{"id":838368,"date":"2025-04-16T17:39:04","date_gmt":"2025-04-16T21:39:04","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/arexvy-recommended-for-adults-aged-50-59-at-increased-risk-for-severe-respiratory-syncytial-virus-rsv-disease-by-us-advisory-committee-on-immunization-practices\/"},"modified":"2025-04-16T17:39:04","modified_gmt":"2025-04-16T21:39:04","slug":"arexvy-recommended-for-adults-aged-50-59-at-increased-risk-for-severe-respiratory-syncytial-virus-rsv-disease-by-us-advisory-committee-on-immunization-practices","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/arexvy-recommended-for-adults-aged-50-59-at-increased-risk-for-severe-respiratory-syncytial-virus-rsv-disease-by-us-advisory-committee-on-immunization-practices\/","title":{"rendered":"AREXVY recommended for adults aged 50-59 at increased risk for severe respiratory syncytial virus (RSV) disease by US Advisory Committee on Immunization Practices"},"content":{"rendered":"<p>        <!--.bwblockalignl { margin-left: 0px; margin-right: auto }\n.bwcellpmargin { margin-bottom: 0px; margin-top: 0px }\n.bwlistdisc { list-style-type: disc }\n.bwpadl0 { padding-left: 0px }\n.bwtablemarginb { margin-bottom: 10px }\n.bwvertalignt { vertical-align: top }body {font:normal small Arial,Helvetica,sans-serif;color:#000;background-color:#fff;padding:24px;margin:0;} a img {border:0;} h3 {font-size:medium;color:#000;margin:0 0 1em 0; text-align:center;}-->  <\/p>\n<p><b>AREXVY recommended for adults aged 50-59 at increased risk for severe respiratory syncytial virus (RSV) disease by US Advisory Committee on Immunization Practices<\/b><\/p>\n<ul class=\"bwlistdisc\">\n<li>\nOver 13 million adults aged 50-59 at increased risk in the US can potentially benefit from RSV immunization<sup>1<\/sup><\/li>\n<li>\nRSV causes an estimated 42,000 hospitalizations* each year in adults aged 50-64 years old in the US<sup>2<\/sup><\/li>\n<\/ul>\n<p>PHILADELPHIA&#8211;(<a href=\"http:\/\/www.businesswire.com\">BUSINESS WIRE<\/a>)&#8211;<br \/>\nGSK plc (LSE\/NYSE: GSK) is pleased that the Advisory Committee on Immunization Practices (ACIP) voted in favor of recommending the use of RSV vaccines<i \/>including GSK\u2019s<i \/>AREXVY<i \/>(Respiratory Syncytial Virus Vaccine, Adjuvanted) in adults aged 50-59 who are at increased risk for severe RSV disease. This includes people with conditions like COPD, asthma, diabetes, heart disease and those in residential care<sup>3<\/sup>. This expands on ACIP\u2019s previous vote in June 2024 to recommend RSV vaccines for adults aged 60-74 who are at increased risk and all adults aged 75 and older. AREXVY is indicated for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 60 years of age and older, as well as individuals 50 through 59 years of age who are at increased risk for LRTD caused by RSV.\n<\/p>\n<p>\nA systematic review of studies in the US shows that RSV is estimated to cause 42,000 hospitalizations* each year in adults aged 50-64 years old.<sup>2<\/sup> Adults with underlying medical conditions, such as chronic obstructive pulmonary disease (COPD), asthma, heart failure and diabetes are at increased risk from severe consequences from an RSV infection compared to those without these conditions.<sup>4,5<\/sup> RSV can exacerbate these conditions and lead to pneumonia, hospitalization, or death.<sup>5<\/sup><\/p>\n<p><b>Tony Wood, Chief Scientific Officer, GSK<\/b>: \u201cWe are pleased with ACIP&#8217;s recommendation to expand the benefits of RSV immunization to more than 13 million adults aged 50-59 who are at increased risk for the severe consequences of this virus. RSV can have a significant impact for those with underlying medical conditions. We look forward to helping protect more people with RSV vaccination.\u201d\n<\/p>\n<p>\nIn making its recommendation, the ACIP considered positive results from a phase III trial [NCT05590403]<sup>6<\/sup> evaluating the immune response and safety of GSK\u2019s RSV vaccine in adults aged 50-59, including those at increased risk for RSV-LRTD due to certain underlying medical conditions compared to older adults aged 60 years and older where efficacy has been demonstrated after a single dose of GSK\u2019s RSV vaccine.\n<\/p>\n<p>\nThe ACIP recommendations will be forwarded for review and approval. Once approved, the final recommendations will be published to advise healthcare providers on appropriate use of the vaccine and to inform insurance coverage.\n<\/p>\n<p><b>About AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted)<br \/>\n<br \/><\/b>AREXVY contains recombinant RSV glycoprotein F stabilized in the prefusion conformation (RSVPreF3). This antigen is combined with GSK\u2019s proprietary AS01<sub>E<\/sub> adjuvant.\n<\/p>\n<p>\nThe vaccine has been approved for the prevention of RSV-LRTD in individuals 60 years of age and older in 61 countries, including Europe, Japan and US. In addition, it is approved in the US, EU\/EEA countries and Japan for use in individuals aged 50-59 who are at increased risk for lower respiratory disease caused by RSV due to certain underlying medical conditions. Regulatory reviews for this extended indication are ongoing in other countries.\n<\/p>\n<p>\nThe use of this vaccine should be in accordance with official recommendations. As with any vaccine, a protective immune response may not be elicited in all vaccinees.\n<\/p>\n<p>\nThe GSK proprietary AS01 adjuvant system contains STIMULON QS-21 adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of Agenus Inc. STIMULON is a trademark of SaponiQx Inc., a subsidiary of Agenus.\n<\/p>\n<p><b>Indication for AREXVY<br \/>\n<br \/><\/b>AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in:\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nIndividuals 60 years of age and older;\n<\/li>\n<li>\nIndividuals 50 through 59 years of age who are at increased risk for LRTD caused by RSV.\n<\/li>\n<\/ul>\n<p><b>Important Safety Information for AREXVY<\/b><\/p>\n<ul class=\"bwlistdisc\">\n<li>\nAREXVY is contraindicated in anyone with a history of a severe allergic reaction (eg, anaphylaxis) to any component of AREXVY\n<\/li>\n<li>\nThe results of a postmarketing observational study suggest an increased risk of Guillain-Barr\u00e9 syndrome during the 42 days following vaccination with AREXVY\n<\/li>\n<li>\nAppropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of AREXVY\n<\/li>\n<li>\nSyncope (fainting) may occur in association with administration of injectable vaccines, including AREXVY. Procedures should be in place to avoid injury from fainting\n<\/li>\n<li>\nImmunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished immune response to AREXVY\u200b\n<\/li>\n<li>\nIn adults 60 years of age and older, the most commonly reported adverse reactions (\u226510%) were injection site pain (60.9%), fatigue (33.6%), myalgia (28.9%), headache (27.2%), and arthralgia (18.1%)\n<\/li>\n<li>\nIn adults 50 through 59 years of age, the most commonly reported adverse reactions (\u226510%) were injection site pain (75.8%), fatigue (39.8%), myalgia (35.6%), headache (31.7%), arthralgia (23.4%), erythema (13.2%), and swelling (10.4%)\n<\/li>\n<li>\nThere are no data on the use of AREXVY in pregnant or breastfeeding individuals. AREXVY is not approved for use in persons &lt;50 years of age\n<\/li>\n<li>\nVaccination with AREXVY may not result in protection of all vaccine recipients\n<\/li>\n<\/ul>\n<p>\nPlease see full <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fgskpro.com%2Fcontent%2Fdam%2Fglobal%2Fhcpportal%2Fen_US%2FPrescribing_Information%2FArexvy%2Fpdf%2FAREXVY.PDF&amp;esheet=54238801&amp;newsitemid=20250415426978&amp;lan=en-US&amp;anchor=Prescribing+Information&amp;index=1&amp;md5=0bdece75dce5ab1b54c1b39c3a9625df\">Prescribing Information<\/a> for AREXVY.\n<\/p>\n<p><b>About RSV in adults<br \/>\n<br \/><\/b>RSV is a common contagious virus affecting the lungs and breathing passages. Adults can be at increased risk for RSV disease due to comorbidities, immune compromised status, or advanced age.<sup>5<\/sup> RSV can exacerbate conditions, including COPD, asthma, and chronic heart failure and can lead to severe outcomes, such as pneumonia, hospitalization, and death.<sup>5 <\/sup>Each year, RSV is estimated to cause approximately 177,000 hospitalizations in adults 65 years and older<sup>7<\/sup> and 42,000* in adults aged 50-64 years old in the US.<sup>2<\/sup><\/p>\n<p><b>About GSK<br \/>\n<br \/><\/b>GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fgsk.com&amp;esheet=54238801&amp;newsitemid=20250415426978&amp;lan=en-US&amp;anchor=gsk.com&amp;index=2&amp;md5=449129c2687e45a93cb83171c97be0ac\">gsk.com<\/a>.\n<\/p>\n<p><b>Cautionary statement regarding forward-looking statements<br \/>\n<br \/><\/b>GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the \u201cRisk Factors\u201d section in GSK\u2019s Annual Report on Form 20-F for 2024.\n<\/p>\n<p><b>Registered in England &amp; Wales:<br \/>\n<br \/><\/b>No. 3888792\n<\/p>\n<p><b>Registered Office:<br \/>\n<br \/><\/b>79 New Oxford Street<br \/>\n<br \/>London<br \/>\n<br \/>WC1A 1DG\n<\/p>\n<table cellspacing=\"0\" class=\"bwtablemarginb bwblockalignl\">\n<tr>\n<td class=\"bwvertalignt bwpadl0\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin\"><b>References<\/b><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwpadl0\" rowspan=\"1\" colspan=\"1\">__________________________________<\/td>\n<\/tr>\n<tr>\n<td class=\"bwpadl0\" rowspan=\"1\" colspan=\"1\" \/><\/tr>\n<tr>\n<td class=\"bwvertalignt bwpadl0\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin\">\n* adjusted for under-detection\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwpadl0\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin\"><sup>1<\/sup> Horn et al, \u201cDisparities in Risk Factors for Severe Respiratory Syncytial Virus Disease among Adults in the United States\u201d, Abstract presented at National Foundation for Infectious Diseases \u2013 27 Annual Conference on Vaccinology Research \u2013 NFID 2024; May 8-10, 2024\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwpadl0\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin\"><sup>2<\/sup> McLaughlin JM et al, \u201cRates of Medically Attended RSV Among US Adults: A Systematic Review and Meta-analysis\u201d in <i>Open Forum Infectious Diseases<\/i>, Volume 9, Issue 7, July 2022\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwpadl0\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin\"><sup>3<\/sup> Centers for Disease Control and Prevention (CDC), RSV vaccine guidance for older adults, August 2024. Available at: <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.cdc.gov%2Frsv%2Fhcp%2Fvaccine-clinical-guidance%2Folder-adults.html&amp;esheet=54238801&amp;newsitemid=20250415426978&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.cdc.gov%2Frsv%2Fhcp%2Fvaccine-clinical-guidance%2Folder-adults.html&amp;index=3&amp;md5=bc27fad38676ef9554b624c13d72a75e\">https:\/\/www.cdc.gov\/rsv\/hcp\/vaccine-clinical-guidance\/older-adults.html<\/a> (Accessed April 2025)\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwpadl0\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin\"><sup>4<\/sup> Branche AR <i>et al<\/i>., &#8220;Incidence of Respiratory Syncytial Virus Infection Among Hospitalized Adults, 2017\u20132020\u201d in <i>Clinical Infectious Diseases,<\/i> 2022:74:1004\u20131011\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwpadl0\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin\"><sup>5<\/sup> Centers for Disease Control and Prevention (CDC), RSV in Adults. Available at: <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.cdc.gov%2Frsv%2Folder-adults%2Findex.html&amp;esheet=54238801&amp;newsitemid=20250415426978&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.cdc.gov%2Frsv%2Folder-adults%2Findex.html&amp;index=4&amp;md5=c8464f6f797185c3b9886d1c93093fe6\">https:\/\/www.cdc.gov\/rsv\/older-adults\/index.html<\/a> &#8211; accessed in April 2025\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwpadl0\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin\"><sup>6<\/sup> M. Ferguson, \u201cNoninferior Immunogenicity and Consistent Safety of Respiratory Syncytial Virus Prefusion F Protein Vaccine in Adults 50-59 Years Compared to \u226560 Years of Age\u201d in <i>Clinical Infectious Diseases<\/i>, 2024 Oct 15;79(4):1074-1084. doi: 10.1093\/cid\/ciae364.\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwpadl0\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin\"><sup>7<\/sup> Falsey, AR <i>et al<\/i>. \u201cRespiratory syncytial virus infection in elderly and high-risk adults\u201d, in <i>New Engl J Med<\/i> 2005; 352:1749-59\n<\/p>\n<\/td>\n<\/tr>\n<\/table>\n<p>\n\u00a0\n<\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20250415426978r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" style=\"width:0;height:0\" \/><span class=\"bwct31415\" \/><\/p>\n<p id=\"mmgallerylink\"><span id=\"mmgallerylink-phrase\">View source version on businesswire.com: <\/span><span id=\"mmgallerylink-link\"><a href=\"https:\/\/www.businesswire.com\/news\/home\/20250415426978\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20250415426978\/en\/<\/a><\/span><\/p>\n<p><b>GSK enquiries<br \/>\n<br \/><\/b>Media:<br \/>\n<br \/>Tim Foley +44 (0) 20 8047 5502 (London)<br \/>\n<br \/>Simon Moore +44 (0) 20 8047 5502 (London)<br \/>\n<br \/>Kathleen Quinn +1 202 603 5003 (Washington DC)<br \/>\n<br \/>Alison Hunt +1 540 742 3391 (Washington DC)\n<\/p>\n<p>\nInvestor Relations:<br \/>\n<br \/>Annabel Brownrigg-Gleeson +44 (0) 7901 101944 (London)<br \/>\n<br \/>James Dodwell +44 (0) 20 8047 2406 (London)<br \/>\n<br \/>Mick Readey +44 (0) 7990 339653 (London)<br \/>\n<br \/>Constantin Fest\u00a0+44 (0) 7831 826525 (London)<br \/>\n<br \/>Steph Mountifield +44 (0) 7796 707505 (London)<br \/>\n<br \/>Jeff McLaughlin +1 215 751 7002 (Philadelphia)<br \/>\n<br \/>Frannie DeFranco +1 215 751 4855 (Philadelphia)\n<\/p>\n<p><b>KEYWORDS:<\/b> United States North America Pennsylvania<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> Seniors Biotechnology Pharmaceutical Managed Care Health Infectious Diseases Consumer Clinical Trials<\/p>\n<p><b>MEDIA:<\/b><\/p>\n<table cellpadding=\"3\" cellspacing=\"3\">\n<tr>\n<td><font face=\"Arial\" size=\"2\"><b>Logo<\/b><\/font><\/td>\n<\/tr>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20250415426978\/en\/2146668\/3\/GSK_Logo_Full_Colour_RGB.jpg\" alt=\"Logo\" \/><\/td>\n<\/tr>\n<tr>\n<td><font face=\"Arial\" size=\"2\"><\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p>AREXVY recommended for adults aged 50-59 at increased risk for severe respiratory syncytial virus (RSV) disease by US Advisory Committee on Immunization Practices Over 13 million adults aged 50-59 at increased risk in the US can potentially benefit from RSV immunization1 RSV causes an estimated 42,000 hospitalizations* each year in adults aged 50-64 years old in the US2 PHILADELPHIA&#8211;(BUSINESS WIRE)&#8211; GSK plc (LSE\/NYSE: GSK) is pleased that the Advisory Committee on Immunization Practices (ACIP) voted in favor of recommending the use of RSV vaccinesincluding GSK\u2019sAREXVY(Respiratory Syncytial Virus Vaccine, Adjuvanted) in adults aged 50-59 who are at increased risk for severe RSV disease. This includes people with conditions like COPD, asthma, diabetes, heart disease and those in residential care3. This expands &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/arexvy-recommended-for-adults-aged-50-59-at-increased-risk-for-severe-respiratory-syncytial-virus-rsv-disease-by-us-advisory-committee-on-immunization-practices\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;AREXVY recommended for adults aged 50-59 at increased risk for severe respiratory syncytial virus (RSV) disease by US Advisory Committee on Immunization Practices&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-838368","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>AREXVY recommended for adults aged 50-59 at increased risk for severe respiratory syncytial virus (RSV) disease by US Advisory Committee on Immunization Practices - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/arexvy-recommended-for-adults-aged-50-59-at-increased-risk-for-severe-respiratory-syncytial-virus-rsv-disease-by-us-advisory-committee-on-immunization-practices\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"AREXVY recommended for adults aged 50-59 at increased risk for severe respiratory syncytial virus (RSV) disease by US Advisory Committee on Immunization Practices - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"AREXVY recommended for adults aged 50-59 at increased risk for severe respiratory syncytial virus (RSV) disease by US Advisory Committee on Immunization Practices Over 13 million adults aged 50-59 at increased risk in the US can potentially benefit from RSV immunization1 RSV causes an estimated 42,000 hospitalizations* each year in adults aged 50-64 years old in the US2 PHILADELPHIA&#8211;(BUSINESS WIRE)&#8211; GSK plc (LSE\/NYSE: GSK) is pleased that the Advisory Committee on Immunization Practices (ACIP) voted in favor of recommending the use of RSV vaccinesincluding GSK\u2019sAREXVY(Respiratory Syncytial Virus Vaccine, Adjuvanted) in adults aged 50-59 who are at increased risk for severe RSV disease. This includes people with conditions like COPD, asthma, diabetes, heart disease and those in residential care3. 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