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Moderna Files With EU to Expand CMA for Covid-19 Vaccine

Dow Jones2022-04-29

By Stephen Nakrosis

Biotechnology company Moderna Inc. on Friday said it filed with the European Medicines Agency to request its Spikevax Covid-19 vaccine be authorized for children aged six months to under six years old.

Moderna said similar requests are underway with international regulatory authorities, based on a two-dose primary series of mRNA-1273, the research name used for Spikevax.

The company said its filing follows a Feb. 24 decision by the EMA's Committee for Medicinal Products for Human Use "to adopt a positive opinion recommending marketing authorization for Moderna's Covid-19 vaccine to include children six years of age and older."

According to Moderna, positive interim results from a Phase 2/3 study showed a "robust neutralizing antibody response in the six months to under six years of age group after a two-dose primary series of mRNA-1273, along with a favorable safety profile."

Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

$(END)$ Dow Jones Newswires

April 29, 2022 11:53 ET (15:53 GMT)

Copyright (c) 2022 Dow Jones & Company, Inc.

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aaronh
·2022-04-30
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Inc.\n</p>\n</font>","collect":0,"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 Files With EU to Expand CMA for Covid-19 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; 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Expand CMA for Covid-19 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\">2022-04-29 23:53</p>\n</div>\n\n</div>\n\n\n</h4>\n\n</header>\n<article>\n<font class=\"NormalMinus1\" face=\"Arial\">\n<pre>\n \n</pre>\n<p>\n  By Stephen Nakrosis \n</p>\n<pre>\n \n</pre>\n<p>\n  Biotechnology company Moderna Inc. on Friday said it filed with the European Medicines Agency to request its Spikevax Covid-19 vaccine be authorized for children aged six months to under six years old. \n</p>\n<p>\n  Moderna said similar requests are underway with international regulatory authorities, based on a two-dose primary series of mRNA-1273, the research name used for Spikevax. \n</p>\n<p>\n  The company said its filing follows a Feb. 24 decision by the EMA's Committee for Medicinal Products for Human Use \"to adopt a positive opinion recommending marketing authorization for Moderna's Covid-19 vaccine to include children six years of age and older.\" \n</p>\n<p>\n  According to Moderna, positive interim results from a Phase 2/3 study showed a \"robust neutralizing antibody response in the six months to under six years of age group after a two-dose primary series of mRNA-1273, along with a favorable safety profile.\" \n</p>\n<pre>\n \n</pre>\n<p>\n  Write to Stephen Nakrosis at stephen.nakrosis@wsj.com \n</p>\n<pre>\n \n</pre>\n<p>\n  <a href=\"https://laohu8.com/S/END\">$(END)$</a> Dow Jones Newswires\n</p>\n<p>\n  April 29, 2022 11:53 ET (15:53 GMT)\n</p>\n<p>\n  Copyright (c) 2022 Dow Jones &amp; Company, Inc.\n</p>\n</font>\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"BNTX":"BioNTech SE","BK4548":"巴美列捷福持仓","BK4139":"生物科技","BK4568":"美国抗疫概念","MRNA":"Moderna, 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