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Italian Medicines Agency Agenzia Italiana del Farmaco

EMA starts rolling review of mRNA COVID-19 vaccine by Moderna Biotech Spain, S.L. - EMA starts rolling review of mRNA COVID-19 vaccine by Moderna Biotech Spain, S.L.

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EMA starts rolling review of mRNA COVID-19 vaccine by Moderna Biotech Spain, S.L.

EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on a vaccine for COVID-19 known as mRNA-1273, which is being developed by Moderna Biotech Spain, S.L. (a subsidiary of Moderna, Inc.).

The CHMP’s decision to start the rolling review of mRNA-1273 is based on preliminary results from non-clinical studies and early clinical studies in adults which suggest that the vaccine triggers the production of antibodies and T cells (cells of the immune system, the body’s natural defences) that target the virus. 

The Committee has started evaluating the first batch of data on the vaccine, which come from laboratory studies (non-clinical data). Large-scale clinical trials involving several thousands of people are ongoing, and results are expected shortly. These results will provide information on how effective the vaccine is in protecting people against COVID-19 and will be assessed once submitted to the agency. All the available data on the safety of the vaccine as well as its pharmaceutical quality (such as its ingredients, the way it is produced, stability and storage conditions) will also be reviewed as they become available.

The rolling review will continue until enough evidence is available to support a formal marketing authorisation application.

EMA will assess the vaccine’s compliance to the usual standards for effectiveness, safety and quality. While the overall review timeline cannot be forecast yet, the process should be shorter than a regular evaluation due to the time gained during the rolling review.


Published on: 16 November 2020

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