Moderna Inc. (NASDAQ: MRNA) is advancing its respiratory vaccine portfolio, with regulatory submissions underway for its seasonal influenza vaccine candidate, mRNA-1010, impacting market sentiment.
Moderna Updates on Flu Vaccine
Following the announcements, Moderna’s stock experienced a slight uptick, with shares currently trading at $30.86, a 0.05% increase, or $1.38, from the previous close as of January 5, 2026.
The pharmaceutical company has filed for marketing authorization of mRNA-1010 with the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), Health Canada, and the Therapeutic Goods Administration (TGA) in Australia, targeting adults aged 50 and older. This move follows positive Phase 3 efficacy results where mRNA-1010 demonstrated a relative vaccine efficacy of 26.6% compared to a licensed standard-dose seasonal influenza vaccine in the same age group.
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“We are proud to announce these filings for the use of our seasonal flu vaccine candidate, a major milestone for our respiratory portfolio,” stated Stéphane Bancel, Chief Executive Officer of Moderna. He further emphasized the potential of mRNA technology to more closely match evolving influenza strains, offering a more effective response to the persistent respiratory threat.
However, Moderna also voluntarily withdrew its Biologics License Application (BLA) for mRNA-1083, a combination flu and COVID-19 vaccine, following discussions with the FDA. The company intends to resubmit the BLA once efficacy data from the ongoing Phase 3 trial of mRNA-1010 becomes available.
In more positive news, the FDA approved Moderna’s next-generation COVID-19 vaccine, mRNA-1283, now marketed as mNEXSPIKE, for adults aged 65 and older and individuals aged 12 to 64 with risk factors for severe COVID-19 outcomes. This vaccine demonstrated improved performance over its predecessor, Spikevax, with a reduced dosage in Phase 3 trials.
Moderna has also been strategically adjusting its development pipeline, halting four programs to focus resources on high-priority areas, including its oncology pipeline in collaboration with Merck. The company aims to complete submissions for mRNA-1010 approval in multiple regions by January 2026.
The markets are reacting to a mix of positive and negative signals. The successful regulatory submissions and approval of mNEXSPIKE are viewed favorably, while the withdrawal of the mRNA-1083 application introduces uncertainty.
