{"id":10191,"date":"2025-03-01T14:03:04","date_gmt":"2025-03-01T19:03:04","guid":{"rendered":"https:\/\/dhss.delaware.gov\/dph\/dhan228\/"},"modified":"2025-03-02T00:49:23","modified_gmt":"2025-03-02T05:49:23","slug":"dhan228","status":"publish","type":"page","link":"https:\/\/dhss.delaware.gov\/dph\/php\/alerts\/dhan228\/","title":{"rendered":"php\/alerts\/dhan228 ~  Division of Public Health &#8211; &#8211; Health Alert  &#8211; Delaware Health and Social Services &#8211; State of Delaware"},"content":{"rendered":"<div data-swiftype-index=\"true\">\n\n\n\n  <br>\n\n\n\n  <div class=\"container\" id=\"main_header\"> \n\n    <!-- BEGIN readspeaker div -->\n\n    <div class=\"rs_skip rsbtn rs_preserve\" id=\"readspeaker_button1\">\n\n      <a accesskey=\"L\" class=\"rsbtn_play\" href=\"https:\/\/app-na.readspeaker.com\/cgi-bin\/rsent?customerid=7262&#038;lang=en_us&#038;readid=main_content&#038;url=https:\/\/dhss.delaware.gov\/dph\/php\/alerts\/dhan228.html\" title=\"Listen to this page using ReadSpeaker\">\n\n        <span class=\"rsbtn_left rsimg rspart\"><span class=\"rsbtn_text\"><span>Listen<\/span><\/span><\/span>\n\n        <span class=\"rsbtn_right rsimg rsplay rspart\"><\/span>\n\n      <\/a>\n\n    <\/div>\n\n    <!-- END readspeaker div -->\n\n\n\n    \n\n    <header class=\"pull-left\">\n\n      <h1>Delaware Health Alert Network #<!--[type=EDIT name=\"DHAN Number\"]-->228 <!--[END]--> <\/h1>\n\n      <h2> <!--[type=EDIT name=\"DHAN Date\"]-->May 18, 2010 9:27 am <!--[END]--> <\/h2>\n\n    <\/header>\n\n  <\/div><br>\n\n \n\n  <div class=\"container\">\n\n    <div class=\"row\">\n\n      <div class=\"col-md-3\" id=\"leftCol\">\n\n        <div class=\"panel-group\" id=\"accordion\">\n\n          <div class=\"panel sectionmenu_panel\">\n\n            <div class=\"panel-heading\">\n\n              <p class=\"panel-title\"><a class=\"agency_nav\" data-parent=\"#accordion\" data-toggle=\"collapse\" href=\"#collapseOne\"><strong><i class=\"fa fa-align-justify fa-fw\"><\/i> Public Health Menu<\/strong><\/a><\/p>\n\n            <\/div>\n\n\n\n            <div class=\"panel-collapse collapse in\" id=\"collapseOne\">\n\n              <div class=\"panel-body\" id=\"clf_nav\">\n\n                  <ul class=\"nav nav-stacked nav-pills-clf\" id=\"agency_sidebar\">\n    <li><a href=\"\/dph\/\"><h2>Home <i class=\"fa fa-home fa-fw\"><\/i><\/h2><\/a><\/li>\n    <li class=\"toplevel\"><a data-parent=\"#agency_sidebar\" data-toggle=\"collapse\" href=\"#HomeMenu\"><h2>About <i class=\"fa fa-caret-right fa-fw\"><\/i><\/h2><\/a>\n      <ul class=\"panel-collapse collapse\" id=\"HomeMenu\">\n        <li><a href=\"\/dph\/about.html\">About DPH<\/a><\/li>\n        <li><a href=\"\/dph\/sections.html\">Sections &#038; 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Wellness<\/a><\/li>\n        <li><a href=\"\/dph\/hsp\/healthyhomes.html\">Healthy Homes<\/a><\/li>\n        <li><a href=\"\/dph\/hsp\/healthywp.html\">Healthy Workplaces<\/a><\/li>\n        <li><a href=\"\/dph\/lab\/labs.html\">Laboratory<\/a><\/li>\n        <li><a href=\"\/dph\/hsp\/feir.html\">Restaurant Inspections<\/a><\/li>\n        <li><a href=\"\/dph\/screen.html\">Screening and Testing<\/a><\/li>\n        <li><a href=\"\/dph\/chca\/dphwichominf01.html\">WIC<\/a><\/li>\n        <li><a href=\"\/dph\/servicesadd.html\">Additional Services<\/a><\/li><li>\n      <\/li><\/ul>\n    <\/li>\n    <li class=\"toplevel\"><a data-parent=\"#sidebar\" data-toggle=\"collapse\" href=\"#InformationMenu\"><h2>Information <i class=\"fa fa-caret-right fa-fw\"><\/i><\/h2><\/a>\n        <ul class=\"panel-collapse collapse\" id=\"InformationMenu\">\n        <li><a href=\"\/dph\/factsheetsaz.html\">A-Z Fact Sheets<\/a><\/li>\n        <li><a href=\"\/dph\/pubreportsaz.html\">A-Z Publications &#038; Reports<\/a><\/li>\n        <li><a href=\"\/dph\/diseasesandconditions.html\">Diseases &#038; Conditions<\/a><\/li>\n        <li><a href=\"\/dph\/faq.html\">FAQ&#8217;s<\/a><\/li>\n        <li><a href=\"\/dph\/php\/alerts.html\">Health Alerts<\/a><\/li>\n        <li><a href=\"\/dph\/healthylifestyles.html\">Healthy Lifestyles<\/a><\/li>\n        <li><a href=\"\/dph\/hipaa.html\">HIPAA<\/a><\/li>\n        <li><a href=\"\/dph\/regs.html\">Regulations<\/a><\/li>\n        <li><a href=\"\/dph\/forms.html\">Request Forms<\/a><\/li>\n        <li><a href=\"\/dph\/links.html\">Links &#038; Resources<\/a><\/li>\n        <li><a href=\"http:\/\/delaware.gov\/help\/foia_request.shtml\">FOIA Request Form<\/a><\/li>\n      <\/ul>\n    <\/li>\n    <li><a id=\"SocialMenuHeader\"><h2>Connect <i class=\"fa fa-thumbs-o-up fa-fw\"><\/i><\/h2><\/a>\n      <ul id=\"SocialMenu\">\n        <li class=\"facebook\"><a href=\"https:\/\/www.facebook.com\/DEPublicHealth\" target=\"_blank\" title=\"Division of Public Health Facebook Page\"><i class=\"fa fa-facebook-square fa-lg\"><\/i> Facebook<\/a><\/li>\n        <li class=\"twitter\"><a href=\"https:\/\/twitter.com\/Delaware_DHSS\" target=\"_blank\" title=\"Delaware Health and Social Services Twitter Account\"><i class=\"fa fa-twitter-square fa-lg\"><\/i> Twitter<\/a><\/li>\n        <!-- <li class=\"googleplus\"><a href=\"#\"><i class=\"fa fa-google-plus-square fa-lg\"><\/i> Google +<\/a><\/li>\n        <li class=\"flickr\"><a href=\"#\"><i class=\"fa fa-flickr fa-lg\"><\/i> Flickr<\/a><\/li>\n        <li class=\"youtube\"><a href=\"#\"><i class=\"fa fa-youtube-square fa-lg\"><\/i> Youtube<\/a><\/li>\n        <li class=\"instagram\"><a href=\"#\"><i class=\"fa fa-instagram fa-lg\"><\/i> Instagram<\/a><\/li>\n        <li class=\"linkedin\"><a href=\"#\"><i class=\"fa fa-linkedin-square fa-lg\"><\/i> Linkedin<\/a><\/li>\n        <li class=\"pinterest\"><a href=\"#\"><i class=\"fa fa-pinterest-square fa-lg\"><\/i> Pinterest<\/a><\/li> -->\n      <\/ul>\n    <\/li>\n  <\/ul>\n\n              <\/div>\n\n            <\/div>\n\n          <\/div>\n\n        <\/div><br>\n\n      <\/div>\n\n\n\n      <div class=\"col-md-9\" id=\"main_content\"> \n\n  \n\n<h2 class=\"center\">Health\n\n<!--[type=EDIT name=\"DHANType\"]-->\n\n\n\n   Update<!--[END]-->\n\n<br>\n\n<!--[type=EDIT name=\"DHAN Heading\"]-->\n\n\n\nUPDATE ON RECOMMENDATIONS FOR THE USE OF ROTAVIRUS VACCINES<!--[END]-->\n\n<\/h2>\n\n\n\n<!--[type=HTMLEDIT name=\"Content\"]-->\n\n\n\n<p>\n\n\n  The Delaware Division of Public Health (DPH) is forwarding this Health Alert from the Centers for Disease Control and Prevention (CDC).\n\n\n<\/p>\n\n\n<h3>\n\n\n  Summary\n\n\n<\/h3>\n\n\n<p>\n\n\n  FDA is updating its recommendations on both Rotarix and RotaTeq, vaccines for the prevention of rotavirus disease in infants. Based on\n\n\n  careful evaluation of a variety of scientific information, FDA has determined it is appropriate for clinicians and health care\n\n\n  professionals to resume the use of Rotarix and to continue the use of RotaTeq.\n\n\n<\/p>\n\n\n<h3>\n\n\n  Background\n\n\n<\/h3>\n\n\n<p>\n\n\n  On <a href=\"http:\/\/www.fda.gov\/BiologicsBloodVaccines\/Vaccines\/ApprovedProducts\/ucm205540.htm\">March 22, 2010<\/a>, FDA provided an early\n\n\n  communication regarding Rotarix, manufactured by GlaxoSmithKline Biologicals (GSK). At that time, FDA recommended that clinicians and\n\n\n  public health professionals in the United States temporarily suspend the use of Rotarix while the agency and manufacturer investigated\n\n\n  the finding of DNA from porcine circovirus type 1 (PCV1) in the vaccine. Since that time, both FDA and GSK have confirmed the presence of\n\n\n  PCV1 in the vaccine. On <a href=\"http:\/\/www.fda.gov\/BiologicsBloodVaccines\/Vaccines\/ApprovedProducts\/ucm211101.htm\">May 6, 2010<\/a>, FDA\n\n\n  provided information about RotaTeq, manufactured by Merck &#038; Co, Inc. FDA indicated that preliminary studies conducted by Merck\n\n\n  identified fragments of DNA from PCV1 and from a related porcine circovirus type 2 (PCV2) in RotaTeq. FDA noted that it would seek input\n\n\n  from its Vaccines and Related Biological Products Advisory Committee (VRBPAC) and provide updates in the near future.\n\n\n<\/p>\n\n\n<h3>\n\n\n  Updated Recommendations\n\n\n<\/h3>\n\n\n<p>\n\n\n  FDA has evaluated laboratory results from the manufacturers and its own laboratories. In addition, FDA\u2019s VRBPAC convened on\n\n\n  <a href=\"http:\/\/www.fda.gov\/AdvisoryCommittees\/CommitteesMeetingMaterials\/BloodVaccinesandOtherBiologics\/VaccinesandRelatedBiologicalProductsAdvisoryCommittee\/ucm197728.htm\">\n\n\n  May 7, 2010<\/a> to discuss the findings of PCV and PCV DNA in rotavirus vaccines. Based on a careful evaluation of this information, a\n\n\n  thorough review of the scientific literature, and input from scientific and public health experts, the Agency is revising its\n\n\n  recommendation to temporarily suspend use of the Rotarix vaccine. FDA has determined it is appropriate for clinicians and health care\n\n\n  professionals to resume the use of Rotarix and to continue the use of RotaTeq.\n\n\n<\/p>\n\n\n<p>\n\n\n  FDA considered the following information in its decision:\n\n\n<\/p>\n\n\n<ul>\n\n\n  <li>Both vaccines have strong safety records, including clinical trials involving tens of thousands of patients as well as clinical\n\n\n  experience with millions of recipients. FDA has no evidence that either PCV1 or PCV2 poses a safety risk in humans, and notes that\n\n\n  neither is known to cause infection or illness in humans.\n\n\n  <\/li>\n\n\n  <li>The benefits of the vaccines are substantial, and include prevention of hospitalization for severe rotavirus disease in the U.S. and\n\n\n  of death in other parts of the world. The benefits of the vaccines, which are known, outweigh the risk, which is theoretical.\n\n\n  <\/li>\n\n\n<\/ul>\n\n\n<h3>\n\n\n  Next Steps\n\n\n<\/h3>\n\n\n<p>\n\n\n  FDA is working with each of the manufacturers (GSK and Merck) to update the labeling for both Rotarix and RotaTeq vaccines to include\n\n\n  information about the presence of PCV1 (Rotarix) and DNA from PCV1 and PCV2 (RotaTeq) in the vaccines.\n\n\n<\/p>\n\n\n<p>\n\n\n  FDA is working with each of the manufacturers to plan the appropriate follow up studies, taking into account the input received from\n\n\n  members of the VRBPAC on May 7, 2010.\n\n\n<\/p>\n\n\n<p>\n\n\n  FDA and the manufacturers will continue to investigate the findings of PCV in rotavirus vaccines, and will evaluate information from\n\n\n  ongoing testing by FDA and the manufacturers. As noted by the firm during the May 7, 2010, VRBPAC meeting, GSK plans to re-derive its\n\n\n  vaccine, in consultation with FDA. Merck is in the early stages of its investigation, and has not yet determined next steps in this\n\n\n  regard.\n\n\n<\/p>\n\n\n<h3>\n\n\n  Updated Information for Clinicians and Public Health Professionals\n\n\n<\/h3>\n\n\n<p>\n\n\n  FDA has determined it is appropriate for clinicians and health care professionals to resume the use of Rotarix and to continue the use of\n\n\n  RotaTeq. FDA also recommends that clinicians and public health professionals inform parents of the findings of PCV DNA or PCV in\n\n\n  rotavirus vaccines, and that there is no evidence that these findings pose a safety risk in humans. Both the prescribing information and\n\n\n  patient labeling will be revised to include this information.\n\n\n<\/p>\n\n\n<p>\n\n\n  The benefits of vaccination against rotavirus disease are substantial, both in the United States and the developing world and far\n\n\n  outweigh any theoretical risk posed by PCV types 1 and 2. The safety record of both rotavirus vaccines is excellent.\n\n\n<\/p>\n\n\n<p>\n\n\n  FDA will keep the public and clinical community updated through <a href=\"http:\/\/www.fda.gov\/\">www.fda.gov<\/a>. For questions, please\n\n\n  contact the GSK response center at 1-888-825-5249 or call the Delaware Division of Public Health Immunization Program at 1-800-282-8672.\n\n\n<\/p>\n\n\n<p>\n\n\n  ************************************\n\n\n<\/p>\n\n\n<p>\n\n\n  You are receiving this email because you are a registered member of the Delaware Health Alert Network. If you are not a member and would\n\n\n  like to subscribe, please register at <a href=\"https:\/\/healthalertde.org\">https:\/\/healthalertde.org<\/a>\n\n\n<\/p><!--[END]-->\n\n  \n\n        <div class=\"panel panel-danger\">\n\n          <div class=\"panel-heading\">    \n\n      <h2>Categories of Health Alert messages:<\/h2>\n\n       <\/div>\n\n       <div class=\"panel-body\">\n\n      <ul>\n\n        <li><strong>Health Alert:<\/strong> Conveys the highest level of importance; warrants immediate action or attention.<\/li>\n\n        <li><strong>Health Advisory:<\/strong> Provides important information for a specific incident or situation; may not require immediate action.<\/li>\n\n        <li><strong>Health Update:<\/strong> Provides updated information regarding an incident or situation; unlikely to require immediate action.<\/li>\n\n            <\/ul>\n\n         <div><strong>NOTE: This page is for informational purposes only and dated material (e.g. temporary websites) may not be available.<\/strong><\/div>\n\n          <\/div> \n\n        <\/div><br>  \n\n\n\n      <\/div>\n\n    <\/div>\n\n  <\/div><!-- \/container -->\n\n  <\/div>","protected":false},"excerpt":{"rendered":"<p>Listen Delaware Health Alert Network #228 May 18, 2010 9:27 am Public Health Menu Home About About DPH Sections &#038; Programs Office Locations Contact Info Calendar Services A-Z Services Air &#038; Water Quality Birth, Death, &#038; Marriage Records Clinics Health Data &#038; Statistics Emergency Preparedness Health &#038; Wellness Healthy Homes Healthy Workplaces Laboratory Restaurant Inspections [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"parent":9294,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-10191","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/pages\/10191","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/comments?post=10191"}],"version-history":[{"count":1,"href":"https:\/\/dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/pages\/10191\/revisions"}],"predecessor-version":[{"id":11367,"href":"https:\/\/dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/pages\/10191\/revisions\/11367"}],"up":[{"embeddable":true,"href":"https:\/\/dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/pages\/9294"}],"wp:attachment":[{"href":"https:\/\/dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/media?parent=10191"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}