The Coalition for Epidemic Preparedness Innovations (CEPI) is to invest up to $54.3 million to support a pivotal Phase III clinical trial that aims to help advance Moderna’s investigational mRNA-based H5 pandemic influenza vaccine candidate, mRNA-1018, to licensure.  

The organisation says the funding marks a significant step forward in global pandemic preparedness that could enable fast, equitable access to vaccines for one of the world’s most pressing health threats. 

This Phase III study would be the first mRNA-based vaccine targeting pandemic influenza to enter a pivotal trial.  

If the vaccine candidate is licensed, CEPI says it would expand the current global portfolio of H5 vaccines with a rapid-response platform that could revolutionise future pandemic response. 

It will also make a significant contribution to the Coalition’s 100 Days Mission, a global goal to develop safe and effective vaccines within 100 days of a new pandemic threat being identified. 

Dr Richard Hatchett, Chief Executive Officer of CEPI, said: “Pandemic influenza remains one of the greatest threats to global health security. With this partnership, we are not just advancing vaccine science, we are fundamentally changing the game. By harnessing the speed and adaptability of mRNA technology, we could shave months off the response time, deliver vaccines at scale, and enable equitable access for all. This is how we plan to protect the world from the next flu pandemic.” 

As part of this agreement, Moderna will allocate 20% of its H5 pandemic vaccine manufacturing capacity for timely supply to low- and middle-income countries at affordable pricing. 

The Phase III trial will build upon positive Phase I/II results which showed rapid and persistent immune responses in healthy adults aged 18 years and older. Potential licensure of the vaccine will also leverage data from a pivotal Phase III trial of Moderna’s investigational seasonal influenza vaccine, mRNA-1010.

Diana Turner, Deputy Editor, DDW