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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
At Monday’s NASCAR event at Talladega Superspeedway, drivers and crew members stood in solidarity with Bubba Wallace, a Black NASCAR driver who said he found a noose in his stall on Sunday.The drivers pushed Wallace’s car to the front of the field moments before the race got underway. 293
Attorneys general from several states plan to jointly file new antitrust litigation against Facebook in the coming days, according to reports from CNBC and the Wall Street Journal.According to CNBC, as many as 40 states are expected to join New York in suing the social media giant. The report also says that the Federal Trade Commission could file a separate but related complaint in district court.While the specifics of the pending lawsuit are unclear, Facebook has been criticized for swallowing up competitors, like Instagram and WhatsApp for fairly reasonable prices.The pending lawsuit would mark the second significant piece of legislation filed against a Silicon Valley giant in recent months. In October, the Justice Department sued Alphabet, the parent company of Google, and alleged the company is a search engine monopoly. 843
At least 10 people have died after flash flooding hit the Aude region of southern France, local officials said Monday.Roads were cut off and cars overturned after three months' worth of rain fell in six hours overnight Sunday into Monday, causing rivers to flood.An 88-year-old nun was killed after water swept through a nunnery in Villardonnel, while four people died overnight in nearby Villegailhenc.The death toll was lowered by the Ministry of the Interior, after initially being placed at 13. Another person is missing and five are seriously injured, officials said.Seven hundred firemen and seven helicopters have been mobilized in response to the flooding, which has reached unprecedented levels in the Aude valley, according to France's flooding watchdog, Vigicrues. 783
At least 48 people were shot within a 24-hour span on Sunday in New York, capping off a violent Fourth of July weekend, police said.Among those shot, 10 of them were fatal.Since Friday, there were 63 victims of gun violence, continuing the rising trend this summer.Most of the shootings were on Sunday, though there were a number of incidents on Saturday, including one in which no one was hurt. Police opened fire in Astoria, Queens on Saturday night when they spotted an individual shooting at someone else. A suspect was taken into custody in that incident.Police also witnessed violence first hand outside the 40th precinct in the Bronx Saturday night. A bullet pierced the front window of their marked cruiser.While in Brooklyn, a flaming firecracker was tossed inside a patrol car with an officer sitting inside.In a pair of tweets from Manhattan police commanders, the chiefs called out city leaders, saying the city is under attack, and they are demanding action.Former police commissioner Ray Kelly criticized Mayor Bill de Blasio for limiting anti-crime units as “crime is raging out of control in New York City.”Police are searching for suspects in multiple shootings.According to the NYPD, there were 575 incidents with 705 victims from Jan. 1 through July 4 of 2020. There were 369 incidents with 423 victims in the same time period last year. Sunday, the NYPD Chief of Detectives, Rodney Harrison tweeted, “The NYPD and the community need to work together as a team to help curb the violence.”Contributing reporting by Jennifer Bisram and Magee Hickey.WPIX's Anthony DiLorenzo first reported this story. 1625