EMA investigates Russia’s Sputnik V vaccine after four deaths reported – case leaked to EU
Sputnik V vaccine financier discusses support from EU leaders
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The EMA, the EU’s regulator, is believed to be taking the reports “seriously” with member states planning to begin negotiations with Moscow over purchasing millions of doses of the vaccine. According to the EU Observer website, the Russian body responsible for the country’s vaccination scheme, have also reported six other people had medical complicating after receiving the jab. This will increase pressure on the EMA to investigate the safety of Russia’s state-backed COVID-19 jab.
A host of EU countries, including Germany, have signalled a willingness to import doses of the immunisation to help bolster their ailing rollouts.
Internal files from the RosPotrebNadzor vaccination body reveal that three women, aged 51, 69 and 74, died shortly after receiving Sputnik V. The fourth fatal case was not identified in the leaked dossier.
Experts attributed the deaths to heart, lung or blood-sugar related complications and claim the Russian-made jab might not be responsible for the incidents.
Virologist Denis Logunov, of the Gamaleya Research Institute of Epidemiology and Microbiology in Moscow, which developed Sputnik V, confirmed the leak.
He told EU Observer: “I requested information about this case and … obtained a response. This case is not fake.”
The 51-year-old woman died suddenly after receiving her second dose of the Sputnik vaccine.
Mr Logunov, who co-authored a paper on the safety and efficacy of the Russian jab for the Lancet medical journal, added: “The case was investigated. No associated with vaccination was found.”
The case files, which have also reported in local media in Russia, were sent to the EMA by an unnamed whistleblower.
A spokeswoman for the EU’s drugs watchdog said: “We can confirm that all reports are treated serious by the EMA.
“In this particular case, the report hints to the safety of the vaccine, which is a fundamental aspect to be evaluated both during the ongoing rolling review and in the assessment subsequent to the filing of a marketing authorisation application.
“For this reason, we cannot comment at this stage on the facts narrated in the report.”
The EMA is currently reviewing the Sputnik V jab “based on results from laboratory studies and clinical studies in adults”.
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A total of 10 complications were found out of the millions of people that have received the Russian-made vaccine, according to the leaked files.
But Russia’s record with transparency has raised questions whether there are more cases yet to be reported.
Epidemiologist Vasily Vlassov, of the HSE University in Moscow, said: “There is a problem with under-registration of side-effects of drugs in Russia in general.
“All non-desirable effects connected in time with the use of the drugs should be considered as a possible side-effect of the drug. It is a fundamental rule. Even death under a train should be considered.”
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Hungary has always started using the Sputnik vaccine as part of its vaccine rollout, one of Europe’s most successful.
Austria, Germany and Italy are in advanced talks with Moscow over buying supplies and joint production of the jab.
The EMA has yet to authorise it for use across the EU, but member states are allowed to authorise it for emergency use.
The bloc’s drugs watchdogs have raised concerns over the way Russia collects data and tests its vaccines.
Russia has urged Slovakia to return a shipment of thousands of doses of its state-funded vaccine.
Bratislava’s drugs agency raised concerns that it had received jabs that were different to those being reviewed by the EMA.
Slovakia bought 200,000 doses of Sputnik V last month but has yet to use any because its national regulators are unable to assess the jab because of issues with data provided by Moscow.
The Russian jab was produced by a state-backed laboratory and funded by the Russian Direct Investment Fund, a Kremin-run cash pot.
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