Moderna Secures $590M for Bird Flu Vaccine, Bolstering Pandemic Preparedness

Moderna, the biotechnology company behind the successful COVID-19 vaccine, has received a significant boost in funding from the U.S. Department of Health and Human Services (HHS). The $590 million award will support the development of an mRNA-based bird flu vaccine, further strengthening the company's position in the global vaccine market and enhancing its mRNA platform capabilities.

The funding, made through the Rapid Response Partnership Vehicle (RRPV) Consortium with support from the Biomedical Advanced Research and Development Authority (BARDA), will enable Moderna to accelerate the development of an H5N1 mRNA influenza vaccine that is well matched to strains currently circulating in cows and birds. This investment aligns with the Biden-Harris Administration's and HHS's top priority of staying ahead of emerging infectious diseases and ensuring Americans have the tools they need to stay safe.

"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."

Moderna's influenza vaccine candidate uses conventional mRNA technology that was leveraged successfully during the COVID-19 response, resulting in one of the first two FDA-authorized and ultimately FDA-licensed COVID-19 vaccines. The company's mRNA platform has demonstrated its flexibility and ease of antigen design, enabling it to enter development for a wide range of viruses, as well as various bacteria and parasites.

In addition to the H5N1 vaccine, the funding will support the expansion of clinical studies for up to five additional subtypes of pandemic influenza. This approach takes advantage of the versatility of Moderna's mRNA platform, leveraging an existing manufacturing platform capability to support product development across multiple health threats.

The RRPV is a 10-year, multi-purpose acquisition vehicle and consortium partnership designed to support advanced research and development of medical countermeasures, such as vaccines, therapeutics, and diagnostics. The consortium leverages BARDA's authority to create flexible, strategic partnerships between government and industry that foster innovation and promote collaboration. BARDA is also providing funding to the RRPV for development of additional mRNA platform capacities.

Moderna's influenza vaccine pipeline is advancing rapidly, with the Company announcing the completion of RSV BLA filing (mRNA-1345), completion of adult enrollment in the Phase 3 trial of mRNA-1647, a first-in-class vaccine against CMV, and the Phase 3 trial of mRNA-1283, a next-generation COVID-19 vaccine. With its partner Merck, the Company plans to begin a second Phase 3 trial of mRNA-4157, its individualized neoantigen therapy (INT), in combination with Keytruda®, for non-small cell lung cancer later this year; updated efficacy follow-up from the ongoing Phase 2 study in adjuvant melanoma expected in Q4.

Moderna's respiratory franchise, now a seasonal business with an annual recurring revenue stream, is targeting an approximately $30 billion annual market, comprised of an approximately $15 billion COVID-19 market, a $10 billion RSV market, and a $6 billion flu market, with the potential for growth with more effective vaccines. Respiratory products sales in 2027 are expected to be in the range of $8 billion to $15 billion, depending on vaccination rates, efficacy, and Company market share.

The investment in Moderna's mRNA-based bird flu vaccine aligns with the Biden administration's pandemic preparedness strategy, focusing on accelerating vaccine development, expanding clinical data, complementing existing technology, and preparing for future pandemics. This funding will enable the company to stay ahead of emerging infectious diseases and ensure that Americans have the tools they need to stay safe.