Moderna begins Phase 3 trial of mRNA-1018 H5 influenza vaccine in the US and UK, supported by CEPI funding to advance pandemic preparedness.
Written By: Samiksha Jadhav, BPharm
Reviewed By: Pharmacally Editorial Team
Moderna has initiated a Phase 3 clinical trial of its investigational mRNA-based H5 pandemic influenza vaccine candidate, mRNA-1018, with the first participants dosed in the United States and the United Kingdom.
The study will evaluate safety and immunogenicity in approximately 4,000 healthy adults aged 18 years and older and is supported by funding of up to $54.3 million from the Coalition for Epidemic Preparedness Innovations (CEPI), announced in December 2025.
H5 influenza, or bird flu, remains under close surveillance as a potential pandemic threat due to its continued circulation and evolution in animal populations.
Stéphane Bancel Chief Executive Officer of Moderna stated that the Phase 3 trial represents progress in strengthening pandemic preparedness and highlighted the importance of mRNA platform scalability in responding to emerging health threats.
Richard Hatchett CEO of CEPI noted that the trial underscores the potential of mRNA technology to improve response speed and equity in addressing emerging pathogens.
The development of mRNA-1018 is supported by broader influenza vaccine efforts at Moderna, including its seasonal candidate mRNA-1010, which is under regulatory review in the United States, European Union, Canada, and Australia.
Richard Pebody Director of Epidemic and Emerging Infections at the UK Health Security Agency stated that although the current risk of avian influenza to humans remains low, continued viral evolution necessitates close monitoring, and the trial represents an important step in improving preparedness.
Under its agreement with CEPI, Moderna has committed to allocating 20% of its H5 pandemic vaccine manufacturing capacity to low- and middle-income countries at affordable pricing in the event of a pandemic, supporting equitable global access if the vaccine is successfully licensed.
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About the Writer
Samiksha Vikram Jadhav is a B.Pharm graduate with a strong academic foundation in pharmaceutical sciences, pharmacology, and drug development. She has a keen interest in healthcare advancements, clinical research, medical writing, and emerging therapies. Her work focuses on presenting developments in the pharmaceutical and healthcare sectors through clear and accurate scientific communication.