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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 President Donald Trump attempted to sow doubt on this week’s presidential election during a Thursday news conference, several Republican lawmakers criticized Trump for his comments.Currently, Joe Biden is projected to be ahead in the Electoral College vote. Biden is ahead by a 264-213 margin, according to the Associated Press.Trump made a multitude of false and misleading statements to sow doubt into the legitimacy of the election. Among them, Trump said that he won the state of Michigan. Biden won Michigan by a 150,000- vote margin.Maryland Gov. Larry Hogan was among those who offered the strongest criticism of Trump. 637
ATLANTA, Ga. – For more than six decades, Manuel’s Tavern has been the spot in Atlanta for people who love politics.“The quintessential political bar,” said Angelo Fuster, who knew the tavern’s original owner, Manuel Maloof, who got into politics himself decades ago. “Every election, we've been here. It is a place that a lot of people here gravitate to.”Folks will be there again on January 5, because the nation’s political attention is now zeroing in on Georgia, where the fate of the U.S. Senate hangs in the balance.Georgia isn’t exactly used to all this attention. The state has reliably been a Republican stronghold for decades. In 2020, though, it’s emerged as the last of the battleground states, with the final two Senate races of this election cycle.In one race, incumbent Republican Sen. David Perdue faces Democratic challenger Jon Ossoff. In the second race, incumbent Republican Sen. Kelly Loeffler faces Democratic challenger Raphael Warnock.“For all those Georgians who are tired of the campaign ads, of their mailboxes being flooded with advertisements from campaigns as well -- get used to it,” said Bernard Fraga, an associate professor of political science at Emory University in Atlanta.Fraga said both major political parties will be throwing their efforts into the two Senate races.“We're gonna have another two months of both sides, the Democratic and Republican candidates, but also the national parties, nonprofit organizations, mobilization groups, working their hardest to make sure that their campaigns win and that voters are active and engaged,” Fraga said.Craig Eberhart is with Men of Higher Standards, a nonpartisan, African American men’s group, focusing on voter registration in Georgia.“It’s gonna be bananas,” Eberhart said.People who live in Georgia can still register to vote through the first week of December. Eberhart believes the state is ready for its place as a battleground state.“For the forthcoming future, Georgia is going to be one of those states that you can't take for granted, you don't have in your back pocket,” Eberhart said. “You're going to have to work to get the vote of the people in Georgia.”Back at Manuel’s Tavern, Angelo Fuster wonders if this runoff might be different from those in years past.“We don't have a real good record of turning out for runoffs,” Fuster said. “I think that there's that energy.”Energy left because the sun hasn’t set on the 2020 elections quite yet. 2454
As the NHL went into what it calls “Phase 2” of its plans to resume the 2019-20 season, the league announced that 23 players tested positive for the coronavirus.The 23 players who tested positive is in addition to 12 players who previously tested positive in early June when the league began “Phase 1” of its reopening plan. All told, the league has had 35 players test positive.So far, the league has administered a total of 2,900 tests, with 396 having been tested so far. The tests have been administered to players representing 24 of 31 teams who will participate in the league’s postseason.The league said it will not identify those who test positive for the virus.The league suspended play in mid-March in an effort to help stop the spread of the virus. The league left off as most teams played roughly 70 games of an 82-game schedule.Days after the league’s shutdown, an Ottawa Senators player became the first player to test positive for the virus.When the league resumes, a tournament be held to conclude the season with games played between two “hub cities.” With coronavirus cases declining in Canada while still on the rise in the US, it is likely the NHL will conclude its season north of the border. 1221
As Tropical Storm Laura began setting its sights on Puerto Rico, and eventually, the Florida coast, Tropical Storm Marco formed late Friday.Marco has top winds of 40 MPH, but is expected to gain strength by the time it reaches the Gulf of Mexico. As of late Friday, however, the storm is not forecast to reach hurricane strength.The storm is then expected to head for the Texas or Louisiana coast.In the meantime, Marco is expected to hit Mexico’s Yucatan Peninsula this weekend.Tropical Storm Laura is also headed toward the Gulf of Mexico, but instead of approaching from the South like Marco, Laura is coming from the east.Laura has top winds of 45 MPH as of late Friday. Before reaching the Gulf of Mexico, it is expected to skirt Puerto Rico and Hispaniola and Florida.The combination of Marco and Laura could cause havoc for emergency managers next week. Laura could two US mainland landfalls – the Florida east coast and somewhere in the Gulf of Mexico. 968