FDA approves Sputnik V for Emergency Use

The Philippine Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Sputnik V, one of Russia’s COVID-19 vaccines, today, 19 March 2021, as announced by FDA Director General Eric Domingo during the Department of Health (DOH)’s Special Briefing.

Authorized for limited use among Filipino individuals aged 18 and above, the non-replicating viral vector COVID-19 vaccine was developed by the Gamaleya Research Institute of Epidemiology and Microbiology through the support of the Russian Direct Investment Fund (RDIF). Both Gamaleya and RDIF were identified by the Department of Science and Technology (DOST), which chairs the Task Group on Vaccine Evaluation and Selection (TG VES), as one of its bilateral partners for the possible conduct of vaccine clinical trials in the Philippines. The DOST-convened Vaccine Expert Panel (VEP) has reviewed the initial clinical trial data of Sputnik V, which served as one of the bases for the FDA’s approval of the vaccine’s EUA application.

As early as August 2020, the DOST-led TG VES has been in contact with Gamaleya and RDIF, through the assistance of both the Department of Foreign Affairs (DFA) and the Embassy of the Russian Federation in the Philippines, in terms of COVID-19 vaccine development, and more recently, in Gamaleya’s submission of the required documents to FDA for their EUA application.

The DOST welcomes this development as the country now has an additional approved vaccine in its portfolio for the National COVID-19 Vaccination Program.