EU regulator postpones test of Sputnik V vaccine – Reuters

Фото: Nation

Sputnik V has been approved by more than 60 countries around the world. But the drug has not yet been approved by the European regulator.

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The Russian Institute of Gamaleya, which developed Sputnik-V, repeatedly refused to provide the experts with the missing information, and explained their actions by “insufficient experience of cooperation with EMA.”

Developers of the Russian vaccine against the COVID-19 coronavirus Sputnik V regularly ignored the provision of data to the European Medicines Agency (EMA), which is considered a standard requirement for drug approval in the EU. Because of this, the regulator has not yet made a decision on this drug. Reuters citing five sources on Tuesday 13 July.

The safety and efficacy review of Sputnik V was again postponed in June as the Russians missed the deadline for providing the regulator with the necessary data on clinical trials of the vaccine. Previously, it was assumed that the vaccine could be approved in May or June.

As a result, since early June, the EMA has received virtually no production data, and the clinical data provided to the agency was incomplete.

Separately, French experts found that Russia was unable to document that the main cell bank (from which the drug was created) complies with specific EU standards to prevent infection with diseases.

Clinical information was lacking at the time of the review, in particular the form for reporting adverse events. It is also unclear how the researchers tracked the results of people who received a placebo.

The supervisory authority rates such reporting gaps on a scale ranging from “critical” and “most serious” to “serious” and “minor”. So far, “nothing has reached a critical threshold,” but there are a few basic things that can be addressed. According to one of the interlocutors, it is unlikely that the check will be completed before the end of the summer.

The Russian Institute of Gamaleya, which developed Sputnik-V, repeatedly refused to provide the experts with the missing information, and explained their actions by “insufficient experience of cooperation with EMA.”

Sputnik V has been approved by more than 60 countries around the world. However, the drug has not yet been approved by the European regulator. In the EU, only Slovakia and Hungary agreed to purchase the drug. Wherein Slovakia sold back to Russia almost the entire batch of vaccine.

It was also reported that WHO detects violations during the Sputnik V spill… The Kremlin acknowledged the problem, but assured that the manufacturing company had already corrected all complaints from WHO.

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