Biotechnology company Moderna Inc's (Nasdaq:MRNA) vaccine against COVID-19 has 94.1% efficacy against COVID-19 and 100% efficacy against the severe form of the disease, the company announced on Monday.
The primary efficacy analysis of the Phase 3 COVE study of mRNA-1273 involving 30,000 participants included 196 cases of COVID-19, of which 30 cases were severe. All 30 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group.
Moderna said that it plans to immediately request Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) and conditional approval from the European Medicines Agency (EMA).
The company has already initiated the rolling review process with the EMA, Health Canada, SwissMedic, the UK Medicines and Healthcare products Regulatory Agency (MHRA), Ministry of Health in Israel, and Health Sciences Authority in Singapore and intends to seek Prequalification (PQ) and/or Emergency Use Listing (EUL) with the World Health Organization (WHO).
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