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2025-05-31 17:25:24
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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

  濮阳东方医院妇科具体位置   

At least five people have been killed in a ferocious storm that hammered the Northeast with powerful winds, relentless rain and historic flooding.The nor'easter moved out to sea Saturday, but not before it knocked out power -- perhaps for days -- to more than 900,000 customers from the mid-Atlantic to New England."People in these homes need to plan for a prolonged outage," Kurt Schwartz, director of the Massachusetts Emergency Management Agency, said Friday night. "This is a multi-day restoration event."RELATED:?'Bomb cyclone' pounds east coast with heavy flooding, high winds   The flooding is "the worst that we've seen in years," said Capt. John Dougan of the Quincy, Massachusetts Police Department, which had carried out more than 250 rescues between 8 a.m. Friday and midmorning Saturday. "We're seeing homes underwater, their basements were flooded out, the electricity was off."Emergency officials urged residents on higher ground to stay indoors, even after the storm pushed out."This is not a time to be out sightseeing and gawking, so please stay at home and stay out of our way," James Boudreau, the town administrator for Scituate, Massachusetts, said Saturday.Some 19 million people were still under a coastal flooding warning early Saturday afternoon.The storm morphed Friday into a "bomb cyclone" after undergoing a rapid pressure drop known as bombogenesis. It slammed much of the Northeast with heavy snow and rain, prompting significant coastal flooding and hurricane-force gusts in New England.Winds along parts of the Massachusetts coast that whipped in excess of 90 miles per hour are due to ease Saturday, CNN forecasters said.The storm also dumped heavy snow from Ohio to New England and into upstate New York, where more than 3 feet was recorded.Weak phone connection? Click here to read text-only versions of CNN's top stories.Latest developments? Power outages: More than 900,000 customers were without power Saturday from Virginia to Massachusetts.? Aftermath response: The governors of Maryland and Virginia issued emergency declarations, allowing state and local agencies to help those affected.? Flight cancellations: About 250 flights in the storm zone were canceled Saturday, according to the flight-tracking website FlightAware.com. That compares with more than 3,000 US flights scratched Friday, most at the busiest Northeast airports in Boston, Philadelphia and New York.? Amtrak back in service: Amtrak resumed modified service at 6:20 a.m. ET Saturday, on its Northeast Corridor between Washington and New York, and planned to resume service between New York and Boston beginning at 8:40 a.m., the provider said.Five killed by falling treesAt least five people died in the storm, all killed by falling trees, authorities said. They include: a 77-year-old woman in Kingsville, Maryland; an 11-year-old boy in Putnam County, New York; a 44-year-old man in James City County, Virginia; a 6-year-old in Chesterfield County, Virginia; and a Newport, Rhode Island, man in his 70s.The 11-year-old was in his home when a large tree came crashing down, trapping him. A responding deputy tried to free the boy, whose mother was taken to hospital.Another young boy, just 6 years old, suffered a similar fate when a tree fell through his Virginia mobile home as he was sleeping on a top bunk bed. The boy was rushed to hospital, but his mother told the station his organs were failing."Doctors say we have to let him go," she told CNN affiliate WRIC. Cynthia Creighton's son was in her car when a neighbor's tree fell on top of the vehicle in Watertown, Massachusetts."The house shook, and we heard a noise. We didn't know what it was," Creighton told CNN affiliate WHDH. "We ran out, my son was still in the car with the tree on top of it."Creighton's son, who was in the back seat, was not injured, she said.Boston under waterHigh tides on Friday powered coastal flooding in Boston and other parts of Massachusetts, leaving streets awash for the second time since a massive nor'easter in early January.Kayakers paddled down Boston streets and National Guard members rescued 50 people from their homes in nearby Quincy, sometimes carrying them to safety in the scoopers of front-end loaders, CNN affiliate WBZ reported.Boston Harbor has only seen tides above 15 feet twice -- in 1978 and in January, during the last bomb cyclone. A high tide late Friday morning came up a little short, reaching 14.67 feet, but still sent water sloshing through the streets of East Boston.More record-setting high tides might strike Boston Harbor on Saturday during the midday high tide.With the moon full, the tide is at its highest point of the month, and the storm surge could drive as much as 4 feet of water into coastal neighborhoods, CNN meteorologists said. Massachusetts emergency officials said tides "will be astronomically high" in the next few days."I encourage all residents to be mindful of the storm and encourage employers to take the weather into consideration, which will mostly impact the coastal areas of our city," Boston Mayor Marty Walsh said.In Boston, many streets were closed and city officials advised people not to drive or walk in high water.Historic flooding prompts rescuesQuincy residents who were rescued from inundated homes told CNN they'd never seen anything like this weekend's flooding."It was pretty scary," said Alyssa Fitzgerald. "Once you saw the National Guard, that's when I was like, 'OK, we should have evacuated.'"Fitzgerald and her husband hunkered down overnight after their home lost power with their 3-year-old son and 1-year-old daughter, she said."Not like anything we've had before," Fitzgerald said. "Much worse than the snowstorm we had."Only a few storms even can compare with this level of flooding, including a 1978 blizzard, a storm in 1991 and January's bomb cyclone, Dougan, the Quincy police captain, said Saturday."We've been doing evacuations all through the night and today," he said.The-CNN-Wire? & ? 2018 Cable News Network, Inc., a Time Warner Company. All rights reserved.  6092

  濮阳东方医院妇科具体位置   

At least 29 people were killed during a week of severe weather conditions and devastating flooding in Italy, the country's interior minister said Sunday.Twelve people were confirmed dead on the island of Sicily on Sunday, including nine members of two families, the fire brigade announced on Twitter.The families were dining together when their house was submerged by water from a nearby river that suddenly overflowed.The fire brigade said its divers had found the bodies. Among the victims were two children, 1 and 3 years old.Italy's civil protection agency said it was still looking for a doctor who had been on his way to work at a hospital Saturday night and was missing.High winds and heavy rain have devastated parts of the country over the past week, causing the worst flooding in at least a decade in Venice, damages of more than 1 billion euros (.14 billion) in Veneto and landslides that have cut off villages, authorities said.The situation in Sicily is "dramatic," Prime Minister Giuseppe Conte said Sunday.Conte will call a cabinet meeting to announce a state of emergency in affected regions, he said at a press conference in Palermo, Sicily. 1168

  

AUSTIN, Texas — A Texas man is making a statement by writing the names of 1,400 Black Americans who have died at the hands of police in the United States on his car.20-year-old Jeremiah Hindberg says he used a database to research Black Americans who have died at the hands of police in the U.S. and came up with 1,400 names.He wrote each one on his vehicle with a silver sharpie.Hindberg says he is using his car in hopes to start a conversation on what the Black Lives Matter movement means to him."A lot of sadness. I cried in my garage for hours," Hindberg said.It took several days to write the names, with George Floyd and Breonna Taylor on the hood."This is my representation of BLM," Hindberg said. "Some group of people that's being treated unfairly, and that should be fixed."Hindberg says the violence he and his father witnessed during the protests in Austin back in late May moved him more than anything he's ever experienced.The two served as medics and helped bring aid to injured protesters.He says many protesters were hurt by "less lethal" rounds fired by police, including his father who was shot in the arm and is still recovering from nerve damage today."It changed who my dad was fundamentally as a person," Hindberg saidAs a food delivery driver, Hindberg says reaction to the car ranges from being cursed out in grocery store parking lots to more warm moments of gratitude."She just looked at me in the eye, and said thank you so much she started to tear up and cry," Hindberg said, describing moments that remind him why he did this to his car. "Somebody knows that they're cared for. They're not just another number, they're not just another person."This story was originally published by KXXV in Waco, Texas. 1743

  

Attorneys for Noor Salman are calling for a dismissal of charges or a mistrial after they say new details from prosecutors reveal that Pulse gunman Omar Mateen's father was an FBI informant who is currently under a criminal investigation.According to a motion filed by the defense, Assistant US Attorney Sara Sweeney sent an email on Saturday to the defense -- in the middle of Salman's trial -- that stated Seddique Mateen was a confidential FBI source from 2005 through June 2016.The email also stated that Seddique Mateen is being investigated for money transfers to Turkey and Pakistan after documents were found in his home on the day of the Pulse attack. 668

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