Moderna Awarded $590 Million for Bird Flu Vaccine Development

bird flu © Berit Kessler - stock.adobe.com

The Department of Health and Human Services (HHS) will award roughly $590 million to Moderna to accelerate the development of mRNA-based pandemic influenza vaccines, including vaccines for avian flu strains, to ensure the United States is better prepared for future potential pandemics, according to a recent HHS news release.

The two main avian influenza strains of interest are the H5N1 strain and the H7N9 strain. Symptoms of avian influenza in humans include conjunctivitis, fever and cough.

The H5N1 strain, commonly found in wild birds, is an area of interest for Moderna because of the recent outbreaks in poultry and dairy cows in the United States. Since 2022, there have been 67 confirmed cases of human transmission and one death, with 66 of these cases diagnosed in 2024, according to the Centers for Disease Control and Prevention (CDC). There have been no confirmed cases of human-to-human spread and although public health risk remains low, the CDC issued an alert last week urging hospitals to test and subtype all influenza A virus-positive specimens from hospitalized patients on an accelerated basis.

In 2023, Moderna initiated a phase 1/2 study to generate safety and immunogenicity data of an investigational pandemic influenza vaccine (mRNA-1018) in healthy adults aged 18 years and older. The study included vaccine candidates against H5 and H7 avian influenza viruses. Based on the positive preliminary data from the phase 1/2 study, Moderna is preparing to advance mRNA-1018 into phase 3.

The results of the phase 1/2 trial will be shared at an upcoming scientific meeting, according to a Moderna news release. If successful, this vaccine could become the first licensed for this strain. H7N9 was first reported in China in 2013.

The vaccine being studied uses Modern's mRNA technology, which was used to develop its COVID-19 and RSV vaccines. mRNA vaccines do not contain viruses or any part of them. Instead, they deliver mRNA that instructs the cells to make certain proteins that activate the immune system.

The company also is using the mRNA technology to develop therapies for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases.

“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,” former HHS Secretary Xavier Becerra said in the news release. “Accelerating the development of new vaccines will allow us to stay ahead and ensure that Americans have the tools they need to stay safe.”

Moderna will also use this award to fund the design and development of up to four additional pandemic influenza vaccines. Safety and efficacy will be tested in phase 1 studies.

The award was made possible through the Rapid Response Partnership Vehicle Consortium with funding provided by the Biomedical Advanced Research and Development Authority, which is part of the HHS Administration for Strategic Preparedness and Response.