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The Food and Drug Administration resisted pressure from the Trump administration on Tuesday by releasing a set of guidelines that could push an emergency use authorization of a coronavirus vaccine past Election Day.The FDA’s new guidance notes that an Oct. 22 meeting of its Vaccines and Related Biological Products Advisory Committee will not be to discuss specific vaccine candidates. The FDA noted that a vaccine candidate must be at least 50% effective. Vaccine candidates should include a median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s risk-benefit."Being open and clear about the circumstances under which the issuance of an emergency use authorization for a COVID-19 vaccine would be appropriate is critical to building public confidence and ensuring the use of COVID-19 vaccines once available,” Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research, said. The FDA's new guidance on emergency use authorization of COVID-19 vaccines underscores that commitment by further outlining the process and recommended scientific data and information that would support an emergency use authorization decision.“In addition to outlining our expectations for vaccine sponsors, we also hope the agency's guidance on COVID-19 vaccines helps the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy for any vaccine that is authorized or approved."Trump previously said he would consider overruling the FDA on its vaccine guidelines in hopes of speeding up the process. There is both health and economic pressure for a vaccine to be developed as the coronavirus continues to claim an average of 800 US lives a day, according to Johns Hopkins University data. The number of deaths per day related to the coronavirus is expected to increase as the weather gets colder, according to the University of Washington’s Institute for Health Metrics and Evaluation.On Tuesday, House Speaker Nancy Pelosi blasted the Trump administration for involving itself in the vaccine approval process.“Trust in the vaccine is key to the acceptance of the American people, which is essential to crushing the virus.“The White House’s decision to reject FDA medical experts’ minimum safety and efficacy standards for emergency use authorization of a vaccine is an extremely dangerous act. We are all praying for a safe and effective vaccine as soon as possible, but the damage of the Trump Administration rushing a vaccine before it is known to be safe and effective could be catastrophic."Dr. Anthony Fauci told CNN's Chris Cuomo on Monday that he expects a vaccine candidate to be given an emergency use authorization by the end of 2020. "By the time we get to November, December, maybe earlier, I don't think it's going to be earlier, but it's still possible," Fauci said. "It will be early, but I think comfortably around November or December we'll know whether or not the vaccine is safe and effective. I actually am cautiously optimistic from what I've seen about preliminary data in phase one, that there's a very good chance we'll have a safe and effective vaccine." 3256

The Department of Justice has issued a clarification after some social media users spread disinformation about the use of masks amid the coronavirus pandemic.As cases of COVID-19 spike throughout the country, several states, counties and cities have issued mandates requiring masks in public — and local media reports from across the country indicate that Facebook users in those areas may have seen a viral post containing inaccurate information.While regulations differ from state to state and city to city, many local governments have determined those with pre-existing conditions that would make wearing a mask difficult are exempt from the ordinances. But some viral Facebook posts indicate that the Department of Justice has required exemption cards for those who cannot wear masks.Many of the viral posts contain a screenshot of the "card," containing the Department of Justice seal and a reference to the "Freedom to Breathe Agency.""The Department of Justice has been made aware of postings or flyers on the internet regarding the Americans with Disabilities Act (ADA) and the use of face masks due to the COVID-19 pandemic, many of which include the Department of Justice's seal. These postings were not issued by the Department and are not endorsed by the Department," the DOJ said on its website.The Freedom To Breathe Agency refers to a private Facebook group opposed to government restrictions related to COVID-19 with about 7,000 members. A website listed on the "card" for the agency is not currently active.The Department of Justice recommends visiting Americans with Disabilities Act website for the latest updates from the department. 1661

The fury of the lava from the Kilauea volcano swallowed a car whole.A time lapse video from Brandon Clement shows a Ford Mustang being consumed on the Big Island.The video from the lava and ash flow across the road, eventually overtaking the car on the side of the road. 278

The FBI continues to investgate reports of a #jetpack near #LAX on 8/30. Anyone with info about activity on or above the ground at the location depicted here should call the FBI. The FBI takes seriously events that threaten US airspace & investigates alleged violations #SafeSkies pic.twitter.com/dLZcZeRDuc— FBI Los Angeles (@FBILosAngeles) September 4, 2020 377

The Centers for Disease Control and Prevention is coming to Stark County, Ohio to investigate the area’s startling rate of teen suicides, according to the Ohio Department of Health.Federal health experts will spend two weeks here to figure out why a dozen Stark County teenagers have died by suicide since the end of summer.The CDC visit comes at the request of local and state health officials. According to the Canton Repository: 449