Business & Regulation Vaccines, Standards & Regulation, COVID-19

V for Victory?

Controversy-ridden vaccine, Sputnik V, (finally and definitely) starts rolling review with the EMA

Stephanie Sutton | 03/12/2021 | Quick Read

The EMA has started a rolling review of Sputnik V, developed by Russia’s Gamaleya National Centre of Epidemiology and Microbiology.

Sputnik V was approved for emergency use in Russia in August, but the approval was met with some criticism; large-scale trials had not been conducted at that time. However, data released in recent months appear to confirm that the vaccine has over 90 percent efficacy. The decision to start the rolling review is based on studies that support the vaccine’s ability to trigger antibodies and immune cells that target SARS-CoV-2 (1).

Russia’s sovereign wealth fund, RDIF, which is responsible for marketing Sputnik V abroad, actually reported in February that the vaccine had already been submitted to the EMA for rolling review, but the EMA later tweeted that it had received no such submission. It has since been reported that the dossier may have been accidentally submitted to the Heads of Medicines Agencies (HMA) by mistake (2).

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Business & Regulation Vaccines, Standards & Regulation, COVID-19

EMA, “EMA starts rolling review of the Sputnik V COVID-19 vaccine,” (2021). Available at: bit.ly/3kSYqiB 
Reuters, “Confusion over Russia's EU vaccine approval bid could be result of misdirected application,” (2021). Available at reut.rs/3edKDBY.

Stephanie Sutton

Making great scientific magazines isn’t just about delivering knowledge and high quality content; it’s also about packaging these in the right words to ensure that someone is truly inspired by a topic. My passion is ensuring that our authors’ expertise is presented as a seamless and enjoyable reading experience, whether in print, in digital or on social media. I’ve spent fourteen years writing and editing features for scientific and manufacturing publications, and in making this content engaging and accessible without sacrificing its scientific integrity. There is nothing better than a magazine with great content that feels great to read.