Moderna has dosed the first participants in the US and UK for a Phase 3 study of its investigational mRNA-based H5 pandemic influenza vaccine, mRNA-1018. This critical step addresses growing concerns over the pandemic potential of avian flu, commonly known as 'bird flu'.
Moderna CEO Stéphane Bancel emphasized that H5 influenza remains a significant pandemic threat, and the Phase 3 trial marks a major advancement in global pandemic preparedness. The study will evaluate the safety and immunogenicity of mRNA-1018 in approximately 4,000 healthy adults aged 18 and above across the US and UK, with a majority recruited in the UK.
This pivotal trial is supported by Moderna's collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI). Dr. Richard Hatchett, CEO of CEPI, highlighted the potential of mRNA technology to revolutionize responses to emerging pathogens, aiming for swift and equitable containment of global threats.
Should the vaccine prove successful and receive licensure, Moderna has committed to allocating 20% of its H5 pandemic vaccine manufacturing capacity for affordable supply to low- and middle-income countries, as per its agreement with CEPI. The UK Health Security Agency continues to monitor avian flu data, noting that while human risk is currently low, the virus's evolution necessitates vigilance.