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Coronavirus Notebook: EMA Explains How To Get A Modified Vaccine Approved, UK Starts Oxford/AZ Variant Vaccine Trial

 
• By Ian Schofield

Draft legislation on strengthening the European Medicines Agency’s role in health crises has cleared another hurdle, and the European Commission is inviting companies to a matchmaking event aimed at scaling up the development and production of COVID-19 therapeutics.

Box of AstraZeneca COVID-19 vaccine
A modified version of the Oxford/AZ vaccine is being studied against the beta variant • Source: Alamy

Companies seeking EU approval of versions of authorized COVID-19 vaccines that have been modified to address variants of the SARS-CoV-2 virus have been advised to contact the European Medicines Agency three months in advance of their planned submission. They have also been told to seek scientific advice as early as possible to discuss the choice of variant.

Modified vaccines will be assessed as variations to the original marketing authorization (MA) under an expedited timetable and the could also undergo a rolling review, says the EMA

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• By Craig Bleifer, Royce DuBiner, Max Bogost, Michael Brody, and Allyson Maur

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