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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

AURORA, Colo. – Hundreds of people are expected to gather Friday evening to demand that three officers involved in the in-custody death of Elijah McClain be fired by the Aurora Police Department.“For ten months Aurora Police Department has shielded Elijah McClain's murderers on their force from facing any form of justice. It was only last Friday, just ahead of a mass march for Elijah, that they pulled the three killers off the streets and put them on paid desk duty,” the Party for Socialism and Liberation – Denver (PSL) said in a statement about the event. “We need to make it clear that this is absolutely NOT enough.”Last Friday, APD announced officers Nathan Woodyard, Jason Rosenblatt and Randy Roedema had been taken off street duty "because of threats and harassment," according to a police spokesperson. Police said those threats involved phone calls as well as email messages.Officials did not disclose to which department the officers were reassigned, but said they were working in a "non-enforcement capacity."The PSL says they expect murder charges “for the three killers” and demand that APD fire all three “IMMEDIATELY.”Organizers of Friday’s protest are also calling for the release of the names — as well as the immediate termination — of all officers involved in an incident involving a photograph taken near the site where McClain struggled with officers. The officers were seen in the picture imitating the carotid hold used on McClain before the 23-year-old Black man died last August.RELATED: Officer who was depicted in photograph at site of Elijah McClain's arrest has resignedThe rally will start at 6 p.m. at the intersection of Billings St. and Evergreen Avenue, the site where organizers say, “Elijah was brutalized and killed and where APD danced on his grave.” From there, protesters will march to the APD headquarters at the Aurora Municipal Center.The march and protest will put APD’s response to test once again, following a violent night of confrontation between officers and protesters last Saturday.MORE: Aurora Police Interim Chief defends police response to Elijah McClain protestOrganizers say there will be people of all ages at Friday’s protest, “who do not want a repeat of last Saturday’s violence from APD, but (who) will not be intimidated out of exercising their First Amendment right to assemble and voice their concerns.”McClain’s death, largely unnoticed for the past 10 months, recently garnered national media attention following nationwide calls to reform interactions between police and Black Americans in the wake of George Floyd’s death.On Tuesday, the Colorado U.S. Attorney's Office, along with several other law enforcement agencies, announced they've been reviewing facts in the death of the 23-year-old Black man since last year for a potential federal civil rights investigation, saying they were aware of the photo allegations which surfaced Monday evening and were gathering further information about the incident.This story was originally published by óscar Contreras on KMGH in Denver. 3062

ATLANTA (AP) — Georgia’s governor, who has opposed local mask mandates and even sued over one in Atlanta, has signed a new executive order that allows local governments to enact mask requirements to help fight the coronavirus pandemic.As with previous orders, the one issued by Gov. Brian Kemp on Saturday says residents and visitors of the state are “strongly encouraged” to wear face coverings when they are outside of their homes, except when eating, drinking or exercising outside.But unlike previous orders, this one allows local governments in counties that have reached a “threshold requirement” to require the wearing of masks on government-owned property.A county meets that threshold if it has had 100 or more confirmed cases of COVID-19 per 100,000 people over the past two weeks. Very few of the state’s counties are below that threshold.The order says mask mandates can’t lead to fines, fees or penalties against private businesses or organizations. For individuals, the order says penalties cannot include a fine more than or prison time.The order also extends shelter-in-place requirements for people who are considered to be at a higher risk of severe illness from the coronavirus.It also bans gatherings larger than 50 people if individuals are closer than 6 feet apart. 1299

As millions of Americans avoid routine doctor’s appointments right now for fear of catching COVID-19, a decades-old practice is suddenly gaining new attention: the house call.“The notion of a house call means the care provider can get a more comprehensive view of you as a person,” explained Stacey Chang, who serves as the executive director for the Design Institute for Health.Chang says a reinvention of the house call could be a viable solution to America’s evolving post-coronavirus healthcare system. New portable technology means doctors can do more than just check your temperature.Health officials across the country are also worried that Americans in isolation are avoiding routine check-ups, which could lead to more long-term issues once the pandemic ends.“The care that didn’t happen, the routine care for managing chronic diseases, we may end up having greater mortality from those missed interventions than what COVID itself caused,” Chang added.Aside from keeping people away from hospitals where COVID-19 might be lurking, the house call gives physicians a chance to get to know their patients. Spending more than 10 minutes with someone in an office would give doctors a better chance to treat chronic diseases.“It’s really a relationship between the person that’s caring for you and the person you’re caring for,” Chang said. 1352

AURORA, Colo. – Police confirmed Monday afternoon that the man they shot and killed early Monday morning is believed to have shot and killed another man who’d broken into his home minutes earlier.The police shooting happened around in Aurora, Colo. Officers had been called the house on reports that a man had broken into the home.“Officers arrived to a very chaotic and violent scene,” Aurora Police Chief Nick Metz wrote in a news release issued Monday afternoon.Metz said officers who arrived at the scene heard gunshots inside the home and ran into an armed man. An officer shot the man, who died at an area hospital.After clearing the scene, according to Metz, officers found a juvenile injured inside and a man shot dead on the bathroom floor. The child was taken to a hospital for “serious, but non-life-threatening injuries” caused by the intruder, he said.Both men’s identities will be released by the Adams County Coroner’s Office, Metz said. The officer who shot the resident of the home is on standard paid leave.The investigation into the shooting will be conducted by the Aurora Police Major Crimes Unit, the Denver Police Department and the 17th Judicial District Attorney’s Office. Police are also asking anyone who witnessed the shooting to call Detective Randy Hansen at 303-739-6710.“This is a very heartbreaking and tragic situation for everyone involved. We are providing assistance through our victim advocates to help the family of the deceased resident through this very difficult time,” Metz said in a statement. 1555