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Novavax yet to submit some files for COVID-19 vaccine approval: FDA

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Jamaine Punzalan, ABS-CBN News

<figure class="op-interactive"><iframe allow="autoplay; fullscreen" frameBorder="0" height="100%" id="ivsplayer01" scrolling="no" src="https://player.ivideosmart.com/ivsplayer/v4/dist/html/iframe-src.html?iframeid=ivsplayer01&amp;key=e8c22c015ca9eafa76f1e3edfa03c603&amp;spid=3001339&amp;vid=1744020" width="100%"></iframe></figure><div class="iwantbar"><p>Video courtesy of PTV </p></div><p>Novavax Inc needs to submit several more documents for its 2-dose COVID-19 vaccine&#x27;s application for emergency use authorization in the Philippines, the Food and Drug Administration said on Monday. </p><p>The American biotech firm last week applied for EUA for its vaccine candidate for people aged 18 and above. </p><p>&quot;Karamihan naman po ng mga listahan [ng requirements] natin, na-submit na nila,&quot; said FDA chief Eric Domingo. &quot;Inuumpisahan na po natin iyong evaluation niyan, both for the vaccine manufacturing side at saka po doon sa safety and efficacy side.&quot; </p><p>(They have submitted most of the requirements in our list. We have started the evaluation, both for the vaccine manufacturing side and the safety and efficacy side.)</p><p>&quot;Pero mayroon pa po silang mga kulang na mga requirements na kailangan i-submit natin bago po tayo makagawa ng desisyon dito,&quot; Domingo said in a televised public briefing. </p><p>(But they lack some requirements that need to be submitted before we can make a decision.)</p><p>The efficacy of Novavax&#x27;s vaccine is &quot;very similar&quot; to other jabs at around 80 to 90 percent, said Domingo.</p><p>Novavax said it also applied for regulatory authorization in India and Indonesia. But it <a href="https://news.abs-cbn.com/overseas/08/06/21/novavax-again-delays-seeking-us-approval-for-vaccine">delayed</a> seeking an EUA in the United States.</p><p>&quot;It&#x27;s a matter of getting validation work done&quot; to demonstrate consistency in the vaccine&#x27;s manufacturing process to the FDA, said Chief Executive Officer Stanley Erck during an interview with Reuters.</p><div class="embed-wrap"><figure data-feedback="fb:likes,fb:comments"><img alt="Vials labelled " coronavirus="" covid-19="" src="http://sa.kapamilya.com/absnews/abscbnnews/media/2021/reuters/08/09/20210809-novavax-covid-19-vaccine-rtr.jpg?ext=.jpg" vaccine=""/><figcaption>Vials labelled &quot;COVID-19 Coronavirus Vaccine&quot; and syringe are seen in front of displayed Novavax logo in this illustration taken, Feb. 9, 2021. <em>Dado Ruvic, Reuters/Illustration/File</em></figcaption></figure></div><p> Despite promising clinical data, the Maryland-based company has lagged rival vaccine makers such as Pfizer Inc and Johnson &amp; Johnson. It has repeatedly delayed regulatory filings and the timeline for ramping up production as it struggled to access raw materials and equipment needed to produce the vaccine.</p><p>&quot;Initially, our doses may be prioritized to low-income countries, where we&#x27;ll be able to support critical unmet demand for primary vaccinations,&quot; Erck said during Novavax&#x27;s quarterly investor call.</p><p>He said Novavax remained on track to produce 100 million doses per month in the current quarter and 150 million doses by the fourth quarter.</p><ul class="op-related-articles">	<li><a href="https://news.abs-cbn.com/news/05/28/21/philippines-to-get-13m-novavax-vaccines-by-third-quarter-of-2021-official">Philippines to get 13M Novavax vaccines by third quarter of 2021: official</a></li></ul><p>Erck told Reuters the company is on track to submit a regulatory filing in the United Kingdom in September followed within weeks by submissions in Australia and Canada. </p><p>Separately, Novavax said a single booster shot of its vaccine given 6 months after an initial 2-dose regimen, elicited a 4.6-fold increase in antibodies.<br/> <br/>Novavax has already manufactured tens of millions of shots and is not worried about them expiring before they are approved for use because the vaccine material is kept frozen, Erck said during the investor call.</p><p>The Philippines&#x27; Food and Drug Administration has granted EUA to the vaccine candidates of the following firms: Pfizer-BioNTech, Oxford-AstraZeneca, Sinovac (CoronaVac), Gamaleya (Sputnik V), Johnson &amp; Johnson (Janssen), Bharat BioTech, and Moderna.</p><p>So far, more than 38.6 million COVID-19 vaccine doses have arrived in the country, broken down as follows:</p><ul>	<li>53% or 20.5 million doses from Sinovac</li>	<li>19% or 7.27 million doses from AstraZeneca</li>	<li>10% from Moderna </li>	<li>9% from Pfizer</li>	<li>8% from Johnson &amp; Johnson</li>	<li>1% from Gamaleya</li></ul><p>Nearly 24.5 million doses have been administered, as of Sunday, of which, almost 13.1 million were first doses.</p><p>The number of those fully vaccinated, meanwhile, stood at nearly 11.4 million, or 16.1% of the target 70.85 million adult individuals, according to the ABS-CBN Investigative and Research Group.</p><div><strong>– With a report from Reuters </strong></div><div class="infogram-embed" data-id="_/yFVE69R1WlSdqY3aCsBF" data-title="COVID-19 VACCINE TRACKER PH" data-type="interactive"> </div><div><script type="text/javascript">!function(e,i,n,s){var t='InfogramEmbeds',d=e.getElementsByTagName('script')[0];if(window[t]&&window[t].initialized)window[t].process&&window[t].process();else if(!e.getElementById(n)){var o=e.createElement('script');o.async=1,o.id=n,o.src='https://e.infogram.com/js/dist/embed-loader-min.js',d.parentNode.insertBefore(o,d)}}(document,0,'infogram-async');</script></div>

Novavax needs to submit several more documents for its COVID-19 vaccine's application for emergency use authorization, the FDA said.

Novavax yet to submit some files for COVID-19 vaccine approval: FDA

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Novavax yet to submit some files for COVID-19 vaccine approval: FDA

Jamaine Punzalan,

ABS-CBN News

Published Aug 09, 2021 06:26 PM PHT

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