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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 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
As the chaotic 2020 presidential race enters its final stretch, Vice President Mike Pence and Democratic vice presidential nominee Kamala Harris will square off in a debate at 9 p.m. ET on Wednesday in Salt Lake City.The COVID-19 pandemic will be at the forefront of Wednesday's debate — both literally and figuratively. As the nation seeks more info regarding President Donald Trump's health amid his COVID-19 infection, both Pence and Harris have agreed to allow debate officials to install plexiglass shields next to their podiums.Harris' staff initially requested the shields, citing the COVID-19 outbreak that's infected several White House staffers. After initially saying the shields were not necessary, Pence's staff agreed to the change on Tuesday night.The Associated Press reports that both Harris and Pence tested negative for the virus on Tuesday morning.Wednesday's debate will be broken into nine 10-minute segments. Each candidate will have two minutes to answer a question from moderator Susan Page, and the other candidate will then have two minutes to respond.The 2020 VP debate will likely hold more important than in years past, given the ages of Trump and his opponent, former Vice President Joe Biden. Trump, 74, was the oldest candidate ever to be elected president in 2016, and Biden, 77, is three years older than Trump. Amid a global pandemic, voters may be taking a keen interest in each administration's chain of command.The Trump campaign is banking on a strong performance from Pence amid slumping poll numbers. An average of national polls shows Biden leading Trump by about nine percentage points, and a recent CNN poll released this week showed that 57% of likely voters favored Biden, compared to just 41% for Trump.Wednesday may also mark the last debate for at least a few weeks. There are two more presidential debates scheduled between now and Nov. 3, but Trump's COVID-19 diagnosis has put the status of the second debate — currently scheduled for a week from Thursday — in doubt. Trump says he still plans to participate, but Biden has said the debate should not take place if the president is still infected with the virus due to safety concerns. 2196
Babies have such a bad reputation when it comes to staying quiet on plane rides that some parents go so far as to hand out treats to fellow passengers before the plane has even taken off. Indeed, George and Amal Clooney, world travelers and parents of twin babies, made headlines late last year for gifting headphones to some passengers, along with a note apologizing in advance for any crying.While there’s no need to pack dozens of gifts in your diaper bag, travel and parenting experts recommend other strategies to increase your chances of a smooth flight with your baby. 603
As the NBA plans to resume action at the end of the month, the bubble the league has implemented in Orlando, Florida, appears to be working.On Monday, the league said that its latest round of tests netted no new confirmed coronavirus cases.The league has implemented a “bubble” for its players, meaning players are being confined to a hotel complex as Florida is grappling with a spike in recent weeks of COVID-19 cases. The complex also contains practice gyms for the players to workout.At the end of June, before players entered the “bubble,” the league found 16 coronavirus cases out of over 300 tested.The NBA is moving forward with a planned relaunch on July 30, with 22 teams of the league’s 30 teams participating in the conclusion of the season and subsequent postseason based at Orlando’s Wide World of Sports. Fans will not be allowed to watch in person.The league suspended play on March 11 when Utah Jazz star Rudy Gobert tested positive for COVID-19 moments before tipoff in a game against the Oklahoma City Thunder. Several games were allowed to conclude that evening, but the NBA has not held a game since. 1129
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