European Medicine Agency (EMA) starts rolling review of mRNA-1273 COVID-19 vaccine by Moderna Biotech Spain

Decision to start rolling review is based on first interim analysis (n=95) of phase 3 study which demonstrated a vaccine efficacy of 94.5% (p <0.0001). Moderna expects marketing authorisation to be based on a final analysis of 151 cases and median follow-up of > 2 months.

SPS commentary:

The UK government has secured 5 million doses of the covid-19 vaccine candidate (mRNA-1273) from US biotech company Moderna after results of this interim analysis and could be delivered to UK spring 2021.

This news comes just over a week after Pfizer announced that its covid-19 vaccine candidate was more than 90% effective, following its interim analysis. Neither Pfizer nor Moderna have published their full results yet, only releasing information through press releases.

European Medicines Agency

Resource links:

UK government secures 5 million doses of the covid-19 vaccine candidate (mRNA-1273) from US biotech company Moderna

Pfizer press release