The regulator of the European Union, the European Medicines Agency, has so far refused to approve the use of the Russian vaccine 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 began using it in a mass inoculation program that was far more effective than the stumbling efforts of most states in the European Union.

Sputnik V is manufactured at seven sites in Russia, as well as factories 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 was originally promised, suggesting manufacturing issues. Large-scale vaccine production is a difficult process, and the ramp-up of production has also posed challenges for western vaccines.

Noting that around 40 countries are using or planning to use the Russian vaccine, the Slovak regulatory agency claimed that “these vaccines are only associated by name.” This raised questions about deviations from the formula discussed 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, these are vaccines with different properties (lyophilisate versus solution, single-dose ampoules versus multidose vials, different storage conditions, composition and manufacturing method).”

The Slovak statement could undermine Russia’s efforts to make Sputnik V a reliable brand. It could also exacerbate lingering doubts left by the highly politicized rollout of the vaccine in Russia, where President Vladimir V. Putin announced the drug was ready for use in August, before clinical trials ended.

Russia has repeatedly denounced the foreign questioning of its vaccine as the fruit of anti-Russian conspiracies and prejudices, ignoring complaints that Mr. Putin, rushing last summer to declare a Russian victory in the race for vaccine, violated standard procedure in declaring Sputnik V safe. before the end of the tests.



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