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	<title>BioHorizon &#187; CAIV-T</title>
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		<title>MedImmune&#8217;s CAIV-T Influenza Vaccine</title>
		<link>http://www.biohorizon.com/2004/11/medimmunes-caiv-t-influenza-vaccine/</link>
		<comments>http://www.biohorizon.com/2004/11/medimmunes-caiv-t-influenza-vaccine/#comments</comments>
		<pubDate>Mon, 01 Nov 2004 18:50:27 +0000</pubDate>
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				<category><![CDATA[Drug]]></category>
		<category><![CDATA[Medicine]]></category>
		<category><![CDATA[Respiratory]]></category>
		<category><![CDATA[Vaccine]]></category>
		<category><![CDATA[CAIV-T]]></category>
		<category><![CDATA[FluInsure]]></category>
		<category><![CDATA[FluMist]]></category>
		<category><![CDATA[Fluvirin]]></category>
		<category><![CDATA[ID Biomedical]]></category>
		<category><![CDATA[Infectious Disease]]></category>
		<category><![CDATA[Influenza]]></category>
		<category><![CDATA[Influenza Vaccine]]></category>
		<category><![CDATA[intranasal]]></category>
		<category><![CDATA[MedImmune]]></category>
		<category><![CDATA[vaccine]]></category>

		<guid isPermaLink="false">http://www.biohorizon.com/?p=174</guid>
		<description><![CDATA[On November 1, 2004 MedImmune announced that enrollment in its Phase 3 CAIV-T influenza vaccine trial had been completed. This pivotal trial is designed to compare the company’s nasally administered cold-adapted vaccine to the standard injectable vaccine in 8,492 children between 6 and 59 months of age. CAIV-T is refrigerator stable and is regarded by [...]]]></description>
			<content:encoded><![CDATA[<p>On November 1, 2004 MedImmune announced that enrollment in its Phase 3 CAIV-T influenza vaccine trial had been completed. This pivotal trial is designed to compare the company’s nasally administered cold-adapted vaccine to the standard injectable vaccine in 8,492 children between 6 and 59 months of age. CAIV-T is refrigerator stable and is regarded by the company as a potential improvement over its FluMist intranasal flu vaccine, which requires freezing. Participants in the study will be followed throughout the 2004-2005 Influenza season to determine safety and efficacy. The company reports that twenty-one trials involving approximately 30,000 subjects have already been completed with FluMist and/or CAIV-T. BioHorizon assigns all technologies a baseline efficacy variable score of 75 upon commencement of a Phase 3 clinical trial.</p>
<p>Uncomplicated influenza is characterized by the sudden onset of constitutional and respiratory signs and symptoms. In the majority of patients, recovery is complete after several days; however, in certain individuals, influenza can exacerbate underlying medical conditions. Young children with influenza infection can have initial symptoms mimicking bacterial sepsis with high fevers; influenza infection has also been associated with encephalopathy, transverse myelitis, Reye syndrome, myositis, myocarditis, and pericarditis. Estimates of influenza related deaths sit in the 19,000-36,000 per annum range.  A study that modeled influenza-related deaths estimated that an average of 92 deaths occurred among children aged <5 years annually during the 1990's. There were 143 laboratory-confirmed pediatric deaths during the 2003–2004 influenza season; 41% were aged <2 years and 45% of  did not have an underlying medical condition. We have assigned a 100 point score to the burden of illness variable.</p>
<p>We believe nasally administered vaccines represent true innovation; however, MedImmune’s FluMist is already approved. Of important note, ID Biomedical’s FluInsure is also in Phase 3 testing. CAIV-T merits a 55/100 score for the innovation status variable. Demand/diffusion scoring is difficult as this year’s flu vaccine shortage due to Fluvirin’s withdrawal highlights.  Under normal supply/demand circumstances, intranasal vaccines will be significantly more expensive than injectable influenza vaccines. We maintain our demand/diffusion score of 10 here to remain consistent with FluInsure’s scoring resulting in a score of 60 for CAIV-T. Health services delivery clients should assess current influenza immunization programs looking specifically at the planned role for inhaled intranasal vaccines. </p>
<p><strong>Technology Details</strong><br />
Target Disease / Indication: Influenza<br />
Technology Classification: Drug/Vaccine<br />
Body System: Respiratory<br />
Program Area: Medicine/Infectious Disease<br />
Regulatory Status: Phase 3<br />
BioHorizon Impact Score: 60100 – Moderate/High</p>
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