Will U.S. ‘s HHS $590 Million Investment Spark a New Era in mRNA Vaccines for Pandemic Flu Threats?

The U.S. Department of Health and Human Services (HHS) will allocate $590 million to Moderna to develop mRNA-based pandemic influenza vaccines. The funding will also enhance mRNA platform capabilities for better preparedness against emerging diseases. Last year, Moderna received $176 million under the same initiative. Since 2023, HHS’s Biomedical Advanced Research and Development Authority (BARDA) has collaborated with Moderna to create mRNA vaccines for potential flu pandemics, including the H5N1 avian influenza strain.

RRPV Supports Moderna’s Phase 3 mRNA Influenza Vaccine Study Amidst Positive Preliminary Data for Pandemic Preparedness

The HHS’s award was granted through the Rapid Response Partnership Vehicle (RRPV) Consortium with funding from BARDA, part of HHS’s Administration for Strategic Preparedness and Response (ASPR). This funding enables Moderna to fast-track the development of an H5N1 mRNA influenza vaccine tailored to strains currently circulating in birds and cows. It also expands clinical data supporting mRNA vaccines for future influenza strains with pandemic potential.

“The award made today is part of the ASPR’s commitment to strengthening pandemic preparedness through investments in innovative technology such as mRNA vaccines,” said Assistant Secretary for Preparedness and Response Dawn O’Connell. “mRNA technology will complement existing vaccine technology, allowing us to move faster and better target emerging viruses to protect Americans’ against future pandemics.”

Moderna’s influenza vaccine candidate relies on the mRNA technology successfully used during the COVID-19 response, which led to one of the first FDA-authorized and later FDA-licensed COVID-19 vaccines. Moderna is currently preparing to launch a phase 3 study for mRNA-1018, targeting H5 and H7 avian influenza viruses. According to the company, the mRNA-1018 vaccine showed “positive preliminary data” in a phase 1/2 study, with results set to be presented at an upcoming medical conference. 

“Avian flu variants have proven to be particularly unpredictable and dangerous to humans in the past. That is why this response has been a top priority for the Biden-Harris Administration and HHS,” 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.”

Phase 3 Trial for H7N9 mRNA Vaccine Launches with Development of Four Additional Pandemic Influenza Vaccines

The Centers for Disease Control and Prevention (CDC) has reported 67 confirmed cases of avian influenza in humans in the U.S., including one death. Although the CDC considers the current public health risk to be “low,” it is closely monitoring the situation and collaborating with states to track individuals exposed to animals.

As a prevention method, Moderna will additionally design and test an H7N9 mRNA pandemic influenza vaccine in a phase 3 clinical trial, which could lead to the first licensed vaccine for H7N9. The company also plans to develop up to four additional novel pandemic influenza vaccines and evaluate their safety and immunogenicity in phase 1 clinical studies. This work will generate essential data to accelerate the development of mRNA vaccines targeting various influenza subtypes with pandemic potential. Moderna’s approach leverages the versatility of its mRNA platform and existing manufacturing capabilities to address multiple health threats efficiently.

Author

Denisse Sandoval