European Union: Complex administration slowed vaccine approval

European Union: Complex administration slowed vaccine approval

Coronavirus vaccines from Pfizer and BioNtech were approved in Europe long after the United States and the United Kingdom, respectively, due to the complex administrative process of the European Medicines Agency. This was said by Euronews, a former expert from the European Medicines Agency.

“There are two things: science and management. The scientific part consists of researching laboratory data, data from animal experiments, and data from three stages of human testing. These processes are almost identical in Europe, the United States, or anywhere else.” Said Stephen Evans, the expert. The former is in the European Medicines Agency.

However, he emphasized that the administrative part is different for the EMA.

“The scientific evaluation is mainly done by two member states. For Pfizer vaccines, it was Sweden and France. However, approval at the EU level requires the participation of experts from all the member states, who also must agree to the scientific evaluation. Basically, all Member states and the European Commission, Evans said that a vote is required to introduce the vaccine.

Euronews: So the fact that the European Medicines Agency approved the vaccine more slowly than the US or UK is not a matter of scientific rigor but rather a question of management?

Evans: I think we can definitely say that. We can also say that this is a rigorous process. Until recently, the UK was also involved and had the opportunity to participate in the scientific assessment. There will inevitably be a division of labor among the 27 member states, with two countries conducting the scientific assessment, but all countries must be involved. Meanwhile, the licensing process itself and related advice is split among the 27 member states.

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