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Manila Bulletin devider Philippines devider National devider Phase 3 clinical trials for Sputnik V simultaneous in Moscow and Manila --DOST

Phase 3 clinical trials for Sputnik V simultaneous in Moscow and Manila --DOST

Published Aug 12, 2020 08:59 pm

Sputnik V, the Russian COVID-19 vaccine, will be registered in the Philippines by conducting a local Phase 3 clinical trial, possibly simultaneous with the Phase 3 clinical trial in Russia, an official from the Department of Science and Technology (DOST) said.

According to the website of the Food and Drug Administration (FDA), Phase 3 involves "300 to 3,000 volunteers who have the disease or condition." Its aim is to test the efficacy and monitoring of adverse reactions.  

DOST Usec. Rowena Cristina Guevara, Chair of the sub-Technical Working Group (TWG) on Vaccine Development, in a text message on Wednesday said that the meeting of the Vaccine Expert Panel with Gamaleya "went well" and "they hope to start with the process within the month".

"The process involves getting confidentiality agreement signed, review of phase 2 and phase 3 clinical trial results, apply for FDA permission to do the trial, and undertake the phase 3 clinical trial," Guevara said.

She added that after the trial, Gamaleya can apply for registration with FDA so that the vaccine can be used in the Philippines. 

The vaccine was developed by the Gamaleya Research Institute in Moscow in coordination with Russia’s Defense Ministry.

Russian President Vladimir Putin announced on Tuesday that his country became the first to clear a COVID-19 vaccine for use whose name pays homage to Sputnik I, the first artificial Earth satellite, created by the Soviet Union. 

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