HQ Team
May 29, 2025: The US Department of Health and Human Services has terminated a contract awarded to Moderna Inc. for the late-stage development of a bird flu vaccine for humans.
The investigational vaccine, called mRNA-1018, was in the mid-stage trials for evaluating safety and immunogenicity in about 300 adults aged 18 and older.
Moderna had expected to advance the program to late-stage development with the US Department of Health and Human Services (HHS).
âModerna received notice that HHS will terminate the award for the late-stage development and the right to purchase pre-pandemic influenza vaccines,â according to a company statement.
âAdds uncertaintyâ
In January, the company was awarded $590 million by the Joe Biden administration to advance the development of its bird flu vaccine and support the expansion of clinical studies for up to five additional subtypes of pandemic influenza.
HHS had awarded $176 million last year to finish the late-stage testing of the vaccine against H5N1 avian influenza.
âWhile the termination of funding from HHS adds uncertainty, we are pleased by the robust immune response and safety profile observed in this interim analysis of the Phase 1/2 study of our H5 avian flu vaccine and we will explore alternative paths forward for the program,â said StĂ©phane Bancel, Chief Executive Officer of Moderna.
âThese clinical data in pandemic influenza underscore the critical role mRNA technology has played as a countermeasure to emerging health threats.â
âExplore alternativesâ
The Phase 1/2 study evaluated a two-dose regimen of Moderna’s investigational avian influenza vaccine.Â
The mRNA-1018 vaccine demonstrated a rapid, potent and durable immune response, according to the statement. The investigational vaccine was generally well-tolerated, with no dose-limiting tolerability concerns observed.Â
Moderna will explore alternatives for late-stage development and manufacturing of the H5 program consistent with the company’s strategic commitment to pandemic preparedness.
The companyâs total revenue for the full year ended 2024 was $3.2 billion compared to $6.8 billion in 2023.
Fall in Covid-19 vaccine sales
The decrease in total revenue was mainly due to lower sales of the company’s Covid-19 vaccine. Net product sales for 2024 were $3.1 billion, a decline of 53% from 2023.Â
The company had attributed the decline to the âtransition to a seasonal commercial market for Covid-19 vaccines, with significantly lower sales volumes in Europe and other international markets as advance purchase agreements phased out.â
In the US, product sales remained consistent year-over-year. Moderna commenced sales of its RSV vaccine during the third quarter of 2024, generating $25 million in revenue for the year.
