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	<title>doses &#8211; Cincy Link</title>
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		<title>US set to offer monkeypox vaccines to states with high case rates</title>
		<link>https://cincylink.com/2023/07/12/us-set-to-offer-monkeypox-vaccines-to-states-with-high-case-rates/</link>
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		<pubDate>Wed, 12 Jul 2023 04:08:42 +0000</pubDate>
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		<guid isPermaLink="false">https://cincylink.com/?p=164033</guid>

					<description><![CDATA[The Biden Administration is expected to detail plans to roll out more monkeypox vaccines across the U.S.The move comes after pressure from states, who have been pushing the Administration to release more doses of monkeypox vaccine from the Strategic National Stockpile which is managed by the Office of the Assistant Secretary for Preparedness and Response &#8230;]]></description>
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					The Biden Administration is expected to detail plans to roll out more monkeypox vaccines across the U.S.The move comes after pressure from states, who have been pushing the Administration to release more doses of monkeypox vaccine from the Strategic National Stockpile which is managed by the Office of the Assistant Secretary for Preparedness and Response at the Department of Health and Human Services.Related video above: LGTBQ community concerns over monkeypox stigmaThe plan will allocate doses based on case rates in a state, focusing on men who have sex with men and their partners, as well as anyone who thinks they might have been recently exposed to the virus, according to two sources familiar with the government's plans who were not authorized to speak with reporters.Currently, 10 states would be considered to be in the first tier for priority in ordering vaccines.The plans are expected to be officially announced later Tuesday evening.They come in the middle of Pride month, a month filled with parties celebrating gender and sexual diversity, and a season that many in public health have worried will only fuel the spread of the monkeypox virus which is spread by close contact, including sex.The vaccination plan may require the U.S. to use two different types of vaccines.The first is a newer, modern vaccine called Jynneos which is manufactured by a Danish company called Bavarian Nordic. It was evaluated and developed and to treat monkeypox infection. The U.S. currently has 64,000 doses of this vaccine in the stockpile. The government will make 56,000 of those doses available to states in phase one of the rollout. More doses of this vaccine have been ordered and are expected to be delivered later this year.The problem is that the U.S. may not have enough doses of Jynneos to vaccinate all who might need it, so public health officials are also considering whether to use a second older type of vaccine called ACAM. The ACAM vaccine was developed to treat smallpox. It's given by using a two-pronged needle that's repeatedly dipped into the vaccine and used to prick the skin on the upper arm, causing a small sore or "pock" to form."It's a very kind of like, old-school technology that basically I don't know any clinicians that actually know how to do that. So it's actually very difficult to roll out because you have to train people in a new vaccine methodology," said Dr. Jay Varma, professor and director of the Cornell Center for Pandemic Prevention and Response in New York City.The other complication is that the ACAM vaccine uses a live, but weakened version of a virus to inoculate a person."It's presumed not to be safe to be able to be used in people with HIV," Varma said. The primary risk group for monkeypox — men who have sex with men — also have high rates of HIV infection.During a call with reporters Tuesday, Dr. Rochelle Walensky, director of the U.S. Centers for Disease Control &amp; Prevention, said five additional labs are in place to accelerate testing. She also urged states to make tests readily available and said additional outreach is underway to make health care workers more aware of what monkeypox looks like and how to treat it.When it comes to vaccines, Walensky said vaccines should be provided for anyone who has been exposed to monkeypox, through both official contract tracing or for those who have been in a location or at an event where there was a case and there was potential exposure.Vaccination after exposure is meant to reduce the risk of developing the virus, Walensky explained, and vaccination should occur within two weeks of exposure. Hearst Television contributed to this report.
				</p>
<div>
<p>The Biden Administration is expected to detail plans to roll out more monkeypox vaccines across the U.S.</p>
<p>The move comes after pressure from states, who have been pushing the Administration to release more doses of monkeypox vaccine from the Strategic National Stockpile which is managed by the Office of the Assistant Secretary for Preparedness and Response at the Department of Health and Human Services.</p>
<p><!-- article/blocks/side-floater --></p>
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<p><strong><em>Related video above: LGTBQ community concerns over monkeypox stigma</em></strong></p>
<p>The plan will allocate doses based on case rates in a state, focusing on men who have sex with men and their partners, as well as anyone who thinks they might have been recently exposed to the virus, according to two sources familiar with the government's plans who were not authorized to speak with reporters.</p>
<p>Currently, 10 states would be considered to be in the first tier for priority in ordering vaccines.</p>
<p>The plans are expected to be officially announced later Tuesday evening.</p>
<p>They come in the middle of Pride month, a month filled with parties celebrating gender and sexual diversity, and a season that many in public health have worried will only fuel the spread of the monkeypox virus which is spread by close contact, including sex.</p>
<p>The vaccination plan may require the U.S. to use two different types of vaccines.</p>
<p>The first is a newer, modern vaccine called Jynneos which is manufactured by a Danish company called Bavarian Nordic. It was evaluated and developed and to treat monkeypox infection. The U.S. currently has 64,000 doses of this vaccine in the stockpile. The government will make 56,000 of those doses available to states in phase one of the rollout. More doses of this vaccine have been ordered and are expected to be delivered later this year.</p>
<p>The problem is that the U.S. may not have enough doses of Jynneos to vaccinate all who might need it, so public health officials are also considering whether to use a second older type of vaccine called ACAM. The ACAM vaccine was developed to treat smallpox. It's given by using a two-pronged needle that's repeatedly dipped into the vaccine and used to prick the skin on the upper arm, causing a small sore or "pock" to form.</p>
<p>"It's a very kind of like, old-school technology that basically I don't know any clinicians that actually know how to do that. So it's actually very difficult to roll out because you have to train people in a new vaccine methodology," said Dr. Jay Varma, professor and director of the Cornell Center for Pandemic Prevention and Response in New York City.</p>
<p>The other complication is that the ACAM vaccine uses a live, but weakened version of a virus to inoculate a person.</p>
<p>"It's presumed not to be safe to be able to be used in people with HIV," Varma said. The primary risk group for monkeypox — men who have sex with men — also have high rates of HIV infection.</p>
<p>During a call with reporters Tuesday, Dr. Rochelle Walensky, director of the U.S. Centers for Disease Control &amp; Prevention, said five additional labs are in place to accelerate testing. She also urged states to make tests readily available and said additional outreach is underway to make health care workers more aware of what monkeypox looks like and how to treat it.</p>
<p>When it comes to vaccines, Walensky said vaccines should be provided for anyone who has been exposed to monkeypox, through both official contract tracing or for those who have been in a location or at an event where there was a case and there was potential exposure.</p>
<p>Vaccination after exposure is meant to reduce the risk of developing the virus, Walensky explained, and vaccination should occur within two weeks of exposure. </p>
<p><em>Hearst Television contributed to this report. </em></p>
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		<title>FDA approves first smartphone app to deliver doses of insulin</title>
		<link>https://cincylink.com/2022/02/19/fda-approves-first-smartphone-app-to-deliver-doses-of-insulin/</link>
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		<pubDate>Sat, 19 Feb 2022 10:47:06 +0000</pubDate>
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		<category><![CDATA[FDA approves first smartphone app to deliver doses of insulin]]></category>
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		<guid isPermaLink="false">https://cincylink.com/?p=148505</guid>

					<description><![CDATA[Your smartphone will now have the ability to deliver doses of insulin after the US Food and Drug Administration clears it. On Thursday, Tandem Diabetes Care announced that the FDA had approved it to deliver insulin through its mobile app, t:connect. “This FDA clearance further validates our commitment to innovation and the diabetes community by &#8230;]]></description>
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<p>Your smartphone will now have the ability to deliver doses of insulin after the US Food and Drug Administration clears it.</p>
<p>On Thursday, Tandem Diabetes Care <a class="Link" href="https://investor.tandemdiabetes.com/news-releases/news-release-details/tandem-diabetes-care-announces-fda-clearance-tslim-x2-insulin-0">announced</a> that the FDA had approved it to deliver insulin through its mobile app, t:connect.</p>
<p>“This FDA clearance further validates our commitment to innovation and the diabetes community by providing one of the most requested feature enhancements,” said John Sheridan, president and CEO of Tandem Diabetes Care, in a press release. “With the improvements in diabetes management provided by Tandem’s Control-IQ technology, giving a meal bolus is now the most common reason a person interacts with their pump, and the ability to do so using a smartphone app offers a convenient and discrete solution.”</p>
<p>The company said it would be offered in the United States for no additional cost to new t:slim X2 insulin pump customers.</p>
<p>"The updated t:connect mobile app is designed to offer t:slim X2 insulin pump users the ability to program and cancel bolus insulin requests through the convenience of their compatible smartphone," the company said.</p>
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		<title>Here&#8217;s how omicron changed the plans for children&#8217;s vaccinations</title>
		<link>https://cincylink.com/2022/02/04/heres-how-omicron-changed-the-plans-for-childrens-vaccinations/</link>
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		<pubDate>Fri, 04 Feb 2022 18:27:11 +0000</pubDate>
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		<guid isPermaLink="false">https://cincylink.com/?p=143862</guid>

					<description><![CDATA[About 18 million children under the age of 5 in the United States could soon be eligible to get a COVID-19 vaccine — but first, the child-sized shot must go through a rigorous authorization process that's taking a different path than the COVID-19 vaccines that came before.On Tuesday, Pfizer and BioNTech announced that they had &#8230;]]></description>
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					About 18 million children under the age of 5 in the United States could soon be eligible to get a COVID-19 vaccine — but first, the child-sized shot must go through a rigorous authorization process that's taking a different path than the COVID-19 vaccines that came before.On Tuesday, Pfizer and BioNTech announced that they had initiated a rolling submission to the U.S. Food and Drug Administration of data for their vaccine for children ages 6 months up to 5 years. The companies expect to complete the request for emergency use authorization soon.It will still go through a thorough safety and efficacy review by U.S. health agencies and experts, but it's a different plan than what was expected late last year.In December, Pfizer announced that it decided to add a third dose to the primary vaccine regimen for young children. It said the original two-dose series did not provide the expected immunity in 2- to 5-year-olds.Still, this week's request seeks authorization for the two-dose vaccine, which could make the vaccine available sooner. Pfizer and BioNTech plan to continue testing a three-dose regimen in this younger age group and say they will submit the additional data on a third dose in the coming months.The company decided to submit for authorization of the two-dose vaccine now "with pediatric COVID-19 cases surpassing 10 million and at the request of the FDA," it said."Having a safe and effective vaccine available for children in this age group is a priority for the agency and we're committed to a timely review of the data, which the agency asked Pfizer to submit in light of the recent omicron surge," acting FDA Commissioner Dr. Janet Woodcock said in a news release.What changed since DecemberIn December, Pfizer said that the vaccines appeared to protect the youngest children — infants and toddlers up to 2 — at the same levels seen in teens and young adults, slashing symptoms in 90% of kids who got the shot. However, the 3-microgram dose did not produce the same immune response in 2- to 5-year-olds.The dose for infants and young children is about one-third of the dose given to children age 5 to 11 and a tenth the size of the dose given to people 12 and older.The company decided to expand its trial to include a third dose, rather than the two doses older children and adults receive in a primary vaccine series.What changed between December and this week's authorization request, public health leaders said, was the omicron variant.During the omicron surge, cases among children "spiked dramatically," the American Academy of Pediatrics said Monday. There have been over 3.5 million child cases reported in January alone."It turns out that has actually facilitated the collection of more important additional clinical data that we did not have in December," U.S. Surgeon General Dr. Vivek Murthy said at a White House COVID-19 briefing Wednesday. "Whether that changes the risk-benefit profile is what the FDA will be assessing, but there has been developments since December on the data front."Tracking COVID-19: • Free at-home COVID-19 tests coming for people on Medicare• More countries are now easing COVID-19 restrictions. Here are the steps some are taking• Spotify to add advisories to podcasts discussing COVID-19Some suggest that the FDA may be pursing a strategy of authorizing the first two doses of a vaccine that may not offer substantial protection until after a third dose, hoping to start kids on the series even as data on third shots is still pending.Children have a lower risk of serious outcomes from a COVID-19 infection compared with elderly or immunocompromised adults. But about 1% of children who catch COVID-19 will be hospitalized. Infections can also lead to long-term consequences in children as they do in adults, increasing the risk for diabetes, autoimmune disease and a delayed reaction to infection called multisystem inflammatory syndrome, which requires hospital care."If the goal of the vaccine is to get baseline immunity in the kids — to prevent really bad outcomes and you're really not using the vaccine as a tool to prevent infection in the first place — two doses could do that," former FDA Commissioner Dr. Scott Gottlieb, who sits on the board of Pfizer, said on CBS on Sunday. "I think that may be why federal health officials are rethinking this. If, in fact, they decide to authorize this on the basis of two doses, it could be out much sooner, perhaps as early as early March."Others agree that it could be a smart approach."When I was on hospital service last, there was a 7-month-old in the intensive care unit," Dr. Paul Offit, a pediatrician and vaccine expert at Children's Hospital of Philadelphia, told CNN. "If you can prevent that safely, and that's number one, and effectively, number two, then prevent it" with a vaccine.Offit sits on the panel of experts that advises the FDA on its vaccine authorizations and will be one of the first to review the new data on the vaccine. The FDA's independent vaccine advisers will meet Feb. 15 to discuss the company's data on the youngest children and make a recommendation on the vaccine.The path to authorizationTo authorize COVID-19 vaccines for emergency use, the FDA has previously set a bar of 50% effectiveness, meaning the shots have to prevent disease or decrease severity in at least 50% of the people who get them.Since the data has not been released, it's unclear whether the Pfizer/BioNTech vaccine for younger children meets that standard after two doses.Most experts CNN spoke with said they couldn't think of another vaccine review process quite like this.One somewhat similar example is the Johnson &amp; Johnson vaccine, which was authorized at one dose while the company tested a second, although the first dose proved sufficient to meet the FDA's authorization requirements.The Pfizer/BioNTech coronavirus vaccine is expected to produce a "good efficacy signal" in children younger than 5, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said Wednesday."The FDA is looking at the data very carefully, and in their typical fashion, they will be very careful in scrutinizing the data and making a recommendation of the decision based on that data," Fauci said.That decision to go ahead and ask for the authorization, though, is still considered odd by some health experts."This does seem very unusual," said Dr. Eric Rubin, a member of the FDA's vaccine advisory committee and assistant professor microbiology and molecular genetics at Harvard Medical School."Regulators have to weigh risk and benefit. And in this case, we know a lot about the risks in older individuals, and they're very low, including older children," Rubin said. "It doesn't have to be that great, as long as we have something that's safe, and then a theoretical benefit could be that you are set up well for future vaccines. But having said all that, it does seem like a very unusual route to take."Rubin thinks that with so many parents eager to get their kids vaccinated, there may also be some lobbying underway."FDA doesn't seem to be immune to political pressures," he said. "And I know that there are some who are saying that it would be good to get a couple doses of vaccine into kids now, in assuming that the third dose is going to be the one that makes a difference."'We need a vaccine for kids'Dr. Helen Talbot, an associate professor of medicine at Vanderbilt University and a member of the CDC's independent vaccine advisory board, the Advisory Committee on Immunization Practices, also hasn't seen the data. But she too believes there may be some pressure from parents."There's families of kids less than 5 who are really pushing. They feel like they're the last ones that don't have access, and there's nothing available for them," Talbot said. She knows this personally, since she gets a lot of emails asking about it, too.Talbot said her questions are around safety data and the potential benefits and risks.She is concerned about people in the middle who aren't quite sure if they want to get their child vaccinated. Only about 3 in 10 parents say they'll get their child under 5 vaccinated against COVID-19 right away, according to survey results from the Kaiser Family Foundation that were released Tuesday. Communication may be key to help parents understand why they should vaccinate their small children, particularly if two doses may not be as protective as three."The FDA is really going to have to be able to eloquently explain the decision," she said.For his part, Dr. Jay Portnoy, a member of the FDA's advisory panel on vaccines, says he's glad to see the FDA speeding up its process."I'm actually relieved," said Portnoy, who's a pediatrician at Children's Mercy Hospital in Kansas City. "Right now, our hospital is filled, not all Covid patients but many COVID patients, including our intensive care unit."Portnoy says parents are anxious and worried."They're forced to send their kids to school, and the schools aren't allowed to mandate masks or anything else," he said."So what is a parent to do? That's just from my perspective. It's about time. We need a vaccine for kids."What happens after authorizationWhite House COVID-19 response coordinator Jeff Zients said Wednesday that the administration is ready to "hit the ground running" to vaccinate young children as soon as Pfizer receives a green light from the federal government.Zients said the U.S. has enough kid-size needles and supplies to administer the vaccines. The administration is also working with local public health partners to make thousands of locations nationwide ready to vaccinate these children."We know many parents are eager to get their kids the protection of the vaccine. We know others have questions. So we're working with our partners to ensure all parents have access to the facts and information they need to make the right decision," Zients said.Pfizer has said it's testing a third dose administered eight weeks after a second dose. Data on a potential third dose, an updated authorization and third-dose rollout would come later on.This may not be the last change to the COVID-19 vaccine schedule.Former CDC Director Dr. Tom Frieden said this week that it may be a while before scientists figure out the best vaccine schedule for children."What the vaccine schedule should be is much more complicated, and that may take months or even years to optimize," Frieden,  president and CEO of Resolve to Save Lives, told CNN's Anderson Cooper."It's probably a three-dose schedule for lots of people, but we really don't know that yet," Frieden said. "Nor do we know the right interval between doses. That's going to be with time, but we do know that vaccines are remarkably effective."
				</p>
<div>
<p>About 18 million children under the age of 5 in the United States could soon be eligible to get a COVID-19 vaccine — but first, the child-sized shot must go through a rigorous authorization process that's taking a different path than the COVID-19 vaccines that came before.</p>
<p>On Tuesday, Pfizer and BioNTech <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-initiate-rolling-submission-emergency" target="_blank" rel="nofollow noopener">announced</a> that they had initiated a rolling submission to the U.S. Food and Drug Administration of data for their vaccine for children ages 6 months up to 5 years. The companies expect to complete the request for emergency use authorization soon.</p>
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<p>It will still go through a thorough safety and efficacy review by U.S. health agencies and experts, but it's a different plan than what was expected late last year.</p>
<p>In December, Pfizer announced that it decided to add a third dose to the primary vaccine regimen for young children. It said the original two-dose series did not provide the expected immunity in 2- to 5-year-olds.</p>
<p>Still, this week's request seeks authorization for the two-dose vaccine, which could make the vaccine available sooner. Pfizer and BioNTech plan to continue testing a three-dose regimen in this younger age group and say they will submit the additional data on a third dose in the coming months.</p>
<p>The company decided to submit for authorization of the two-dose vaccine now "with pediatric COVID-19 cases surpassing 10 million and at the request of the FDA," it said.</p>
<p>"Having a safe and effective vaccine available for children in this age group is a priority for the agency and we're committed to a timely review of the data, which the agency asked Pfizer to submit in light of the recent omicron surge," acting FDA Commissioner Dr. Janet Woodcock said in a news release.</p>
<h3 class="body-h3">What changed since December</h3>
<p>In December, Pfizer said that the vaccines appeared to protect the youngest children — infants and toddlers up to 2 — at the same levels seen in teens and young adults, slashing symptoms in 90% of kids who got the shot. However, the 3-microgram dose did not produce the same immune response in 2- to 5-year-olds.</p>
<p>The dose for infants and young children is about one-third of the dose given to children age 5 to 11<strong> </strong>and a tenth the size of the dose given to people 12 and older.</p>
<p>The company decided to expand its trial to include a third dose, rather than the two doses older children and adults receive in a primary vaccine series.</p>
<p>What changed between December and this week's authorization request, public health leaders said, was the omicron variant.</p>
<p>During the omicron surge, cases among children "spiked dramatically," the<a href="https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/children-and-covid-19-state-level-data-report/" target="_blank" rel="nofollow noopener"> American Academy of Pediatrics</a> said Monday. There have been over 3.5 million child cases reported in January alone.</p>
<p>"It turns out that has actually facilitated the collection of more important additional clinical data that we did not have in December," U.S. Surgeon General Dr. Vivek Murthy said at a White House COVID-19 briefing Wednesday. "Whether that changes the risk-benefit profile is what the FDA will be assessing, but there has been developments since December on the data front."</p>
<p><strong>Tracking COVID-19: </strong></p>
<p>• Free at-home COVID-19 tests coming for people on Medicare</p>
<p>• More countries are now easing COVID-19 restrictions. Here are the steps some are taking</p>
<p>• Spotify to add advisories to podcasts discussing COVID-19</p>
<p>Some suggest that the FDA may be pursing a strategy of authorizing the first two doses of a vaccine that may not offer substantial protection until after a third dose, hoping to start kids on the series even as data on third shots is still pending.</p>
<p>Children have a lower risk of serious outcomes from a COVID-19 infection compared with elderly or immunocompromised adults. But about 1% of children who catch COVID-19 will be hospitalized. Infections can also lead to long-term consequences in children as they do in adults, increasing the risk for diabetes, autoimmune disease and a delayed reaction to infection called multisystem inflammatory syndrome, which requires hospital care.</p>
<p>"If the goal of the vaccine is to get baseline immunity in the kids — to prevent really bad outcomes and you're really not using the vaccine as a tool to prevent infection in the first place — two doses could do that," former FDA Commissioner Dr. Scott Gottlieb, who sits on the board of Pfizer, said on CBS on Sunday. "I think that may be why federal health officials are rethinking this. If, in fact, they decide to authorize this on the basis of two doses, it could be out much sooner, perhaps as early as early March."</p>
<p>Others agree that it could be a smart approach.</p>
<p>"When I was on hospital service last, there was a 7-month-old in the intensive care unit," Dr. Paul Offit, a pediatrician and vaccine expert at Children's Hospital of Philadelphia, told CNN. "If you can prevent that safely, and that's number one, and effectively, number two, then prevent it" with a vaccine.</p>
<p>Offit sits on the panel of experts that advises the FDA on its vaccine authorizations and will be one of the first to review the new data on the vaccine. The FDA's independent vaccine advisers will meet Feb. 15 to discuss the company's data on the youngest children and make a recommendation on the vaccine.</p>
<h3 class="body-h3">The path to authorization</h3>
<p>To authorize COVID-19 vaccines for emergency use, the FDA has previously set a bar of 50% effectiveness, meaning the shots have to prevent disease or decrease severity in at least 50% of the people who get them.</p>
<p>Since the data has not been released, it's unclear whether the Pfizer/BioNTech vaccine for younger children meets that standard after two doses.</p>
<p>Most experts CNN spoke with said they couldn't think of another vaccine review process quite like this.</p>
<p>One somewhat similar example is the Johnson &amp; Johnson vaccine, which was authorized at one dose while the company tested a second, although the first dose proved sufficient to meet the FDA's authorization requirements.</p>
<p>The Pfizer/BioNTech coronavirus vaccine is expected to produce a "good efficacy signal" in children younger than 5, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said Wednesday.</p>
<p>"The FDA is looking at the data very carefully, and in their typical fashion, they will be very careful in scrutinizing the data and making a recommendation of the decision based on that data," Fauci said.</p>
<p>That decision to go ahead and ask for the authorization, though, is still considered odd by some health experts.</p>
<p>"This does seem very unusual," said Dr. Eric Rubin, a member of the FDA's vaccine advisory committee and assistant professor microbiology and molecular genetics at Harvard Medical School.</p>
<p>"Regulators have to weigh risk and benefit. And in this case, we know a lot about the risks in older individuals, and they're very low, including older children," Rubin said. "It doesn't have to be that great, as long as we have something that's safe, and then a theoretical benefit could be that you are set up well for future vaccines. But having said all that, it does seem like a very unusual route to take."</p>
<p>Rubin thinks that with so many parents eager to get their kids vaccinated, there may also be some lobbying underway.</p>
<p>"FDA doesn't seem to be immune to political pressures," he said. "And I know that there are some who are saying that it would be good to get a couple doses of vaccine into kids now, in assuming that the third dose is going to be the one that makes a difference."</p>
<h3 class="body-h3">'We need a vaccine for kids'</h3>
<p><a href="https://wag.app.vanderbilt.edu/PublicPage/Faculty/Details/32055" target="_blank" rel="nofollow noopener">Dr. Helen Talbot</a>, an associate professor of medicine at Vanderbilt University and a member of the CDC's independent vaccine advisory board, the Advisory Committee on Immunization Practices, also hasn't seen the data. But she too believes there may be some pressure from parents.</p>
<p>"There's families of kids less than 5 who are really pushing. They feel like they're the last ones that don't have access, and there's nothing available for them," Talbot said. She knows this personally, since she gets a lot of emails asking about it, too.</p>
<p>Talbot said her questions are around safety data and the potential benefits and risks.</p>
<p>She is concerned about people in the middle who aren't quite sure if they want to get their child vaccinated. Only about 3 in 10 parents say they'll get their child under 5 vaccinated against COVID-19 right away, according to survey results from the<a href="https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-january-2022-parents-and-kids-update/?utm_campaign=KFF-2022-polling-surveys&amp;utm_medium=email&amp;_hsmi=2&amp;_hsenc=p2ANqtz-_Dr1_IumfA0IhCg2Gnk4V7r_XjiSduJQ2hl_0ETeNqH28wiLAKMNEnyyHtBFay1cquWG6OdyUxDO9z3Qj1UMYWvpivFA&amp;utm_content=2&amp;utm_source=hs_email" target="_blank" rel="nofollow noopener"> Kaiser Family Foundation</a> that were released Tuesday.</p>
<p>Communication may be key to help parents understand why they should vaccinate their small children, particularly if two doses may not be as protective as three.</p>
<p>"The FDA is really going to have to be able to eloquently explain the decision," she said.</p>
<p>For his part, Dr. Jay Portnoy, a member of the FDA's advisory panel on vaccines, says he's glad to see the FDA speeding up its process.</p>
<p>"I'm actually relieved," said Portnoy, who's a pediatrician at Children's Mercy Hospital in Kansas City. "Right now, our hospital is filled, not all Covid patients but many COVID patients, including our intensive care unit."</p>
<p>Portnoy says parents are anxious and worried.</p>
<p>"They're forced to send their kids to school, and the schools aren't allowed to mandate masks or anything else," he said."So what is a parent to do? That's just from my perspective. It's about time. We need a vaccine for kids."</p>
<h3 class="body-h3">What happens after authorization</h3>
<p>White House COVID-19 response coordinator Jeff Zients said Wednesday that the administration is ready to "hit the ground running" to vaccinate young children as soon as Pfizer receives a green light from the federal government.</p>
<p>Zients said the U.S. has enough kid-size needles and supplies to administer the vaccines. The administration is also working with local public health partners to make thousands of locations nationwide ready to vaccinate these children.</p>
<p>"We know many parents are eager to get their kids the protection of the vaccine. We know others have questions. So we're working with our partners to ensure all parents have access to the facts and information they need to make the right decision," Zients said.</p>
<p>Pfizer has said it's testing a third dose administered eight weeks after a second dose. Data on a potential third dose, an updated authorization and third-dose rollout would come later on.</p>
<p>This may not be the last change to the COVID-19 vaccine schedule.</p>
<p>Former CDC Director Dr. Tom Frieden said this week that it may be a while before scientists figure out the best vaccine schedule for children.</p>
<p>"What the vaccine schedule should be is much more complicated, and that may take months or even years to optimize," Frieden,  president and CEO of Resolve to Save Lives, told CNN's Anderson Cooper.</p>
<p>"It's probably a three-dose schedule for lots of people, but we really don't know that yet," Frieden said. "Nor do we know the right interval between doses. That's going to be with time, but we do know that vaccines are remarkably effective."</p>
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		<title>The US has officially shared more than 200M COVID-19 shots with the world</title>
		<link>https://cincylink.com/2021/10/22/the-us-has-officially-shared-more-than-200m-covid-19-shots-with-the-world/</link>
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		<pubDate>Fri, 22 Oct 2021 04:27:58 +0000</pubDate>
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					<description><![CDATA[Good morning everyone and thank you for joining us today to beat the pandemic here. We need to beat it everywhere. And I made. And I'm keeping the promise that America will become the arsenal of vaccines as where the arsenal for democracy. During World War Two, We've already shipped nearly 160 million doses to &#8230;]]></description>
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<p>
											Good morning everyone and thank you for joining us today to beat the pandemic here. We need to beat it everywhere. And I made. And I'm keeping the promise that America will become the arsenal of vaccines as where the arsenal for democracy. During World War Two, We've already shipped nearly 160 million doses to 100 countries. More than every other country has donated combined. America's donations of a half a billion fighter vaccines through kovacs have already begun to ship. Today. I'm announcing another historic commitment. The United States is buying another half billion doses of fighter to donate to low and middle income countries around the world. This is another half billion doses that will all be shipped by this time next year. And the United States is leading the world on vaccination donations we need, as we're doing that, we need other high income countries to deliver on their own ambitious vaccine donations and pledges And while vaccinating the world is the ultimate solution to COVID-19. We know that we have to act to save lives. Now. That's why the United States has provided nearly $14 billion dollars to reduce covid 19 deaths and mitigate transmission through bulk oxygen, support, expanded testing and strengthening health care systems and more. And we're going to help all of us build back better to prepare for the next pandemic because there will be a next time we all know that
									</p>
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<p>
					The U.S. on Thursday donated its 200 millionth COVID-19 shot to help vaccinate the rest of the world, the White House announced. The Biden administration aims to lead a global vaccination campaign even as it rolls out boosters for domestic use, which critics say diverts doses from those who are in greater need around the world.The donated doses include more than 120 million in surplus from the U.S. stockpile of shots, as well as the initial deliveries of the 1 billion doses the Biden administration has purchased from Pfizer for overseas donation by September 2022. More than 100 countries and territories have received the American doses, and the U.S. remains the largest vaccine donor in the world.“These 200 million COVID-19 vaccine doses have helped bring health and hope to millions of people, but our work is far from over,” U.S. Agency for International Development Administrator Samantha Power said in a statement. “To end the pandemic, and prevent the emergence of new variants, as well as future outbreaks within our nation’s borders, we must continue to do our part to help vaccinate the world.”While aid groups have praised the U.S. for leading the world in vaccine donations, they have criticized the U.S. for approving booster doses for use in the country while many people in lower-income nations have no protection at all. The Food and Drug Administration approved booster doses of the Moderna and Johnson &amp; Johnson vaccines Wednesday, following last month's authorization of a third dose of the Pfizer shot.“The reality is, the more wealthy countries use booster shots, the further we will be from ending the pandemic," said Tom Hart, acting CEO of the One Campaign. “While some argue that we can both administer boosters and vaccinate the world, the simple fact is that boosters divert supply from an urgent area of need — administering first shots around the world.”While half the planet has been vaccinated, there are massive geographic and wealth disparities. The majority of global shots have been administered in high- and moderate-income countries.
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<p>The U.S. on Thursday donated its 200 millionth COVID-19 shot to help vaccinate the rest of the world, the White House announced. The Biden administration aims to lead a global vaccination campaign even as it rolls out boosters for domestic use, which critics say <a href="https://apnews.com/article/business-health-coronavirus-pandemic-united-nations-world-health-organization-6384ff91c399679824311ac26e3c768a" rel="nofollow">diverts doses from those who are in greater need around the world</a>.</p>
<p>The donated doses include more than 120 million in surplus from the U.S. stockpile of shots, as well as the initial deliveries of the 1 billion doses the Biden administration has purchased from Pfizer for overseas donation by September 2022. More than 100 countries and territories have received the American doses, and the U.S. remains the largest vaccine donor in the world.</p>
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<p>“These 200 million COVID-19 vaccine doses have helped bring health and hope to millions of people, but our work is far from over,” U.S. Agency for International Development Administrator Samantha Power said in a statement. “To end the pandemic, and prevent the emergence of new variants, as well as future outbreaks within our nation’s borders, we must continue to do our part to help vaccinate the world.”</p>
<p>While aid groups have praised the U.S. for leading the world in vaccine donations, they have criticized the U.S. for approving booster doses for use in the country while many people in lower-income nations have no protection at all. The Food and Drug Administration <a href="https://apnews.com/article/coronavirus-pandemic-science-business-health-coronavirus-vaccine-5ba0ada40600e590fc3ab38bba046a94" rel="nofollow">approved booster doses of the Moderna and Johnson &amp; Johnson vaccines</a> Wednesday, following last month's <a href="https://apnews.com/article/science-health-coronavirus-pandemic-coronavirus-vaccine-203d8c288858e815175880753cbc9b8f" rel="nofollow">authorization of a third dose of the Pfizer shot</a>.</p>
<p>“The reality is, the more wealthy countries use booster shots, the further we will be from ending the pandemic," said Tom Hart, acting CEO of the One Campaign. “While some argue that we can both administer boosters and vaccinate the world, the simple fact is that boosters divert supply from an urgent area of need — administering first shots around the world.”</p>
<p>While half the planet has been vaccinated, there are massive geographic and wealth disparities. The majority of global shots have been administered in high- and moderate-income countries.</p>
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		<title>President Biden doubles America&#8217;s global COVID-19 vaccine donation</title>
		<link>https://cincylink.com/2021/09/23/president-biden-doubles-americas-global-covid-19-vaccine-donation/</link>
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		<pubDate>Thu, 23 Sep 2021 04:19:20 +0000</pubDate>
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					<description><![CDATA[President Joe Biden announced Wednesday that the United States is doubling its purchase of Pfizer's COVID-19 shots to share with the world to 1 billion doses as he embraces the goal of vaccinating 70% of the global population within the next year.The stepped-up U.S. commitment marks the cornerstone of the global vaccination summit Biden convened &#8230;]]></description>
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<p>
					President Joe Biden announced Wednesday that the United States is doubling its purchase of Pfizer's COVID-19 shots to share with the world to 1 billion doses as he embraces the goal of vaccinating 70% of the global population within the next year.The stepped-up U.S. commitment marks the cornerstone of the global vaccination summit Biden convened virtually on the sidelines of the U.N. General Assembly, where he encouraged well-off nations to do more to get the coronavirus under control.World leaders, aid groups and global health organizations are growing increasingly vocal about the slow pace of global vaccinations and the inequity of access to shots between residents of wealthier and poorer nations.The U.S. purchase of another 500 million shots brings the total U.S. vaccination commitment to more than 1.1 billion doses through 2022. About 160 million shots supplied by the U.S. have already been distributed to more than 100 countries, representing more donations than the rest of the world combined. The remaining American doses will be distributed other the coming year."To beat the pandemic here, we need to beat it everywhere," Biden said. He added that with the new commitments, "For every one shot we've administered to date in America, we have now committed to do three shots to the rest of the world."The latest purchase reflects only a fraction of what will be necessary to meet a goal of vaccinating 70% of the global population — and 70% of the citizens of each nation — by next September’s U.N. meeting. It's a target pushed by global aid groups that Biden threw his weight behind.Biden is pressing other countries to do more in their vaccine sharing plans."We need other high income countries to deliver on their own ambitious vaccine donations and pledges," Biden said. He called on wealthy countries to commit to donating, rather than selling the shots to poorer nations, and to provide them "with no political strings attached."Biden said the U.S. would also increase its funding to global aid groups that are administering shotsThe American response has come under criticism for being too modest, particularly as the administration advocates for providing booster shots to tens of millions of Americans before vulnerable people in poorer nations have received even a first dose."We have observed failures of multilateralism to respond in an equitable, coordinated way to the most acute moments. The existing gaps between nations with regard to the vaccination process are unheard of," Colombian President Iván Duque said Tuesday at the United Nations.More than 5.9 billion COVID-19 doses have been administered globally over the past year, representing about 43% of the global population. But there are vast disparities in distribution, with many lower-income nations struggling to vaccinate even the most vulnerable share of their populations, and some yet to exceed 2% to 3% vaccination rates.Chilean President Sebastian Piñera said the "triumph" of speedy vaccine development was offset by political "failure" that produced inequitable distribution. "In science, cooperation prevailed; in politics, individualism. In science, shared information reigned; in politics, reserve. In science, teamwork predominated; in politics, isolated effort," Piñera said.The World Health Organization says only 15% of promised donations of vaccines — from rich countries that have access to large quantities of them — have been delivered. The U.N. health agency has said it wants countries to fulfill their dose-sharing pledges "immediately" and make shots available for programs that benefit poor countries and Africa in particular.COVAX, the U.N.-backed program to ship vaccines to all countries has struggled with production issues, supply shortages and a near-cornering of the market for vaccines by wealthy nations.The WHO has urged companies that produce vaccines to prioritize COVAX and make public their supply schedules. It also has appealed to wealthy countries to avoid broad rollouts of booster shots so doses can be made available to health care workers and vulnerable people in the developing world. Such calls have largely gone ignored.COVAX has missed nearly all of its vaccine-sharing targets. Its managers also have lowered their ambitions to ship vaccines by the end of this year, from an original target of some 2 billion doses worldwide to hopes for 1.4 billion now. Even that mark could be missed.As of Tuesday, COVAX had shipped more than 296 million doses to 141 countries.The 70% global target is ambitious, not least because of the U.S. experience.Biden had set a goal of vaccinating 70% of the U.S. adult population by July 4, but persistent vaccine hesitance contributed to the nation not meeting that target until a month later. Nearly 64% of the entire U.S. population has received at least one dose and less than 55% is fully vaccinated, according to data from the Centers for Disease Control and Prevention.U.S. officials hope to increase those figures in the coming months, both through encouraging the use of vaccination mandates and by vaccinating children once regulators clear the shots for the under-12 population.Aid groups have warned that the persistent inequities risk extending the global pandemic, and that could lead to new and more dangerous variants. The delta variant raging across the U.S. has proved to be more transmissible than the original strain, though the existing vaccines have been effective at preventing nearly all serious illness and death.___Associated Press writers Jamey Keaten in Geneva, Josh Boak at the United Nations and David Biller in Rio de Janeiro contributed to this report.
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					<strong class="dateline">WASHINGTON —</strong> 											</p>
<p>President Joe Biden announced Wednesday that the United States is doubling its purchase of Pfizer's COVID-19 shots to share with the world to 1 billion doses as he embraces the goal of vaccinating 70% of the global population within the next year.</p>
<p>The stepped-up U.S. commitment marks the cornerstone of the global vaccination summit Biden convened virtually on the sidelines of the U.N. General Assembly, where he encouraged well-off nations to do more to get the coronavirus under control.</p>
<p>World leaders, aid groups and global health organizations are growing increasingly vocal about the slow pace of global vaccinations and the inequity of access to shots between residents of wealthier and poorer nations.</p>
<p>The U.S. purchase of another 500 million shots brings the total U.S. vaccination commitment to more than 1.1 billion doses through 2022. About 160 million shots supplied by the U.S. have already been distributed to more than 100 countries, representing more donations than the rest of the world combined. The remaining American doses will be distributed other the coming year.</p>
<p>"To beat the pandemic here, we need to beat it everywhere," Biden said. He added that with the new commitments, "For every one shot we've administered to date in America, we have now committed to do three shots to the rest of the world."</p>
<p>The latest purchase reflects only a fraction of what will be necessary to meet a goal of vaccinating 70% of the global population — and 70% of the citizens of each nation — by next September’s U.N. meeting. It's a target pushed by global aid groups that Biden threw his weight behind.</p>
<p>Biden is pressing other countries to do more in their vaccine sharing plans.</p>
<p>"We need other high income countries to deliver on their own ambitious vaccine donations and pledges," Biden said. He called on wealthy countries to commit to donating, rather than selling the shots to poorer nations, and to provide them "with no political strings attached."</p>
<p>Biden said the U.S. would also increase its funding to global aid groups that are administering shots</p>
<p>The American response has come under criticism for being too modest, particularly as the administration advocates for providing booster shots to tens of millions of Americans before vulnerable people in poorer nations have received even a first dose.</p>
<p>"We have observed failures of multilateralism to respond in an equitable, coordinated way to the most acute moments. The existing gaps between nations with regard to the vaccination process are unheard of," Colombian President Iván Duque said Tuesday at the United Nations.</p>
<p>More than 5.9 billion COVID-19 doses have been administered globally over the past year, representing about 43% of the global population. But there are vast disparities in distribution, with many lower-income nations struggling to vaccinate even the most vulnerable share of their populations, and some yet to exceed 2% to 3% vaccination rates.</p>
<p>Chilean President Sebastian Piñera said the "triumph" of speedy vaccine development was offset by political "failure" that produced inequitable distribution. "In science, cooperation prevailed; in politics, individualism. In science, shared information reigned; in politics, reserve. In science, teamwork predominated; in politics, isolated effort," Piñera said.</p>
<p>The World Health Organization says only 15% of promised donations of vaccines — from rich countries that have access to large quantities of them — have been delivered. The U.N. health agency has said it wants countries to fulfill their dose-sharing pledges "immediately" and make shots available for programs that benefit poor countries and Africa in particular.</p>
<p>COVAX, the U.N.-backed program to ship vaccines to all countries has struggled with production issues, supply shortages and a near-cornering of the market for vaccines by wealthy nations.</p>
<p>The WHO has urged companies that produce vaccines to prioritize COVAX and make public their supply schedules. It also has appealed to wealthy countries to avoid broad rollouts of booster shots so doses can be made available to health care workers and vulnerable people in the developing world. Such calls have largely gone ignored.</p>
<p>COVAX has missed nearly all of its vaccine-sharing targets. Its managers also have lowered their ambitions to ship vaccines by the end of this year, from an original target of some 2 billion doses worldwide to hopes for 1.4 billion now. Even that mark could be missed.</p>
<p>As of Tuesday, COVAX had shipped more than 296 million doses to 141 countries.</p>
<p>The 70% global target is ambitious, not least because of the U.S. experience.</p>
<p>Biden had set a goal of vaccinating 70% of the U.S. adult population by July 4, but persistent vaccine hesitance contributed to the nation not meeting that target until a month later. Nearly 64% of the entire U.S. population has received at least one dose and less than 55% is fully vaccinated, according to data from the Centers for Disease Control and Prevention.</p>
<p>U.S. officials hope to increase those figures in the coming months, both through encouraging the use of vaccination mandates and by vaccinating children once regulators clear the shots for the under-12 population.</p>
<p>Aid groups have warned that the persistent inequities risk extending the global pandemic, and that could lead to new and more dangerous variants. The delta variant raging across the U.S. has proved to be more transmissible than the original strain, though the existing vaccines have been effective at preventing nearly all serious illness and death.</p>
<p>___</p>
<p><em>Associated Press writers Jamey Keaten in Geneva, Josh Boak at the United Nations and David Biller in Rio de Janeiro contributed to this report.</em></p>
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		<title>Pharmacist who sabotaged vaccine to plead guilty to federal charges</title>
		<link>https://cincylink.com/2021/08/31/pharmacist-who-sabotaged-vaccine-to-plead-guilty-to-federal-charges/</link>
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		<pubDate>Tue, 31 Aug 2021 05:08:11 +0000</pubDate>
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					<description><![CDATA[The Wisconsin pharmacist who pulled dozens of COVID-19 vaccine vials from a hospital refrigerator, agreed to plead guilty in federal court of attempting to tamper with the vaccine, a review by sister station WISN 12 News of the plea agreement determined.The agreement, which was filed in the U.S. District Court for the Eastern District of &#8230;]]></description>
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<p>
					The Wisconsin pharmacist who pulled dozens of COVID-19 vaccine vials from a hospital refrigerator, agreed to plead guilty in federal court of attempting to tamper with the vaccine, a review by sister station WISN 12 News of the plea agreement determined.The agreement, which was filed in the U.S. District Court for the Eastern District of Wisconsin, allowed Steven Brandenburg, of Grafton, to avoid an indictment by a federal grand jury and plea to two counts of  attempting to tamper with consumer products, with reckless disregard for the risk that another person will be placed in danger of death or bodily injury, the records show.According to the deal, Brandenburg, 46,  admitted to pulling the same box of Moderna COVID-19 vaccine out of the refrigerator at Aurora Medical Center - Grafton on consecutive days late last month. The Moderna vaccine needs to be stored at specific temperatures to remain effective. "Recklessly disregarding his knowledge of the applicable storage specifications and the associated risks, Brandenburg, on two successive shifts that began on the evenings of December 24 and December 25, 2020, removed the same box of Moderna COVID-19 Vaccine from the refrigerator in the pharmacy at the Grafton Facility, for periods of multiple hours, intending to render that same vaccine inert or ineffective," the plea document noted.During the investigation, it was determined 57 people had received doses of the vaccine from the vials in the box Brandenburg handled.According to the plea agreement, he believed in various "conspiracy theories," subscribed to notions of "alternative history" and was skeptical of vaccines in general and the Moderna vaccine specifically."Distributing the COVID-19 vaccine is critical to overcoming this pandemic, which continues to end lives and upend our economy," United States Attorney Matthew Krueger said in a news release. "As these charges show, the Justice Department will pursue anyone — and especially any medical professional — who tampers with the vaccine."When asked about the plea deal, Brandenburg's attorney told WISN 12 News, "No comment." Brandenburg  agreed to plead guilty to the charges, which each carry a maximum sentence of 10 years' imprisonment and a $250,000 fine. A Justice Department official said the judge has complete discretion to go higher.Brandenburg agreed to pay restitution and will be sentenced at a later date.Brandenburg faces one misdemeanor charge of attempted criminal damage to property in Oazukee County Court.He pleaded not guilty to that count.Brandenburg was scheduled to be back in Ozaukee County Court on March 18.Two weeks ago, a state review board suspended Brandenburg's pharmacy license. The hospital also fired Brandenburg. In a court document filed five days after the last sabotage attempt, Brandenburg's wife told a divorce judge she feared for their children's safety.Brandenburg's wife, Gretchen, relayed what she claimed their youngest daughter told her after a weekend stay with her dad."This is not our home, Heaven is our home," the mother said the 6-year-old told her."Based on these statements, I am concerned that the children are in imminent harm, specially that Steven would take the children to heaven,” the wife told the judge.
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					<strong class="dateline">MILWAUKEE —</strong> 											</p>
<p>The Wisconsin pharmacist who pulled dozens of COVID-19 vaccine vials from a hospital refrigerator, agreed to plead guilty in federal court of attempting to tamper with the vaccine, a review by sister station WISN 12 News of the plea agreement determined.</p>
<p>The agreement, which was filed in the U.S. District Court for the Eastern District of Wisconsin, allowed Steven Brandenburg, of Grafton, to avoid an indictment by a federal grand jury and plea to two counts of  attempting to tamper with consumer products, with reckless disregard for the risk that another person will be placed in danger of death or bodily injury, the records show.</p>
<p>According to the deal, Brandenburg, 46,  admitted to pulling the same box of Moderna COVID-19 vaccine out of the refrigerator at Aurora Medical Center - Grafton on consecutive days late last month. The Moderna vaccine needs to be stored at specific temperatures to remain effective.</p>
<p>"Recklessly disregarding his knowledge of the applicable storage specifications and the associated risks, Brandenburg, on two successive shifts that began on the evenings of December 24 and December 25, 2020, removed the same box of Moderna COVID-19 Vaccine from the refrigerator in the pharmacy at the Grafton Facility, for periods of multiple hours, intending to render that same vaccine inert or ineffective," the plea document noted.</p>
<p>During the investigation, it was determined 57 people had received doses of the vaccine from the vials in the box Brandenburg handled.</p>
<p>According to the plea agreement, he believed in various "conspiracy theories," subscribed to notions of "alternative history" and was skeptical of vaccines in general and the Moderna vaccine specifically.</p>
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<p lang="en" dir="ltr">Records: Steven Brandenburg removed the same box of <a href="https://twitter.com/hashtag/Moderna?src=hash&amp;ref_src=twsrc^tfw" rel="nofollow">#Moderna</a> vaccine from fridge on consecutive days. Officials still trying to determine if the tampering rendered them ineffective for the 57 people who received doses from that box. <a href="https://twitter.com/WISN12News?ref_src=twsrc^tfw" rel="nofollow">@WISN12News</a> <a href="https://t.co/8XQcTH3n2x" rel="nofollow">pic.twitter.com/8XQcTH3n2x</a></p>
<p>— Derrick Rose (@DRoseTV) <a href="https://twitter.com/DRoseTV/status/1354174384722874368?ref_src=twsrc^tfw" rel="nofollow">January 26, 2021</a></p></blockquote></div>
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<p>"Distributing the COVID-19 vaccine is critical to overcoming this pandemic, which continues to end lives and upend our economy," United States Attorney Matthew Krueger said in a news release. "As these charges show, the Justice Department will pursue anyone — and especially any medical professional — who tampers with the vaccine."</p>
<p>When asked about the plea deal, Brandenburg's attorney told WISN 12 News, "No comment." </p>
<p>Brandenburg  agreed to plead guilty to the charges, which each carry a maximum sentence of 10 years' imprisonment and a $250,000 fine. A Justice Department official said the judge has complete discretion to go higher.</p>
<p>Brandenburg agreed to pay restitution and will be sentenced at a later date.</p>
<p>Brandenburg faces one misdemeanor charge of attempted criminal damage to property in Oazukee County Court.</p>
<p>He pleaded not guilty to that count.</p>
<p>Brandenburg was scheduled to be back in Ozaukee County Court on March 18.</p>
<p>Two weeks ago, a state review board suspended Brandenburg's pharmacy license. The hospital also fired Brandenburg. </p>
<p>In a court document filed five days after the last sabotage attempt, Brandenburg's wife told a divorce judge she feared for their children's safety.</p>
<p>Brandenburg's wife, Gretchen, relayed what she claimed their youngest daughter told her after a weekend stay with her dad.</p>
<p>"This is not our home, Heaven is our home," the mother said the 6-year-old told her.</p>
<p>"Based on these statements, I am concerned that the children are in imminent harm, specially that Steven would take the children to heaven,” the wife told the judge.</p>
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		<title>Here&#8217;s when the US will see a lot more vaccine doses</title>
		<link>https://cincylink.com/2021/07/29/heres-when-the-us-will-see-a-lot-more-vaccine-doses/</link>
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		<pubDate>Thu, 29 Jul 2021 04:48:35 +0000</pubDate>
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					<description><![CDATA[Scottie Andrew and Daniel Wolfe, CNN Here's when the US will see a lot more vaccine doses Updated: 7:33 AM EST Mar 2, 2021 Hide Transcript Show Transcript We have a plan to roll it out as quickly as Johnson and Johnson can make it. But the truth is, no matter how fast they go, &#8230;]]></description>
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						 Scottie Andrew and Daniel Wolfe, CNN<br />
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<p>Here's when the US will see a lot more vaccine doses</p>
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					Updated: 7:33 AM EST Mar 2, 2021
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											We have a plan to roll it out as quickly as Johnson and Johnson can make it. But the truth is, no matter how fast they go, it's never gonna feel fast enough. The number out of the gate, meaning right after an authorization, be closer to 10 million. Now we're hearing four million. How's the public to make sense of that? We don't ultimately control the distribution and the volumes of the vaccines and final vital form. We're playing that middle step, making a new vaccine by the millions. It was always going to be an impressive feat. Shaun Kirk is the executive vice president of manufacturing and technical operations at Emergent Bio Solutions, and right now he feels the weight of the world on his shoulders can't sacrifice safety and quality for speed. And it's his job to strike that balance. What is the biggest hurdle then to scaling up? The bottleneck is often time, and these things just don't happen overnight. It can be a multi year time frame that we've undertaken, unfortunately, been able to compress that down. Emergent Bio Solutions is one of Johnson and Johnson's manufacturing partners, and its sprawling 112,000 square foot facility in Baltimore. It plays the key role of actually producing the viral vectors for the vaccine, basically the part that makes it work. What limits the capacity here? We're dependent upon a variety of different critical suppliers who also are rallying to the cause. So the entirety of this industrial orchestration, if you will, is very significant, and it's very complex. For starters, they have to grow the tissue cultures and these large reactors, so they're dealing with actual living organisms. They have to ensure they have all the proper nutrients they need to grow and then go through the purification steps to remove any debris. The manufacturing of biologic vaccine processes like these typically takes several weeks upwards of a month. What's important to note is that we are in a cadence, which means we don't wait for a single lot to move all the way through before we initiate another lot. After all, that, the newly manufactured vaccine is frozen and shipped more than 600 miles to another company, cattle, and that's in Bloomington, Indiana. What happens there? Fill and finish, and then every single vial is visually inspected. Hundreds per minute will pass through this process. It's fast, a breakneck speed, Kirk says. But again, in the middle of a pandemic, nothing is fast enough. We expect to reach the maximum, that commercial cadence. But we'll always look for opportunities to further refine and partnership with our customers to tease out as many doses as possible. When they say a billion doses, potentially by the end of 2021. That number sounds reasonable to you based on what you know. But suffice it to say we've got a little bit farther to go to get there. But that's all according to the plan and contracts that we have with Johnson and Johnson, every dose, every vial can still make a difference for the billions of people around the world waiting for their shot at protection. Dr. Sanjay Gupta, CNN reporting.
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					Millions more COVID-19 vaccines are on the way.Moderna, Pfizer and now Johnson &amp; Johnson will deliver enough doses to fully vaccinate 130 million people -- more than one-third of the U.S. population -- by the end of March, the pharmaceutical companies told a House subcommittee last week.Moderna plans to deliver 100 million doses by the end of the month, said Dr. Stephen Hoge, the company's president. It'll deliver another 100 million by the end of May and 100 million more by the end of July.Pfizer will deliver 120 million doses by the end of the month, 80 million more doses by the end of May and 100 million more by the end of July, said chief business officer John Young.Johnson &amp; Johnson, whose single-dose vaccine was approved just last week, will deliver 20 million doses by the end of March and aims to deliver 100 million by July, said Dr. Richard Nettles, vice president of U.S. Medical Affairs at the company's vaccine arm, Janssen.By the end of July, the companies aim to deliver enough vaccines to vaccinate 400 million people, which is about 70 million more than the current U.S. population.A fourth COVID-19 vaccine could become available in the U.S. in April, when AstraZeneca could secure FDA authorization of its vaccine. Dr. Ruud Dobber, the executive vice president and president of AstraZeneca's biopharmaceuticals business unit, said the company will immediately release 30 million doses upon authorization of the vaccine and up to 50 million doses by the end of April.
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<p>Millions more COVID-19 vaccines are on the way.</p>
<p>Moderna, Pfizer and now Johnson &amp; Johnson will deliver enough doses to fully vaccinate 130 million people -- more than one-third of the U.S. population -- by the end of March, the pharmaceutical companies told a House subcommittee last week.</p>
<p><strong>Moderna</strong> plans to deliver 100 million doses by the end of the month, said Dr. Stephen Hoge, the company's president. It'll deliver another 100 million by the end of May and 100 million more by the end of July.</p>
<p><strong>Pfizer</strong> will deliver 120 million doses by the end of the month, 80 million more doses by the end of May and 100 million more by the end of July, said chief business officer John Young.</p>
<p><strong>Johnson &amp; Johnson</strong>, whose single-dose vaccine was approved just last week, will deliver 20 million doses by the end of March and aims to deliver 100 million by July, said Dr. Richard Nettles, vice president of U.S. Medical Affairs at the company's vaccine arm, Janssen.</p>
<p>By the end of July, the companies aim to deliver enough vaccines to vaccinate 400 million people, which is about 70 million more than the current U.S. population.</p>
<p>A fourth COVID-19 vaccine could become available in the U.S. in April, when AstraZeneca could secure FDA authorization of its vaccine. Dr. Ruud Dobber, the executive vice president and president of AstraZeneca's biopharmaceuticals business unit, said the company will immediately release 30 million doses upon authorization of the vaccine and up to 50 million doses by the end of April.</p>
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