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The FDA announced on Friday that it has issued an emergency use authorization for a second coronavirus vaccine. Its approval comes just one week after the FDA gave an emergency use authorization for a similar vaccine by Pfizer. That vaccine began distribution earlier this week. Moderna’s vaccine has been hailed as a medical breakthrough. The vaccine has been considered 94.1% effective against the virus. According to Moderna, none of the thousands who were given two shots of the vaccine had severe COVID-19 symptoms. That is compared to 30 patients who were given a placebo who had symptoms.In order to obtain an emergency use authorization, the FDA weighed the vaccine’s benefits against possible side effects. An emergency use authorization is not a full FDA approval, but it allows those outside of a clinical or hospital setting to obtain the vaccine. “With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” FDA Commissioner Stephen M. Hahn said in a statement. “Through the FDA’s open and transparent scientific review process, two COVID-19 vaccines have been authorized in an expedited timeframe while adhering to the rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization that the American people have come to expect from the FDA. These standards and our review process, which are the same we have used in reviewing the first COVID-19 vaccine and intend to use for any other COVID-19 vaccines, included input from independent scientific and public health experts as well as a thorough analysis of the data by the agency’s career staff.”According to Moderna, approximately 20 million doses will be delivered to the U.S. government by the end of December 2020. Moderna said it expects to have between 100 million and 125 million doses available globally in the first quarter of 2021, with 85-100 million of those available in the U.S.While the vaccine could nearly eliminate the number of hospitalizations and deaths associated with the virus, the shot might result in some symptoms.In an interview with CNN last month, Operation Warp Speed chief scientific adviser Moncef Slaoui said that 10 to 15% of those immunized had noticeable side effects.“Most people will have much less noticeable side effects. That frankly -- in comparison to a 95% protection against an infection that can be deadly or significantly debilitating -- I think is an appropriate balance," he told CNN. 2648
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 community in Mayfield Heights, Ohio is mourning the loss of a 17-year-old student who died on Wednesday night. Steven "Stevie" Grieshammer was a junior on the swim team at Mayfield High School. On February 25 during swimming exercises he did not come up from the water, according to a Facebook post by his aunt Missy Bifro Grieshammer. "He was a wonderful boy, a loving son, a fantastic swimmer, and just the sweetest nephew we could have. We will miss him every day," his uncle wrote in remembrance.According to his family, he spent days in a coma.Mayfield City Schools superintendent Dr. Keith Kelly released the following statement to parents and students.Our deepest condolences and most heartfelt thoughts and prayers go out to the Grieshammer family. We will remember Stevie. He touched many through his kindness and determinination. Remain strong and support one another. Keep his memory close by being inspired by his life.— Keith Kelly (@suptmayfield) March 1, 2018 1016
The country’s top infectious disease expert is standing by his prediction that even if a COVID-19 vaccine is available by the end of this year, Americans should not expect a return to normalcy until late next year.Dr. Anthony Fauci’s latest comments come in an interview with MSNBC Friday in which he says, “If you're talking about getting back to a degree of normality which resembles where we were prior to covid, it's going to be toward the middle of 2021, maybe even end of 2021.”These statements come as more states are relaxing social distancing and lockdown measures; opening more theaters, gyms, salons and indoor dining.Dr. Fauci, who is the director of the National Institute for Allergy and Infectious Diseases, remains confident a vaccine will be available by the end of the year. However, he says just because it’s available doesn’t mean a quick return to pre-COVID life."But by the time you mobilize the distribution of the vaccine and get a majority or more of the population vaccinated and protected, that’s likely not going to happen until the end of 2021," Dr. Fauci told host Andrea Mitchell.He also expressed concern about states reopening certain indoor activities, because of the increased risk of contracting COVID-19. 1249
The death of a 22-year-old African-American man shortly after a struggle with police last week has been ruled a homicide, authorities in Jefferson Parish, Louisiana said Monday.Keeven Robinson, of Metairie, died last Thursday, following a police chase and an altercation with narcotics detectives from the Jefferson Parish Sheriff's Office, located outside of New Orleans, according to authorities.An initial autopsy found significant traumatic injuries to the soft tissue of Robinson's neck, said Jefferson Parish Coroner Dr. Gerry Cvitanovich, who cautioned that the results from the autopsy, which was conducted Saturday, are preliminary and more tests need to be conducted.Cvitanovich said the findings are consistent with compressional asphyxia, which will likely be cause of death at the end of the process.The four detectives involved in the incident are white, said Sheriff Joseph P. Lopinto, who declined to release their names at this point."I understand ... this investigation will be under a microscope, understand it fully," Lopinto told reporters.Gaylor Spiller, president of the West Jefferson Parish NAACP branch, said Robinson's family is also seeking a second independent autopsy."I like the fact that Sheriff Lopinto stepped up to plate, and he's doing his part," Spiller said, according CNN affiliate WDSU. "He knows that the NAACP will be on his trail."Robinson was being investigated by narcotics detectives early Thursday, Lt. Jason Rivarde, spokesman for Jefferson Parish Sheriff's Office, told CNN.Undercover detectives assigned to the case tracked Robinson down at a local gas station and tried to arrest him, according to Rivarde. But Robinson jumped back in his vehicle and led police on a chase after spotting them, Rivarde said.The suspect rammed several police cars before crashing his vehicle, according to Rivarde.Robinson took off on foot, jumping several fences before deputies caught him in a backyard of a nearby residential neighborhood, Rivarde said.Rivarde says a struggle ensued with deputies who eventually handcuffed Robinson. Once handcuffed, detectives noticed Robinson was not breathing, Rivarde said. Detectives administered life saving techniques before Robinson was taken to a local hospital where he died, Rivarde said.The agency is not equipped with body cameras or dash cameras, according to Rivarde."They were in a struggle," Lopinto said. "They used force." He added that the officers admitted to using force during the arrest.But the sheriff said he's "not coming to the conclusion that this was a chokehold."Lopinto said he contacted the Louisiana State Police on Saturday after he was told of the initial findings, and asked them to assist in the investigation.The sheriff said he has "every faith" in his officers to do their job well."I know they have the expertise because this is what they do every day, but I also understand that an independent set of eyes is something that's appropriate in a case like this," he said.The four detectives involved in the arrest were read their rights and have given statements, Lopinto said.They are being reassigned to administrative duty pending the outcome of the investigation, the sheriff's said.The FBI's Civil Rights Task force is also looking into the matter after he contacted them Saturday, the sheriff said.The actions of the coroner's office were largely praised Monday by Robinson's family.Hester Hilliard, an attorney for Robinson's family, thanked the coroner's office "for their professionalism and their transparency.""Today is just as hard as Thursday for this family. They're grieving, and today they had to find out that Keeven lost his life at the hands of another," she said, according DSU. "And that's very, very hard for them.""Now, it's time for us to move on to making funeral arrangements for a 22-year-old that should not have died," she said.In an interview with CNN, Hilliard said she is hoping "to see the same justice for Keeven as with any other individual who has died at the hands of someone other than the police.""We are hoping for a thorough investigation, an arrest and prosecution of those that caused his death unjustifiably," she said. 4201