COVID-19 Has ‘Permanently Changed’ How The EMA Works
During the pandemic, the EU drugs regulator became more flexible and agile and went beyond the formal boundaries of its mandate, says its executive director Emer Cooke, who also warns of the need for the agency to retain the trust of the public.
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The European Medicines Agency says it is talking with international partners and pharmaceutical companies about the epidemiological situation with SARS-CoV-2 and how authorized COVID-19 vaccines can best be adapted to emerging variants.
The EU’s conditional approval of four COVID-19 vaccines and its decision to extend the use of Pfizer/BioNTech’s Comirnaty to a younger age group were challenged in the court last year but the cases were declared inadmissible.
The head of the European Medicines Agency says a group of international regulators got together to ensure “global alignment” on the approach to be taken on COVID-19 vaccination.