The U.S. Department of Health and Human Services (HHS) has awarded Moderna approximately $590 million to accelerate the development of mRNA-based pandemic influenza vaccines. This substantial funding aims to bolster national preparedness against emerging infectious diseases, particularly avian influenza strains.
The funding, provided through the Biomedical Advanced Research and Development Authority (BARDA), will support the late-stage development and licensure of pre-pandemic mRNA vaccines. Moderna plans to use the funds to advance its H5N1 mRNA influenza vaccine, which is closely matched to currently circulating strains in cows and birds. The company will also expand clinical studies to evaluate mRNA vaccines against up to five additional subtypes of pandemic influenza.
Advancing mRNA-1018 to Phase 3
In 2023, Moderna initiated a Phase 1/2 study to assess the safety and immunogenicity of its investigational pandemic influenza vaccine, mRNA-1018, in healthy adults aged 18 and older. The study included vaccine candidates targeting H5 and H7 avian influenza viruses. Based on positive preliminary data, Moderna is preparing to advance mRNA-1018 into Phase 3 clinical trials. The company anticipates sharing the Phase 1/2 results at an upcoming scientific meeting.
Addressing Avian Influenza Threat
Avian influenza, particularly the H5N1 strain, has raised concerns among health officials due to its potential to infect humans. As of recent reports, there have been 67 confirmed human cases in the U.S., including one death in Louisiana. While the CDC currently assesses the public health risk as low, with no evidence of human-to-human transmission, the HHS emphasizes the importance of proactive measures.
"Avian flu variants have proven to be particularly unpredictable and dangerous to humans in the past," said HHS Secretary Xavier Becerra. "Accelerating the development of new vaccines will allow us to stay ahead and ensure that Americans have the tools they need to stay safe."
Expanding Vaccine Development
In addition to the H5N1 vaccine, Moderna will design and test an H7N9 mRNA pandemic influenza vaccine in a Phase 3 clinical study. If successful, this vaccine could potentially become the first licensed for H7N9. The company also plans to design up to four additional novel pandemic influenza vaccines and evaluate their safety and immunogenicity in Phase 1 clinical studies.
This new funding builds upon a previous $176 million award from HHS in July 2024, further solidifying the government's commitment to leveraging mRNA technology for rapid vaccine development. The existing U.S. strategic national stockpile contains bird flu vaccine candidates made with older technology.
