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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 debate over guns continues in Washington and in communities across the country, there's at least one place where owning a gun is technically required by law.In Kennesaw, Georgia, local law says that "every head of household residing in the city limits is required to maintain a firearm.""If you're going to commit a crime in Kennesaw and you're the criminal -- are you going to take a chance that that homeowner is a law-abiding citizen?" asked Kennesaw Mayor Derek Easterling.Wayne Arnold is one of those citizens. Among the weapons he keeps at home are an AR-15-style .223 caliber rifle, a variety of handguns and more."It gives me the ability to protect myself as opposed to being somewhere where you weren't allowed to have a firearm or it was frowned upon," said Arnold."More or less a political statement" 826

Authorities will begin distributing an experimental Ebola vaccine in Mbandaka, a major city in the Democratic Republic of Congo, on Monday to try to stop the spread of the deadly virus.Healthcare workers in Mbandaka, the capital of Equateur Province and home to 1.2 million people, will be the first to receive the vaccine, World Health Organization spokesman Tarik Ja?arevi? said.The confirmation of the first case in Mbandaka last week has raised concerns that the virus could spread faster than expected. So far, 26 people have died in the outbreak, according to the WHO.The vaccine, called rVSV-ZEBOV, will likely be distributed to some 8,000 to 10,000 people in its first phase, Peter Salama, deputy director-general of emergency preparedness and response at the WHO, said Friday.It will be given to people who have had contact with people infected with Ebola and contacts of those contacts, Salama said.Ebola is an incredibly contagious virus which causes the sudden onset of symptoms including fever, fatigue and muscle pain within two to 21 days after infection. Patients suffer vomiting, rash and diarrhea, impaired kidney and liver function -- and in some cases internal and external bleeding.An outbreak in 2014 in West Africa killed more than 11,000 people in months. 1287
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
At a White House news conference on Friday, leaders of Operation Warp Speed said that two coronavirus vaccines could receive emergency use authorization from the FDA in the coming weeks.In addition, Dr. Moncef Slaoui, who is the scientific head of Operation Warp Speed, projected that up to 20 million coronavirus vaccines could be shipped by the end of the year."If approved, they could be used for immunization in the U.S. population in the month of December," Slaoui said. "And we plan to have enough vaccine doses available for use in the U.S. population to immunize about 20 million individuals in the month of December, and another 25 to 30 million per month on an ongoing basis thereon."Given that doses of the two vaccines come in two doses, it could take many months and be well into 2021 before the majority of the American population is vaccinated against the coronavirus.The update came as the virus spreads throughout the country at an alarming and uncontrolled rate. At least 100,000 Americans are confirmed to have contracted the virus every day for the last 10 days, culminating in a record-shattering 153,000 cases on Thursday. Hospitalizations linked to the virus have reached all-time highs since the pandemic began, and deaths linked to the virus are beginning to tick up as well.The update also comes days after Pfizer announced that its vaccine candidate has been 90% effective in Phase 3 trials. The company says it is on track to apply for Emergency Use Status by the end of the month, meaning that some Americans could receive the vaccine before the year's end.New York Gov. Andrew Cuomo, who said his state would independently review vaccine candidates before authorizing distribution to the state, was a frequent target during Friday’s news briefing.“Vaccines will be allocated pro rata by population so we ensure fair and equitable across. We need the states who are part of the planning to accept the vaccine,” saidArmy General Gustave F. Perna, who is overseeing logistics and distribution for Operation Warp Speed. “We are working closely along with the CDC, the jurisdictions and states to ensure vaccine can safely and quickly get to those who need it first.”Trump blasted Cuomo for utilizing an independent review process separate from the FDA. "We won't be delivering it to New York until we have authorization to do so," Trump said. "That pains me to say that. This is a very successful, amazing vaccine that 90% or more. The governor, Gov. Cuomo will have to let us know when he's ready for it. Otherwise, we can't be delivering it to a state that won't be giving it to its people immediately. I know the people of New York very well, I know they want it. The governor will let us know when he's ready."Pfizer said it expects to have 50 million doses of its vaccine ready for global distribution by the end of 2020, and 1 billion doses globally by the end of 2021. That's why other vaccines are also being looked in hopes of getting as many Americans vaccinated as soon as possible. Trump and others on Operation Warp Speed confirmed that health care workers and the elderly would be first to receive doses of the vaccine. Dr. Anthony Fauci, the Trump administration's top infectious disease expert, predicted earlier this week that the vaccine would be widely available in April.Previously, Trump had suggested that a vaccine would have been approved in October and widely available by the start of 2021. Project Warp Speed leaders, however, credited the federal government's response to the virus even if the vaccine has not been distributed as quickly as previously suggested.Friday's remarks were Trump's first on-camera comments since Joe Biden was projected as the winner of the presidential election. Trump had not delivered comments to the press on-camera since Nov. 5, when at a press conference in the White House press room he falsely claimed he would win the presidential election on still-baseless claims of widespread voter fraud.Trump has appeared on camera just once in the last week — a Veteran's Day appearance at Arlington National Cemetery at which he did not speak.Trump's extended media blackout is out of step with the first four years of his administration. Trump has rarely shied away from speaking with reporters, as he often makes himself available for on-camera interviews with the White House press pool on the front lawn and has taken to calling friendly media outlets for phone interviews.However, since last Thursday, Trump has only delivered statements through his Twitter account, where he has continued to spread misinformation about the 2020 election. In the past week, Twitter has taken action on about 50 of Trump's tweets or retweets — be it adding a link to more information, adding a fact check or hiding the tweet from timelines completely. 4827
来源:资阳报