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Sinovac applies for EUA of COVID-19 vaccine in Philippines, but docs incomplete - FDA

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Kristine Sabillo, ABS-CBN News

<figure class="op-interactive"><iframe height="315" src="https://www.youtube.com/embed/e2asuSykj9I?enablejsapi=1" width="560"></iframe></figure><div class="iwantbar"><em>Video courtesy of Department of Health</em></div><p>MANILA <strong>(UPDATE 2)</strong> — China&#x27;s Sinovac has applied for emergency use authorization (EUA) of its COVID-19 vaccine in the Philippines, but the documents submitted by the company were incomplete, the Food and Drug Administration said Thursday.</p><p>“And the last to submit to us yesterday afternoon, nag-submit ng application ang Sinovac. Ang EUA nito is from China, and they are undergoing pre-assessment now,” FDA Director General Eric Domingo said during a virtual briefing. </p><p>(And the last to submit to us yesterday afternoon is Sinovac. Their EUA is from China, and they are undergoing pre-assessment now.)</p><p>Domingo said the Chinese firm’s documents were incomplete, as they only included Phase I and Phase II clinical trial data.<br/> <br/>&quot;So we will have to ask for the clinical trial Phase III report, which I think they are collating now kasi several countries yata ginawa ito. Until we see Phase 3 results, hindi naman natin talaga maa-assess,” he said.</p><p>(So we will have to ask for the clinical trial Phase III report, which I think they are collating now because they did it in several countries. Until we see Phase 3 results, we cannot assess.)</p><p>Domingo explained that Phase III trial results are crucial in deciding whether the vaccine’s benefits outweigh its risks, as required by the EUA.</p><p>An EUA would allow a vaccine to be imported, distributed and administered in the Philippines through a national immunization program even though it is still under development. It also allows the country to recognize the EUA issued by other countries and expedite the approval process from 6 months to just 21 days.</p><p>Domingo said the evaluation will only start once Sinovac submits their Phase 3 results. He said the approval of its EUA application will depend on how soon complete documents will be sent and how fast the company will respond to their questions. </p><p>However, he pointed out that he cannot ensure if Sinovac&#x27;s application will be approved within 21 days since its candidate vaccine has not yet received an EUA from a stringent regulatory authority (SRA).</p><p>Having an EUA from an SRA, which is recognized by the World Health Organization (reference: <a href="https://www.who.int/medicines/regulation/sras/en/">https://www.who.int/medicines/regulation/sras/en/</a>), can bolster a company’s application. Domingo said the expedited 21-day processing of EUA applications in the country is only for vaccines approved by an SRA.</p><p>While Sinovac&#x27;s vaccine has been granted EUA by China&#x27;s regulatory body, the latter is not considered an SRA, under the WHO listing. Russia&#x27;s regulatory body is also not an SRA.</p><p>It was previously announced that the Philippines will be receiving 25 million doses from Sinovac, with the first batch arriving in February.</p><ul class="op-related-articles">	<li><a href="https://news.abs-cbn.com/news/01/11/21/philippines-secures-25-million-covid-19-vaccine-doses-from-chinas-sinovac">Philippines secures 25 million COVID-19 vaccine doses from China&#x27;s Sinovac</a></li>	<li><a href="https://news.abs-cbn.com/news/01/12/21/chinese-covid-19-vaccine-is-only-option-for-filipinos-until-june-palace">Chinese COVID-19 vaccine is only option for Filipinos until June: Palace</a></li>	<li><a href="https://news.abs-cbn.com/spotlight/12/30/20/confused-between-sinovac-and-sinopharm-what-to-know-about-their-covid-19-vaccines">Confused between Sinovac and Sinopharm? What to know about their COVID-19 vaccines</a></li></ul><p>The FDA announced Thursday it has granted its first OCVID-19 vaccine EUA to Pfizer.</p><ul class="op-related-articles">	<li><a href="https://news.abs-cbn.com/news/01/14/21/philippines-approves-pfizers-covid-19-vaccine-for-emergency-use">READ: Philippines approves Pfizer&#x27;s COVID-19 vaccine for emergency use</a></li></ul><div><strong>ASTRAZENECA</strong></div><p>Expected to be approved also this month is AstraZeneca’s EUA. The British company submitted its application on Jan. 6 after receiving an EUA from the United Kingdom, Argentina and India.</p><p>Domingo said only UK is considered an SRA.</p><p>The official said the FDA’s expert panel will be sending questions on Thursday to AstraZeneca for clarifications on its vaccine&#x27;s clinical trial data.</p><p>“Pag na-complete naman ang trial data, they plan to make a conclusion soon and make recommendations,” he said.</p><p>(Once the trial data is completed, they plan to make a conclusion soon and make recommendations.)</p><div><strong>GAMALEYA</strong></div><p>Gamaleya Institute of the Russian government also applied for EUA last Jan. 7.</p><p>“Ito yung merong a few documents na needed that we asked them to complete. But we have also sent rin this week their preliminary data nila for evaluation,” Domingo said.</p><p>(There are a few documents needed that we asked them to complete. But we have also sent their preliminary data for evaluation.)</p><p>Once complete data from Gamaleya is received, questions will be sent to the company for clarifications.</p><ul class="op-related-articles">	<li><a href="https://news.abs-cbn.com/news/01/14/21/pfizer-gamaleya-covid-19-vaccines-may-arrive-in-ph-in-february-palace">Pfizer, Gamaleya COVID-19 vaccines may arrive in PH in February: Palace</a></li></ul><p>The Philippines has recorded 492,700 confirmed COVID-19 cases, as of Wednesday, including 24,478 active infections, 9,699 that led to deaths, and 458,523 recoveries.</p><ul class="op-related-articles">	<li><a href="https://news.abs-cbn.com/news/01/13/21/ph-reports-146-new-covid-related-deaths-highest-in-4-months-total-cases-reach-492700">PH reports 146 new COVID-related deaths, highest in 4 months; total cases reach 492,700</a></li></ul><p>The government aims to inoculate up to 70 million Filipinos this year.</p><div><strong>RELATED VIDEOS</strong></div><figure class="op-interactive"><iframe height="315" src="https://www.youtube.com/embed/NPTsv97LTVE?enablejsapi=1" width="560"></iframe></figure><div class="iwantbar">Watch more in <a href="//www.iwantv.com.ph/">iWantv</a> or <a href="//tfc.tv/">TFC.tv</a></div><figure class="op-interactive"><iframe height="315" src="https://www.youtube.com/embed/x8Rr23oaNqY?enablejsapi=1" width="560"></iframe></figure><div class="iwantbar">Watch more in <a href="//www.iwantv.com.ph/">iWantv</a> or <a href="//tfc.tv/">TFC.tv</a></div><div class="iwantbar"> </div>

<p>China's Sinovac has applied for emergency use authorization (EUA) of its COVID-19 vaccine in the Philippines, but the documents submitted by the company were incomplete, the Food and Drug Administration said Thursday.</p>

China's Sinovac has applied for emergency use authorization (EUA) of its COVID-19 vaccine in the Philippines, but the documents submitted by the company were incomplete, the Food and Drug Administration said Thursday.

Sinovac applies for EUA of COVID-19 vaccine in Philippines, but docs incomplete - FDA

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Sinovac applies for EUA of COVID-19 vaccine in Philippines, but docs incomplete - FDA

Kristine Sabillo,

ABS-CBN News

Published Jan 14, 2021 12:37 PM PHT

|

Updated Jan 14, 2021 03:24 PM PHT

Read More:

COVID-19

COVID-19 vaccine

COVID-19 vaccine in the Philippines

Sinovac

emergency use authorization

Department of Health

Food and Drug Administration

Eric Domingo

EUA

COVID-19 Philippines

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