US-based biotechnology company Moderna has claimed that its COVID-19 vaccine candidate was 100 per cent effective against severe COVID-19 cases, while it was 94.1 per cent effective in a full efficacy analysis. Primary efficacy analysis of the Phase 3 COVE study of its vaccine candidate (mRNA-1273) included 196 cases of COVID-19, of which 30 cases were severe.
The vaccine efficacy was 94.5 per cent at the first interim analysis with a total of 95 participants with confirmed cases of COVID-19.
"The primary efficacy analysis of the Phase 3 study of mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis," Moderna said in a press release.
The drug maker claimed that efficacy was consistent across age, race and ethnicity, and gender demographics. The 196 COVID-19 cases included 33 older adults (aged above 65 years) and 42 participants from diverse communities (including 29 Hispanic or LatinX, 6 Black or African Americans, 4 Asian Americans and 3 multiracial participants).
The company said that safety data continue to accrue and the study continues to be monitored by an independent, NIH-appointed Data Safety Monitoring Board (DSMB).
Moderna also announced that it plans to request an Emergency Use Authorisation (EUA) from the US Food and Drug Administration (USFDA) and conditional approval from the European Medicines Agency (EMA). The company anticipates that the shipping of its vaccine to designated distribution points throughout the US will occur shortly after receiving EUA.
"The company has already initiated the rolling review process with the EMA, 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 Organization (WHO)," it said.
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 that Phase 3 COVE study has exceeded two months of median follow-up post vaccination as required by the USFDA for emergency use authorisation.
Additionally, Moderna announced that the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review the safety and efficacy data package for mRNA-1273 will likely be scheduled forDecember 17. The company expects that theUS Centers for Disease Control and Prevention(CDC) Advisory Committee on Immunisation Practices (ACIP) will make a recommendation on immunisation priorities.