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Philippines grants EUA to COVID-19 vaccine of China's Sinovac

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Jamaine Punzalan and Kristine Sabillo, ABS-CBN News 

<div class='embed-wrap'><figure data-feedback='fb:likes,fb:comments'><img src='http://sa.kapamilya.com/absnews/abscbnnews/media/2021/news/02/22/20210126-sinovac.jpg' ><figcaption>A worker performs a quality check in the packaging facility of Chinese vaccine maker Sinovac Biotech, developing an experimental coronavirus disease (COVID-19) vaccine, during a government-organized media tour in Beijing, China, Sept. 24, 2020. <em>Thomas Peter, Reuters/File</em></figcaption></figure></div><p>MANILA <strong>(UPDATE)</strong> — The Food and Drug Administration has granted an emergency use authorization for the COVID-19 vaccine of China's Sinovac Biotech, paving the way for its delivery to the Philippines, an official said Monday.</p><p>“After a thorough and rigorous review of the currently available published and unpublished data by our regulatory and medical experts, the FDA is granting an emergency use authorization to the COVID-19 vaccine of Sinovac Life Sciences Company, known as SARS-CoV-2 vaccine Vero Cell Inactivated, o yung trade name nya ay CoronaVac," FDA Director General Eric Domingo said during a Laging Handa briefing.</p><p>"The benefit of using the vaccine outweighs the known and potential risk,” he added.</p><p>Domingo said that interim data from Sinovac show the vaccine has an efficacy rate on patients aged 18 to 59 years of 65.3%, based on trials in Indonesia, and up to 91.2% based on trials done in Turkey.</p><p>“However, it has a lower efficacy rate of 50.4% when used on health care workers exposed to COVID-19. Therefore, it is not recommended for use in this group,” the official said.</p><div><strong>3 TO 5 DAYS</strong></div><p>Before the announcement, Health Secretary Francisco Duque III said during the same briefing that China’s Sinovac is the COVID-19 vaccine brand likely to arrive in the Philippines before the month ends.</p><ul class='op-related-articles'>	<li><a href='https://news.abs-cbn.com/news/02/19/21/vaccine-czar-apologizes-for-delay-in-arrival-of-covid-19-shots'>READ: Vaccine czar apologizes for delay in arrival of COVID-19 shots</a></li></ul><p>“Malamang, Sinovac po yan ang posibleng dumating na 600,000 doses (Sinovac’s 600,000 doses is likely to arrive). Good for 300,000 individuals,” Duque said. </p><p>He said that once the EUA is released, it will only take 3 to 5 days for the Chinese Embassy to prepare the shipment of the vaccines.</p><p>This is the third COVID-19 vaccine product that has received an EUA in the Philippines, following those developed by Pfizer and AstraZeneca.</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'>Philippines approves Pfizer's COVID-19 vaccine for emergency use</a></li>	<li><a href='https://news.abs-cbn.com/news/01/28/21/ph-approves-astrazeneca-covid-19-vaccine-for-emergency-use'>PH approves AstraZeneca’s COVID-19 vaccine for emergency use</a></li></ul><p>Palace spokesman Harry Roque earlier said 600,000 Beijing-donated Sinovac shots would arrive on Feb. 23. He said 100,000 of these doses would go to the military, and the rest to health workers.</p><p>However, Roque later said that the lack of an EUA might delay the arrival of the Sinovac vaccines.</p><div><strong>MILD TO MODERATE SIDE EFFECTS</strong></div><p>Domingo said experts recommend two equal and standard doses of 0.5 mL each, given 4 weeks apart, for patients receiving Sinovac's vaccine.</p><p>“The adverse events reported were transient and mostly mild to moderate similar to common vaccine reactions," he said.</p><p>"No specific safety concerns were identified. But it must be noted that this only reflects limited follow-up, and more adverse effects may emerge that’s why close surveillance and monitoring is needed after the immunization,” he added.</p><p>Besides being certified Halal by Indonesia, Domingo said Sinovac is a “good option for individuals who have allergies to components of other available vaccines such as the polyethylene glycol and polysorbate.”</p><p>The 2 ingredients are said to cause anaphylaxis and severe allergies, although such effects were very rare.</p><p>Polyethylene glycol is said to be among the ingredients of mRNA vaccines like that of Pfizer’s, while polysorbate is said to be in viral vector vaccines.</p><p>Before Sinovac’s EUA was approved, the government was expecting Pfizer to send the first batch of doses through the COVAX Facility. </p><p>But the shipment was delayed due to a pending indemnification agreement. The Philippine government said it already signed the agreement with COVAX, but the World Health Organization, which is a member of COVAX Facility, said it is still waiting a separate indemnification deal from Pfizer.</p><ul class='op-related-articles'>	<li><a href='https://news.abs-cbn.com/news/02/18/21/ph-still-has-to-sign-separate-indemnity-deal-with-pfizer-for-its-covid-19-vaccine-says-who'>READ: PH still has to sign separate indemnity deal with Pfizer for its COVID-19 vaccine, says WHO</a></li></ul><p>Vaccine czar Carlito Galvez, Jr. previously said the delay will only take a week. There is still no update as of press time.</p><ul class='op-related-articles'>	<li><a href='https://news.abs-cbn.com/news/02/12/21/ph-wont-lose-44-million-vaccines-from-covax-despite-delay-galvez'>READ: PH won't lose 44 million vaccines from COVAX despite delay: Galvez</a></li></ul><p>The FDA is currently evaluating the EUA application of Russia’s Gamaleya Institute, and awaiting documents from India’s Bharat Biotech.</p><p>Several countries, including in Asia, have already rolled out their respective COVID-19 vaccination programs.</p><p>More than 561,000 coronavirus infections have been confirmed in the Philippines, as of Sunday, including 26,238 active cases.</p><div><strong>RELATED VIDEOS</strong></div><figure class='op-interactive'><iframe height='315' src='https://www.youtube.com/embed/WupUTUI33Dk?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/OfxfTaUf1rI?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>The Food and Drug Administration has granted an emergency use authorization for the COVID-19 vaccine of China's Sinovac Biotech, paving the way for its delivery to the Philippines, an official said Monday.</p>

The Food and Drug Administration has granted an emergency use authorization for the COVID-19 vaccine of China's Sinovac Biotech, paving the way for its delivery to the Philippines, an official said Monday.

Philippines grants EUA to COVID-19 vaccine of China's Sinovac

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Philippines grants EUA to COVID-19 vaccine of China's Sinovac

Jamaine Punzalan and Kristine Sabillo,

ABS-CBN News

Published February 22, 2021 12:06 PM PHT

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Updated February 22, 2021 12:55 PM PHT

Read More:

COVID-19 vaccine

COVID-19 vaccine in the Philippines

Sinovac

emergency use authorization

Department of Health

Food and Drug Administration

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