FDA grants Sputnik-V EUA

By Amado Inigo

MANILA — The Food and Drug Administration (FDA) has granted the Russian-made Sputnik-V an emergency use authorization for coronavirus disease 2019 (Covid-19).

The Russian-made Sputnik-V has an overall efficacy rate of 91 percent.

Approval of the Russian vaccine came in handy FDA Director-General Eric Domingo said as the vaccine developed by the Gamaleya Research Institute of Epidemiology and Microbiology has satisfied the conditions for a EUA.

“Today, we would like to announce that after a rigorous and by a thorough review by the regulatory and medical experts of the currently available published and unpublished data, the FDA is granting emergency use authorization to the Sputnik-V Gam-Cov-Vac Covid-19 vaccine,” Domingo said in a hybrid press briefing on Friday.

The FDA chief also cited the interim data of the Phase 3 trial of vaccine published in Lancet, which indicated that Sputnik-V Gam-Cov-Vac has shown an overall efficacy of 91.6 percent in preventing the new coronavirus.

“The efficacy rate is consistent among all age groups 18 and older,” he added. (AI/MTVN)

Leave a Reply