December 9, 2020
ROME (Reuters) – Russia and China have not requested authorisation from the European Medicines Agency (EMA) for their COVID-19 vaccines and the agency is not under political pressure to speed up vaccine approvals, the regulator’s chief said in remarks published on Wednesday.
“For the time being they have not sought authorisation for their vaccines. If they do, we will study the data,” EMA’s Executive Director Emer Cooke told Italian daily la Repubblica, when asked about the Chinese and Russian vaccines.
China has approved three vaccine candidates developed by Sinovac and state-owned Sinopharm for emergency use.
Russia was the first country to grant regulatory approval for a novel coronavirus vaccine, doing so before large-scale trials were complete, stirring concern among scientists and doctors about the safety and efficacy of the shot.
The Russian vaccine Sputnik V is being developed by Moscow’s Gamaleya Research Institute and marketed by Russia’s sovereign wealth fund, the Russian Direct Investment Fund (RDIF).
Cooke said the agency was not under any pressure to accelerate procedures to authorise the vaccine developed by Pfizer and BioNTech or one by Moderna.
“If anything, the pressure is scientific, because we want to be certain to do what is best for citizens” she said, adding that EMA acted independently.
She said the agency was still expecting to complete its review of the Pfizer and BioNTEch vaccine by Dec. 29 and to finalise its review of the Moderna vaccine by Jan. 12.
The European Union Commission authorises vaccines based on EMA’s scientific advice after consultation with the 27 EU states.
(Reporting by Giulia Segreti)
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