The vaccine can in principle be approved and used in Norway in the long term. – It is clear that some of these messages have come via a whistleblower, says Steinar Madsen in the Norwegian Medicines Agency.
Four people recently died in Russia shortly after receiving the Russian-produced Sputnik vaccine. The cases, which until recently have been unknown to the public, are considered serious by the EU’s drug inspectorate EMA, writes EUObserver.
Another six people also had medical complications after taking the vaccine. It appears in internal documents from the Russian health inspectorate RosPotrebNadzor. Both EMA and EUObserver have gained access to the leaked documents.
Also read: FHI calculations: Use of this vaccine can give short-term pleasure, but long-term hangover
Three of the dead were women aged 51, 69 and 74. Gender and age are not identified for the fourth death mentioned in the internal leaks the documents.
The deaths are heart, lung or blood sugar related, and “may or may not have been caused by the Sputnik vaccine”, suggests the documents, according to EUObserver.
EUObserver has done a thorough job and has published and linked to the Russian-language documents.
The Russian Sputnik vaccine is currently being assessed by the European Medicines Agency (EMA).
– Point one is that we know too little about what has happened here. Point two is that the pharmaceutical companies have an unconditional duty to report all serious side effects to the pharmaceutical authorities. If they have not complied with this requirement, then it is very serious, says medical director of the Norwegian Medicines Agency, Steinar Madsen, to Nettavisen.
– Arrived via a notifier
The 10 reported reports of serious side effects make up a minimal proportion of the many millions who feel perfectly fine after taking the Sputnik vaccine in Russia. However, as the EUObserver website points out, the secrecy surrounding these cases raises the question of whether there are similar cases of serious side effects, which have been withheld from the general public and the drug authorities.
– That is exactly what the big question is. It is clear that some of these adverse reaction reports have reached the EMA via a whistleblower. It is clear that this makes one begin to doubt whether reporting of side effects meets the standard we demand in western countries. This is very important for the EMA to find out. And as far as I have understood, EMA will continue to work on this to get to the bottom of the matter, says Madsen.
If the EMA ultimately approves the Sputnik vaccine, and the European Commission decides to purchase the vaccine on behalf of its member countries, the Sputnik vaccine can in principle also be used in Norway.
– It is of course an opportunity, says Madsen.
EMA: – Being treated seriously
The six reported cases of medical complications are among younger men and women. One of them is only 25 years old. People should have different symptoms such as difficulty breathing, swelling, cramps, muscle weakness, dizziness, high blood pressure and fever after receiving the dose of Sputnik.
EMA confirms to EUObserver that they have also been given access to the documents, which were sent to EMA on March 26 via a e-post from a Russian whistleblower who wished to remain anonymous.
– We can confirm that all the reported cases are treated seriously by EMA and are assessed directly, says a spokesperson for EMA to EUObserver.
– In this specific case, the report refers to the safety of the vaccine, which is a fundamental aspect that must be evaluated, both during the ongoing review and in the subsequent assessment after submitting an application for approval. For this reason, we are currently unable to comment on the facts that appear in the report, says the EMA spokesperson.
Germany has already announced that it is planning talks on purchasing the Sputnik vaccine if it is approved by the EMA.
Confirms one of the deaths
Virologist Denis Logunov at the Gamaleya Research Center for Epidemiology and Microbiology in Moscow, confirms to the website EUObserver that he himself has investigated one of the deaths (51-year-old) mentioned in the documents.
– The case was investigated. No connection to the vaccination was found, he says.
Logunov co-authored a research article on the safety of the Sputnik vaccine recently published in The Lancet.
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