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The Salt Lake Tribune reported late Monday night that at least one person has died in a 'shots fired' incident on the University of Utah's campus. According to the university, it asked those on campus to "shelter in place" Monday night as authorities looked for the gunman, and other possible victims. Traffic was reportedly blocked off, and mass transit was shut down in the immediate vicinity of the shooting. The suspect is said to be 24-year-old Austin J. Boutain, who was wearing a coat, jeans and beanie, with a teardrop tattoo on his face. The university added that he may have been driving a forest green pick-up truck with Colorado plates.As of early Tuesday morning, he was still on the loose, and considered dangerous. 767
The U.S. Food and Drug Administration says that Sunshine Mills, Inc. has expanded its voluntary recall on dog food to include more products.The products were produced between April 3-5, 2020, and contain an unsafe level of aflatoxin, a toxin produced by the mold Aspergillus flavus, and at high levels, cause illness and death in pets, the FDA said.The products were recalled after a sample contained an unsafe level of aflatoxin was found by the Louisiana Department of Agriculture & Forestry.The products include Family Pet Meaty Cuts, Heartland Farms, Champ, Field Trial, and Good Dog, distributed across the U.S. at retail stores.If you purchased any of the recalled items, the FDA says that you stop using them, throw them out, or return them to the place of purchase for a full refund.You can check to see if your product has been recalled by clicking here. 875

The Trump campaign has filed a second lawsuit to stop ballot counting the day after the election. This time in Pennsylvania.In a release sent to supporters, the president’s campaign says they are taking several legal actions concerning Pennsylvania ballots. The first is they are “moving to intervene in the existing Supreme Court litigation over the Pennsylvania Supreme Court’s unlawful extension of the mail-in ballot receipt deadline.”Trump’s campaign is also filing suit to stop ballot counting because they claim election officials are counting and processing ballots out of sight of Republican poll observers.“In Philadelphia and elsewhere, Democrat officials forced our observers to stay 25 feet or more from the counting process, leaving no meaningful way whatsoever for our observers to do their jobs,” the statement from Justin Clark, Trump’s deputy campaign manager, reads.With about 84 percent of the ballots counted, Trump leads Biden by almost 300,000 votes. This is similar language used by the Trump campaign when they said they filed in Michigan Wednesday morning. The Trump campaign says it is calling for a temporary halt in the counting in Michigan until it is given “meaningful access” in numerous locations and allowed to review ballots that already have been opened and processed. Trump is running slightly behind Democratic nominee Joe Biden in Michigan. 1387
The U.S. regulators who will decide the fate of COVID-19 vaccines are taking an unusual step: Asking outside scientists if their standards are high enough.The Food and Drug Administration may have to decide by year’s end whether to allow use of the first vaccines against the virus. Thursday, a federal advisory committee pulls back the curtain on that decision process, debating whether the guidelines FDA has set for vaccine developers are rigorous enough.“We will not cut corners, and we will only use science and data to make that determination,” FDA Commissioner Stephen Hahn pledged at a meeting of the Milken Institute Wednesday.Exactly how much data his agency needs to be sure a vaccine is safe and effective is a key question for the advisers. An even bigger one: If the FDA allows emergency use of a vaccine before final testing is finished, will that destroy chances of ever learning just how well that shot -- and maybe competitors still being studied -- really work?“We can’t lose sight of the fact that it is in our societal interest to see these trials to completion,” said Dr. Luciana Borio, a former FDA acting chief scientist who will be watching the advisers’ debate.Plus, multiple vaccines are being studied -- shots made with different technologies that each have pros and cons.“The first vaccine is not necessarily the best vaccine,” cautioned Dr. M. Miles Braun, a former FDA scientist now with Georgetown University School of Medicine. If the trials aren’t allowed to finish, it may be difficult or impossible to ever know for sure.It’s a critical moment in FDA’s 114-year history. The government has spent billions to race a vaccine through a research process that usually takes years, and FDA faces unprecedented pressure from the Trump administration, fueling public skepticism that politics could overrule science.Interest is so high, FDA is airing the meeting on YouTube. Here are some key issues the committee will discuss:HOW MUCH EVIDENCE IS NEEDED?FDA is requiring manufacturers to do studies of at least 30,000 people to prove if a vaccine protects and how safe it is. Those studies must include adequate numbers of people at highest risk from COVID-19 -- older adults, minorities and anyone with underlying health problems.FDA has made clear that any vaccine must be at least 50% effective. And while the studies are designed to run for two years, companies may get enough evidence the shots are protective -- in at least some people -- to stop the trials early and seek what’s called an “emergency use authorization” for wider vaccinations.Despite White House objections, the FDA told vaccine makers earlier this month not to seek that speedier review until they’ve tracked at least half their trial participants for two months. With other vaccines, that’s about the amount of time when major side effects crop up.That’s not long enough, said the head of the non-profit ECRI Institute, which reviews medical technology for hospitals and insurers. In comments submitted to the advisory committee, ECRI’s Dr. Marcus Schabacker said FDA should require six months of follow-up.“Doing any less would simply risk too much, and the consequences may be severe,” he wrote. “A weak vaccine that loses public trust could poison the well for epidemic control for many years.”WOULD EMERGENCY USE DERAIL FULL ANSWERS ABOUT VACCINES?Normally when a study ends because of evidence that a vaccine is working, the participants who got dummy shots are offered the real thing.But if FDA allows emergency use of a COVID-19 vaccine, that’s not the same as having full proof the shot works, Borio cautioned.And if the participants in the placebo group are immediately offered the real shot, researchers may not be able to get answers about all the high-risk groups in the study — or tell how long the vaccine’s protection lasts, a process expected to take many more months.But Pfizer Inc., which with Germany’s BioNTech is developing one of the leading candidates, told FDA that if it’s granted emergency use authorization, it “would have an ethical obligation” to alert study participants who got a placebo and allow them vaccine access. The company wants FDA to look into “other scientifically and statistically sound methods” to determine long-term safety and effectiveness.Pfizer’s stance is likely to face pushback. The Infectious Diseases Society of America states that FDA’s panelists “should insist” that vaccine developers “present a compelling case” for how they will complete their trials if FDA grants early authorization of their vaccine.Clearing a vaccine based on premature or faulty data “could cause more harm” by “further eroding public confidence in all vaccines,” the group said.It’s an unprecedented dilemma. The FDA has previously allowed emergency use of only one vaccine, a decades-old shot that in 2005 was authorized to prevent anthrax poisoning.This time around, multiple COVID-19 vaccines are in the pipeline. Pfizer competitor Johnson & Johnson cautioned that early FDA clearance of one vaccine could “jeopardize integrity” of other ongoing trials if patients decide to drop out to seek the first cleared shot instead.The company asked regulators to explain what options are available to ensure completion of all ongoing COVID-19 vaccine trials.WHAT ABOUT LONG-TERM SAFETY MONITORING?Even a study of 30,000 people cannot spot a side effect that only strikes 1 in 100,000. So the government is planning extra scrutiny of every COVID-19 vaccine to hit the market.At first there will be limited doses given to just certain high-risk people -- and those early recipients are to get text messages daily for the first week after vaccination, and then weekly out to six weeks, asking how they’re feeling.FDA also will be checking databases of electronic health records and insurance claims, looking for any red flags.“There’s a kind of tracking that has to take place here on a massive basis that hasn’t taken place before,” said Dr. Jesse Goodman of Georgetown University, a former director of the FDA’s vaccine and biologics center.___The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content. 6274
The sister of Charleston church shooter Dylann Roof was arrested Wednesday on charges of bringing weapons and drugs to her South Carolina high school, authorities said.Morgan Roof, 18, was arrested after a school resource officer at the A.C. Flora High School in Columbia, South Carolina was notified that Roof was carrying marijuana, pepper spray and a knife on campus, the Richland County Sheriff's Department said.Roof had also made an alarming Snapchat post expressing anger about the National School Walkout, The Post and Courier reported. A 17-minute walkout was staged at schools around the country on Wednesday to honor the 17 people killed at Florida's Marjory Stoneman Douglas High School last month and call for stricter gun control laws.No A.C. Flora High students were harmed Wednesday, authorities said.Roof was charged with simple possession of marijuana and two counts of carrying weapons on school grounds. A judge set a ,000 bond for Roof under the condition that she would not return to the school, CNN affiliate WIS reported.It's unclear whether she has an attorney.In a letter to parents, the high school principal addressed multiple incidents that took place Tuesday and Wednesday on campus, including the one involving Roof."I realize that rumors and the tragic school shootings in Florida are events that can cause anxiety for our students, parents, faculty, and the community," Principal Susan Childs wrote. "Be assured that the safety of our students will always be our top priority. We must continue to work together to maintain a safe and positive learning environment."South Carolina Governor Henry McMaster said "potential tragedy was avoided" Wednesday thanks to the students and educators who reported "suspicious activity" to a school resource officer."We owe a debt of gratitude to all involved who acted so quickly and decisively," McMaster said in a statement."For months, I have called on the General Assembly to join me in placing a trained, certified police officer in every school, in every county, all day, every day," the governor added.Roof's brother, Dylann, was formally sentenced to death last year for killing nine people at a historically black church in Charleston, South Carolina in 2015.The-CNN-Wire 2260
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