The European Regulator, the European Medicines Agency, has so far refused to approve the Russian vaccine for use, and only two members of the bloc, Hungary and Slovakia, have orders for Sputnik V. Serbia, which is not a member of the block is not, placed. , Sputnik V also ordered and began using it in a mass vaccination program that was much more successful than the obstacles of most states of the European Union.
Even Germany, a hobbyist for the procedure, has expressed increasing interest in Sputnik V. Health Minister Jens Spahn told public broadcaster WDR on Thursday that he wants to start bilateral talks with Russia over a possible purchase of the vaccine, which only goes through. if approved by the European Medicines Agency.
The previous day, Bavarian governor Markus Söder said his government had signed a preliminary agreement to buy 2.5 million doses of the vaccine, to be produced at a Russian factory in the southern state. The agreement is also subject to EMA approval.
Sputnik V is manufactured in seven locations in Russia, as well as in 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, indicating manufacturing defects. The production of scale vaccines is a difficult process, and the upward production has also created problems for Western vaccines.
The Slovak regulatory agency noted that about 40 countries use or plan to use the Russian vaccine, claiming that ‘these vaccines are only linked to the name’. This has raised questions about deviations from the formula reviewed in The Lancet.
“The comparability and consistency of different groups produced in different places has not been demonstrated,” the Slovak regulator said. “In several cases it appears to be vaccines with different properties (lyophilisate versus solution, single dose ampoules versus multiple dose vials, different storage conditions, composition and method of manufacture).”
The declaration by Slovakia could jeopardize Russia’s efforts to establish Sputnik V as a trusted brand. It could also exacerbate long-standing doubts about Russia’s highly politicized vaccination, where President Vladimir V. Putin announced the drug was ready for use in August before clinical trials were completed.