Russia’s COVID-19 vaccine not automatically approved in PH – FDA exec

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An official from Food and Drugs Administration said Wednesday that there would be no automatic approval for the Sputnik V, the developed by .

director-general Health Undersecretary Eric Domingo said in an interview with Dobol B sa News TV said it would take two to four weeks for them to review the vaccine and come up with a decision.

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“Ang FDA, sinusuri niya lahat ng data. Kailangna maipakita po sa amin ‘yung data, findings, tsaka ‘yung scientific na mga information about the vaccine to assure na safe siya at tsaka effective siya,” he said.

(The FDA, it checks all the data. We need to see the data, findings, as well as the scientific information about the vaccine to ensure that it is safe and effective.)

“Hindi naman po ibig sabihin porke na-approve na, e approve na po sa lahat. Porke approve na siya sa Russia, e automatic approval dito,” he added.

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(It does not mean that if it is approved in Russia that it would also be approved here.)

Domingo, citing information from a discussion with the World Health Organization (WHO), said that there were doubts about Russia’s early approval of Sputnik V.

Also read: Duterte welcomes Russia’s COVID-19 vaccine offer

Russia’s COVID-19 vaccine not automatically approved in PH – FDA

“Ang huling update natin ay sa Russia mukhang nasa Phase 2 clinical trial pa lamang at patapos pa lamang. Kaya siguro nagulat din ang buong mundo na biglang kine-claim nila na approved na,” he said.

(Our last update is that in Russia, it looks like it is still in Phase 2 clinical trial and is just finishing. So maybe the whole world was also surprised that they suddenly claimed to have been approved.)

“Hindi natin alam kung ano ‘yung approval process na nangyari sa Russia or baka talagang nag-approve na sila after Phase 2 o kung talagang na-complete nila ‘yung Phase 3,’ he added.

(We do not know what the approval process happened in Russia or maybe they really approved after Phase 2 or if they really completed Phase 3.)

Domingo said the FDA would get additional information about the approval of the COVID-19 vaccine Sputnik V.

President Vladimir Putin announced Tuesday that Russia became the first country to register a COVID-19 vaccine after less than two months of human testing.

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