FDA grants emergency use authorization to Russian jab
THE Food and Drug Administration (FDA) granted the Russian-made Sputnik-V vaccine for coronavirus disease 2019 (Covid-19) an emergency use authorization (EUA) as it showed an overall efficacy rate of 91 percent.
FDA Director General Eric Domingo said the vaccine developed by the Gamaleya Research Institute of Epidemiology and Microbiology has satisfied the conditions for an EUA.
“Today, we would like to announce that after a rigorous and by thorough review by the regulatory and medical experts of the currently available published and unpublished data, the FDA is granting emergency use authorization to the Sputnik-V Gam-Cov-Vac Covid-19 vaccine,” Domingo said in a virtual briefing on Friday.
Domingo 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.