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The Food and Drug Administration (FDA) released a key report Tuesday that said a COVID-19 vaccine made by Moderna is safe and effective — the latest in a series of rubber stamp approvals that could allow the vaccine to be distributed by the end of the month.The FDA report on Tuesday upheld the clinical trials, which have shown the vaccine to be 95% effective with no severe side-effects. The FDA report says that the data is "consistent with the recommendations set forth in FDA’s Guidance on Emergency Use Authorization for Vaccines to Prevent COVID-19.""FDA has determined that the Sponsor has provided adequate information to ensure the vaccine’s quality and consistency for authorization of the product under an EUA,” the report reads.The next step in approval for the Moderna vaccine will come on Thursday when the FDA's Vaccines and Related Biological Products Advisory Committee will meet and vote on whether to approve the Moderna vaccine for Emergency Use Authorization.The vaccine would then need approval from the FDA as a whole, and then a recommendation from the CDC before health care professionals can begin injections.The release of the FDA report comes a day after the first Americans received initial doses of a COVID-19 vaccine made by Pfizer.Should Moderna's vaccine follow the same approval schedule as the Pfizer vaccine, health care professionals should begin injections by Monday.The U.S. purchased 100 million doses of the Moderna vaccine earlier this year, and Moderna will have millions of doses ready to ship as soon as it receives Emergency Use Authorization.Late last week, the federal government purchased an additional 100 million doses of the vaccine, meaning it expects to have 200 million doses by spring 2021.The decision to purchase more doses of Moderna's vaccine came days after the New York Times reported that the U.S. government chose not to purchase more doses of the Pfizer vaccine when it had the chance earlier this year. 1977

The Daytona International Speedway announced the Daytona 500 will have limited fan capacity next year due to COVID-19.Organizers said they will continue to work with local and state health officials regarding fan attendance at the 63rd annual event set for Feb. 14."While the stands may not be 101,500 strong, one truth remains: we are as committed as ever to delivering a best-in-class experience at the World Center of Racing for The Great American Race. From the awe of the U.S. Air Force Thunderbirds flyover, to the rumble of 40 engines roaring around the high banks on the biggest stage in motorsports – the DAYTONA 500 is sure to once again deliver the pageantry, thrills, and drama for all fans, especially those able to attend in person." The 63rd Annual #DAYTONA500 will have limited fan capacity. The grandstands may not look the same, but you can rest assured The Great American Race will once again have the aura and atmosphere of the biggest event in motorsports. ??: https://t.co/9cEIKinY8Y pic.twitter.com/ZSTM13Jra3— Daytona International Speedway (@DISupdates) December 2, 2020 Organizers said on its website they will work to accomodate those who have already purchased tickets to the race. "To ensure social distancing between groups who will be in attendance, many fans will be reseated in new locations," organizers said.The speedway is expected to complete the reseating process by early January.Everyone at the racetrack will be screened before they enter the facility and they'll also be required to wear face coverings while maintaining six feet social distancing, organizers said.This story was first reported by Lisette Lopez at WFTS in Tampa Bay, Florida. 1699

The fatal New York City helicopter crash that killed everyone on board except the pilot may have been caused by a passenger's piece of luggage, the pilot told investigators.The pilot said one of the passenger's bags may have inadvertently hit the emergency fuel shutoff button, leading to the crash that killed five passengers, a senior law enforcement official said.The National Transportation Safety Board will try to determine the cause of the Sunday evening crash, the Federal Aviation Administration said. The NTSB tweeted that an investigation team of 14 people would arrive Monday morning.  610

The coronavirus outbreak has put a hold on many things over the last few months, including some elective surgeries.When Nohely Uriostegui and her husband, Jose Pava, found out they were pregnant with a little boy, they were ecstatic. Then, the unfortunate news: their baby had spina bifida."After that, she said we’re going to do a test. You might be eligible for an in-utero surgery," said Uriostegui.That means surgery while the baby is still in the womb, and it had to be performed before 26 weeks of pregnancy. Everything was set up to go in Chicago until a phone call came from her doctor."He said, 'You know what? Based on COVID, everybody here on the team doesn’t feel like it’s an essential type of surgery,’" recalled Uriostegui.The same situation was unfolding for all types of patients around the country. Those hoping surgery could help their chronic pain were told they’d have to endure it for months longer. Organ transplant candidates were forced to wait as well. For Nohely and Jose, a delay meant they might miss their window to help their baby. But then, hope from three states away in Colorado."For this family, the clock was ticking. She had until she was 26 weeks to have fetal intervention, and that was literally five days, four days away. And they had to get from Chicago to here, be evaluated, have surgery set up to be performed, and so, we were able to do that for them," said Colorado Fetal Care Center surgeon Dr. Ken Liechty.The couple decided to travel to Colorado to have the procedure done."I got there on the 4th; my surgery was set for Monday, April 6, which was the exact same date that I was going to get it done in Chicago, and it was one day before I hit the 26-week mark," said Uriostegui."It’s open fetal surgery on the fetus as the actual patient," said Dr. Liechty. "We excise the cyst, we put the spinal cord back into the spinal canal."Doctors then put the muscle back over to seal it, close the skin over it, and then close the uterus. Without the in-utero surgery, Dr. Liechty says 90 percent of babies with spina bifida have a shunt put in to decompress the brain. However, that likely wouldn’t have been the only surgery he would have needed."These shunts fail, they can get infected, they can have all kinds of problems, they average seven surgeries at least for these shunts in their first few years of their life," said Dr. Liechty.In the time of this pandemic, that could mean more waiting as hospital beds begin to fill back up with coronavirus patients."COVID-19 caused a lot of places around the country to reexamine what cases could be done in their facilities, and a number of fetal centers are actually located in adult centers," said Dr. Liechty.Those places are filling up faster than children's hospitals, causing families like Uriostegui and her husband to almost miss opportunities to help their children before they even enter the world."The neurosurgeon over there actually said to us last time, that if you were to look at him, you would have never guessed that he’s born with spina bifida or that we went through this whole journey," said Uriostegui. 3126

The Department of Justice is suing to block California laws that extend protections for immigrants living in the United States illegally, commonly referred to as "sanctuary laws."The lawsuit by the Trump administration claims three of the state's laws intentionally undermine federal immigration law, according to The Associated Press.One of the laws prevents local police agencies from asking people about their immigration status or assisting in federal immigration enforcement activities. The Justice Department says these laws are unconstitutional.Attorney General Jeff Sessions, speaking at a law enforcement event in Sacramento Wednesday, said the administration's lawsuit against California was to "invalidate these unjust immigration laws" because the state's laws are a "violation of common sense."Sessions told those in attendance at the California Peace Officers Association's Legislative Day that the state has "a problem" and told California officials to "stop actively obstructing law enforcement … stop protecting lawbreakers."The attorney general singled out Oakland Mayor Libby Schaaf, who recently issued a public warning of an impending immigration raid in her city. Sessions claims that Immigration and Customs Enforcement officers "failed to make 800 arrests" because of Schaaf's statements. 1320

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