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).
The technology transfer for BrainStorm's NurOwn® autologous cell therapy at Catalent’s facility has been finalized. NurOwn will be manufactured at Catalent’s world-class 32,000 square-foot cell therapy manufacturing facility in Houston.
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References
- EMA, “EMA starts rolling review of the Sputnik V COVID-19 vaccine,” (2021). Available at: https://bit.ly/3kSYqiB
- Reuters, “Confusion over Russia's EU vaccine approval bid could be result of misdirected application,” (2021). Available at https://reut.rs/3edKDBY.
