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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

AVALON, Calif. (AP) — The nonprofit organization that owns a majority of California’s Santa Catalina Island plans to boost eco-tourism by adding more bison to existing herds, recharging a debate over their environmental impacts. The Los Angeles Times reports the Catalina Island Conservancy says there has not been a bison calf born on the island in seven years and the herd size has dwindled to 100. The conservancy board is working to bring two pregnant bison to the island. A biologist says bison herds stay on isolated patches of grass and adding more animals will not result in more bison sightings by eco-tourists. 628

ATLANTA — The funeral for the late civil rights icon and congressman John Lewis will be held Thursday at Atlanta’s historic Ebenezer Baptist Church, which the Rev. Martin Luther King Jr. once led. Lewis’ family announced that the funeral will be private, but the public is invited to pay tribute over the coming days during a series of celebrations of Lewis’ life beginning Saturday in his hometown of Troy, Alabama. Ceremonies will also be held in Selma, Alabama, and his body will lie in state at the Alabama State Capitol in Montgomery, the Georgia State Capitol in Atlanta and the U.S. Capitol in Washington.Lewis, 80, died Friday after a six-month battle with pancreatic cancer. He represented Georgia as a Congressman for more than 30 years, winning 17 elections. He also fought for Civil Rights for Black people in the 1960s, originally gaining notoriety as one of the 13 original "Freedom Riders." 914

ATLANTA, Ga. – A top official with the Centers for Disease Control and Prevention (CDC) said Wednesday that experts are seeing a “distressing trend” as coronavirus cases surge across the United States, particularly in the Midwest.“Unfortunately, we're seeing a distressing trend here in the United States,” said Dr. Jay Butler, Deputy Director for Infectious Diseases. “Smaller, more intimate gatherings of family, friends and neighbors may be driving transmission as well, especially as they move indoors.”Butler also urged Americans to continue taking the necessary precautions to prevent the spread of the coronavirus, like practicing social distancing, washing your hands and wearing masks.“I recognize we are all getting tired of the impact that COVID-19 has had on our lives, we get tired of wearing masks, but it continues to be as important as it’s ever been and I’d say it’s more important than ever as we move into the fall season.”Butler made the comments during a press briefing with CDC Director Dr. Robert Redfield and Health and Human Services (HHS) Secretary Alex Azar.CDC, HHS give an update on COVID-19 response https://t.co/YxLSMGZgbs— Reuters Science News (@ReutersScience) October 21, 2020 During the briefing, Azar and Redfield discussed Operation Warp Speed, a partnership initiated by the Trump administration to accelerate the testing, supply, development and distribution COVID-19 vaccines, therapeutics and diagnostics.The goal of partnership is to produce and deliver 300 million doses of a safe and effective vaccine with initial doses available by January 2021, according to the HHS website.Azar provided an updated timeline on when we can expect vaccine to be distributed and who will receive the first doses. According to him, a vaccine would be widely available by late March or early April.“We expect that we would have by the end of this year, enough vaccine that is FDA authorized, to be able to vaccinate all of our vulnerable, the most vulnerable individuals,” said Azar. “Then by the end of January, we expect we’ll have enough to vaccinate all seniors as well as our health care workers and first responders. And by the end of March to early April, enough vaccine for all Americans who would want to take a vaccine.”Wednesday’s briefing comes as many states report increases in the number of COVID-19 cases. The U.S. has surpassed 8.3 million cases and more than 221,500 people have died across the nation from the disease, according to an ongoing tally by Johns Hopkins University.Experts are concerned there may be a major spike in cases during the fall and winter months, which will strain the country's health care system, which will also be caring for flu patients.With many people still struggling amid the pandemic, Congress and the Trump administration still have not come to a deal on another COVID-19 relief bill. As for the Senate, Majority Leader Mitch McConnell has signaled his chamber may not support the potential deal. 2983

As the debate over arming teachers in schools reverberates across the country, Kansas is doubling down on the idea.A new bill would not only authorize the arming of Kansas school staff, it would hold schools responsible if a shooting were to occur and the teachers and staff present were not allowed to be armed.Here's the exact wording?from House Bill 2789:"In any action against a unified school district arising out of acts or omissions regarding the possession or use of firearms on the premises of such school district, there shall be a rebuttable presumption of negligence on the part of such school district when it is shown by evidence that such school district did not authorize any employee of such school district, other than school security officers, to carry concealed handguns..."The House bill is causing some serious contention in the Kansas state capitol. During a House Insurance Committee hearing on Tuesday, Rep. Blake Carpenter, one of the bill's authors, quoted the movie "American Sniper" and said violence in school was a matter of "when" and not "if.""It's not if our kids will be killed; it is when they will be killed and what we are doing to prevent it," he said,?according to the Kansas City Star.CNN has reached out to Carpenter for comment.The bill has received significant pushback. A group of protesters was present at Tuesday's hearing, and Rep. Brett Parker, a Democratic opponent of the bill, shared a photo of stacks of papers he says are written testimonies against it.Kansas teachers?are technically already allowed by state law to carry guns on public school campuses as long as they have a permit and meet any school-specific requirements. But according to the Kansas City Star the 2013 legislation caused problems with insurance providers for some of the state's school districts, who refused to extend coverage because of the liability of armed staff.As a result, some districts put their own policies in place, overriding the law and disallowing the concealed carry of weapons on school property.The bill currently before the House committee also addresses this by forbidding insurance companies from refusing coverage just because a school district allows teachers and staff to be armed."No insurance company shall charge unfair discriminatory premiums, policy fees or rates for, or refuse to provide, any policy or contract of real or personal property insurance, liability insurance or policy containing liability coverage for any unified school district solely because such school district authorizes employees of such school district to carry concealed handguns on the premises of schools and attendance centers operated by such school district..." the bill states. 2742