CEPI steps in to fund Moderna's pandemic flu jab

Moderna's mRNA-based pandemic flu vaccine – which had federal funding pulled earlier this year amid an increasingly vaccine-sceptic stance by the Trump administration – has been thrown a lifeline by an international consortium.

The Coalition for Epidemic Preparedness Innovations (CEPI), a public-private partnership, is providing up to $54.3 million in financial backing for the mRNA-1018 candidate, which should be enough to advance it into phase 3 testing.

At the start of the year, Moderna was sitting on federal contracts worth up to $760 million to develop flu vaccines, including a $176 million contract to develop a candidate for H5 strains of bird flu. Those were cancelled in May by HHS Secretary Robert F Kennedy Jr, who has steered the department and its agencies in an increasingly anti-vaccine direction since his appointment.

Kennedy has made no secret of his scepticism about the safety of mRNA vaccines, and the decision to pull funding from mRNA-1018 came shortly after Moderna revealed positive interim data from a phase 1/2 trial of the candidate, which targets the H5N8 bird flu subtype as well as another strain known as H7N9. The data showed a rapid, potent, and durable immune response to two doses of the jab.

According to CEPI, the new funding should be enough to cover a pivotal phase 3 trial in the UK and US that will start early next year and, if positive, should support licensure of the vaccine.

It's a boost for Moderna, which made billions from the sale of mRNA-based COVID-19 vaccines but has seen the business sharply reduced by changes to immunisation recommendations and insurance coverage in the US.

In November, Moderna agreed a $1.5 billion loan facility over five years to give it "increased flexibility" as it strives to a target of achieving breakeven in its finances in 2028.

The move comes amid a major outbreak of bird flu in the US and other countries around the world, decimating wild bird populations and hitting the poultry and dairy cow sectors. According to CDC data, there have been 71 cases of human infection since 2024, resulting in two deaths. Most are linked to close contact with livestock, and so far, there is no evidence for human-to-human transmission that could lead to a pandemic.

If mRNA-1018 does get authorised, Moderna has committed to allocating 20% of its H5 pandemic vaccine manufacturing capacity for supply to low-and middle-income countries at affordable pricing as part of its funding deal with CEPI.

In the event of an H5N1 influenza pandemic, the Moderna Innovation and Technology Centre in the UK would be expected to support the response, including through the manufacture of an approved H5N1 vaccine, subject to the necessary regulatory and government processes.

"Pandemic influenza remains one of the greatest threats to global health security.," commented CEPI chief executive Dr Richard Hatchett.

"With this partnership, we are not just advancing vaccine science, we are fundamentally changing the game," he added. "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."

Prior to the loss of federal funding, the Trump administration indicated that its pandemic preparedness efforts would now be focused on universal vaccines based on an inactivated, whole-virus platform, a scheme called Generation Gold Standard.