EMA starts rolling review of Russia's Sputnik V vaccine

The European Medicines Agency (EMA) started on Thursday the rolling review of Russian COVID-19 vaccine Sputnik V amid rising concerns over the current shortfall in supply of jabs in the European Union (EU).

The application of Sputnik V, developed by Russia's Gamaleya National Centre of Epidemiology and Microbiology, was submitted by its EU partner R-Pharm Germany GmbH.

"EMA will evaluate data as they become available to decide if the benefits outweigh the risks. The rolling review will continue until enough evidence is available for formal marketing authorisation application," said the agency.

Meanwhile, the European Commission confirmed on Thursday it hasn't initiated any contact with Gamaleya. "Currently no talks are ongoing to integrate Sputnik V in the portfolio", said Stefan De Keersmaecker, the commission's spokesperson for public health.

"It is not because a vaccine is approved at European level following a positive assessment by EMA that there is any obligation on the Commission to include it in our portfolio," declared Eric Mamer, the commission's chief spokesperson, during a daily briefing.

So far, three COVID-19 vaccines developed by BioNTech-Pfizer, Moderna and AstraZeneca have been authorized by the EU. Another one produced by Janssen is under evaluation at EMA.

The EU has a vaccine strategy that allows the commission to negotiate on behalf of the bloc with pharmaceutical companies to secure the diverse portfolio of vaccines. But the recent shortage of doses have pushed some member countries to start contracting with Russian and Chinese vaccine developers.

In total, 258 candidate vaccines are still being developed worldwide -- 76 of them in clinical trials -- in countries including Germany, China, Russia, Britain, and the United States, according to information released by the World Health Organization on Tuesday.