EMA announces rolling review of coronavirus (COVID-19) vaccine, mRNA-1273

EMA announces rolling review of coronavirus (COVID-19) vaccine, mRNA-1273

The European Medicines Agency (EMA) has announced that its human medicines committee (CHMP) will begin a rolling review of data on mRNA-1273, a coronavirus (COVID-19) vaccine which is being developed by Moderna Biotech Spain. CHMP has already started reviewing the first batch of data, which is non-clinical, and will in due course review the data from large-scale clinical trials. The rolling review will continue until sufficient evidence is available to support a formal marketing authorisation application.

Preliminary results from non-clinical studies and early clinical studies in adults, suggest that mRNA-1273 produces antibodies and T cells (cells of the immune system) that target the virus. The results from the clinical trials will provide information on the effectiveness of the vaccine to protect against coronavirus. The EMA will also assess the safety and quality of the vaccine once more data is available.

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

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