The Philippines’ Food and Drug Administration (FDA) has approved the Emergency Use Authorization (EUA) application of Russia’s Sputnik V vaccine.
“It is decided that all conditions for an EUA (emergency use authorization) are present and that the benefit of using the vaccine outweighs the known and potential risks,” Food and Drug Administration (FDA) chief Eric Domingo said in a briefing on Friday.
The FDA chief said the Sputnik V vaccine can only be used on individuals aged 18 years and older.
“The study was done in people 18 years and above. About 1/4 of them had comorbidities and a big group, around 10%, was senior citizens. It showed that the efficacy of the drug was quite uniform among all age groups,” he said.
The FDA first cancelled it’s supposed trip to Russia after the manufacturer Gamaleya Institute submitted the necessary documents for the approval of their EUA.
The Russian vaccine is the only vaccine reviewed at the Lancet medical journal and has a reported 91.6% efficacy rate.
Sputnik V is the fourth vaccine to receive EUA from Philippine regulators.
