Moderna’s mRNA vaccine for influenza prevention has passed a US Food and Drug Administration (FDA) Advisory Committee (AdCom) meeting, meaning the company has successfully navigated a volatile backdrop with the modality in the US.
The FDA panel of experts discussed the benefits of the vaccine, known as mRNA-1010 or mFlusiva, in preventing the disease in two age groups.
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The Vaccines and Related Biological Products Advisory Committee (VRBPAC) determined unanimously that the benefits of mRNA-1010 outweigh its risks. Both votes – for use in adults 50 to 64 years of age and in adults 65 years of age and older – ended 9-0 in favour of Moderna’s candidate.
Shares in Moderna rose 3.5% to $63.96 at market open on 18 June following the vote, up from a market close of $61.80.
The panel will now pass their findings to the FDA’s review team. While the agency is not beholden to the outcome of AdComs, it often follows their recommendation. Moderna has received a US FDA Prescription Drug User Fee Act (PDUFA) goal date of 5 August 2026.
In a research note, Citi analysts said: “We view the unanimous 9-0 VRBPAC yes votes for Moderna’s mRNA-1010 as a clear positive and meaningful de-risking event into the PDUFA. Indeed, Moderna shares are up following the vote, reflecting improved approval confidence.”
During the session, Moderna highlighted data from mRNA-1010’s Phase III clinical programme. In results from the pivotal trial (NCT06602024) first reported in June 2025, mRNA-1010 achieved a 26.6% higher relative effectiveness compared to a licensed standard-dose seasonal influenza vaccine.
Moderna’s CEO Stéphane Bancel stated: “We appreciate the thoughtful review by the members of VRBPAC and their recognition of the clinical evidence supporting mRNA-1010. Influenza continues to cause substantial illness and hospitalisations among older adults each year. We believe mRNA-1010 has the potential to provide an important new option for seasonal flu prevention and further demonstrate the versatility of our mRNA platform. We look forward to continuing to work with the FDA as it completes its review.”
Moderna’s mRNA prospects rise
The positive vote marks a turnaround for Moderna’s prospects in the US vaccine sector, after mRNA-1010 was embroiled in regulatory controversy earlier in the year. In February, the FDA refused to accept Moderna’s application for review – in a letter, the agency highlighted the lack of a properly conducted study.
The move was surprising at the time, given that Moderna’s investigational vaccine uses the same underlying mRNA technology as its marketed Covid-19 jab Spikevax, which the FDA approved in 2022. It became the highest-profile regulatory shunning of an mRNA-based product since the modality came under the political spotlight under the Trump administration.
In August, RFK Jr cut $500m worth of mRNA vaccine research funding, impacting around 22 projects being run at the Biomedical Advanced Research and Development Authority (BARDA). Knock-on effects were also felt in the cancer mRNA vaccine space, as per experts interviewed by Pharmaceutical Technology.
Moderna is targeting approvals of new infectious disease vaccines as it rebuilds its commercial footprint in a post-pandemic sector. According to William Blair analysts, the AdCom meeting should have a positive read-through to Moderna’s dual flu/Covid vaccine (mCombriax). which uses mRNA components of mRNA-1010 and mNexspike. In May 2025, Moderna voluntarily withdrew its US application for the combo shot after a consultation with the FDA.
William Blair analysts commented: “While sentiment surrounding Moderna’s vaccine franchise begins to regain positivity and momentum swells for upcoming pivotal data from its oncology franchise, we remain hesitant on Moderna’s vaccine growth trajectory given recent FDA headwinds on mCombriax.”
