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.
Even Germany, a stickler for procedure, has expressed growing interest in Sputnik V. Health Minister Jens Spahn told the public broadcaster WDR on Thursday that he would like to start bilateral talks with Russia over a potential purchase of the vaccine, which would go through only if it is approved by the European Medicines Agency.
The previous day, Markus Söder, the governor of Bavaria, said his government had signed a preliminary agreement to buy 2.5 million doses of the vaccine, which are to be produced at a Russian-owned plant in the southern state. That deal, too, is contingent on E.M.A. approval.
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.