EMA will not approve Russian and Chinese vaccines unless they request authorisation

Both countries have signalled no intention of requesting the approval and the European regulator’s chief said on Wednesday that the agency has no intention of speeding up the authorisation process.

EMA Executive Director Emer Cooke told the Italian daily La Repubblica that there is no political pressure to approve the vaccines and that the agency “will study the data” once both countries file for authorisation.

“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.

China has already 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. This generated widespread concerns among the medical sector regarding the safety and efficacy of the jab.

The EMA is set to complete its review of the Pfizer and BioNTech vaccine by 29 December and finalise the review of the Moderna vaccine by 12 January of 2021.