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	<title>University of Maryland School of Medicine &#8211; Cincy Link</title>
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		<title>Moderna prepares to submit RSV﻿ vaccine for FDA approval</title>
		<link>https://cincylink.com/2023/06/05/moderna-prepares-to-submit-rsv-vaccine-for-fda-approval/</link>
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		<pubDate>Mon, 05 Jun 2023 21:28:06 +0000</pubDate>
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					<description><![CDATA[BREAKTHROUGH FOR US TO HAVE A VACCINE AVAILABLE. &#62;&#62; MODERNA RELEASED FOR PRELIMINARY RESULTS OF THEIR VACCINE FOR RSV SHOWING IT IS MORE THAN 80% EFFECTIVE AT PREVENTING SERIOUS DISEASE IN PEOPLE OVER 60. AND IS PREPARING TO SUBMIT TO THE FDA FOR APPROVAL. THIS FOLLOWS SUBMISSIONS FROM PFIZER AND GLAXOSMITHKLINE LATE LAST YEAR. &#62;&#62; &#8230;]]></description>
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											BREAKTHROUGH FOR US TO HAVE A VACCINE AVAILABLE. &gt;&gt; MODERNA RELEASED FOR PRELIMINARY RESULTS OF THEIR VACCINE FOR RSV SHOWING IT IS MORE THAN 80% EFFECTIVE AT PREVENTING SERIOUS DISEASE IN PEOPLE OVER 60. AND IS PREPARING TO SUBMIT TO THE FDA FOR APPROVAL. THIS FOLLOWS SUBMISSIONS FROM PFIZER AND GLAXOSMITHKLINE LATE LAST YEAR. &gt;&gt; THE PFIZER VACCINE, THEY ALSO RELEASED RESULTS ON GIVING THAT SAME VACCINE TO PREGNANT WOMEN. AND THEN WHAT HAPPENS IS THE WOMAN, THE ANTIBODIES THAT THE WOMAN MAKES GET PASSED THROUGH THE PLACENTA INTO THE BABY. THEY SHOWED VERY GOOD PROTECTION IN THE FIRST THREE MONTHS OF LIFE. &gt;&gt; BABIES A YOUNG KIDS ARE ONE OF THE HIGH-RISK GROUPS FOR DEVELOPING COMPLICATIONS AND DYING FROM RSV. CLINICAL TRIALS ARE UNDERWAY ON A VACCINE FOR THEM. THESE WOULD BE THE FIRST RSV VACCINES APPROVED, A FEAT BECAUSE RESEARCHERS HAVE BEEN WORKING ON THEM SINCE THE 1960’S. MODERNA’S VERSION USES A MRNA TECHNOLOGY MADE FAMOUS BY THE COVID SHOT. &gt;&gt; THE REASON WHY THEY CAN MOVE SO QUICKLY ON THE COVID VACCINE WAS BECAUSE THEY HAD ALREADY BEEN STUDYING THIS VACCINE, THIS RSV VACCINE WE ARE LEARNING ABOUT NOW AND THEY USED THAT SAME TECHNOLOGY AND A LOT OF THE TRICKS THEY HAD FOUND FROM THAT TO DEVELOP THE COVID VACCINE. DR. CAMPBELL CAUTIONS THESE RESULTS ARE PRELIMINARY AND ARE NOT PEER REVIEW. SO, WHILE PROMISING, HE IS WAITING FOR FULL DETAILS. &gt;&gt; DOESN’T TAKE AWAY FROM THAT THIS IS REALLY EXCITING NEWS. BUT I AND I THINK EVERYONE SHOULD BE WAITING TO SEE WHAT THE FINAL, ALL THE DATA SHOW. FOR THIS VACCINE AND THE OTHER RSV VACCINES. &gt;&gt; DR. CAMPBELL SAYS RESEARCHERS ARE HOPEFUL THAT SOME OF THESE VACCINES WILL BE READY IN TIME FOR THIS YEAR’S RSV. SEASON THIS FALL.
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<p>Researchers on cusp of rolling out new vaccine for RSV</p>
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<p>Study: Moderna RSV vaccine more than 80% effective at preventing RSV in older adults</p>
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												<img decoding="async" src="https://cdn.cincylink.com/pub/content/uploads/sites/27/2023/01/Moderna-prepares-to-submit-RSV﻿-vaccine-for-FDA-approval.png" class="lazyload lazyload-in-view branding" alt="WBAL"/></p>
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					Updated: 4:36 AM EST Jan 21, 2023
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					Researchers are on the cusp of rolling out a new vaccine to combat the respiratory syncytial virus amid an increase in cases in recent months.RSV has become the second leading cause of hospitalization, and tens of thousands of people a year die from it. Children under 2 and adults older than 60 are most at risk for serious disease, and a vaccine has been elusive -- until now."It will be a huge, huge breakthrough for us to have an RSV vaccine available," said Dr. James Campbell, professor of pediatrics and the University of Maryland School of Medicine.RELATED: Sinai pediatrician describes ICU availability amid increase in RSV casesModerna released preliminary results of their vaccine for RSV that shows it's more than 80% effective at preventing serious disease in people older than 60. The company is preparing to submit the vaccine to the Food and Drug Administration for approval, which follows submissions from Pfizer and GlaxoSmithKline late last year."The Pfizer vaccine, they also relayed results on giving that same vaccine to pregnant women, and then what happens is the antibodies the woman makes, gets passed through the placenta into the baby, and they showed very good protection in the first three months of life," Campbell said.Clinical trials are underway on a vaccine for babies and young children, who are among the high-risk groups for developing complications and dying from RSV.RELATED: Maryland hospitals concerned over surge of children with RSVThese would be the first RSV vaccines approved, which would be a feat because researchers have been working on them since the 1960s. Moderna's version uses the mRNA technology made famous by its COVID-19 vaccine."The reason why they could move so quickly on the COVID vaccine was because they had already been studying this RSV vaccine that we're just learning about now, and they used that same technology, and a lot of the tricks they found from that, in order to develop the COVID vaccine," Campbell said.RSV video playlist below:Campbell cautioned the results in the RSV vaccine study are preliminary and are not yet peer-reviewed, so while promising, he's waiting for the full details."That doesn't take away that this is really exciting news, but I think everyone should be waiting to see what the final, all the data show for this vaccine and the other RSV vaccines," Campbell said.Campbell said researchers are hopeful that some of these vaccines will be approved in time for RSV season in the fall.LINK: Maryland Department of Health website for RSV
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<p>Researchers are on the cusp of rolling out a new vaccine to combat the respiratory syncytial virus amid an increase in cases in recent months.</p>
<p>RSV has become the second leading cause of hospitalization, and tens of thousands of people a year die from it. Children under 2 and adults older than 60 are most at risk for serious disease, and a vaccine has been elusive -- until now.</p>
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<p>"It will be a huge, huge breakthrough for us to have an RSV vaccine available," said Dr. James Campbell, professor of pediatrics and the University of Maryland School of Medicine.</p>
<p><strong>RELATED</strong>: <a href="https://www.wbaltv.com/article/rsv-cases-in-maryland-weigh-down-hospitals-icus/41936297">Sinai pediatrician describes ICU availability amid increase in RSV cases</a></p>
<p><a href="https://investors.modernatx.com/news/news-details/2023/Moderna-Announces-mRNA-1345-an-Investigational-Respiratory-Syncytial-Virus-RSV-Vaccine-Has-Met-Primary-Efficacy-Endpoints-in-Phase-3-Trial-in-Older-Adults/default.aspx" target="_blank" rel="nofollow noopener">Moderna released preliminary results of their vaccine for RSV</a> that shows it's more than 80% effective at preventing serious disease in people older than 60. The company is preparing to submit the vaccine to the Food and Drug Administration for approval, which follows submissions from Pfizer and GlaxoSmithKline late last year.</p>
<p>"The Pfizer vaccine, they also relayed results on giving that same vaccine to pregnant women, and then what happens is the antibodies the woman makes, gets passed through the placenta into the baby, and they showed very good protection in the first three months of life," Campbell said.</p>
<p>Clinical trials are underway on a vaccine for babies and young children, who are among the high-risk groups for developing complications and dying from RSV.</p>
<p><strong>RELATED</strong>: <a href="https://www.wbaltv.com/article/respiratory-syncytial-virus-rsv-maryland-hospitals-children/41768918">Maryland hospitals concerned over surge of children with RSV</a></p>
<p>These would be the first RSV vaccines approved, which would be a feat because researchers have been working on them since the 1960s. Moderna's version uses the <a href="https://www.wbaltv.com/article/coronavirus-vaccine-moderna-university-of-maryland-researchers-encouraged-by-results/34687222">mRNA technology made famous by its COVID-19 vaccine</a>.</p>
<p>"The reason why they could move so quickly on the COVID vaccine was because they had already been studying this RSV vaccine that we're just learning about now, and they used that same technology, and a lot of the tricks they found from that, in order to develop the COVID vaccine," Campbell said.<strong><em><br /></em></strong></p>
<p><strong><em>RSV video playlist below:</em></strong></p>
<p>Campbell cautioned the results in the RSV vaccine study are preliminary and are not yet peer-reviewed, so while promising, he's waiting for the full details.</p>
<p>"That doesn't take away that this is really exciting news, but I think everyone should be waiting to see what the final, all the data show for this vaccine and the other RSV vaccines," Campbell said.</p>
<p>Campbell said researchers are hopeful that some of these vaccines will be approved in time for RSV season in the fall.</p>
<p><strong>LINK</strong>: <a href="https://health.maryland.gov/phpa/OIDEOR/CIDSOR/Pages/Respiratory-Syncytial-Virus-(RSV).aspx" rel="nofollow">Maryland Department of Health website for RSV</a></p>
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		<title>Images show effects of lung damage among unvaccinated people</title>
		<link>https://cincylink.com/2022/01/20/images-show-effects-of-lung-damage-among-unvaccinated-people/</link>
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		<pubDate>Thu, 20 Jan 2022 10:37:09 +0000</pubDate>
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					<description><![CDATA[The extent of potential damage COVID-19 can cause on the lungs and long-term damage can depend on whether a person is vaccinated. A Maryland radiologist wants people to see what he sees in COVID-19 patients, hoping to move the unvaccinated to get vaccinated.Dr. Omer Awan, who is the associate vice chair of education in the &#8230;]]></description>
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<p>
					The extent of potential damage COVID-19 can cause on the lungs and long-term damage can depend on whether a person is vaccinated. A Maryland radiologist wants people to see what he sees in COVID-19 patients, hoping to move the unvaccinated to get vaccinated.Dr. Omer Awan, who is the associate vice chair of education in the Department of Diagnostic Radiology at the University of Maryland School of Medicine, wants the public to understand and see the difference for themselves."There is a dramatic difference in chest X-rays we see in patients that have been fully vaccinated who test positive for COVID-19 and those who are not vaccinated," Awan said. Awan showed sister station WBAL computed tomography images of a vaccinated COVID-19 patient and compared it to images showing unvaccinated lung damage."You can see in the vaccinated individual, much of the lung is black, and that's a good thing because the black demonstrates air," Awan said.It was a much different story in the lung of an unvaccinated person."The burden of disease or the burden of infection is much more pronounced in an unvaccinated individual versus a vaccinated individual," Awan said. Tracking the omicron surgeWhen am I contagious if infected with omicron?CDC study: Vaccination protects against COVID hospitalization significantly more than prior infection  Biden administration to give away 400 million N95 masks. Here's what you need to know CDC moves 22 new destinations into its highest-risk level for travel due to omicronAwan said the symptoms of a vaccinated person are milder than in an unvaccinated person."Oftentimes, those that are unvaccinated will have full-blown shortness of breath. They may require oxygen therapy. There's a higher propensity for them to go into the ICU," Awan said.Awan said he hopes the images will change minds."If you see images, you can see clearly the proof in vaccination and how effective the vaccines are by looking at a chest X-ray. Oftentimes, that's more helpful from a visual standpoint than just hearing people spit out statistics," Awan said.
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					<strong class="dateline">BALTIMORE —</strong> 											</p>
<p>The extent of potential damage COVID-19 can cause on the lungs and long-term damage can depend on whether a person is vaccinated. </p>
<p>A Maryland radiologist wants people to see what he sees in COVID-19 patients, hoping to move the unvaccinated to get vaccinated.</p>
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<p>Dr. Omer Awan, who is the associate vice chair of education in the Department of Diagnostic Radiology at the University of Maryland School of Medicine, wants the public to understand and see the difference for themselves.</p>
<p>"There is a dramatic difference in chest X-rays we see in patients that have been fully vaccinated who test positive for COVID-19 and those who are not vaccinated," Awan said. </p>
<p>Awan showed sister station WBAL computed tomography images of a vaccinated COVID-19 patient and compared it to images showing unvaccinated lung damage.</p>
<p>"You can see in the vaccinated individual, much of the lung is black, and that's a good thing because the black demonstrates air," Awan said.</p>
<p>It was a much different story in the lung of an unvaccinated person.</p>
<p>"The burden of disease or the burden of infection is much more pronounced in an unvaccinated individual versus a vaccinated individual," Awan said. </p>
<h3>Tracking the omicron surge</h3>
<p>Awan said the symptoms of a vaccinated person are milder than in an unvaccinated person.</p>
<p>"Oftentimes, those that are unvaccinated will have full-blown shortness of breath. They may require oxygen therapy. There's a higher propensity for them to go into the ICU," Awan said.</p>
<p>Awan said he hopes the images will change minds.</p>
<p>"If you see images, you can see clearly the proof in vaccination and how effective the vaccines are by looking at a chest X-ray. Oftentimes, that's more helpful from a visual standpoint than just hearing people spit out statistics," Awan said. </p>
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		<title>COVID-19 survivor, double lung recipient encourages people to get vaccine</title>
		<link>https://cincylink.com/2021/09/17/covid-19-survivor-double-lung-recipient-encourages-people-to-get-vaccine/</link>
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		<pubDate>Fri, 17 Sep 2021 04:28:23 +0000</pubDate>
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					<description><![CDATA[If you're still hesitant about getting a vaccine or don't want to mask up, one young man said he hopes his story will help change your mind.In March 2021, Blake Bargatze, 24, went to a concert in Florida where he lived. He thought the crowd would be small. Bargatze was not vaccinated, and he did &#8230;]]></description>
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<p>
					If you're still hesitant about getting a vaccine or don't want to mask up, one young man said he hopes his story will help change your mind.In March 2021, Blake Bargatze, 24, went to a concert in Florida where he lived. He thought the crowd would be small. Bargatze was not vaccinated, and he did wear a mask. "Once I got in there, there was way too many and I got really hot, so I took it (mask) off, which probably wasn't the wisest decision on my part," Bargatze said.His mother Cheryl Nuclo wasn't happy with him."When I found out he went to that concert, I was pretty upset about it," Nuclo said.Two days later, Bargatze was diagnosed with COVID-19."I had a really bad headache and body aches and after that, I started having a really high fever -- went from 102 to 103 and up to 104," Bargatze said.On April 10, he was admitted to the hospital where it went downhill quickly. He had to be intubated and the coronavirus was damaging his lungs. His mother had him flown to his native Atlanta where she lived. That's where Bargatze got bad news."They gave the choice saying, 'We could either get a double lung transplant, which is the only way you have to survive or we're going to make you comfortable enough so you can pass,'" Bargatze said.Bargatze decided to fight."He couldn't get out of bed, he couldn't walk -- he could raise his fingers, basically," Nuclo said.After making inquiries all over, Bargatze finally decided on the University of Maryland Medical Center since they had done two successful double lung transplants on COVID-19 patients."He was young, determined, willing to move to Baltimore," said Dr. Robert Reed, medical director for lung transplantation at University of Maryland School of Medicine.Reed said they thought they could help Bargatze."His lungs looked awful. They looked like little chunks of liver. They didn't look like lungs at all, they were red, they were foggy. There was no saving those lungs," Reed said. "COVID-19 just destroyed them just chewed them up."Bargatze got the transplant in June, went through rehab and is now living in Ellicott City with his mother while he recovers. He takes 50 pills a day."I just try to make the best of it. I'm here, I'm alive today and I'm thankful," he said.Bargatze said the pills he'll take for the rest of his life, and his scar will forever remind him of what he went through."I would strongly encourage getting the vaccine to protect yourself and your family, and if you're against the vaccine, at least be courteous and wear a mask wherever you go. This isn't always about ourselves, it's about the people around us," Bargatze said.
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					<strong class="dateline">BALTIMORE —</strong> 											</p>
<p>If you're still hesitant about getting a vaccine or don't want to mask up, one young man said he hopes his story will help change your mind.</p>
<p>In March 2021, Blake Bargatze, 24, went to a concert in Florida where he lived. He thought the crowd would be small. Bargatze was not vaccinated, and he did wear a mask. </p>
<p>"Once I got in there, there was way too many and I got really hot, so I took it (mask) off, which probably wasn't the wisest decision on my part," Bargatze said.</p>
<p>His mother Cheryl Nuclo wasn't happy with him.</p>
<p>"When I found out he went to that concert, I was pretty upset about it," Nuclo said.</p>
<p>Two days later, Bargatze was diagnosed with COVID-19.</p>
<p>"I had a really bad headache and body aches and after that, I started having a really high fever -- went from 102 to 103 and up to 104," Bargatze said.</p>
<p>On April 10, he was admitted to the hospital where it went downhill quickly. He had to be intubated and the coronavirus was damaging his lungs. His mother had him flown to his native Atlanta where she lived. That's where Bargatze got bad news.</p>
<p>"They gave the choice saying, 'We could either get a double lung transplant, which is the only way you have to survive or we're going to make you comfortable enough so you can pass,'" Bargatze said.</p>
<p>Bargatze decided to fight.</p>
<p>"He couldn't get out of bed, he couldn't walk -- he could raise his fingers, basically," Nuclo said.</p>
<p>After making inquiries all over, Bargatze finally decided on the University of Maryland Medical Center since they had done two successful double lung transplants on COVID-19 patients.</p>
<p>"He was young, determined, willing to move to Baltimore," said Dr. Robert Reed, medical director for lung transplantation at University of Maryland School of Medicine.</p>
<p>Reed said they thought they could help Bargatze.</p>
<p>"His lungs looked awful. They looked like little chunks of liver. They didn't look like lungs at all, they were red, they were foggy. There was no saving those lungs," Reed said. "COVID-19 just destroyed them just chewed them up."</p>
<p>Bargatze got the transplant in June, went through rehab and is now living in Ellicott City with his mother while he recovers. He takes 50 pills a day.</p>
<p>"I just try to make the best of it. I'm here, I'm alive today and I'm thankful," he said.</p>
<p>Bargatze said the pills he'll take for the rest of his life, and his scar will forever remind him of what he went through.</p>
<p>"I would strongly encourage getting the vaccine to protect yourself and your family, and if you're against the vaccine, at least be courteous and wear a mask wherever you go. This isn't always about ourselves, it's about the people around us," Bargatze said.</p>
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