While Hungary and Slovakia have already placed national orders, the European Medicines Agency (EMA) announced on Thursday 4 March that it was starting an ongoing evaluation of the Russian Sputnik V vaccine against Covid-19. However, it is too early at this stage to know whether this step will lead to a centralised marketing authorisation or a European pre-purchase agreement.
To justify its announcement, the EMA indicated that it has sufficient encouraging clinical and laboratory data to start an ongoing review. This phase allows the producer to progressively submit its scientific conclusions on the efficacy, safety and quality of the vaccine.
According to interim results of phase III trials published by the medical journal The Lancet and validated by independent experts, Sputnik V developed by the Gamaleja Institute is 91.6% effective against symptomatic forms of Covid-19.
If the analyses are positive, the institute can then file an application for a conditional marketing authorisation with the EU, on which the EMA and then the European Commission will have to make a decision.
However, the granting of a marketing authorisation does not necessarily mean that the Commission will enter into a pre-purchase agreement with the producer. Commission spokesman Eric Mamer qualified his statement by saying that no discussions were underway at this stage.
“However, it is a joint strategy. Member States and the Commission can decide at any time to include any vaccine in their portfolio”, added Stefan de Keersmaecker, a spokesman for the European institution. “This decision will be made based on its merits”, Mamer added.
“Europe must learn from its mistakes”, stresses Frank Vandenbroucke
Despite the lack of centralised authorisation, Hungary and Slovakia have each ordered 2 million doses of Sputnik V and the Czech Republic is considering following suit. The Russian RDIF fund, which is promoting the Russian vaccine internationally, has already announced that it could supply 50 million doses to Europe “from June”.
Earlier this week, Austria and Denmark also took a sideways step, announcing their alliance with Israel to research and produce second-generation vaccines against possible mutations of the Sars-cov-2 virus, despite a similar initiative at European level known as the HERA Incubator (see EUROPE 12669/12).
Austria is one of three countries, along with the Czech Republic and Slovakia, to receive an additional 100,000 doses from the EU due to an outbreak of Covid-19 infections in the Tyrol region. This “gift” can be explained by a higher than expected production of Pfizer/BioNTech vaccines in March.
But this good news is marred by delays on the part of AstraZeneca which are proving difficult to resolve, and the slow pace of vaccination campaigns in the Member States.
Questioned on Belgian public radio on Thursday morning, Belgian Health Minister Frank Vandenbroucke invited the EU to examine its conscience. “At the European level, we have been too optimistic. We trusted AstraZeneca without really checking their production capacity in depth. Europe must learn from its mistakes”, he said. (Original version in French by Sophie Petitjean)