Moderna Inc. (NASDAQ:MRNA) has announced that it has finalized the enrolment of 30,000 subjects in the Phase 3 COVE trial of its experimental COVID-19 vaccine candidate, mRNA-1273. This is a huge milestone for the company and efforts of developing a COVID-19 vaccine
Moderna has completed the second dosing of 25,650 participants
The study is being conducted in partnership with the National Institute of Allergy and Infectious Diseases (NIAID). It is part of the NIH and Biomedical Advanced Research and Development Authority (BARDA). The company indicated that over 25,650 subjects have received their second shot of the mRNA-1273 vaccine to date. According to the company, the study participants include over 11,000 individuals from minority communities, including over 3,000 black or African-American and 6,000 Hispanic or Latin-American subjects.
Moderna is expected to determine if they will apply for Emergency Use Authorization (EUA) to the FDA. The application will be based on whether the potential benefits of the COVID-19 vaccine will outweigh the risks. This will be after the 2-months median safety follow-up has been attained after full vaccination.
COVE study includes seniors and individuals at high risk of severe COVID-19
The company has shared a statement at the US FDA vaccines and Related Biological Products Advisory Committee meeting. Moderna has collaborated with NIH and BARDA, including the NIAID’s COVID-19 Prevention network in conducting the Phase 3 COVE study. The study is being conducted under Operation Warp speed. The company’s partner PPD (NASDAQ:PPD) has helped the successful execution of the COVE study. The partner had also supported the Phase 2 trial of mRNA-1273.
Moderna’s Phase 3 COVE study has been designed to evaluate individuals at high risk of severe COVID-19. So far, over 7,000 seniors above 65 years have been enrolled in the study, including over 5,000 individuals below 65 years but at high risk of infection. These are individuals with diabetes, cardiac disease, and severe obesity who are at high risk. These medically high-risk individuals account for 42% of the total subjects in the Phase 3 COVE study.