Arcturus Confident in Retaining BARDA Funding for Bird Flu Vaccine Trial Amid Moderna Uncertainty

Arcturus Therapeutics, a San Diego-based biopharmaceutical company, has expressed confidence in maintaining its government funding for an ongoing bird flu vaccine trial, despite recent reports suggesting potential cuts to Moderna's similar program. This development comes as the pharmaceutical industry intensifies efforts to combat emerging influenza threats and bolster pandemic preparedness.

BARDA Funding and Clinical Trial Progress

Arcturus initiated a phase 1 trial for its self-amplifying mRNA vaccine, LUNAR-H5N1, in December. The study, aiming to enroll 200 healthy adults in the United States, is fully supported by a Biomedical Advanced Research and Development Authority (BARDA) contract worth up to $63 million.

Joseph Payne, CEO of Arcturus, emphasized the importance of the trial, stating, "Clinically validating our low-dose STARR mRNA technology in H5N1 flu is a crucial step towards pandemic preparedness." The company is collaborating with BARDA and CSL in this global effort.

An Arcturus spokesperson recently told Fierce Biotech, "We have not heard anything from BARDA regarding termination of our contract and it would be highly unlikely due to the timing of this trial and the follow-up safety reviews for the participants in the trial." The company expects an interim readout from the trial in the second half of this year.

Moderna's Uncertain Funding Situation

In contrast to Arcturus' optimism, Moderna's bird flu vaccine program faces potential setbacks. The company secured a $590 million contract from BARDA in January to support two phase 3 studies of its mRNA vaccine against different bird flu strains and to advance four new influenza vaccines into phase 1 trials.

However, recent reports from Bloomberg suggest that the Department of Health and Human Services (HHS) is reevaluating this contract. When approached for comment, Moderna declined to respond, while an HHS spokesperson stated that "four years of the Biden administration's failed oversight have made it necessary to review agreements for vaccine production."

Emerging Threats and Industry Response

The increased focus on bird flu vaccines comes as certain strains continue to spread among chickens and dairy cows, with occasional transmission to humans. While not currently widespread in human populations, virologists remain concerned about the potential for another pandemic.

Arcturus' efforts in this field have already yielded results beyond the H5N1 program. The company recently celebrated a regulatory milestone when the European Commission approved its COVID-19 vaccine, KOSTAIVE, which utilizes the same self-amplifying mRNA technology.

As pharmaceutical companies race to develop defenses against potential pandemic threats, the industry watches closely to see how government funding decisions will shape the landscape of vaccine development and pandemic preparedness in the coming months.