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An ever-changing landscape - European regulator looks to speed up authorisation process for modified vaccines addressing COVID-19 variants

At a time where drug makers are taking action to develop modified versions of their vaccines in order to address the evolving variants of COVID-19, European regulators are also taking steps to facilitate the timely review and approval of such modified vaccines.

Given the urgency in the current landscape, and to enable science to keep up with the increasing variations of the disease, European regulators have acknowledged that in order to effectively protect against such variants, new guidelines may need to be published to speed up the process and to increase the efficiencies of clinical trials. The chair of the vaccine evaluation team at the European Medicines Agency ("EMA"), Marco Cavaleri, has stated that steps may be taken such as reducing the number of participants required to take part in the clinical trials and applying a more streamlined approach to avoid drug makers having to submit preliminary data twice.

Europe’s medicines regulator is planning to speed up assessments of any COVID-19 vaccines that are modified to protect against variants of the virus

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pharmaceuticals, healthcare, europe, clinical trials, covid-19, vaccine

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