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On Thursday, Sputnik V became the seventh vaccine to be reviewed by the European Medicines Agency, EMA, during the pandemic. The Pfizer / Biontech, Moderna and Astra Zeneca vaccine has already received the green light. Next in line for possible approval is Janssen. At the same time, the vaccine authority evaluations of Curevac and Novavax are ongoing.
EMA is now reviewing data on the Russian vaccine on an ongoing basis and will examine whether Sputnik V meets the EU standard for protective effect and safety.
– Production inspections have been scheduled, but also clinical studies. Just watch to see that they turned out well, says Richard Bergström.
The Sputnik V vaccine has been developed by the Russian research institute Gamaleya and is administered in two doses at 21-day intervals. Since the EU has not previously cooperated with the company that makes the vaccine, the controls will be very careful, says Richard Bergström.
– When it comes to established companies, normally only random samples are carried out. But with startups, more extensive inspections are done, he says.
The EU today has agreements with several vaccine manufacturers whose products have not yet received the green light. Negotiations on Sputnik V, on the other hand, have just started.
– The first conversation took place last week. I spoke to them again today. At present, it is not yet clear whether we will have an agreement at EU level or whether several Member States will cooperate and sign an agreement. We have slightly different opportunities there, says Richard Bergström.
Most of the details of the deal, such as price, volumes, and delivery time, are kept. But if all goes well, Richard Bergström expects a dose to Sweden in June.
– But there are many things that should be true then. We will get both an agreement and approval for the vaccine. The company is not as established as some of the others and that makes it harder to predict, he says.
If deliveries arrive however, until early summer it won’t be as big as, say, Pfizer / Biontech.
– Sputnik will not be a big part of our vaccine business this semester. But it is absolutely possible that it is used in some of the Swedish vaccines, says Richard Bergström.
