EMA Provides Rapid Feedback on GSK Ebola Vaccine


Applied Clinical Trials

European Medicines Agency has given 'rapid scientific advice'

For the first time in the current Ebola outbreak, the European Medicines Agency (EMA) has given ‘rapid scientific advice’ using an accelerated procedure to GSK on its development plan for an Ebola vaccine.

Through rapid scientific advice, developers can receive EMA’s expert opinion and advice on topics such as clinical trial design, manufacturing-related questions as well as safety monitoring of medicines. EMA established this procedure to contribute to the global response against Ebola and to help companies speed up the development of vaccines and treatments.

EMA hopes this procedure will help companies to generate the robust data and information needed to assess that treatments and vaccines against Ebola actually work, are acceptably safe and of high quality. It says it will assess any data in a ‘rolling review’, as soon as they become available.

The initial review and any subsequent updates will be shared with healthcare decision-makers in countries affected by the current Ebola outbreak. This will help them to take informed decisions on whether and how they want to use vaccines and medicines in their specific situation.

Read the full release here.

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