FDA unlikely to approve Sputnik V emergency use this month

ABS-CBN News

Posted at Feb 04 2021 12:20 PM

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MANILA - The Food and Drug Administration said Wednesday it was unlikely that the emergency use application of Russia's Gamaleya Institute for the Sputnik V vaccine would be approved this month.

The vaccine is 91.6 percent effective against COVID-19, according to results published in medical journal The Lancet.

The FDA had set a period of 21 days for vaccines that have emergency use authorization (EUA) from stringent regulators, Domingo said.

"Kailangan din nating i-check 'yung quality side, 'yung manufacturing, very consistent sila na every batch tama walang contamination. Ayoko namang madaliin ating experts, hangga't may konting question pa sila ma-settle muna before we make any decision," he told ABS-CBN's Teleradyo.

(We need to check its quality, the manufacturing, if they're consistent in every batch and there's no contamination. I don't want to rush our experts. If they have some questions these need to be settled first before we make any decision.)