Russia's Sputnik V approved for emergency use in PH

CNN Philippines (Metro Manila, March 18) — The local Food and Drug Administration has granted emergency use authorization to Russian firm Gamaleya's COVID-19 vaccine Sputnik V.

"After a rigorous and thorough review by regulatory and medical experts of the currently available published and unpublished data, the FDA is granting emergency use to the Sputnik V," FDA Director General Director Eric Domingo announced Friday in a media briefing.

"It is decided that all conditions for an EUA are present and that the benefit of using the vaccine outweighs the known and potential risks," he added.

Sputnik V is the fourth COVID-19 vaccine to be approved for emergency use in the country. Coronavirus shots made by Pfizer, AstraZeneca, and Sinovac earlier received EUA from the Philippine drug regulator. Meanwhile, the EUA application of India-based Bharat Biotech for its vaccine called Covaxin is undergoing regulatory review.

Domingo said the Sputnik V shot can only be administered to clinically healthy individuals aged 18 years old and above.

An analysis of Phase 3 clinical trials published in the scientific journal The Lancet showed that Gamaleya's vaccine had an efficacy of 91.6% when two doses were given 21 days apart. Nearly 20,000 took part in the study. 

Domingo said 25% of the Sputnik V trial participants have comorbidities, but they responded well to the vaccine.