Key insights
- Moderna initiated a Phase 3 trial for its H5 bird flu vaccine (mRNA-1018) in the US and UK. CEPI is supporting the advancement of the vaccine. Moderna's stock has surged 116% over the past year. Successful data from the trial could positively impact investor confidence in Moderna's pipeline and potentially boost the stock further.
CAMBRIDGE, Mass. - Moderna (NASDAQ:MRNA) has dosed the first participants in a Phase 3 clinical trial of its investigational H5 pandemic influenza vaccine, mRNA-1018, according to a company statement released today.
The trial will enroll approximately 4,000 healthy adults aged 18 years and older in the U.S. and UK to evaluate the safety and immunogenicity of the mRNA-based vaccine candidate.
The Coalition for Epidemic Preparedness Innovations (CEPI) announced in December 2025 that it will invest up to $54.3 million to support the advancement of mRNA-1018 toward licensure.
"H5 influenza, or bird flu, remains a pandemic threat. The start of our Phase 3 trial for an H5 influenza vaccine marks a significant milestone in our ongoing efforts to strengthen global pandemic preparedness," said Stéphane Bancel, Chief Executive Officer of Moderna.The vaccine development comes as Moderna’s stock has surged 116% over the past year, trading at $54.23 with a market capitalization of $21.4 billion. According to InvestingPro analysis, the stock currently appears overvalued relative to its Fair Value, though investors have shown strong confidence in the company’s pipeline. InvestingPro offers access to over 10 additional exclusive tips and comprehensive financial metrics for MRNA subscribers.
If successful, regulatory submissions for mRNA-1018 will be supported by data from Moderna’s seasonal influenza vaccine candidate, mRNA-1010, which has been accepted for review in the U.S., the European Union, Canada and Australia.
Dr. Richard Pebody, Director of Epidemic and Emerging Infections at the UK Health Security Agency, stated that while the current risk to humans from avian influenza remains low, the virus continues to evolve and spread in birds and various animal hosts.
Under its agreement with CEPI, Moderna has committed to allocate 20% of its H5 pandemic vaccine manufacturing capacity for supply to low- and middle-income countries at affordable pricing in the event the vaccine is licensed and an influenza pandemic occurs.For deeper insights into Moderna’s financial health and growth prospects, investors can access the comprehensive Pro Research Report, available for MRNA and 1,400+ other US equities.
The information in this article is based on a press release statement from Moderna.
In other recent news, Moderna Inc. announced that the European Commission has granted marketing authorization for its combination vaccine, mCOMBRIAX, aimed at preventing influenza and COVID-19 in individuals aged 50 and older. This authorization is applicable across all 27 European Union member states, as well as Iceland, Liechtenstein, and Norway. Additionally, Moderna reported promising results from a Phase 1/2 study of its investigational cancer therapy, mRNA-4359. The therapy, when combined with pembrolizumab, showed an 83% overall response rate in patients with advanced melanoma.
In a significant legal development, Moderna has reached a settlement agreement with Arbutus Biopharma Corporation and Genevant Sciences GmbH, resolving patent litigation related to its infectious disease vaccines. Moderna will pay a lump sum of $950 million by July 2026, with no future royalties owed. Furthermore, Moderna has also agreed to a separate settlement of up to $2.25 billion with Genevant Sciences and Arbutus Biopharma to address a patent dispute concerning its COVID vaccine. These settlements conclude all related U.S. and international legal actions against Moderna.
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