Russia's Gamaleya bids for emergency vaccine use instead of clinical trials

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Metro Manila (CNN Philippines, January 8) — Russian firm Gamaleya Institute has withdrawn its application to hold clinical trials in the country as it seeks emergency use authorization of its COVID-19 vaccine Sputnik V.

Rowena Guevara, Department of Science and Technology Undersecretary for Research and Development, said the Moscow-based company's application for phase 3 trials was withdrawn on Jan. 6. But on the same day, it also expressed intent to apply for an EUA at the Food and Drug Administration.

"Napakasimple ng rason nila: mag-aaply na sila ng EUA kaya hindi na sila magki-clinical trial dito," she said in an online media forum on Friday.

[Translation: The reason is simple. they will apply for EUA so they will no longer hold trials here.]

In a statement Friday night, the FDA confirmed receiving Gamaleya’s application on Thursday.

“The submission was pre-assessed and the applicant was instructed to comply with the lacking documents,” FDA Director General Eric Domingo said.

Gamaleya is the third vaccine maker to apply for emergency use authorization in the country, joining Pfizer and AstraZeneca. It usually takes the FDA 21 days to decide if the drug will be allowed for use in the country.

In November 2020, Russia said the Sputnik V coronavirus vaccine is 91.4% effective, according to data from its ongoing phase 3 trials. The DOST said the vaccine has received EUA approval in Russia, Argentina, and Belarus.