The European Union’s regulator, the European Medicines Company, has up to now declined to approve the Russian vaccine to be used and solely two members of the bloc, Hungary and Slovakia, have positioned orders for Sputnik V. Serbia, which isn’t a member of the bloc, has additionally ordered Sputnik V and begun utilizing it in a mass inoculation program that has been way more profitable than the stumbling efforts of most European Union states.
Sputnik V is manufactured at seven places in Russia, and in addition at vegetation in India and South Korea. Various different international locations have signed manufacturing contracts, together with Brazil, Turkey and Serbia. Russia has persistently delivered fewer doses of the vaccine than initially promised, suggesting glitches in manufacturing. Producing vaccines at scale is a tough course of and ramping up manufacturing has introduced issues for Western vaccines, too.
Noting that about 40 international locations are utilizing or scheduled to make use of the Russian vaccine, the Slovak regulatory company asserted that “these vaccines are solely related by the title.” That raised questions on deviations from the system reviewed in The Lancet.
“The comparability and consistency of various batches produced at completely different places has not been demonstrated,” the Slovak regulator mentioned. “In a number of instances, they look like vaccines with completely different properties (lyophilisate versus resolution, single-dose ampoules versus multi-dose vials, completely different storage situations, composition and methodology of manufacture).”
The Slovak assertion may injury Russia’s efforts to determine Sputnik V as a dependable model. It may additionally exacerbate lingering doubts left by the vaccine’s extremely politicized rollout in Russia, the place President Vladimir V. Putin introduced that the drug was prepared to be used in August, earlier than medical trials had completed.
Russia has repeatedly denounced overseas questioning of its vaccine because the fruit of anti-Russian conspiracies and prejudice, ignoring complaints that Mr. Putin, dashing final summer time to declare a Russian victory within the race for a vaccine, violated commonplace process by declaring Sputnik V secure earlier than trials had completed.