Moderna’s H5 avian flu vaccine shows promise in early trial

CAMBRIDGE, MA - Moderna, Inc. (NASDAQ:MRNA), the $10 billion biotech company whose shares have declined over 37% year-to-date, has disclosed positive interim data from its Phase 1/2 study assessing the mRNA-1018 vaccine for H5 avian influenza, despite facing a setback with the U.S. Department of Health and Human Services (HHS) terminating funding for late-stage development.

The clinical trial, involving roughly 300 healthy adults, revealed a strong immune response and satisfactory safety profile for the vaccine candidate. Initial results indicated a 44.5-fold increase in hemagglutination inhibition (HAI) antibody titers, reaching protective levels in 97.8% of participants three weeks after the second dose. According to InvestingPro data, Moderna maintains a strong financial position with more cash than debt and a healthy current ratio of 4.22.

Despite the promising findings, Moderna received notice today that HHS will not continue supporting the vaccine’s late-stage development. CEO Stéphane Bancel stated, "While the termination of funding from HHS adds uncertainty, we are pleased by the robust immune response and safety profile observed in this interim analysis...and we will explore alternative paths forward for the program." Get deeper insights into Moderna’s financial health and 10+ additional exclusive ProTips with InvestingPro.

Moderna’s mRNA technology, which played a crucial role in developing one of the first COVID-19 vaccines, is also at the core of mRNA-1018. The company is committed to pandemic preparedness and will seek other avenues for the vaccine’s late-stage development and manufacturing.

The interim results are expected to be presented at a scientific meeting soon. This announcement is based on a press release statement from Moderna.

In other recent news, Moderna, Inc. has submitted an updated COVID-19 vaccine formula, Spikevax 2025-2026, to the U.S. Food and Drug Administration (FDA) for review. This new vaccine targets the SARS-CoV-2 variant LP.8.1, aligning with the FDA’s guidance for COVID-19 vaccines. In another development, Moderna has voluntarily withdrawn its application for its flu/COVID combination vaccine, mRNA-1083, after consulting with the FDA. The company plans to resubmit the application later in the year, incorporating new efficacy data from an ongoing trial. Brookline Capital Markets has maintained its Buy rating and $198 price target for Moderna, expressing confidence in the company’s timeline for the mRNA-1083 vaccine. The firm anticipates that the vaccine could launch in 2026, potentially generating $2.23 billion in sales by 2030. Meanwhile, the FDA has announced plans to require new clinical trials for COVID-19 boosters for healthy individuals under 65. This decision could impact the availability of vaccines from manufacturers like Moderna. Additionally, the Department of Health and Human Services is expected to announce changes to the CDC’s recommendations for routine COVID-19 vaccinations for children and pregnant women, potentially affecting Moderna’s vaccine distribution.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.