Russia’s Sputnik V COVID-19 vaccine is stuck in regulatory limbo as the country’s Food and Drug Administration reported it still lacks some crucial documents to speed up its approval for emergency use.
Among these documents is a Good Manufacturing Practice certification, which FDA Director General Eric Domingo explained would assure local regulators of the consistency of the vaccine.
Domingo said, “It assures us that each and every vial that would come out would be identical to those used in the studies and then used somewhere else, and it’s going to be the same quality, and the stability, when it gets here, when it travels, will be maintained.”
He said the Russian vaccine’s local distributor, Philipine Archipelago International Trading Corporation, would have to apply for a GMP certification, after which a team from the FDA would be sent to Russia to inspect the vaccine’s factory.
He added, “Usually the inspection only takes three days.”