Russia’s Gamaleya to submit COVID-19 vaccine EUA application in PH -- DOST | Inquirer News

Russia’s Gamaleya to submit COVID-19 vaccine EUA application in PH — DOST

/ 11:53 AM January 08, 2021

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A handout photo provided by the Russian Direct Investment Fund (RDIF) shows samples of a vaccine against the coronavirus disease (COVID-19) developed by the Gamaleya Research Institute of Epidemiology and Microbiology, in Moscow, Russia August 6, 2020. Picture taken August 6, 2020. The Russian Direct Investment Fund (RDIF)/Handout via REUTERS

MANILA, Philippines — Russia’s Gamaleya Institute is set to submit its application for emergency use authorization (EUA) for its COVID-19 vaccine in the Philippines, the Department of Science and Technology (DOST) announced Friday.

DOST Undersecretary Rowena Guevarra said Gamaleya Institute is expected to submit its application for EUA for its COVID-19 vaccine, Sputnik V, within the day or on Saturday, January 9.

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Securing an EUA from the Food and Drug Administration (FDA) will allow a new vaccine to be administered in the country.

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In turn, Gamaleya Institute withdrew its prior application to conduct Phase 3 clinical trials in the country.

“Napakasimple ng rason nila—they are already applying for emergency use authorization that’s why they will no longer have clinical trials here,” Guevarra said in a press briefing.

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Food and Drug Administration building

The Food and Drug Administration central office

American drugmaker Pfizer and British drugmaker AstraZeneca earlier submitted their respective applications for an EUA in the country.

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“Itong tatlo na ito (Pfizer, AstraZeneca, and Gamaleya) meron na silang EUA sa ibang bansa. Tulad ng Pfizer, may EUA na sila sa UK, sa USA, sa Kuwait, Mexico, sa Singapore at Canada,” Guevarra said.

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“‘Yung AstraZeneca naman, sa UK, Mexico, Argentina, at India. At yung Gamaleya sa Russia, sa Argentina, at sa Belarus,” the DOST official added.

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TAGS: COVID-19 Vaccine, EUA, FDA, Gamaleya

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