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Maryland-based vaccine developer, Novavax, has received .6 billion from the federal government to complete late-stage clinical development; set up large-scale manufacturing; and deliver 100 million doses of NVX?CoV2373, its COVID-19 vaccine candidate, as early as late 2020.This is the largest vaccine deal to date with the Trump administration as part of their Operation Warp Speed, which is focused on making a COVID-19 vaccine and treatments available as quickly as possible.Novavax has not brought any of their developed vaccines to market. According to information on their website, they have developed several vaccines for infectious diseases, however they are all in various stages of development or clinical trials. These include vaccines for the seasonal flu and RSV. Other vaccines created by Novavax are not actively being developed or studied at this time, including ones for Ebola, MERS, and SARS.According to a statement from Novavax, the agreement with the federal government includes the company demonstrating being able to rapidly get manufacturing and large-scale production of the vaccine going once approved. Novavax hopes to conduct their late-stage clinical study with 30,000 subjects in fall 2020.An early-stage clinical study took place in Australia in May on 130 participants. Study results are expected at the end of July.“Today’s .6 billion investment supports the Novavax candidate, depending on success in clinical trials, all the way through to manufacturing 100 million doses for the American people,” said U.S. Health and Human Services Secretary Alex Azar.Regeneron Pharmaceuticals has also received 0 million through Operation Warp Speed on Tuesday, to make and supply its COVID-19 vaccine candidate, REGN-COV2. Their vaccine is currently in phase 2 and phase 3 clinical studies for the treatment and prevention of COVID-19.Regeneron has several vaccines on the market currently, including Dupixent, used to treat allergic diseases such as eczema, asthma and nasal polyps which result in chronic sinusitis, and Praluent, used to treat high cholesterol. 2101
MEDINA, Ohio — With every move of a foot or lift of a leg, 13-year-old Isabel Kirby inspires herself and the people around her."More exercise equals more progress," she said. "If you don't have a good attitude about it, you're not gonna feel up to doing things."The teen from Chippewa Lake, Ohio, was suddenly paralyzed from the waist down eight months ago and was diagnosed with a rare, rapid onset disease known at acute flaccid myelitis or AFM.Isabel is making great progress working with therapists twice a week at the main campus at Akron Children's Hospital and their facility in Medina, Ohio.Back in January, Isabel said she was unable to move her legs.During therapy this week, she lifted her legs from a table and a wheelchair and walked with braces called reciprocating gait orthosis (RGO). Physical therapist Renee Parsons provided assistance and encouragement.Isabel is also able to move the pedals on a stationary bike with electrical stimulation and swim in a pool on her own. She can almost stand upright holding the sides of the pool."She just blows me away, honestly. Amazing. She is focused and motivated and strong and brave," said her mom, Noel Kirby.In a few weeks, the family will head to New Jersey to allow Isabel to participate in Project Walk, which helps people recover from life-changing paralysis. Donations through a GoFuneMe account are helping to pay the out-of-pocket costs for the five-day visit.Isabel, who plays softball and is heading into eighth grade at Cloverleaf Middle School, remains hopeful that one day she will be able to walk again on her own."I think I could get to that point," she said."She's gonna do it. She's gonna make it happen," her mom said. "She's trying everything she can to get to where she wants to walk again."Hours after the Kirby family opened presents on Christmas morning, Isabel complained of weakness in her legs.Her parents thought it was growing pains or possibly dehydration, but the next day, Isabel was unable to walk. The eventual AFM diagnosis stunned the family."I just think that people need to know that this is out there, that this exists because we didn't," Noel said.The Centers for Disease Control and Prevention recently warned of a potential AFM outbreak by the end of the year.There have been more than 600 confirmed cases nationwide since the CDC began tracking the illness in 2014. The numbers have spiked higher in even years, which is part of the reason for the concern over 2020.However, Dr. Matthew Ginsberg from Akron Children's Hospital, stressed AFM is still very rare with about 200 to 250 U.S. cases in peak years."Any child who has an onset of weakness in the arms and legs should seek emergency medical attention," Ginsberg said.Medical experts say many children with AFM will have a fever or respiratory illness days before the weakness occurs. AFM has been associated with Enterovirus D68."It's thought to be caused either by a viral infection that affects some of the nerve cells in the spinal cord or inflammation reaction to that viral infection," Ginsburg said.Isabel is thrilled that she's doing better as she works towards her goal to walk again while stressing that keeping a positive attitude is important to her recovery."Life happens, honestly. Things just happen," she said. "You just got to go on with it. Do what you can and get better."This article was written by Bob Jones for WEWS. 3407
LOUISVILLE, Ky. (LEX 18) — Chief of Police Robert J. Schroeder is declaring a state of emergency for the Louisville Metro Police Department (LMPD) as they wait for Attorney General Daniel Cameron's decision whether or not to indict the officers in the Breonna Taylor case.The department has canceled all off days and vacation requests until further notice."The public may also see barriers being staged around downtown, which is another part of our preparations," Sgt. Lamont Washington said in the statement. "It is important to note that the AG has no timetable for the announcement."Taylor, a 26-year-old emergency medical worker, was killed by Louisville police serving a "no-knock" narcotics search warrant at her apartment. They found no drugs in her home. The city announced a settlement with the Taylor family last week that included a million payment and changes to department policies.An officer was shot during the raid by Taylor's boyfriend, who has said he thought he was defending against a home invasion. The boyfriend was initially charged, but those charges were later dropped.The Louisville Metro Police Department fired one of the officers involved, Brett Hankison, in June, saying he violated procedures by showing "extreme indifference to the value of human life." The other officers involved in the case — Jon Mattingly and Myles Cosgrove — have been placed on administrative reassignment."To ensure we have the appropriate level of staffing to provide for public safety services and our policing functions, effective immediately the LMPD will operate under the emergency staffing and reporting guidelines as outlined in the Standard Operating Procedures, Emergency Response Plan, and collective bargaining agreements until further notice," a memo sent Monday to all personnel states.A handful of buildings around Louisville have been identified as potential places for "backlash" if a decision is announced this week. Windows have been boarded up at the Gene Snyder U.S. Courthouse & Customhouse. The courthouse is closed this week according to an official order, with planned court business rescheduled or moved online.This story originally reported by Jordan Mickle on LEX18.com. 2221
Mayor Bottoms & Interim Chief Bryant speak on 8-year-old murdered over the holiday weekend. https://t.co/iCjls5QC47— Atlanta Police Department (@Atlanta_Police) July 5, 2020 185
MARGATE, Fla. — A South Florida woman just couldn't wait to have her baby.Susan Anderson and her husband, Joseph, had almost made it inside Natural BirthWorks in Margate last Friday when baby Julia decided to meet the world early.Doorbell video shared by owner Gelena Hinkley showed the moment of birth.Video shows the mother crouching over in the parking lot while midwife Sandy Lobaina stands behind her.Anderson screamed just as two police officers, who happened to be in the area at the time, walked up to her."She's OK," Lobaina said. "I'm the midwife. She's here to have the baby."Anderson let out a big scream and Lobaina caught the baby as the officers watched in disbelief.After Julia's birth, Anderson was helped into the medical center by the child's father and Lobaina.In the video Hinkley ran into the frame just moments after the birth — but not fast enough."Un-freaking-believable," Hinkley said, seemingly disappointed she missed the party."What was going through my mind was, 'Get in the tub. Get in the tub.' Because I just wanted that relief," Anderson said.Lobaina said she has some crazy births before, but this was a first."Babies sometimes come really quick…and you just got to be quick, put your gloves on and just go," Lobaina said.Although Hinkley missed all the action, she's seen the video and has a good sense of humor."It was the best handoff ever," she said. This story was originally published by Miranda Christian and Peter Burke on WPTV in Palm Beach, Florida. 1502