$176 Million Awarded for Another Pandemic Influenza Vaccine

In the past two years, H5 influenza virus subtypes have caused severe disease in birds and mammals in the United States. Because of various media reports, there is concern about the risk of these viruses spreading to humans, which could generate another pandemic.

On June 27, 2024, the U.S. Centers for Disease Control and Prevention (CDC) confirmed that the risk to people is very low. However, the U.S. government continues its multi-year effort to prepare for this risk.

Moderna, Inc. today announced a project award of $176 million to accelerate the development of mRNA-based pandemic influenza vaccines. The award program is within the U.S. Department of Health and Human Services (HHS).

The project award will support the late-stage development of an mRNA-based vaccine to enable the licensure of a pre-pandemic vaccine against the H5 influenza virus.

This new HHS agreement also includes additional options to prepare and accelerate responses to future public health threats.

"mRNA vaccine technology offers advantages in efficacy, speed of development, and production scalability and reliability in addressing infectious disease outbreaks, as demonstrated during the COVID-19 pandemic," said Stéphane Bancel, Chief Executive Officer of Moderna, in a press release on July 2, 2024.

In July 2023, Moderna initiated a Phase 1/2 study to generate safety and immunogenicity data for the investigational pandemic influenza vaccine (mRNA-1018) in healthy adults. The study includes vaccine candidates against H5 and H7 avian influenza viruses.

Results from the study are expected in 2024 and will inform Phase 3 development plans.

Currently, there are U.S. FDA-approved pandemic vaccines (Audenz) and various development initiatives underway, funded by the U.S. government. 

Furthermore, the CDC has confirmed annual flu shots may not be effective against these influenza subtypes.