Germany is willing to negotiate a bilateral contract with the manufacturer of the Russian vaccine Sputnik V, Health Minister Jens Spahn told the WDR broadcaster on Thursday. Germany has been trying for weeks to get the European Commission to centrally negotiate an agreement with Moscow so that the Russian preparation is distributed in the 27 as soon as the European Medicines Agency (EMA) gives its approval, but for now, Brussels has shown no interest and has not even started what it calls “exploratory talks.”
Spahn specified that, unlike what other Eastern European partners, such as Hungary or Slovakia, have done, Germany does not intend to authorize the vaccine unilaterally, but to wait for the EMA to approve it for all of Europe. The minister’s statements came a day after the president of the State of Bavaria, Markus Söder, announced that his region has signed a preliminary to supply 2.5 million doses of Sputnik V contract. Like Spahn, Söder stressed that the deal is contingent on European authorization. The doses, which will not arrive until July, will be manufactured in a pharmaceutical plant owned by the German subsidiary of Russia’s R-Pharm, which has invested 30 million euros to adapt to the mass production of vaccines.
Spahn assured his European Union counterparts in their meeting on Wednesday that Germany is willing to negotiate “bilaterally” with Russia, according to Reuters. The minister added that Moscow “must provide the necessary data” to the EMA so that it can approve the vaccine, and specified that Russia first has to specify how many doses it can deliver and on what date. So far the production capacity of Sputnik V has been quite limited and the Russian authorities have sought agreements with pharmaceutical plants to expand it in Europe. Vaccine deliveries belonging to the EU centralized purchasing portfolio are expected to multiply in the second and third quarters,
There is still no scheduled date for the EMA to rule on the efficacy and safety of the Russian vaccine. On Wednesday it became known that this body will carry out an “inspection of good clinical practices” on the way the trials were carried out in Russia. The agency’s executive director, Emer Cooke, noted that this is “a normal process” during drug evaluation and simply seeks to confirm that the clinical trials were adequate, both scientifically and ethically. Sputnik was tested on military and state employees who, according to the Kremlin, participated voluntarily.
Both the Bavarian leader and Merkel’s government have been promoting the rapid authorization of the Sputnik vaccine in Europe for weeks and encouraging Brussels to initiate procedures with Russia to start distributing it as soon as the agency gives the green light. For now, the European Commission has not started negotiations with Moscow for centralized purchasing, unlike what it has done with other vaccines that have not yet been approved by the European regulator. The commissioner responsible for vaccines, Thierry Breton, assured at the end of March that Sputnik is not necessary for the EU because, by the time it arrives – perhaps in July – the supply of those already authorized will be more than enough to cover the needs of the Twenty-seven.
So far, the EMA has licensed four vaccines: those from Pfizer-BioNTech, Moderna, AstraZeneca, and Janssen. The Commission has signed contracts with all four, which has also closed deals on two still unauthorized drugs, Sanofi-GSK and CureVac. In addition, Brussels is holding negotiations or “exploratory talks” with Novavax and Valneva.
Both Hungary and Slovakia have purchased the Russian vaccine outside of the EU centralized procurement program and without waiting for EMA approval. In both cases, their national drug agencies have approved the vaccine only for their territory. Doses cannot be exported or circulated within the Union. Brussels ensures that each state is free to approve the drugs it deems appropriate because vaccine policy is a state competence. Austria has announced that it will also unilaterally buy Sputnik V. Brussels considers that these countries do not break the unity agreed between the 27 because it is a vaccine that does not appear in the common portfolio, like Pfizer, Moderna, AstraZeneca, or Janssen.
