The European Union’s regulator, the European Medicines Agency, has so far declined to approve the Russian vaccine for use and only two members of the bloc, Hungary and Slovakia, have placed orders for Sputnik V. Serbia, which is not a member of the bloc, has also ordered Sputnik V and begun using it in a mass inoculation program that has been far more successful than the stumbling efforts of most European Union states.
Sputnik V is manufactured at seven locations in Russia, and also at plants in India and South Korea. A number of other countries have signed manufacturing contracts, including Brazil, Turkey and Serbia. Russia has consistently delivered fewer doses of the vaccine than initially promised, suggesting glitches in manufacturing. Producing vaccines at scale is a difficult process and ramping up production has presented problems for Western vaccines, too.
Noting that about 40 countries are using or scheduled to use the Russian vaccine, the Slovak regulatory agency asserted that “these vaccines are only associated by the name.” That raised questions about deviations from the formula reviewed in The Lancet.
“The comparability and consistency of different batches produced at different locations has not been demonstrated,” the Slovak regulator said. “In several cases, they appear to be vaccines with different properties (lyophilisate versus solution, single-dose ampoules versus multi-dose vials, different storage conditions, composition and method of manufacture).”
The Slovak statement could damage Russia’s efforts to establish Sputnik V as a reliable brand. It could also exacerbate lingering doubts left by the vaccine’s highly politicized rollout in Russia, where President Vladimir V. Putin announced that the drug was ready for use in August, before clinical trials had finished.
Russia has repeatedly denounced foreign questioning of its vaccine as the fruit of anti-Russian conspiracies and prejudice, ignoring complaints that Mr. Putin, rushing last summer to declare a Russian victory in the race for a vaccine, violated standard procedure by declaring Sputnik V safe before trials had finished.