At present, inspectors are located in Russia on behalf of the European Medicines Agency (EMA). If the Russian Sputnik V vaccine is approved, it could arrive in Sweden as early as June, when an agreement is in place according to the Swedish Vaccine Coordinator Richard Bergström.
There are inspectors from three different countries. It is part of the approval process. Not only for screening production but also for screening clinical trials, he says.
The vaccine has been criticized
The clinical trial has already been criticized during the first and second phase of the study. A group of researchers questioned the results in a high-level article in The Lancet, saying, among other things, that the data were too small and that the results were very similar. When the third phase, a larger base study, was published, it confirmed the results of previous studies.
Anders Bjorkman is professor of infectious disease at the Karolinska Institute and one of the researchers who criticized the Phase 3 study. It is believed that more random results should appear.
In the first and second phase of the study, the different immune responses to the Sputnik vaccine became very similar between the small groups, which is not usually the case. Different age groups showed exactly the same effect (90-92%) despite the fact that all the values were based on a study with a relatively small number of participants, so this opportunity meant very different results, says Anders Bjorkmann.
Access to more data
Rickard Bergstrom is aware of the criticism but indicates that the EMA will have a bigger base to work on.
Regulatory authorities see these details and have a lot more information than magazines do, says Richard Bergstrom.
Anders Bjorkmann also welcomes a major investigation.
– Sputnik V may be a very good vaccine, but everyone who receives the vaccine has a right to know that it has been properly investigated, says Anders Björkman.
These are low doses
If Sputnik is approved by the EMA, the vaccine could arrive in Sweden as early as June. That’s about 200,000 doses a month, and it’s pretty little. Vaccine production in Russia has a relatively small capacity. But the country signs contractual agreements with vaccine manufacturers across Europe. According to Richard Bergstrom, she is in talks with a Swedish company.
But during the first three to six months, the volumes will come from Russia and there isn’t much capacity, says Richard Bergstrom.
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