EU inspectors to take a close look at Russia’s Sputnik V

EU medical inspectors are heading to Russia to evaluate the Sputnik V COVID-19 vaccine. But will their work clear up doubts surrounding the jab?

Officials from the European Medicines Agency will soon travel to Russia to evaluate the Sputnik V COVID-19 vaccine. "An inspection of a manufacturing site is a normal step in the context of the evaluation of any marketing authorization application in the EU," according to the agency. "EMA has a legal obligation to verify that manufacturers of medicinal products for which a marketing authorization is sought in the EU, comply with good manufacturing practice (GMP)."

The EMA's director, Emer Cooke, announced the inspection of manufacturing sites in March. She said officials would also visit clinics that had tested the vaccine in order to verify compliance with good clinical practice.

"Clinical trials supporting EU marketing authorization should comply with GCP, an international ethical and scientific quality standard for designing, recording and reporting trials in humans. Compliance with this standard provides assurance that the rights, safety and well-being of trial participants are protected and that clinical-trial data are credible," according to EMA.

The agency says it will not publish the results of its inspections until the entire evaluation process for approval has been completed. Though the agency would not say when exactly inspectors would travel, Russian authorities have cited April 10 as the date.