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	<title>august &#8211; Cincy Link</title>
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		<title>The movies coming to theaters in August</title>
		<link>https://cincylink.com/2023/07/07/the-movies-coming-to-theaters-in-august/</link>
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		<pubDate>Fri, 07 Jul 2023 04:08:43 +0000</pubDate>
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		<guid isPermaLink="false">https://cincylink.com/?p=166956</guid>

					<description><![CDATA[This summer has been full of blockbusters at the movie theaters and August will be no different.Here's a look at what's cominig to the big screen over the next few weeks. Aug. 5"Bullet Train"While on board a fast-moving bullet train, five assassins discover that their missions are similar.Cast includes Brad Pitt, Joey King, Sandra Bullock &#8230;]]></description>
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<p>
					This summer has been full of blockbusters at the movie theaters and August will be no different.Here's a look at what's cominig to the big screen over the next few weeks. Aug. 5"Bullet Train"While on board a fast-moving bullet train, five assassins discover that their missions are similar.Cast includes Brad Pitt, Joey King, Sandra Bullock and Michael Shannon.  "Bodies Bodies Bodies"A hurricane party at a remote family mansion turns deadly.Cast includes Pete Davidson, Amandla Stenberg, Maria Bakalova and Rachel Sennott."Resurrection"Margaret's past catches up to her when David comes back into her life. Cast includes Rebecca Hall, Tim Roth and Grace Kaufman.  "Collide"A group of characters are linked together during the course of an evening at a restaurant in Los Angeles.Cast includes Ryan Phillippe, Kat Graham and Jim Gaffigan. "My Favorite Girlfriend"Conrad finally meets a girl who's the perfect fit, but has multiple personalities. Cast includes Bonnie Piesse, Tyler Johnson and Michael DiBacco. Aug. 12"Mack &amp; Rita"A 30-year-old writer wakes up to find herself 70 years old during a weekend in Palm Springs.  Cast includes Martin Short, Diane Keaton and Wendie Malick."Fall"Becky and Hunter are best friends who find themselves on top of a radio tower 2,000 feet in the sky.Cast includes Jeffrey Dean Morgan, Grace Caroline Currey and Virginia Gardner."Rogue Agent"Robert Freegard is a career conman who disguised himself as an agent and fooled people into going into hiding. It gets even more interesting when the woman who fell for him helps bring him down. Cast includes Sarah Goldburg, James Norton and Gemma Arterton. "Summering"Four young girls confront growing pains and experience an adventure during the weekend before middle school begins.  Cast includes Lia Barnett, Sanai Victoria and Madalen Mills.Aug. 19"Beast"A massive lion begins hunting a father and his two teenage daughters in the Savanna. Cast includes Idris Elba,  Sharlto Copley and Iyana Halley.Aug. 26"The Invitation"When a young woman is swept off her feet, she quickly learns it may be too good to be true. Cast includes Alana Boden, Thomas Doherty and Nathalie Emmanuel. "Maneater"A group of friends is followed by a large shark after an accident on a vacation to an island in paradise. Cast includes Shane West, Nicky Whelan and Jeff Fahey."Breaking"A Marine encounters numerous obstacles as he tries to adjust to civilian life.  Cast includes John Boyega, Nicole Beharie and Selenis Leyva.Aug. 31"Three Thousand Years of Longing"On a trip to Istanbul, a lonely scholar is offered three wishes in exchange for his freedom. Cast includes Idris Elba, Tilda Swinton and Pia Thunderbolt.
				</p>
<div>
<p>This summer has been full of blockbusters at the movie theaters and August will be no different.</p>
<p><!-- article/blocks/side-floater --></p>
<p><!-- article/blocks/side-floater --></p>
<p>Here's a look at what's cominig to the big screen over the next few weeks. </p>
<h2 class="body-h2">Aug. 5</h2>
<p><strong>"Bullet Train"</strong></p>
<p>While on board a fast-moving bullet train, five assassins discover that their missions are similar.</p>
<p>Cast includes Brad Pitt, Joey King, Sandra Bullock and Michael Shannon. </p>
<p><strong>"Bodies Bodies Bodies"</strong></p>
<p>A hurricane party at a remote family mansion turns deadly.</p>
<p>Cast includes Pete Davidson, Amandla Stenberg, Maria Bakalova and Rachel Sennott.</p>
<p><strong>"Resurrection"</strong></p>
<p>Margaret's past catches up to her when David comes back into her life. </p>
<p>Cast includes Rebecca Hall, Tim Roth and Grace Kaufman. </p>
<p><strong>"Collide"</strong></p>
<p>A group of characters are linked together during the course of an evening at a restaurant in Los Angeles.</p>
<p>Cast includes Ryan Phillippe, Kat Graham and Jim Gaffigan. </p>
<p><strong>"My Favorite Girlfriend"</strong></p>
<p>Conrad finally meets a girl who's the perfect fit, but has multiple personalities. </p>
<p>Cast includes Bonnie Piesse, Tyler Johnson and Michael DiBacco.</p>
<h2 class="body-h2">Aug. 12</h2>
<p><strong>"Mack &amp; Rita"</strong></p>
<p>A 30-year-old writer wakes up to find herself 70 years old during a weekend in Palm Springs.  </p>
<p>Cast includes Martin Short, Diane Keaton and Wendie Malick.</p>
<p><strong>"Fall"</strong></p>
<p>Becky and Hunter are best friends who find themselves on top of a radio tower 2,000 feet in the sky.</p>
<p>Cast includes Jeffrey Dean Morgan, Grace Caroline Currey and Virginia Gardner.</p>
<p><strong>"Rogue Agent"</strong></p>
<p>Robert Freegard is a career conman who disguised himself as an agent and fooled people into going into hiding. It gets even more interesting when the woman who fell for him helps bring him down. </p>
<p>Cast includes Sarah Goldburg, James Norton and Gemma Arterton. </p>
<p><strong>"Summering"</strong></p>
<p>Four young girls confront growing pains and experience an adventure during the weekend before middle school begins.  </p>
<p>Cast includes Lia Barnett, Sanai Victoria and Madalen Mills.</p>
<h2 class="body-h2">Aug. 19</h2>
<p><strong>"Beast"</strong></p>
<p>A massive lion begins hunting a father and his two teenage daughters in the Savanna. </p>
<p>Cast includes Idris Elba,  Sharlto Copley and Iyana Halley.</p>
<h2 class="body-h2">Aug. 26</h2>
<p><strong>"The Invitation"</strong></p>
<p>When a young woman is swept off her feet, she quickly learns it may be too good to be true. </p>
<p>Cast includes Alana Boden, Thomas Doherty and Nathalie Emmanuel.</p>
<p><strong>"Maneater"</strong></p>
<p>A group of friends is followed by a large shark after an accident on a vacation to an island in paradise. </p>
<p>Cast includes Shane West, Nicky Whelan and Jeff Fahey.</p>
<p><strong><strong><br /></strong></strong></p>
<p><strong>"Breaking"</strong></p>
<p>A Marine encounters numerous obstacles as he tries to adjust to civilian life.  </p>
<p>Cast includes John Boyega, Nicole Beharie and Selenis Leyva.</p>
<h2 class="body-h2">Aug. 31</h2>
<p><strong>"Three Thousand Years of Longing"</strong></p>
<p>On a trip to Istanbul, a lonely scholar is offered three wishes in exchange for his freedom. </p>
<p>Cast includes Idris Elba, Tilda Swinton and Pia Thunderbolt.</p>
<p><strong><br /></strong></p></div>
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		<title>Text, calls didn&#8217;t go through before family of 3 died while hiking</title>
		<link>https://cincylink.com/2022/02/18/text-calls-didnt-go-through-before-family-of-3-died-while-hiking/</link>
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		<pubDate>Sat, 19 Feb 2022 02:17:58 +0000</pubDate>
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		<guid isPermaLink="false">https://cincylink.com/?p=148404</guid>

					<description><![CDATA[Nearly six months after a California family and their dog died of extreme heat exhaustion and dehydration while hiking, phone data was released on Thursday that shows a text message and several phone calls did not go through due to poor cellphone reception.John Gerrish, his wife, Ellen Chung, their 1-year-old daughter, Miju, and their dog &#8230;]]></description>
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<p>
					Nearly six months after a California family and their dog died of extreme heat exhaustion and dehydration while hiking, phone data was released on Thursday that shows a text message and several phone calls did not go through due to poor cellphone reception.John Gerrish, his wife, Ellen Chung, their 1-year-old daughter, Miju, and their dog were walking in extreme heat in a remote area close to the Merced River in the Sierra National Forest last August before they died.Jonathan Gerrish's phone showed the family took multiple photos throughout their hike from 7:44 to 10:29 a.m., according to the release. At 12:25 p.m, they took a screenshot of their location on the trail map.A single text message at 11:56 a.m. saying, "Can you help us. On savage lundy trail heading back to Hites cove trail. No water or ver (over) heating with baby" did not go through due to not having cell service in the area, the release said. Five calls were also found to have been attempted but were not successful due to the same reason. The first was at 12:09 p.m. and the last four were attempted within one minute of each other at 12:36 p.m. They were found dead on Aug. 17 just 1.6 miles from their vehicle after a family friend reported them missing. In October, the cause of death for all three family members was determined to be hyperthermia and dehydration. Temperatures ranged from 107 to 109 degrees Fahrenheit and their water container was empty, authorities said.The details found on the phone support the findings of a heat-related incident, authorities said.  "The cellphone data results were the last thing both the family and detectives were waiting on. The extracted information confirms our initial findings. I am very proud of my team and our partner agencies for all the work they put in. Their dedication has allowed us to close this case and answer lingering questions the family had, bringing them a little peace," Mariposa County Sheriff Jeremy Briese said.
				</p>
<div>
<p>Nearly six months after a California family and their dog died of extreme heat exhaustion and dehydration while hiking, phone data was released on Thursday that shows a text message and several phone calls did not go through due to poor cellphone reception.</p>
<p>John Gerrish, his wife, Ellen Chung, their 1-year-old daughter, Miju, and their dog were walking in extreme heat in a remote area close to the Merced River in the Sierra National Forest last August before they died.</p>
<p><!-- article/blocks/side-floater --></p>
<p><!-- article/blocks/side-floater --></p>
<p>Jonathan Gerrish's phone showed the family took multiple photos throughout their hike from 7:44 to 10:29 a.m., according to the release. At 12:25 p.m, they took a screenshot of their location on the trail map.</p>
<p>A single text message at 11:56 a.m. saying, "Can you help us. On savage lundy trail heading back to Hites cove trail. No water or ver (over) heating with baby" did not go through due to not having cell service in the area, the release said. </p>
<p>Five calls were also found to have been attempted but were not successful due to the same reason. The first was at 12:09 p.m. and the last four were attempted within one minute of each other at 12:36 p.m. </p>
<p>They were found dead on Aug. 17 just 1.6 miles from their vehicle after a family friend reported them missing. In October, the cause of death for all three family members was determined to be hyperthermia and dehydration. </p>
<p>Temperatures ranged from 107 to 109 degrees Fahrenheit and their water container was empty, authorities said.</p>
<p>The details found on the phone support the findings of a heat-related incident, authorities said.  </p>
<p>"The cellphone data results were the last thing both the family and detectives were waiting on. The extracted information confirms our initial findings. I am very proud of my team and our partner agencies for all the work they put in. Their dedication has allowed us to close this case and answer lingering questions the family had, bringing them a little peace," Mariposa County Sheriff Jeremy Briese said.</p>
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		<title>Why we seem to embrace fall earlier every year</title>
		<link>https://cincylink.com/2021/09/11/why-we-seem-to-embrace-fall-earlier-every-year/</link>
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		<dc:creator><![CDATA[cincylink]]></dc:creator>
		<pubDate>Sat, 11 Sep 2021 04:57:16 +0000</pubDate>
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		<guid isPermaLink="false">https://cincylink.com/?p=91127</guid>

					<description><![CDATA[The week after Labor Day has historically represented the unofficial start of fall, and though most leaves have retained their green color, the season of pumpkin spice is already in full effect.On Aug. 24 -- a full month before the official start of fall -- Starbucks posted a tweet that sent half of the internet &#8230;]]></description>
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<p>
					The week after Labor Day has historically represented the unofficial start of fall, and though most leaves have retained their green color, the season of pumpkin spice is already in full effect.On Aug. 24 -- a full month before the official start of fall -- Starbucks posted a tweet that sent half of the internet into a frenzy, while the other half shook their heads in despair: "Pumpkin has entered the chat."It was a de facto announcement about the return of the coffee chain's cult favorite Pumpkin Spice Latte, a drink some look forward to all year. A week earlier, competitor Dunkin' posted about the return of their own pumpkin coffee confection.Every year, it feels like pumpkin spice mania comes earlier and earlier. Though some of these products may be blatant marketing ploys, some segments of society seem to welcome it back with open arms every time. From coffee to candles to deodorant, pumpkin spice is ubiquitous -- a signal that fall is upon us once more. Even if it's still 90 degrees outside and there's nary a golden leaf in sight, it's suddenly time for fires, apple picking and cozy sweaters. Fall begins when we say it does!But why do so many crave the return of this season so much? What are we really reaching for when we cling to the edge of fall's garment, hoping it will envelop us sooner than it has before?Part of it is nostalgia. Part of it is the warmth the season brings. But it could also just be the events of the past 18 months that are causing many of us to feel ready for fall early.With fall, comes nostalgiaSome of the joyous anticipation of fall is just that: anticipation. When our mouths drool while imagining warm mugs of apple cider and pumpkin bread, it's the anticipation that gets us excited, rather than the actual reward, one psychologist says."So come August, we're like fall is kind of around the corner, we're anticipating all the good things that are coming," said Richard Lopez, professor of psychology at Bard College.There are powerful cues that play into the nostalgia surrounding fall -- possibly even more so than with other seasons. There's a nip in the air, the leaves are different colors, kids and their oversized backpacks are schlepping to school -- all of these signs are triggers that, oftentimes, remind us of our younger selves, Lopez said.Think of holidays like Halloween, and the childlike joy it brings, with its costumes and bright orange-wrapped chocolate. Or even specials like "It's the Great Pumpkin, Charlie Brown." These are things that bring many of us back to an earlier, more simpler time.Those layers of positive memories and nostalgia, coupled with the anticipation of what's to come, all play into the excitement many feel about fall, Lopez said."It's this change of season; there's a lot of things to look forward to. We had those same experiences when we were young," he said. "Other times of year, there isn't that effect with that nostalgia or that anticipation."Tom Hanks' character in the 1998 movie "You've Got Mail" sums it up perfectly: "Don't you love New York in the fall?" he asks. "It makes me want to buy school supplies."Fall can offer comfort in tumultuous timesBut when we think of fall, it's not just nostalgia at play. There's a cozy aspect as well, visions of s'mores and snuggly hayrides. Even in beloved pumpkin spice sweets, it's not the pumpkin flavor that most people love, it's the warming spices of nutmeg, cinnamon and ginger.The season, quite literally, makes people feel warm. And by extension, that could make folks feel safe, or cared for. The general wariness many feel from the last 18 months due to the uncertainty of the COVID-19 pandemic, civil unrest last summer and climate change-related weather events this year, could also be part of why people are craving fall sooner rather than later.Human beings naturally want certainty and order, Lopez said. Recent events, amplified by social media and near-instant access to news, have denied that."It's just a lot to handle," he said. "All these things were true before, but we didn't have these kinds of events at this scale to force us to think about it."This could make this upcoming fall a little more difficult, Lopez said."We want that feeling of safety and coziness, but ... in previous years, pre-Covid, we'd have an active spring and an active summer, and then we'd love to go home and cozy up," he said. "But home is a strange place now, because we've spent so much time here."It means that those associations we've had with home, safety, coziness, comfort -- maybe even fall -- could be changing.That doesn't mean that fall won't be as cozy as it has been in the past, or that those first few sips of sweet pumpkin coffee won't hit. It just means many Americans are different now than they were prior to March 2020. It's OK if fall feels different, too.
				</p>
<div>
<p>The week after Labor Day has historically represented the unofficial start of fall, and though most leaves have retained their green color, the season of pumpkin spice is already in full effect.</p>
<p>On Aug. 24 -- a full month before the official start of fall -- Starbucks <a href="https://twitter.com/Starbucks/status/1430152993278627844" target="_blank" rel="nofollow noopener">posted a tweet</a> that sent half of the internet into a frenzy, while the other half shook their heads in despair: "Pumpkin has entered the chat."</p>
<p>It was a de facto announcement about the return of the coffee chain's cult favorite Pumpkin Spice Latte, a drink some look forward to all year. A week earlier, competitor<a href="https://twitter.com/dunkindonuts/status/1428031676811251712" target="_blank" rel="nofollow noopener"> Dunkin' posted</a> about the return of their own pumpkin coffee confection.</p>
<p>Every year, it feels like pumpkin spice mania comes earlier and earlier. Though some of these products may be blatant marketing ploys, some segments of society seem to welcome it back with open arms every time. From coffee to candles to deodorant, pumpkin spice is ubiquitous -- a signal that fall is upon us once more. Even if it's still 90 degrees outside and there's nary a golden leaf in sight, it's suddenly time for fires, apple picking and cozy sweaters. Fall begins when we say it does!</p>
<p>But why do so many crave the return of this season so much? What are we really reaching for when we cling to the edge of fall's garment, hoping it will envelop us sooner than it has before?</p>
<p>Part of it is nostalgia. Part of it is the warmth the season brings. But it could also just be the events of the past 18 months that are causing many of us to feel ready for fall early.</p>
<h3>With fall, comes nostalgia</h3>
<p>Some of the joyous anticipation of fall is just that: anticipation. When our mouths drool while imagining warm mugs of apple cider and pumpkin bread, it's the anticipation that gets us excited, rather than the actual reward,<strong> </strong>one psychologist says.</p>
<p>"So come August, we're like fall is kind of around the corner, we're anticipating all the good things that are coming," said Richard Lopez, professor of psychology at Bard College.</p>
<p>There are powerful cues that play into the nostalgia surrounding fall -- possibly even more so than with other seasons. There's a nip in the air, the leaves are different colors, kids and their oversized backpacks are schlepping to school -- all of these signs are triggers that, oftentimes, remind us of our younger selves, Lopez said.</p>
<p>Think of holidays like Halloween, and the childlike joy it brings, with its costumes and bright orange-wrapped chocolate. Or even specials like "It's the Great Pumpkin, Charlie Brown." These are things that bring many of<strong> </strong>us back to an earlier, more simpler time.</p>
<p>Those layers of positive memories and nostalgia, coupled with the anticipation of what's to come, all play into the excitement many feel about fall, Lopez said.</p>
<p>"It's this change of season; there's a lot of things to look forward to. We had those same experiences when we were young," he said. "Other times of year, there isn't that effect with that nostalgia or that anticipation."</p>
<p>Tom Hanks' character in the 1998 movie "You've Got Mail" sums it up perfectly: "Don't you love New York in the fall?" he asks. "It makes me want to buy school supplies."</p>
<h3>Fall can offer comfort in tumultuous times</h3>
<p>But when we think of fall, it's not just nostalgia at play. There's a <em>cozy</em> aspect as well, visions of s'mores and snuggly hayrides. Even in beloved pumpkin spice sweets, it's not the pumpkin flavor that most people love, it's the warming spices of nutmeg, cinnamon and ginger.</p>
<p>The season, quite literally, makes people feel warm. And by extension, that could make folks feel safe, or cared for. The general wariness many feel from the last 18 months due to the uncertainty of the COVID-19 pandemic, civil unrest last summer and <a href="https://www.cnn.com/2021/09/02/weather/ida-northeast-flooding-thursday/index.html" target="_blank" rel="nofollow noopener">climate change-related weather events</a> this year, could also be part of why people are craving fall sooner rather than later.</p>
<p>Human beings naturally want certainty and order, Lopez said. Recent events, amplified by social media and near-instant access to news, have denied that.</p>
<p>"It's just a lot to handle," he said. "All these things were true before, but we didn't have these kinds of events at this scale to force us to think about it."</p>
<p>This could make this upcoming fall a little more difficult, Lopez said.</p>
<p>"We want that feeling of safety and coziness, but ... in previous years, pre-Covid, we'd have an active spring and an active summer, and then we'd love to go home and cozy up," he said. "But home is a strange place now, because we've spent so much time here."</p>
<p>It means that those associations we've had with home, safety, coziness, comfort -- maybe even fall -- could be changing.</p>
<p>That doesn't mean that fall won't be as cozy as it has been in the past, or that those first few sips of sweet pumpkin coffee won't hit. It just means many Americans are different now than they were prior to March 2020. It's OK if fall feels different, too.</p>
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		<title>Full FDA approval of a COVID-19 vaccine could come as early as the end of August, Biden says</title>
		<link>https://cincylink.com/2021/07/23/full-fda-approval-of-a-covid-19-vaccine-could-come-as-early-as-the-end-of-august-biden-says/</link>
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		<pubDate>Fri, 23 Jul 2021 04:07:34 +0000</pubDate>
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					Related video above: Children Under 12 Expected to Be COVID Vaccine-Eligible by Winter, if This HappensTo date, more than 339 million doses of COVID-19 vaccine have been administered to give people protection from the coronavirus; several studies show that the three vaccines authorized for emergency use in the U.S. work and are safe; and the government continues to give them out in schools and at ball fields, and yet, not one has been formally approved by the U.S. Food and Drug Administration.By all accounts, the approval process for the vaccines is moving faster than it ever has before. However, the FDA has yet to disclose a timeline for when its work will be complete and data is still being reviewed.On Wednesday, President Joe Biden told CNN's Don Lemon during a CNN Townhall that he expects COVID-19 vaccines could get full approval "quickly.""They're not promising me any specific date, but my expectation, talking to the group of scientists we put together... plus others in the field, is that sometime, maybe in the beginning of the school year, at the end of August, beginning September, October, they'll get a final approval," Biden said.Earlier Wednesday, the National Institutes of Health Director Dr. Francis Collins told CNN's Jim Acosta that full approval could come in the "next couple of months."Pfizer's timelineVaccine maker Pfizer appears to be the furthest along in the process.In July, the company announced that the FDA granted its vaccine a priority review, so that sets the regulatory clock for six months, meaning technically the company should know if it has approval by January. A standard review is 10 months.The acting commissioner of the FDA, Dr. Janet Woodcock, has said the FDA intends to complete the review in advance of its January deadline."So, we all know that's not going to take that long," said Melissa Tice, program director of regulatory affairs and assistant professor of clinical research and leadership at George Washington University School of Medicine &amp; Health Sciences.Because the FDA has already reviewed the manufacturing materials and has been reviewing clinical data all along, Tice said, "We don't expect it to go the full six-month priority review clock."Tice says she thinks full approval for Pfizer's vaccine could come in September. Some experts like Dr. Paul Offit, the director of the Vaccine Education Center think it may be as early as August.Moderna's timeline For vaccine maker Moderna, the company told CNN Wednesday that it does not have a specific time frame for approval. It is still working with the FDA on what's called a rolling submission for approval -- it shares new data with the agency as it is generated."We are still in the process of completing our rolling submission, which we announced on June 1st. It is not complete at this time," Ray Jordan, a spokesperson for Moderna said. "It's not the case that the FDA has our final submission and that we are waiting to hear from them."Moderna expects it may have its materials complete this fall. The time frame for approval would then be subject to the FDA regulatory review process, Moderna said.Where the process is nowHistorically, getting a vaccine licensed by the fall would be fast, especially with as much as the FDA has to review.At this point, what takes time is that the agency has to go through absolutely everything, it cannot skip a page, and there is a lot of everything."When we were reviewing applications back when they were on paper, there was so much, it would not fit on the freight elevator. That's how big the application is, you have lots of data to review," said Norman Baylor, who had run the FDA's Office of Vaccines Research and Review and been through this process several times. He's the current CEO of Biologics Consulting.The COVID-19 vaccines received authorization based on interim data that showed the vaccines were safe and effective for only about three months. "Although, when something's 95% effective, you can assume it's probably going to be highly effective for a while," Offit said.For full approval, the FDA has at least six months of efficacy data to review. "People are saying 'why is it taking so long?' Well, the FDA wants to make sure that it has a protective duration, long-term effect," Tice said. "It's not that the agency, I think, has any concerns about the vaccine per se, they just per licensure requirements, you have to have this additional data.""The FDA does not cut corners on making sure of the quality, the purity, the potency of your products."Offit believes the data review should go pretty quickly since the FDA has been getting data all along. What often takes time is that the FDA has to also validate the process that makes the vaccine for it to be licensed. Every step has to be validated."Whether it's the computers that are being used or cleaning out the vats, or whatever it is, it's a lot of boxes to tick to ensure that there's consistency in each lot to the next," Offit said.That means an interdisciplinary team of FDA experts is pouring through millions of documents, running their own analysis, getting any clarification that it needs from the vaccine companies, and giving the manufacturing process a thorough inspection.And it's not just one FDA person that does the review, Baylor said. There's a secondary and tertiary review. So a clinician would review the material and then a supervisor would need to review it and then it goes up to the division director."We have some reviewers who are reviewing long into the night, really, this is not a 9 to 5 review," Baylor said. "The public is not aware, but yes people are giving up their vacations, working on weekends, Saturdays and Sundays. You're working into the night.""The FDA is not sitting down twiddling their thumbs," Baylor said.Calls to move fasterWhile historically, the process has moved quickly, for some it's not fast enough.Dr. Eric Topol wrote an editorial for the "New York Times" earlier this month that argued that the millions of people who have gotten these mRNA vaccines demonstrate these vaccines work. "This is the most studied biologic in the history of mankind for safety and efficacy," Topol told CNN."I have been frustrated because I know it should have been approved by now," Topol said. "Janet Woodcock made a statement that this was 'among the highest priorities.' No, it has to be the number one priority."In response to Topol's editorial, the FDA's current Director of the Center for Biologics Evaluation and Research, Peter Marks argued that "any vaccine approval without completion of the high-quality review and evaluation that Americans expect the agency to perform would undermine the FDA's statutory responsibilities, affect trust in the agency and do little to help combat vaccine hesitancy."Why full approval mattersYet, as vaccination rates have dropped dramatically in the U.S., some have pointed to approval as one sure way to speed up the process.A Kaiser Family Foundation survey of U.S. adults released this week found that among the one-third of adults surveyed who are not yet vaccinated, 16% said the vaccine was too new, too unknown or not tested enough. Some said in this poll that they wouldn't get a vaccine until it is required. While companies are allowed to require the vaccine, experts believe more will make it a requirement if -- and when -- it gets full approval."If it was approved with the full approval from FDA -- which we all anticipate may be coming pretty soon...Maybe in the next couple of months -- then the legal ability to mandate becomes a lot stronger," Collins, the NIH director, said.
				</p>
<div>
					<strong class="dateline">CNN —</strong> 											</p>
<p><strong><em>Related video above: Children Under 12 Expected to Be COVID Vaccine-Eligible by Winter, if This Happens</em></strong></p>
<p>To date, more than 339 million doses of COVID-19 vaccine have been administered to give people protection from the coronavirus; several studies show that the three vaccines authorized for emergency use in the U.S. work and are safe; and the government continues to give them out in schools and at ball fields, and yet, not one has been formally approved by the U.S. Food and Drug Administration.</p>
<p>By all accounts, the approval process for the vaccines is moving faster than it ever has before. However, the FDA has yet to disclose a timeline for when its work will be complete and data is still being reviewed.</p>
<p>On Wednesday, President Joe Biden told CNN's Don Lemon during a CNN Townhall that he expects COVID-19 vaccines could get full approval "quickly."</p>
<p>"They're not promising me any specific date, but my expectation, talking to the group of scientists we put together... plus others in the field, is that sometime, maybe in the beginning of the school year, at the end of August, beginning September, October, they'll get a final approval," Biden said.</p>
<p>Earlier Wednesday, the National Institutes of Health Director Dr. Francis Collins told CNN's Jim Acosta that full approval could come in the "next couple of months."</p>
<h3>Pfizer's timeline</h3>
<p>Vaccine maker Pfizer appears to be the furthest along in the process.</p>
<p>In July, the company <a href="https://cdn.pfizer.com/pfizercom/2021-07/BLA_Acceptance_Media_Statement_FINAL.pdf" target="_blank" rel="nofollow noopener">announced</a> that the FDA granted its vaccine a priority review, so that sets the regulatory clock for six months, meaning technically the company should know if it has approval by January. A standard review is 10 months.</p>
<p>The acting commissioner of the FDA, Dr. Janet Woodcock, has said the FDA intends to complete the review in advance of its January deadline.</p>
<p>"So, we all know that's not going to take that long," said <a href="https://www.gwumc.edu/smhs/facultydirectory/profile.cfm?empName=Melissa%20Tice&amp;FacID=2069428193" target="_blank" rel="nofollow noopener">Melissa Tice</a>, program director of regulatory affairs and assistant professor of clinical research and leadership at George Washington University School of Medicine &amp; Health Sciences.</p>
<p>Because the FDA has already reviewed the manufacturing materials and has been reviewing clinical data all along, Tice said, "We don't expect it to go the full six-month priority review clock."</p>
<p>Tice says she thinks full approval for Pfizer's vaccine could come in September. Some experts like <a href="https://www.chop.edu/doctors/offit-paul-a" target="_blank" rel="nofollow noopener">Dr. Paul Offit,</a> the director of the Vaccine Education Center think it may be as early as August.</p>
<h3>Moderna's timeline </h3>
<p>For vaccine maker <a href="https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-initiation-rolling-submission-biologics" target="_blank" rel="nofollow noopener">Moderna</a>, the company told CNN Wednesday that it does not have a specific time frame for approval. It is still working with the FDA on what's called a rolling submission for approval -- it shares new data with the agency as it is generated.</p>
<p>"We are still in the process of completing our rolling submission, which we announced on June 1st. It is not complete at this time," Ray Jordan, a spokesperson for Moderna said. "It's not the case that the FDA has our final submission and that we are waiting to hear from them."</p>
<p>Moderna expects it may have its materials complete this fall. The time frame for approval would then be subject to the FDA regulatory review process, Moderna said.</p>
<h3>Where the process is now</h3>
<p>Historically, getting a vaccine licensed by the fall would be fast, especially with as much as the FDA has to review.</p>
<p>At this point, what takes time is that the agency has to go through absolutely everything, it cannot skip a page, and there is a lot of everything.</p>
<p>"When we were reviewing applications back when they were on paper, there was so much, it would not fit on the freight elevator. That's how big the application is, you have lots of data to review," said Norman Baylor, who had run the FDA's <a href="https://www.fda.gov/media/81708/download#:~:text=In%20summary%2C%20the%20Office%20of,vaccine%20and%20related%20product%20applications" target="_blank" rel="nofollow noopener">Office of Vaccines Research and Review</a> and been through this process several times. He's the current CEO of Biologics Consulting.</p>
<p>The COVID-19 vaccines received authorization based on interim data that showed the vaccines were safe and effective for only about three months. "Although, when something's 95% effective, you can assume it's probably going to be highly effective for a while," Offit said.</p>
<p>For full approval, the FDA has at least six months of efficacy data to review. "People are saying 'why is it taking so long?' Well, the FDA wants to make sure that it has a protective duration, long-term effect," Tice said. "It's not that the agency, I think, has any concerns about the vaccine per se, they just per licensure requirements, you have to have this additional data."</p>
<p>"The FDA does not cut corners on making sure of the quality, the purity, the potency of your products."</p>
<p>Offit believes the data review should go pretty quickly since the FDA has been getting data all along. What often takes time is that the FDA has to also validate the process that makes the vaccine for it to be licensed. Every step has to be validated.</p>
<p>"Whether it's the computers that are being used or cleaning out the vats, or whatever it is, it's a lot of boxes to tick to ensure that there's consistency in each lot to the next," Offit said.</p>
<p>That means an interdisciplinary team of FDA experts is pouring through millions of documents, running their own analysis, getting any clarification that it needs from the vaccine companies, and giving the manufacturing process a thorough inspection.</p>
<p>And it's not just one FDA person that does the review, Baylor said. There's a secondary and tertiary review. So a clinician would review the material and then a supervisor would need to review it and then it goes up to the division director.</p>
<p>"We have some reviewers who are reviewing long into the night, really, this is not a 9 to 5 review," Baylor said. "The public is not aware, but yes people are giving up their vacations, working on weekends, Saturdays and Sundays. You're working into the night."</p>
<p>"The FDA is not sitting down twiddling their thumbs," Baylor said.</p>
<h3>Calls to move faster</h3>
<p>While historically, the process has moved quickly, for some it's not fast enough.</p>
<p><a href="https://www.scripps.edu/faculty/topol/" target="_blank" rel="nofollow noopener">Dr. Eric Topol</a> wrote an editorial for the <a href="https://www.nytimes.com/2021/07/01/opinion/fda-vaccines-full-approval.html" target="_blank" rel="nofollow noopener">"New York Times" </a>earlier this month that argued that the millions of people who have gotten these mRNA vaccines demonstrate these vaccines work. "This is the most studied biologic in the history of mankind for safety and efficacy," Topol told CNN.</p>
<p>"I have been frustrated because I know it should have been approved by now," Topol said. "Janet Woodcock made a statement that this was 'among the highest priorities.' No, it has to be the number one priority."</p>
<p>In response to Topol's editorial, the FDA's current Director of the Center for Biologics Evaluation and Research, <a href="https://www.nytimes.com/2021/07/09/opinion/letters/fda-covid-vaccines.html" target="_blank" rel="nofollow noopener">Peter Marks </a>argued that "any vaccine approval without completion of the high-quality review and evaluation that Americans expect the agency to perform would undermine the FDA's statutory responsibilities, affect trust in the agency and do little to help combat vaccine hesitancy."</p>
<h3>Why full approval matters</h3>
<p>Yet, as vaccination rates have dropped dramatically in the U.S., some have pointed to approval as one sure way to speed up the process.</p>
<p>A <a href="https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-in-their-own-words-six-months-later/?utm_campaign=KFF-2021-polling-surveys&amp;utm_medium=email&amp;_hsmi=2&amp;_hsenc=p2ANqtz-8yI04oX672NiBW6tsPNUaH4PcKREBEOkg7pLQKlJHv8EdXYakQQ3SdKG79UMgpbdlwTOcwdTiMBtMV9WSG5C8t9aS07w&amp;utm_content=2&amp;utm_source=hs_email" target="_blank" rel="nofollow noopener">Kaiser Family Foundation</a> survey of U.S. adults released this week found that among the one-third of adults surveyed who are not yet vaccinated, 16% said the vaccine was too new, too unknown or not tested enough. Some said in this poll that they wouldn't get a vaccine until it is required. While companies are allowed to require the vaccine, experts believe more will make it a requirement if -- and when -- it gets full approval.</p>
<p>"If it was approved with the full approval from FDA -- which we all anticipate may be coming pretty soon...Maybe in the next couple of months -- then the legal ability to mandate becomes a lot stronger," Collins, the NIH director, said. </p>
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		<title>Donut Judge Me 2019 Cincinnati &#8211; 5</title>
		<link>https://cincylink.com/2020/04/21/donut-judge-me-2019-cincinnati-5/</link>
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		<pubDate>Tue, 21 Apr 2020 04:00:12 +0000</pubDate>
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<br />Donut Judge Me 2019 Cincinnati<br />
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