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EMA begins rolling review process for Sputnik V COVID-19 vaccine

Late-stage trial results found vaccine gives 91.6% protection against COVID-19

The European Medicines Agency (EMA) has started a rolling review of Russia’s Sputnik V COVID-19 vaccine, the regulatory agency announced today.

The vaccine, developed by Russia’s Gamaleya Institute, consists of two strains of adenoviruses, which usually cause the common cold and are used as ‘vectors’ to carry the gene for the SARS-CoV-2 spike protein.

Late-stage trial results published in The Lancet found that the vaccine was 91.6% effective at protecting against COVID-19.

The observed vaccine efficacy was greater than 87% in all age and gender subgroups, according to researchers, with efficacy in participants over the age of 60 years found to be 91.8%.

The results also suggested the vaccine was 100% effective in preventing severe COVID-19.

The vaccine was reported to be well tolerated, with only 45 (0.3%) of 16,427 participants in the vaccine group reporting serious adverse events.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) started the rolling review based on results from both laboratory studies and clinical studies in adults.

It will assess all available data for the vaccine until it has enough for a formal marketing authorisation application.

“We welcome the start of the rolling review procedure by EMA of Sputnik V. We have provided EMA with comprehensive data on the Russian vaccine, which is now approved for use in more than 40 countries,” said Kirill Dmitriev, chief executive officer of the Russian Direct Investment Fund (RDIF).

“Following EMA approval, we would be able to provide vaccine[s] for 50 million Europeans starting from June 2021,” he added.

Similarly to AstraZeneca(AZ)/Oxford University’s COVID-19 vaccine, Sputnik V can be stored at standard refrigerator temperatures of +2°C to +8°C.

In February, the Ministry for Health of the Republic of Azerbaijan approved clinical trials in the country testing a combination of Sputnik V and the AZ/Oxford vaccine.

The trial, which was due to begin at the end of February, will evaluate the immunogenicity and safety of the vaccine combination against COVID19.

In December 2020, the RDIF, the Gamaleya Institute, AZ and R-Pharm signed a memorandum of intent aimed at cooperation in vaccine development during a meeting with Russian president Vladimir Putin.

Article by
Lucy Parsons

4th March 2021

From: Regulatory

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