First bird flu mRNA vaccine enters late-stage trial

Moderna moved its H5N1 vaccine candidate into the first late-stage human trial for a pandemic bird flu shot made with mRNA technology. The Phase 3 study will evaluate the safety and immunogenicity of mRNA-1018 in healthy adults ages 18 and older, and is expected to enroll approximately 4,000 participants across the US and the UK. They're healthy adults being studied so scientists can understand how the vaccine behaves before any emergency forces their hand.


Bird flu, specifically the H5N1 strain, has been spreading quietly but persistently. The CDC says A(H5) bird flu is widespread in wild birds globally, causing outbreaks in poultry and US dairy cows, with sporadic human cases among dairy and poultry workers.


Moderna's CEO Stéphane Bancel was direct about the stakes: "H5 influenza, or bird flu, remains a pandemic threat. The start of our Phase 3 trial for an H5 influenza vaccine marks a significant milestone in our ongoing efforts to strengthen global pandemic preparedness. Our platform technology's efficiency and scalability are critical to supporting global health security and responding to potential future threats."


“Although the current risk to the human population of avian influenza remains low, the virus continues to evolve and spread in birds and various animal hosts in the UK and elsewhere,” said Dr. Richard Pebody, Director of Epidemic and Emerging Infections at the UK Health Security Agency (UKHSA). “UKHSA remains alert to the potential that this pathogen could adapt to spread from person to person, and will continue to monitor all available data. This important initiative to trial a new mRNA pandemic influenza vaccine is a key step towards further strengthening our ability to protect people against future influenza pandemics.”


Should the vaccine prove effective and receive regulatory approval, Moderna has committed to allocating 20% of its mRNA-1018 manufacturing capacity for affordable supply to low- and middle-income countries under its agreement with CEPI. “The first-of-its-kind pivotal trial of an mRNA-based pandemic influenza vaccine underscores the potential of this technology to reshape how we confront emerging pathogens,” said Dr. Richard Hatchett, CEO of CEPI. “If successful, these efforts could transform our ability to respond swiftly and equitably to one of the world’s most enduring threats.”