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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 (KGTV) - An Atlanta Delta flight was forced to return to the ground shortly after takeoff when black smoke began billowing from one of its engines.The Delta aircraft took off from Hartsfield-Jackson Atlanta International Airport Wednesday shortly after 6 p.m. EDT when the smoke was reported, according to airport officials. Multiple reports indicate the plane was heading for London's Heathrow Airport.About 43 minutes after takeoff, the plane returned to the ground and airport fire crews hosed down the engine. The plane was then towed back to its terminal.RELATED: Southwest passenger is first to die on a US airline since 2009No injuries were reported and the airport endured "minimal impact" to other operations, officials said.The emergency landing occurs one day after a Southwest Airlines plane blew an engine while traveling from New York to Dallas and was forced to land in Philadelphia.Jennifer Riordan, 43, was struck by shrapnel from the engine and partially sucked out of a window. She later died from her injuries. Seven other passengers were also injured in the incident. 1144
As the NBA prepares to resume the 2020-21 season tomorrow, basketball commissioner Adam Silver told Good Morning America on Wednesday that the league would “cease completely” if an outbreak of the virus occurred within the league.Silver’s comments come as baseball’s Miami Marlins has had a number of its players and coaches test positive for the virus in recent days, forcing the team to suspend play for the week. Likewise, the Philadelphia Phillies, which played the Marlins last weekend, have suspended several games this week.“it’s not an exact science because nobody’s ever done this before,” Silver said. “I think we have plans in place where we might pause, similar to what baseball is doing now. Probably, if we had any significant spread is immediately stop. One thing we’d try do is try to track those cases to determine where they’re coming from and whether there had been spread on campus. Ultimately, I think we would cease completely if we saw that it was spreading around the campus and something more than an isolated case was happening."Unlike baseball, basketball has kept its players in a “bubble” in Orlando, Florida. Even though the virus is circulating through the state, the latest round of COVID-19 tests showed no players or coaches tested positive for the virus in Orlando.But that hasn’t stopped Silver from being anxious about the resumption of play. After all, it took just positive test, Utah Jazz star Rudy Gobert, to shut down the league back in March.“There is a high case rate in Florida down in Orange County, where Orlando is, as well obviously what is happening in baseball with the Marlins, so it is something we are keeping track of very closely,” Silver said. “We have confidence in this protocol that we designed… Everyone that is on that campus is tested on a daily basis.”The MLS and NHL have followed similar plans by isolating players. Both leagues have in recent days not reported any COVID-19 cases. The MLS had two teams withdraw from its mid-season tournament due to the spread of the virus, but has been virus free for two weeks. 2089
AUSTIN, Texas (AP) — Democratic presidential candidate Beto O'Rourke says President Donald Trump should resign as Congress begins an impeachment investigation.O'Rourke said Saturday there shouldn't be a fear of an impeachment probe intensifying partisan divisions. The former Texas congressman said at the Texas Tribune Festival in Austin that he believes impeaching Trump would ultimately unify the country.But O'Rourke says "the best thing" Trump can do at this point is to step down. Trump defiantly denies any wrongdoing.The 2020 Democratic presidential field is unanimous in its support of Congress for launching an impeachment investigation. The White House's handling of Trump's calls with foreign leaders is at the heart of the House impeachment inquiry.O'Rourke has been lagging in the polls but says he's in the race "until the very end." 856
BALDWIN PARK, Calif. - Arson officials in Los Angeles are investigating after someone set an official ballot drop box on fire Sunday night in Baldwin Park.The Baldwin Park Police Department said on Facebook that they and the Los Angeles County Fire Department responded to a ballot box on fire outside the Baldwin Park Library just before 8:30 p.m.According to police, ballots recovered from the box were turned over to the Los Angeles County Registrar's Office. 470