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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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{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 Files With EU to 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":{"BK4535":"淡马锡持仓","BK4548":"巴美列捷福持仓","BK4551":"寇图资本持仓","BNTX":"BioNTech SE","CMA":"联信银行","BK4139":"生物科技","BK4568":"美国抗疫概念","MRNA":"Moderna, 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