Biotechnology company Moderna said on Monday that it will request the US and European regulators to issue an emergency authorisation for its coronavirus vaccine, which it said is 100% effective against severe COVID-19 cases.
Moderna said the primary efficacy analysis of the Phase-3 study of its vaccine candidate mRNA-1273 conducted on 196 cases indicates a vaccine efficacy of 94.1 per cent. While the vaccine efficacy against COVID-19 was 94.1 per cent, vaccine efficacy against severe COVID-19 was 100 per cent, the company said.
Moderna plans to request an Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) and conditional approval from the European Medicines Agency (EMA) for the vaccine.
This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and importantly, the ability to prevent severe COVID-19 disease. We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalisations and death, Chief Executive Officer of Moderna Stephane Bancel said.
Bancel said the company will file today (Monday) for an Emergency Use Authorisation from the FDA and continue forging ahead with the rolling reviews that have already been initiated with several regulatory agencies around the globe.
Moderna anticipates that the shipping of the vaccine to designated distribution points throughout the US will occur shortly after an Emergency Use Authorisation is granted.
Moderna will also submit an application for Conditional Marketing Authorisation (CMA) with the European Medicines Agency (EMA). The company has already initiated the rolling review process with other global regulatory bodies such as Health Canada, SwissMedic, the United Kingdom 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 Organisation (WHO).
The Phase 3 study, known as the COVE study, enrolled more than 30,000 participants in the US and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services.
The company said efficacy was consistent across age, race and ethnicity, and gender demographics. The 196 COVID-19 cases included 33 older adults (ages 65+) and 42 participants identified as being from diverse communities (including 29 Hispanic or LatinX, 6 Black or African Americans, 4 Asian Americans and 3 multiracial participants). Based on prior analysis, the most common side effects included injection site pain, fatigue, headache, and redness at the injection site.
The company will submit data from the Phase 3 COVE study to a peer-reviewed publication.
Moderna is working with the US CDC and other authorities and global stakeholders to be prepared for distribution of the vaccine in the event that it receives an EUA and similar global authorisations and approvals. By the end of 2020, the company expects to have approximately 20 million doses of the vaccine available in the US and remains on track to manufacture 500 million to 1 billion doses globally in 2021.