The Department of Health and Human Services (HHS) has axed a $590 million contract with Moderna, raising doubts about how the biotech will fund late-phase development of a pandemic bird flu vaccine.
Moderna won the contract at the back end of the Biden administration. The biotech took mRNA-1018, a mRNA vaccine candidate that encodes for hemagglutinin glycoproteins, into a phase 1/2 trial in 2023. In 2024, Moderna won a $176 million contract to develop mRNA-based pandemic influenza vaccines. The HHS expanded the agreement in January, providing $590 million to fund late-phase development.
But May 28, Moderna revealed the HHS has terminated the award for late-stage development and right to purchase pre-pandemic influenza vaccines. The company is now exploring alternatives for late-phase development and manufacturing of the bird flu vaccine.
The news comes three months after the HHS said it was reevaluating its contract with the U.S. Big Biotech, coming several weeks after Robert F. Kennedy Jr. was sworn in as chief of the department. RFK Jr. called COVID-19 shots, which overwhelmingly use mRNA, “the deadliest vaccine ever made” in 2021, and the nonprofit he founded tried to get the FDA to rescind approvals.
Moderna shared news of the contract termination alongside data from its phase 1/2 trial of mRNA-1018. At baseline, 2.1% of the 300 adults who took part in the trial had hemagglutination inhibition antibody titers above the threshold of protection. Three weeks after receiving the second of two doses, 97.8% of participants had antibody titers above the threshold.
The vaccine was generally well tolerated, Moderna said, with no dose-limiting tolerability concerns. Most solicited adverse reactions were mild, being classified in grade 1 or 2, and didn’t rise significantly between the first and second doses. Moderna plans to share more clinical data at an upcoming scientific meeting.
Previously, Moderna expected to move mRNA-1018 into late-phase development using the HHS funding. The company said it is now seeking alternatives consistent with its “strategic commitment to pandemic preparedness.”
The loss of the funding comes at a time when the biotech is cutting spending. Moderna reduced its R&D spending by 19% in the first quarter. At the same time, the company outlined plans to cut its operating expenses by up to $1.7 billion.