WHO close to finish Sputnik V review, EMA still demands data

12:34, 21 October 2021
WHO close to finish Sputnik V review, EMA still demands data Photo:

The World Health Organization is approaching the last frontier in a reviewing process of Russia’s vaccine against coronavirus, Sputnik V, as a team of examiners is expected to pay a visit to Russia, the Russian Direct Investment Fund said.

The Twitter page for Sputnik V reads: “WHO confirmed Sputnik V pre-qualification process is on track and entering its final stage. A group of WHO inspectors is due to visit Russia shortly to round up all the necessary inspections & paperwork on #SputnikV, one of the world’s safest & most efficient vaccines.”

However, the European Medicines Agency is not sure about whether to approve Russia’s Sputnik V in the first quarter of 2022 as there is still some lacking data that must be reviewed to complete the approval process, said Reuters citing a source with knowledge of the matter.

If the agency receives the missing data by the end of November, “then the regulators may well decide in the first quarter of next year,” source said.

The source decided to remain non-pronounced because of “the sensitivity of the matter,” Reuters said.

The EMA has been working under the consideration of Russia’s Sputnik V since March and had been expected to announce the results of its review and subsequent potential approval by May or June. 

The initial results of Phase #3 issued in The Lancet in February showed the vaccine’s effectiveness of 92%. Later Russia said that the efficiency of its vaccine against the Delta variant was approximately 83%.

The vaccine is being widely used in Russia and has been authorized in 70 countries.