{"id":10175,"date":"2025-03-01T14:03:00","date_gmt":"2025-03-01T19:03:00","guid":{"rendered":"https:\/\/dhss.delaware.gov\/dph\/dhan213\/"},"modified":"2025-03-02T00:49:19","modified_gmt":"2025-03-02T05:49:19","slug":"dhan213","status":"publish","type":"page","link":"https:\/\/dhss.delaware.gov\/dph\/php\/alerts\/dhan213\/","title":{"rendered":"php\/alerts\/dhan213 ~  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\/dhan213.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\"]-->213 <!--[END]--> <\/h1>\n\n      <h2> <!--[type=EDIT name=\"DHAN Date\"]-->December 16, 2009 9:32 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; Programs<\/a><\/li>\n        <li><a href=\"\/dph\/ofclocations.html\">Office Locations<\/a><\/li>\n        <li><a href=\"\/dph\/contact.html\">Contact Info<\/a><\/li>\n      \n        <li><a href=\"\/calendars.html\" target=\"_blank\">Calendar<\/a><\/li>\n      <\/ul>\n    <\/li>\n    <li class=\"toplevel\"><a data-parent=\"#sidebar\" data-toggle=\"collapse\" href=\"#ServicesMenu\"><h2>Services <i class=\"fa fa-caret-right fa-fw\"><\/i><\/h2><\/a>\n      <ul class=\"panel-collapse collapse\" id=\"ServicesMenu\">\n        <li><a href=\"\/dph\/servicesaz.html\">A-Z Services<\/a><\/li>\n        <li><a href=\"\/dph\/hsp\/environmental.html\">Air &#038; Water Quality<\/a><\/li>\n        <li><a href=\"\/dph\/ss\/vitalstats.html\">Birth, Death, &#038; Marriage Records<\/a><\/li>\n        <li><a href=\"\/dph\/clinics.html\">Clinics<\/a><\/li>\n        <li><a href=\"\/dph\/healthdatastats.html\">Health Data &#038; Statistics<\/a><\/li>\n        <li><a href=\"\/dph\/php\/emsps.html\">Emergency Preparedness<\/a><\/li>\n        <li><a href=\"\/dph\/healthandwellness.html\">Health &#038; 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; 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For more information from the Division of Public Health, contact the Division\n\n\n\n\n\n\nor Public Health Immunization Program at 1-800-282-8672.<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<p><em>Summary:<\/em> As part of its quality assurance program, Sanofi Pasteur, Inc., performs additional\n\n\n\n\n\n\nroutine, ongoing testing of influenza vaccines after the vaccine has been distributed to health care providers\n\n\n\n\n\n\nto ensure that vaccines continue to meet required specifications. In recent testing of the amount of antigen\n\n\n\n\n\n\nin its influenza A (H1N1) monovalent vaccine, Sanofi Pasteur found four distributed lots of single-dose,\n\n\n\n\n\n\npre-filled syringe pediatric (0.25 mL.) vaccine with antigen content lower than required potency levels.\n\n\n\n\n\n\nThe manufacturer is conducting a non-safety related voluntary recall of these affected lots of vaccine.<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<h3>Background<\/h3>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<p>After performing these tests, Sanofi Pasteur notified the Centers for Disease Control and Prevention\n\n\n\n\n\n\n(CDC) and the Food and Drug Administration (FDA) that the antigen content in one lot of pediatric syringes\n\n\n\n\n\n\nthat had been distributed to providers was later found to have dropped below a pre-specified limit. As\n\n\n\n\n\n\na result of this finding, Sanofi Pasteur tested additional lots and found that three other lots that had\n\n\n\n\n\n\nbeen distributed also had an antigen content that had fallen below pre-specified limits. This means that\n\n\n\n\n\n\ndoses from these four vaccine lots no longer meet the specifications for antigen content.<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<h3>Recommendations<\/h3>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<p>While the antigen content of these lots is now below the specification limit for the product, CDC and\n\n\n\n\n\n\nFDA are in agreement that the small decrease in antigen content is unlikely to result in a clinically\n\n\n\n\n\n\nsignificant reduction in immune response among persons who have received the vaccine. For this reason,\n\n\n\n\n\n\nthere is no need to revaccinate persons who have received vaccine from these lots.<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<p>Providers are being asked to return any vaccine to the manufacturer in the following lots that remains\n\n\n\n\n\n\nunused:<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<ul>\n\n\n\n\n\n\n\n<li class=\"dblspace\">0.25 mL pre-filled syringes, 10-packs (NDC # 49281-650-25, sometimes coded as 49281-0650-25):\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<ul>\n\n\n\n\n\n\n\n<li>UT023DA<\/li>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<li>UT028DA<\/li>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<li>UT028CB<\/li>\n\n\n\n\n\n\n\n<\/ul>\n\n\n\n\n\n\n\n<\/li>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<li>0.25 mL pre-filled syringes, 25-packs (NDC # 49281-650-70, sometimes coded as 49281-0650-70): \n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<ul>\n\n\n\n\n\n\n\n<li>UT030CA<\/li>\n\n\n\n\n\n\n\n<\/ul>\n\n\n\n\n\n\n\n<\/li>\n\n\n\n\n\n\n\n<\/ul>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<p>These lots were shipped in November and are intended for children 6 months through 35 months of age.\n\n\n\n\n\n\nSanofi Pasteur has sent directions for returning unused vaccine from these lots to providers that received\n\n\n\n\n\n\nthe vaccine.<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<p>Eight providers in Delaware received 1,840 doses of vaccine from the affected lots. These providers\n\n\n\n\n\n\nwill be contacted by DPH and by the vaccine manufacturer Sanofi on the process to return any unused vaccine.<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<p>All vaccines are thoroughly tested prior to release and shipping to determine that they meet all manufacturer\n\n\n\n\n\n\nand FDA standards for purity, potency and safety. The affected vaccine met all specifications at the time\n\n\n\n\n\n\nof release. CDC and FDA have determined that there are no safety concerns for children who have received\n\n\n\n\n\n\nthis vaccine. Sanofi Pasteur has discontinued distribution of the 0.25 mL syringes of H1N1 pediatric vaccines.<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<p>The drop in antigen content below the required specification that is described here is specific to\n\n\n\n\n\n\nSanofi Pasteur\u2019s pediatric H1N1 monovalent vaccine in 0.25 mL pre-filled syringes. The same vaccine\n\n\n\n\n\n\npackaged in other forms, such as 0.5 mL pre-filled syringes for older children and adults and multi-dose\n\n\n\n\n\n\nvials, continue to meet specifications.<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<p>The antigen content in the affected lots of vaccine is only slightly below the specification limit.\n\n\n\n\n\n\nThe slightly reduced concentration of vaccine antigen found in retesting these lots is still expected\n\n\n\n\n\n\nto be effective in stimulating a protective response. There is no need to re-administer a dose to those\n\n\n\n\n\n\nwho received vaccine from these lots. However, as is recommended for all 2009 H1N1 vaccines, all children\n\n\n\n\n\n\nless than 10 years old should get the recommended two doses of H1N1 vaccine approximately a month apart\n\n\n\n\n\n\nfor the optimal immune response. So, children less than 10 years old who have only received one dose of\n\n\n\n\n\n\nvaccine thus far should still receive a second dose of 2009 H1N1 vaccine.<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<p>For children 6 months of age and older, vaccine is available in multi-dose vials. The vaccine in multi-dose\n\n\n\n\n\n\nvials is safe and effective vaccine for children. One difference between vaccine in pre-filled syringes\n\n\n\n\n\n\nand the multidose vials is that the multidose vials contain a preservative (thimerosal) to prevent potential\n\n\n\n\n\n\ncontamination after the vial is opened. The standard dose for this preparation for administration to infants\n\n\n\n\n\n\n6-35 months old is the same as for the pre-filled syringes, 0.25 mL. For healthy children at least 2 years\n\n\n\n\n\n\nof age, the nasal spray (live, attenuated influenza vaccine) is also an option. The nasal spray vaccine\n\n\n\n\n\n\nis produced in single units that do not contain thimerosal.<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<h4>For More Information:<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<ul>\n\n\n\n\n\n\n\n<li class=\"dblspace\">For Questions and Answers related to the withdrawn vaccine see <a href=\"http:\/\/www.cdc.gov\/h1n1flu\/vaccination\/syringes_qa.htm\" target=\"_blank\" title=\"http:\/\/wwwdev.cdc.gov\/h1n1flu\/vaccination\/syringes_qa.htm\">http:\/\/www.cdc.gov\/h1n1flu\/vaccination\/syringes_qa.htm<\/a><\/li>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<li class=\"dblspace\">Call CDC\u2019s toll-free information line, 800-CDC-INFO (800-232-4636) TTY: (888)\n\n\n\n\n\n\n232-6348, which is available 24 hours a day, every day.<\/li>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<li class=\"dblspace\">Sanofi Pasteur will provide you with additional communication materials upon request.\n\n\n\n\n\n\nPlease call 1-888-241-9288 for these items. For other inquiries, please contact Sanofi Pasteur Customer\n\n\n\n\n\n\nServices at 1-800-VACCINE (1-800-822-2463).<\/li>\n\n\n\n\n\n\n\n<\/ul>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<p class=\"center\">************************************<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<p>You are receiving this email because you are a registered member of the Delaware Health Alert Network.\n\n\n\n\n\n\nIf you are not a member and would like to subscribe, please register at <a href=\"https:\/\/www.healthalertde.org\/\">https:\/\/www.healthalertde.org\/<\/a><\/p>\n\n\n\n\n\n\n\n<!--[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 #213 December 16, 2009 9:32 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-10175","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/pages\/10175","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=10175"}],"version-history":[{"count":1,"href":"https:\/\/dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/pages\/10175\/revisions"}],"predecessor-version":[{"id":11351,"href":"https:\/\/dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/pages\/10175\/revisions\/11351"}],"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=10175"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}