Vaccine coordinator: Sputnik V approved for too vague reasons

Priority groups such as health professionals, teachers and social workers are the first to receive the injections, as they are seen to be most exposed to corona infection when Russia begins mass vaccinations.

The Sputnik V vaccine has been developed by the Russian research institute Gamaleya and is administered in two doses at 21-day intervals. It has been approved for use, despite the fact that the latest phase 3 study has not yet been completed and is claimed to have a 92 percent protective effect.

Swedish vaccine coordinator Richard Bergström has doubts about safety and protective effect.

– We have no information on how your program is structured. It has been so secret, without transparency as with the other companies. An approval has been given based on so little information, he says.

Until now, Russia has only safety data from 15,000 people, although the phase 3 study with 40,000 people is ongoing. Richard Bergström believes that it is inconceivable that a vaccine would be approved in the EU for such vague reasons.

– The process is very strange, that’s why we don’t work in the EU. We had not approved the vaccine only in phase 1 and 2 studies. It is as if we had issued an approval for the other companies in September. We wait until the studies are finished, it may take a while.

This week, Russia reportedly participated in a meeting of experts at the UN General Assembly, where Swedish experts were also invited, but the Gamaleya research institute postponed the meeting until December 10. Bergström, who himself would have been present, interprets this to mean that they need more time to prepare.

– They will be roasted.

Richard Bergström considers however, the vaccine is scientifically interesting.

Sputnik V is, like the Astra Zeneca and Johnson & Johnson vaccine, a so-called viral vector vaccine, in which a virus from the common cold is used as a carrier of a genetic code for the so-called nail protein. The characteristic of the Russian vaccine is that researchers have used two different cold viruses to introduce the protein from the nail into cells. He gives you a dose with one first and then a dose with the other.

– A challenge with this technology, also for Astra Zeneca and Johnson & Johnson, is the risk of immunity to the vaccine itself. Using two different cold viruses, as in the Russian vaccine, is possibly one way to fix this problem. It will be interesting to see the results of your study.

Bergström does not rule out that the EU may buy the Russian vaccine later, but at present it is unlikely.

– The EU has already signed agreements with two vaccines of this type. Russia also seems to have production problems, they have to vaccinate a large number of people and it is not certain that they have the capacity to supply us.

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