EMA concludes evaluation of Sputnik V compliance with clinical practice

The Hague, May 12 (EFE).- The European Medicines Agency (EMA) said Wednesday it had concluded its evaluation of good clinical practice in trials for Russian vaccine Sputnik V.

The EU regulator also announced it will closely monitor vaccination campaigns across member states to establish how long the vaccine is effective against Covid-19 and whether a third dose will be necessary.

The EMA’s Head of Clinical Studies and Manufacturing Fergus Sweeney said EU inspectors are now visiting Sputnik V manufacturing sites to verify compliance.

Results from both evaluations will contribute to the final assessment of the Russian vaccine, which could lead to a recommendation to authorize its use in the EU.

“The inspectors have been visiting the clinics and locations where the trial has been carried out in order to ensure that the ethical standards are being complied with and the data reported in the clinical study reports can be verified, talking to people involved to make sure that the protocols were followed,” Sweeney said.

The inspection of manufacturing sites in Russia aims to verify “all of the proper standards and controls that govern the careful process of manufacturing” and ensure the “consistency of manufacture of the product.”

Marco Cavaleri, head of Vaccine Strategy, pointed out that the EMA is currently reviewing four Covid-19 vaccines for potential approval in the EU in addition to the four it has authorized so far.

“We do not know yet when would be the right time for giving a third dose and that is why we are monitoring carefully how the antibodies are decaying over time,” he said.

“But also importantly we need to look into real-world evidence to have a good understanding of when we start seeing some reduction in protection.”

Cavaleri stressed that the EMA is also analyzing the Indian variant of coronavirus, and added that there is promising evidence of mRNA vaccines, Pfizer and Moderna, effectively neutralizing the Indian strain. EFE


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