patrick.net

The U.S. government has handed Moderna almost $600 million to accelerate its work on various bird flu vaccines as well as work on mRNA vaccines for other influenza strains with pandemic potential.

The U.S. Department of Health and Human Services’ (HHS') Biomedical Advanced Research and Development Authority (BARDA) has been working with Moderna since 2023 to help develop mRNA vaccines that would be needed to stave off a potential flu pandemic, including from the avian influenza strain H5N1. Last year, the biopharma received $176 million as part of the same initiative.

Moderna is already making preparations to launch a phase 3 study of mRNA-1018, a vaccine against H5 and H7 avian influenza viruses. The mRNA-1018 vaccine has produced “positive preliminary data” in a phase 1/2 study, according to Moderna, which plans to unveil the findings at an upcoming medical conference.

The HHS said the fresh funding, announced Jan. 17, will allow Moderna “to accelerate development of an H5N1 mRNA influenza vaccine that is well matched to strains currently circulating in cows and birds and expands the clinical data supporting the use of mRNA vaccines that may be needed if other influenza strains emerge with pandemic potential.”

RELATED

BARDA hands Moderna $176M to push avian flu vaccine through trials
Moderna will also run a phase 3 trial of a vaccine against H7N9, another strain of avian influenza.

Beyond that, the HHS is expecting Moderna to design up to four new flu vaccines that can be put into phase 1 studies. The hope is that this initiative will “create the necessary background data to enable accelerated development of an mRNA vaccine targeted to various influenza virus subtypes of pandemic potential,” the government agency said in its release.

The funding comes from the BARDA’s Rapid Response Partnership Vehicle Consortium and was made in the twilight days of the Biden administration. It will likely come as welcome news to Moderna, which last week slashed its guidance and pledged to find $1 billion in cost cuts against a backdrop of unimpressive COVID-19 and respiratory syncytial virus vaccine sales.

“Avian flu variants have proven to be particularly unpredictable and dangerous to humans in the past,” outgoing HHS Secretary Xavier Becerra said in the release. “That is why this response has been a top priority for the Biden-Harris Administration and HHS. Accelerating the development of new vaccines will allow us to stay ahead and ensure that Americans have the tools they need to stay safe.”

There have been 67 confirmed cases of avian influenza in humans in the U.S., with one death linked to the virus, according to the Centers for Disease Control and Prevention. While the agency labels the current public health risk as “low,” it is “watching the situation carefully and working with states to monitor people with animal exposures.”

https://www.fiercebiotech.com/biotech/hhs-gives-moderna-590m-accelerate-bird-flu-vaccine-trials