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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
Message from Ron Paul: "I am doing fine. Thank you for your concern." pic.twitter.com/aALmLn8xIj— Ron Paul (@RonPaul) September 25, 2020 144
MILAN (AP) — The Mount Etna observatory says lava and ash are spewing from a new fracture on the active Sicilian volcano amid an unusually high level of seismic activity.The Etna observatory said a swarm of 130 tremors have been recorded by Monday midday, the most powerful registering a magnitude of 4.0. It reported lava flows from the volcano and said a new fracture had opened near its southeast crater.The owner of a refuge on the volcano says hikers are being brought down from higher elevations to 1,900 meters (6,230 feet) for their safety. But there are no reports of injuries, and so far the spewing ash was not causing disruptions to residents of nearby towns and cities.Etna, the largest of Italy's three active volcanoes, has been particularly active since July. 783
MARATHON, Fla. (AP) — Officials say a pregnant woman jumped into the water to save her 30-year-old husband when a shark latched onto his shoulder as he was snorkeling in the Florida Keys.The attack happened Sunday morning along Sombrero Reef, off Marathon. Andrew Eddy had just gotten into the water when the shark bit into him.Deputies say the Atlanta man's wife, Margot Dukes-Eddy, dove into the water without hesitation and pulled him to safety.Medics waiting on the beach flew Eddy to Miami for treatment. His condition wasn't available, but deputies described the injury to his shoulder as severe.No one else was injured by the shark.The Monroe County Sheriff’s Office says the shark was described by witnesses as being 8 to 10 feet long.“This was a very rare medical crisis for the Florida Keys, but everyone came together — including those witnesses on the boat to 911 Communicators to all our emergency responders — in order to ensure this victim received life-saving care,” said Sheriff Rick Ramsay in a press release. 1035
MACOMB TOWNSHIP, Mich. — A Michigan model for American Girl Dolls is opening up about her health. Alyea Rourke, who has modeled as the Hawaiian American Girl doll Nanea Mitchell, says she's been diagnosed with a disease so rare it took nearly two years to diagnose."It seemed like a giant dream to me. I was just so scared I immediately thought I will never be able to skate again," the now 14-year-old said.Alyea was diagnosed with chronic recurrent multi-focal osteomyelitis (CRMO), a potentially serious and unique form of bone disease that can be long-lasting. Right now, there's no known cure, doctors say. "They described to us was possibly an ear issue, or it was an infection in the jaw or it could’ve been a tooth decay or something like that. So we went probably through about seven doctors before we got an answer," said Lynda Rourke, Alyea's mother. Despite the pain affecting her ability to skate and chance to live a regular teen life, the 14-year-old has tried to stay positive. "I'm not letting it stop me from skating and doing what I love," she said.Alyea's family has set up a GoFundMe?account for support with medical expenses. 1216