EMA Experts Positively Evaluate Sputnik V Production Standards, Vaccine Developer Says

MOSCOW (Sputnik) - The European Medicines Agency (EMA) experts have positively evaluated production standards for Sputnik V COVID-19 vaccine, Denis Logunov, the deputy head of the Gamaleya Research Centre, said on Tuesday.

"Regarding how the production standards are recognised, work is underway here, because after all, production standards in Europe, China and Russia must be harmonised, and this part of the work is to recognise production standards, the recognition of how clinical trials were carried out … the EMA has already arrived and we have no critical remarks regarding the conduct of clinical trials, we received a positive conclusion," Logunov told the Soloviev Live Youtube channel.

Sputnik V has been under review by the EMA since March 2021. Hungary and Slovakia approved the vaccine without waiting for EMA authorisation.

Sputnik V, the world's first registered vaccine against the COVID-19 infection, was unveiled on 11 August 2020, following Phase 1 and 2 clinical trials. Phase 3 clinical trial results were published in the Lancet magazine on 2 February 2021. The vaccine is based on a well-studied human adenovirus vector platform. The efficacy of Sputnik V has been proven at 97.6%, based on the analysis of data on the occurrence of the COVID-19 infection among Russians vaccinated with both components from December 2020 to late March 2021.

Sputnik V has already been authorised in 71 countries with a total population of more than 4 billion people.