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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 the battle between the United States and California over immigration makes its way in court, the war of words is just beginning.The Justice Department sued California late Tuesday, alleging that state policies that prohibit some cooperation with federal immigration enforcement are unconstitutional.California Attorney General Xavier Becerra fired back hours later, saying his state should not be forced to do the federal job of trying to enforce immigration laws."We're not gonna have them coerce us into doing things that they want us to do simply because they don't want to do it them themselves," he told CNN's Anderson Cooper on Wednesday night.Sessions slams policies 684

ATLANTA — Typically voters in other states don't typically pay attention to elections in other states. But that is not the case with the Jan. 5 Georgia runoff with control of the United States Senate on the line. WHAT'S AT STAKE Two Senate seats are up for grabs. Currently, Republicans control both of them and if they win reelection in one of them they will control the Senate for the next two years. If Democrats sweep both races, Democrats will control the Senate for two years. The outcome will determine how much political power President-elect Joe Biden has. Having control of the Senate would give Biden more ability to confirm nominees and pass progressive bills, which includes COVID economic relief. EARLY VOTING On Monday, early voting got underway with thousands casting their ballot in Georgia. 816

As the nation debates on whether to reopen schools this fall, President Donald Trump said schools should “100%” be open this fall, despite concerns from educator unions and others over the spread of the coronavirus.During his coronavirus news conference on Wednesday, Trump was asked whether he planned on sending his son and grandchildren back to school this fall.“Yes, I am comfortable with that,” Trump said.“I would like to see the schools open. Open 100% and we will do it safely, we will do carefully but when you look at the statistics -- I just read having to do with children and safety ---- they are very impressive. They have very strong immune systems,” Trump added.Trump said that it is his belief that children are less likely to spread the virus. But research thus far has not been conclusive to back Trump’s claims.A study released from South Korea and published by the CDC found that while children under age 9 were less likely to spread the virus, youth ages 10 through 19 were just as likely as adults of spreading the virus.The study also found that closing schools in several Chinese cities, including Wuhan, showed that school closure and social distancing significantly reduced the rate of COVID-19 among contacts of school-aged children. “The role of household transmission of SARS-CoV-2 amid reopening of schools and loosening of social distancing underscores the need for a time-sensitive epidemiologic study to guide public health policy,” the researchers wrote.The American Federation of Teachers this week pointed toward a three-point plan that the US should implement for reopening schools.“Our plan details three conditions essential for schools to reopen,” wrote Randi Weingarten, president of the American Federation of Teachers. “First, the average daily community infection rate among those tested for the coronavirus must be very low. (New York Gov. Andrew Cuomo has required the rate not to exceed 5 percent for at least 14 days.) Second, schools must employ public health protocols, including 6-feet social distancing, masks, deep cleaning and handwashing stations. Third, adequate resources must be available to enact these safeguards, including funding for additional nurses, guidance counselors and teachers to reduce class size.”Weingarten said that Trump has politicized reopening schools, and she called on Congress to approve giving schools additional funding to reopen. Weingarten projects that it would take 6 billion nationwide to provide essential services for schools."Expenses have increased because of the fight against coronavirus," she said. "They not only need funds to provide essential services, the average school will need an additional .2 million, or ,300 per student, to open its doors safely." 2770

AUSTIN, Texas (AP) — A federal judge has ruled that Texas’ statewide mask mandate must extend to inside polling places. But election officials Wednesday did not appear to be rushing to enforce the order. It was handed down after more than 8 million people have already cast ballots. U.S. District Judge Jason Pulliam said not requiring face coverings in Texas polling places created a discriminatory burden on Black and Latino voters, who are at higher risk of death and severe illness from the coronavirus. Texas Governor Greg Abbott had included an exemption for polling places in his statewide mask mandate. The governor said he encourages people to wear a face mask but exempted polling places from the mandate because he didn't want voters turned away from the polls just because they didn't have a mask, according to the Texas Tribune. Texas Attorney General Ken Paxton immediately appealed Tuesday’s ruling. Texas is three weeks into early voting, but Pulliam said enforcing a mask order would not be disruptive.According to the U.S. Elections Project, which is tracking early voter data, there have been more than 8.1 million votes cast already in Texas as of Wednesday afternoon. That's roughly 90 percent of all votes cast in the 2016 election. 1263