Moderna Pulls FDA Application for Flu-Covid Combo Vaccine

Dow Jones

May 21, 2025

By Dean Seal

Moderna has withdrawn its pending application for a combination vaccine for both the flu and Covid-19, saying it will resubmit later this year once it has more data.

The maker of the Spikevax Covid-19 vaccine and Mresvia RSV vaccine said Wednesday that the withdrawal of mRNA-1083, which was developed for adults aged 50 years and older, was done in consultation with the U.S. Food and Drug Administration.

The company plans to submit a new biologics license application later this year after it has vaccine efficacy data from an ongoing Phase 3 trial of its investigational seasonal flu vaccine, mRNA-1010. Interim data from that trail should be available this summer.

Shares ticked down 1.7% to $27.52 in premarket trading.

Write to Dean Seal at dean.seal@wsj.com

(END) Dow Jones Newswires

May 21, 2025 07:36 ET (11:36 GMT)

At the request of the copyright holder, you need to log in to view this content

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Most Discussed

{"basename":"","ssrTDKData":{"titleTemplate":"%s - Tiger Brokers","title":"Tiger Brokers | Global Stocks, Options & Futures Trading App","description":"Tiger Brokers, one-stop investment in US stocks, SGX stocks, HK stocks, A-shares & other global assets. One of the best stock trading platforms in Singapore.","keywords":"tiger brokers,tiger trade,tiger brokers singapore,broker online,stock trading in singapore,share trading singapore,brokerage firm singapore,trading app,stock broker singapore,stock trading platforms,trading account","social":{"ogDescription":"Tiger Brokers, one-stop investment in US stocks, SGX stocks, HK stocks, A-shares & other global assets. One of the best stock trading platforms in Singapore.","ogImage":"https://c1.itigergrowtha.com/portal5/static/media/og-logo.be62fbe1.png","ogUrl":"https://www.itiger.com/news/2537987494"},"companyName":"Tiger Brokers"},"pageData":{"isMobile":false,"isTiger":false,"isTTM":true,"region":"SGP","license":"TBSG","edition":"fundamental"},"isCrawlerRequest":true,"__swrFallback__":{"@#url:\"https://stock-news.skytigris.cn/v3/news\",params:#id:\"2537987494\",edition:\"fundamental\",auth_exemption:1,,,undefined,":{"share":"https://ttm.financial/m/news/2537987494?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2025-05-21 19:36","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2537987494","market":"sg","top_or_hot":-1,"title":"Moderna Pulls FDA Application for Flu-Covid Combo Vaccine","media":"Dow Jones","content":"<font class=\"NormalMinus1\" face=\"Arial\">\n<p>\n  By Dean Seal \n</p>\n<pre>\n \n</pre>\n<p>\n  Moderna has withdrawn its pending application for a combination vaccine for both the flu and Covid-19, saying it will resubmit later this year once it has more data. \n</p>\n<p>\n  The maker of the Spikevax Covid-19 vaccine and Mresvia RSV vaccine said Wednesday that the withdrawal of mRNA-1083, which was developed for adults aged 50 years and older, was done in consultation with the U.S. Food and Drug Administration. \n</p>\n<p>\n  The company plans to submit a new biologics license application later this year after it has vaccine efficacy data from an ongoing Phase 3 trial of its investigational seasonal flu vaccine, mRNA-1010. Interim data from that trail should be available this summer. \n</p>\n<p>\n  Shares ticked down 1.7% to $27.52 in premarket trading. \n</p>\n<pre>\n \n</pre>\n<p>\n  Write to Dean Seal at dean.seal@wsj.com \n</p>\n<pre>\n \n</pre>\n<p>\n  (END) Dow Jones Newswires\n</p>\n<p>\n  May 21, 2025 07:36 ET (11:36 GMT)\n</p>\n<p>\n  Copyright (c) 2025 Dow Jones &amp; Company, Inc.\n</p>\n</font>","source":null,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Moderna Pulls FDA Application for Flu-Covid Combo Vaccine</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nModerna Pulls FDA Application for Flu-Covid Combo Vaccine\n</h2>\n\n<h4 class=\"meta\">\n\n\n<div class=\"head\" \">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/150f88aa4d182df19190059f4a365e99);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Dow Jones </p>\n<p class=\"h-time\">2025-05-21 19:36</p>\n</div>\n\n</div>\n\n\n</h4>\n\n</header>\n<article>\n<font class=\"NormalMinus1\" face=\"Arial\">\n<p>\n  By Dean Seal \n</p>\n<pre>\n \n</pre>\n<p>\n  Moderna has withdrawn its pending application for a combination vaccine for both the flu and Covid-19, saying it will resubmit later this year once it has more data. \n</p>\n<p>\n  The maker of the Spikevax Covid-19 vaccine and Mresvia RSV vaccine said Wednesday that the withdrawal of mRNA-1083, which was developed for adults aged 50 years and older, was done in consultation with the U.S. Food and Drug Administration. \n</p>\n<p>\n  The company plans to submit a new biologics license application later this year after it has vaccine efficacy data from an ongoing Phase 3 trial of its investigational seasonal flu vaccine, mRNA-1010. Interim data from that trail should be available this summer. \n</p>\n<p>\n  Shares ticked down 1.7% to $27.52 in premarket trading. \n</p>\n<pre>\n \n</pre>\n<p>\n  Write to Dean Seal at dean.seal@wsj.com \n</p>\n<pre>\n \n</pre>\n<p>\n  (END) Dow Jones Newswires\n</p>\n<p>\n  May 21, 2025 07:36 ET (11:36 GMT)\n</p>\n<p>\n  Copyright (c) 2025 Dow Jones &amp; Company, Inc.\n</p>\n</font>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4548","symbol_name":"巴美列捷福持仓","start_time":0,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","article_id":"2537987494","we_media_id":"106","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2537987494","pubTimestamp":1747827360,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Dow Jones","introduction":"Dow Jones publishes the world’s most trusted business news and financial information in a variety of media.","home_visible":0,"id":"106","head_image":"https://static.tigerbbs.com/150f88aa4d182df19190059f4a365e99"},"summary":"Moderna has withdrawn its pending application for a combination vaccine for both the flu and Covid-19, saying it will resubmit later this year once it has more data.The maker of the Spikevax Covid-19 vaccine and Mresvia RSV vaccine said Wednesday that the withdrawal of mRNA-1083, which was developed for adults aged 50 years and older, was done in consultation with the U.S. Food and Drug Administration.The company plans to submit a new biologics license application later this year after it has vaccine efficacy data from an ongoing Phase 3 trial of its investigational seasonal flu vaccine, mRNA-1010. Interim data from that trail should be available this summer.Shares ticked down 1.7% to $27.52 in premarket trading.","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4548":"巴美列捷福持仓","BK4139":"生物科技","BK4532":"文艺复兴科技持仓","BK4533":"AQR资本管理(全球第二大对冲基金)","BK4501":"段永平概念","MRNA":"Moderna, Inc.","BK4551":"寇图资本持仓","BK4568":"美国抗疫概念","BK4585":"ETF&股票定投概念","BK4588":"碎股","BK4534":"瑞士信贷持仓"},"translate_title":"Moderna撤回FDA流感-新冠组合疫苗申请","themeId":"52df96ee01e83146d7f80ba674bc9ceb","isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"MRNA":0.9},"content_text":"By Dean Seal \n\n\n \n\n\n  Moderna has withdrawn its pending application for a combination vaccine for both the flu and Covid-19, saying it will resubmit later this year once it has more data. \n\n\n  The maker of the Spikevax Covid-19 vaccine and Mresvia RSV vaccine said Wednesday that the withdrawal of mRNA-1083, which was developed for adults aged 50 years and older, was done in consultation with the U.S. Food and Drug Administration. \n\n\n  The company plans to submit a new biologics license application later this year after it has vaccine efficacy data from an ongoing Phase 3 trial of its investigational seasonal flu vaccine, mRNA-1010. Interim data from that trail should be available this summer. \n\n\n  Shares ticked down 1.7% to $27.52 in premarket trading. \n\n\n \n\n\n  Write to Dean Seal at dean.seal@wsj.com \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  May 21, 2025 07:36 ET (11:36 GMT)\n\n\n  Copyright (c) 2025 Dow Jones & Company, Inc.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"-1","news_tag":"productRelease","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":true,"code":"91000000","status":"200"}}}