{"id":3575,"date":"2023-05-16T18:19:43","date_gmt":"2023-05-16T23:19:43","guid":{"rendered":"https:\/\/www.unmc.edu\/healthsecurity\/transmission\/?p=3575"},"modified":"2023-05-16T18:19:46","modified_gmt":"2023-05-16T23:19:46","slug":"safety-data-on-maternal-rsv-vaccine-favorable-fda-staff-says","status":"publish","type":"post","link":"https:\/\/www.unmc.edu\/healthsecurity\/transmission\/2023\/05\/16\/safety-data-on-maternal-rsv-vaccine-favorable-fda-staff-says\/","title":{"rendered":"Safety Data on Maternal RSV Vaccine &#8216;Favorable,&#8217; FDA Staff Says"},"content":{"rendered":"<div class=\"panel body-content\"><div class=\"panel__container\">\n<p><a href=\"https:\/\/www.medpagetoday.com\/infectiousdisease\/generalinfectiousdisease\/104534?xid=nl_mpt_DHE_2023-05-16&amp;eun=g1462072d0r&amp;utm_source=Sailthru&amp;utm_medium=email&amp;utm_campaign=Daily%20Headlines%20Evening%202023-05-16&amp;utm_term=NL_Daily_DHE_dual-gmail-definition\">MedPageToday<\/a> <\/p>\n\n\n\n<p>A maternal respiratory syncytial virus (RSV) vaccine candidate prevents infections in infants and comes with &#8220;generally favorable&#8221; safety data, said FDA staff in\u00a0<a rel=\"noreferrer noopener\" href=\"https:\/\/www.fda.gov\/media\/168185\/download\" target=\"_blank\">briefing documents<\/a> \u00a0released ahead of an advisory committee meeting this week, but the reviewers &#8220;noted potential uncertainty based on the numerical imbalance in premature deliveries.&#8221;<\/p>\n\n\n\n<p>On Thursday, members of the\u00a0<a rel=\"noreferrer noopener\" href=\"https:\/\/www.fda.gov\/advisory-committees\/advisory-committee-calendar\/vaccines-and-related-biological-products-advisory-committee-may-18-2023-meeting-announcement\" target=\"_blank\">Vaccines and Related Biological Products Advisory Committeeo<\/a> \u00a0(VRBPAC) will weigh in on whether the available data support the safety and efficacy of Pfizer&#8217;s RSV prefusion F protein vaccine when given to mothers in the second or third trimester of pregnancy for preventing RSV-related lower respiratory tract illness in infants, including severe cases. <\/p>\n\n\n\n<p>The FDA recently\u00a0<a rel=\"noreferrer noopener\" href=\"https:\/\/www.medpagetoday.com\/infectiousdisease\/uritheflu\/104319\" target=\"_blank\">approved the first-ever RSV vaccine <\/a>\u00a0for older adults, but no vaccine exists for protecting infants, a particularly vulnerable group. A prior effort at developing a formalin-inactivated\u00a0<a rel=\"noreferrer noopener\" href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/4305198\/\" target=\"_blank\">RSV vaccine in the late 1960s failed <\/a>\u00a0when vaccinated infants developed enhanced respiratory disease following their first infection.<\/p>\n\n\n\n<p>RSV infections make up the bulk of lower respiratory tract infections in infants, with hospitalization rates ranging from 1% to 3%, and peaking in early infancy, according to the briefing documents. Mortality rates for hospitalized infants range from 1% to 3% as well.<\/p>\n\n\n\n<p>&#8220;Risk factors for severe disease include prematurity, underlying chronic lung or heart disease, and immunodeficiency; however, healthy infants 0 to 6 months of age are also at significant risk for morbidity and mortality,&#8221; wrote agency staff.<\/p>\n<\/div><\/div>","protected":false},"excerpt":{"rendered":"<p>MedPageToday A maternal respiratory syncytial virus (RSV) vaccine candidate prevents infections in infants and comes with &#8220;generally favorable&#8221; safety data, said FDA staff in\u00a0briefing documents \u00a0released ahead of an advisory committee meeting this week, but the reviewers &#8220;noted potential uncertainty based on the numerical imbalance in premature deliveries.&#8221; On Thursday, members of the\u00a0Vaccines and Related [&hellip;]<\/p>\n","protected":false},"author":11,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":false,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[8],"tags":[],"class_list":["post-3575","post","type-post","status-publish","format-standard","hentry","category-vaccine-headlines"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/www.unmc.edu\/healthsecurity\/transmission\/wp-json\/wp\/v2\/posts\/3575","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.unmc.edu\/healthsecurity\/transmission\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.unmc.edu\/healthsecurity\/transmission\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.unmc.edu\/healthsecurity\/transmission\/wp-json\/wp\/v2\/users\/11"}],"replies":[{"embeddable":true,"href":"https:\/\/www.unmc.edu\/healthsecurity\/transmission\/wp-json\/wp\/v2\/comments?post=3575"}],"version-history":[{"count":1,"href":"https:\/\/www.unmc.edu\/healthsecurity\/transmission\/wp-json\/wp\/v2\/posts\/3575\/revisions"}],"predecessor-version":[{"id":3576,"href":"https:\/\/www.unmc.edu\/healthsecurity\/transmission\/wp-json\/wp\/v2\/posts\/3575\/revisions\/3576"}],"wp:attachment":[{"href":"https:\/\/www.unmc.edu\/healthsecurity\/transmission\/wp-json\/wp\/v2\/media?parent=3575"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.unmc.edu\/healthsecurity\/transmission\/wp-json\/wp\/v2\/categories?post=3575"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.unmc.edu\/healthsecurity\/transmission\/wp-json\/wp\/v2\/tags?post=3575"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}