The European Commission is not negotiating the purchase of the Russian Sputnik V coronavirus vaccine and any positive evaluation of it by the European Medicines Agency does not necessarily mean that it will be included in the common vaccine procurement strategy, a Commission spokesman said on Thursday.
No talks are ongoing to include Sputnik V in the European vaccine portfolio, the Commission’s health policy spokesman Stefan De Keersmaecker said, adding that the Commission and EU member states can always include a new vaccine in the European portfolio.
The Commission’s chief spokesman Eeric Mamer noted that any positive evaluation of any vaccine by the European Medicines Agency (EMA) did not automatically mean that the Commission was then required to include the vaccine in question in the European portfolio. These are two completely separate issues, he added.
EMA, the EU medical regulator, announced on Thursday it had started a rolling review of Sputnik V, a COVID-19 vaccine developed by Russia’s Gamaleya National Centre of Epidemiology and Microbiology, for possible approval of its use in the EU.
“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,” the regulator said.
As part of its European vaccine strategy, the Commission has so far signed contracts with six COVID-19 vaccine manufacturers – AstraZeneca, Johnson&Johnson, Pfizer/BioNTech, CureVac, Moderna and Sanofi-GSK. Preliminary talks have been held with two more manufacturers, Novavax and Valneva, but contracts have not been signed yet.
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