EU Regulators Complete Special Ethics Probe Into Sputnik V Clinical Trials – EMA
The results of the EMA probe into the ethics of Sputnik V’s clinical trials will only be published after all stages are complete
The European Medicines Agency (EMA) has completed a special investigation into how Russia conducted clinical trials for its Sputnik V vaccine as part of the jab’s application for approval in the EU.
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“In the context of the evaluation of the Sputnik V vaccine, European inspectors have carried out Good Clinical Practice (GCP) inspections in Russia and Good Manufacturing Practice (GMP) inspections are planned to take place in May,” the EMA told The Moscow Times in an emailed statement.
Both stages need to be passed before the EMA will approve the jab. The results of the EMA probe into the ethics and conduct of Sputnik V’s clinical trials will only be published after both stages are complete.
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Moscow was dealt a blow to its vaccine diplomacy efforts this week when Brazil’s medical authorities followed Slovakia’s in turning down Sputnik V after their own lab inspections revealed the vaccine contained a live version of a common cold-causing virus — a defect which could be a safety issue for recipients with low immunity.
Gaining approval in the EU would be a big victory for Sputnik V, which has so far been approved in 59 countries around the world. German officials have said they are in talks with Russia to buy 30 million doses of Sputnik V once it is approved by the EMA, while Austria has also said it will order the vaccine once approved.