but two individuals are considered to be in serious, life-threatening condition. Some individuals who were released from the hospital needed to be treated a second time for an additional apparent overdose, Fontana said.K2 is a synthetic cannabinoid related to marijuana that is frequently laced with other drugs, said Dr. Sandy Bogucki of the Yale School of Public Health.In two cases, Narcan was not effective in the field, but a high dose of Narcan at the hospital was effective in combating the overdose effects. Because of that, authorities believe there was some form of opioid or synthetic fentanyl involved in the substance.The response from emergency responders has been "tremendous," Fontana said.He said authorities have been treating and sometimes transporting six or seven people at one time and the actions of first responders have been "lifesaving." 2131

BABSON PARK, Fla. — A second university in Polk County, Florida has announced that they will be joining a program that will allow its staff and faculty to legally carry guns on campus.The announcement comes just eight days after a gunman opened fire on a Florida high school killing 17 people.The Polk County Sheriff's Office, in partnership with Webber International University, is establishing the Sheriff's Sentinel Program to enhance the safety of an already safe and secure community of students, faculty, staff, and guests at the University's campus in Babson Park, Florida."Prayers are not enough," Polk County Sheriff Grady Judd said in a press conference on Thursday. “The only thing that stops a bad guy with a gun is a good guy with a gun."Sheriff Judd explained that each teacher or staff member will have to go through extensive training through the program before they are given a gun."My babies — your babies — are in that classroom, and that active shooter is coming down the hallway with that thousand yard stare and that gun in their hand, do you want somebody to step out and stop him? Or do you want him to go into the classroom and slaughter your babies?" 1194

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