Core Insights - Moderna (MRNA) has received up to $54.3 million from the Coalition for Epidemic Preparedness Innovations (CEPI) to support a pivotal phase III study of its mRNA-based H5 pandemic influenza vaccine candidate, mRNA-1018 [1][8] Group 1: Study Details - The phase III study will be the first of its kind for an mRNA-based pandemic influenza vaccine and is set to begin in early 2026 [2][8] - The study will assess the safety and immunogenicity of mRNA-1018 in the U.S. and the U.K., building on positive phase I/II data [3][8] - Potential licensure may also depend on data from a phase III study of Moderna's seasonal influenza vaccine, mRNA-1010 [3] Group 2: Global Impact and Accessibility - If approved, Moderna plans to allocate 20% of its H5 vaccine production for low and middle-income countries at affordable prices [4][8] - The mRNA-1018 vaccine would enhance the global H5 vaccine portfolio and support CEPI's goal of developing effective vaccines within 100 days of identifying a new pandemic threat [9] Group 3: Broader Development Activities - The project is part of a larger collaboration between CEPI and Moderna aimed at rapidly developing vaccines for epidemic and pandemic threats using mRNA technology [6] - Moderna is currently developing over 40 mRNA-based investigational candidates across various clinical stages, targeting multiple indications including cancer [9][10] Group 4: Market Performance - Over the past six months, Moderna's shares have increased by 19.5%, while the industry has risen by 22.4% [5] - Following the end of the COVID-19 pandemic, sales of Moderna's COVID-19 vaccines have significantly declined, making the successful development of other vaccine candidates crucial for the company [11]
MRNA to Get CEPI Funding for Phase III Study on Pandemic Influenza Jab