Moderna Announces Global Regulatory Submissions for Its Investigational Seasonal Influenza Vaccine

Rhea-AI Summary

Moderna (NASDAQ:MRNA) filed for marketing authorization of its investigational seasonal influenza vaccine mRNA-1010 with the FDA, EMA, Health Canada and the TGA in Australia for adults aged 50 and older on January 5, 2026.

Regulatory applications rely on positive Phase 3 data: in study P304 mRNA-1010 met a prespecified superiority criterion with a relative vaccine efficacy (rVE) of 26.6% (95% CI 16.7%–35.4%) across adults ≥50 and an rVE of 27.4% in participants ≥65. Prior study P303 showed superior seroconversion rates and GMRs versus high-dose and standard-dose licensed vaccines. Safety was described as favorable, with most solicited adverse reactions reported as mild.

Positive

• Filed marketing applications with FDA, EMA, Health Canada, TGA
• P304 met prespecified superiority with rVE 26.6% (95% CI 16.7%–35.4%)
• rVE 27.4% in participants aged 65 and older
• P303 showed superior seroconversion rates and GMRs versus licensed vaccines
• Reported favorable safety profile; majority of solicited adverse reactions were mild

Negative

• Regulatory submissions are pending; no approvals granted yet
• rVE 26.6% indicates moderate incremental efficacy versus comparator
• Efficacy confidence interval lower bound at 16.7% implies statistical uncertainty range

Key Figures

Relative vaccine efficacy 26.6% (95% CI: 16.7%, 35.4%) Phase 3 P304, adults ≥50 years

Relative vaccine efficacy 27.4% Subgroup, participants aged ≥65 years

Age group 50 years and older Target population for mRNA-1010 submissions

Age subgroup 65 years and older Subgroup in Phase 3 efficacy analysis

Phase Phase 3 Efficacy study P304 supporting submissions

Phase Phase 3 Study P303 showing superior seroconversion and GMR

Market Reality Check

$34.30 Last Close

Volume Volume 9,140,477 is slightly below 20-day average 10,282,080 (relative 0.89x). normal

Technical Price at $30.86, trading above 200-day MA at $27.39 and 36.92% below 52-week high.

Peers on Argus

MRNA gained 4.65%, outpacing peers like HALO (+3.81%) and MDGL (+2.04%). Momentum scanner shows no broad sector move, suggesting a stock-specific reaction to the influenza filing news.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 18	Pandemic flu funding	Positive	+1.4%	CEPI committed up to <b>$54.3M</b> for Phase 3 H5 influenza trial.
Dec 17	Conference appearance	Neutral	+2.1%	Scheduled presentation at the 44th J.P. Morgan Healthcare Conference.
Dec 15	COVID-19 CHMP opinion	Positive	+1.6%	EMA committee issued positive opinion for mNEXSPIKE (mRNA-1283) marketing authorization.
Nov 20	Analyst Day strategy	Positive	-7.5%	Outlined 2026 revenue growth targets and cost reductions with vaccine expansion plans.
Nov 20	Credit facility	Neutral	-7.5%	Announced up to <b>$1.5B</b> term loan facility with staged delayed draws.

Pattern Detected

Recent clinically and strategically positive news often saw modest gains, while broader strategy/financing updates coincided with notable single-day declines.

Recent Company History

Over the past few months, Moderna reported several milestones across its vaccine and pipeline strategy. A CEPI-funded Phase 3 trial for H5 pandemic influenza and an EMA positive opinion for a COVID-19 vaccine aligned with small positive price reactions. In contrast, Analyst Day strategy targets and a new credit facility coincided with -7.53% moves. Today’s seasonal flu regulatory submissions extend the respiratory franchise narrative, adding another late-stage vaccine seeking approvals across the U.S., EU, Canada and Australia.

Market Pulse Summary

This announcement details global regulatory submissions for Moderna’s investigational seasonal influenza vaccine mRNA-1010, supported by Phase 3 data showing 26.6% relative vaccine efficacy in adults aged 50+ and 27.4% in those 65+. It extends prior progress in respiratory vaccines and builds on earlier positive pandemic influenza and COVID-19 updates. Investors may focus on eventual approval decisions, real‑world effectiveness, safety profile, and how this product could contribute to Moderna’s longer‑term growth plans.

Key Terms

relative vaccine efficacy medical

"mRNA-1010 achieved the most stringent superiority criterion... with a relative vaccine efficacy (rVE) of 26.6%"

Relative vaccine efficacy measures how much better one vaccine prevents illness compared with another vaccine or a different standard, expressed as a percentage change in risk. Think of it like comparing two umbrellas by how much more rain one keeps off you than the other; investors watch this metric because higher relative efficacy can drive stronger demand, pricing power, regulatory favor and longer-term revenue, while lower efficacy can hurt market share and valuation.

seroconversion medical

"mRNA-1010 had demonstrated superior seroconversion rates and geometric mean titer ratios"

Seroconversion is the change from having no detectable antibodies in the blood to having measurable antibodies after an infection or vaccination, like a light switching on that shows the immune system has noticed a germ or a vaccine. For investors, it matters because seroconversion rates are used as clear, measurable outcomes in clinical trials and public health studies; higher or faster seroconversion can signal stronger protection, influence regulatory decisions, and affect a company’s commercial prospects.

geometric mean titer ratios medical

"demonstrated superior seroconversion rates and geometric mean titer ratios (GMR) against all strains"

The geometric mean titer ratio is the comparison of average antibody levels between two groups, calculated using the geometric mean because antibody measurements are skewed and multiplicative rather than additive. It tells you how many times higher (or lower) the typical immune response is in one group versus another, much like comparing average growth rates rather than simple averages, and helps investors assess relative clinical strength, potential market value, and regulatory prospects of vaccines or treatments.

phase 3 medical

"The regulatory applications are based on positive data from multiple Phase 3 studies."

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

solicited adverse reactions medical

"The majority of solicited adverse reactions (SARs) have been mild."

Adverse reactions that trial participants are specifically asked about and tracked on a checklist or diary during a defined period after treatment, such as soreness at an injection site or fever. Like a restaurant asking patrons to rate certain menu items, solicited adverse reactions capture expected, short-term side effects in a standardized way so investors can compare how tolerable a product is, which influences regulatory review, market acceptance and risk assessment.

AI-generated analysis. Not financial advice.

Moderna has filed for marketing authorization in the U.S., EU, Canada and Australia for mRNA-1010

CAMBRIDGE, MA / ACCESS Newswire / January 5, 2026 / Moderna, Inc. (NASDAQ:MRNA) today provided an update on regulatory submissions for its investigational seasonal influenza vaccine, mRNA-1010, for adults aged 50 years and older. The Company has filed for marketing authorization with the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), Health Canada, and the Therapeutic Goods Administration (TGA) in Australia.

"We are proud to announce these filings for the use of our seasonal flu vaccine candidate, a major milestone for our respiratory portfolio," said Stéphane Bancel, Chief Executive Officer of Moderna. "The issue of vaccine mismatch due to virus mutations has long worried influenza experts and, as we have seen this flu season, can lead to a heightened public health burden. The agility and flexibility of mRNA technology offer the potential to more closely match evolving strains and more effectively respond to one of the world's most persistent respiratory threats. If approved, this potential new product launch and geographic expansion represent an important opportunity to support Moderna's continued growth in 2027 and beyond."

The regulatory applications are based on positive data from multiple Phase 3 studies. In a Phase 3 efficacy study (P304), mRNA-1010 achieved the most stringent superiority criterion prespecified in the protocol, with a relative vaccine efficacy (rVE) of 26.6% (95% CI; 16.7%, 35.4%) across all adults aged 50 years and older. Subgroup analyses confirmed a consistently strong rVE point estimate across age groups, risk factors and previous influenza vaccination status. In participants aged 65 years and older, mRNA-1010 demonstrated an rVE of 27.4%. In a previous Phase 3 study (P303), mRNA-1010 had demonstrated superior seroconversion rates and geometric mean titer ratios (GMR) against all strains included in the vaccine compared to both high-dose and standard-dose licensed seasonal influenza vaccine.

mRNA-1010 has been found to be well tolerated with a favorable safety profile. The majority of solicited adverse reactions (SARs) have been mild. Injection site pain was the most common local SAR, and fatigue, headache and myalgia were the most common systemic SARs reported.

About Moderna

Moderna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna's mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more.

With a global team and a unique culture, driven by the company's values and mindsets, Moderna's mission is to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X, Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: Moderna's regulatory submissions; mRNA-1010's efficacy and safety; and the ability of mRNA technology to more closely match evolving strains and more effectively respond to respiratory threats. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and in subsequent filings made by Moderna with the U.S. Securities and Exchange Commission, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release.

Moderna Contacts

Media:
Chris Ridley
Head of Global Media Relations
+1 617-800-3651
Chris.Ridley@modernatx.com

Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.com

SOURCE: Moderna, Inc.

View the original press release on ACCESS Newswire

FAQ

Which agencies did Moderna (MRNA) file mRNA-1010 marketing applications with on January 5, 2026?

Moderna filed with the FDA, EMA, Health Canada and the TGA in Australia for adults aged 50 and older.

What Phase 3 results support Moderna's (MRNA) mRNA-1010 regulatory submissions?

Phase 3 P304 met prespecified superiority with rVE 26.6% (95% CI 16.7%–35.4%); P303 showed superior seroconversion rates and GMRs versus licensed vaccines.

What was mRNA-1010's reported efficacy in adults aged 65+ in Moderna's (MRNA) data?

In participants aged 65 and older, mRNA-1010 demonstrated a reported rVE of 27.4%.

What safety findings did Moderna (MRNA) report for mRNA-1010?

mRNA-1010 was reported to have a favorable safety profile; most solicited adverse reactions were mild, with injection site pain, fatigue, headache and myalgia common.

Does Moderna (MRNA) have regulatory approval for mRNA-1010 following the January 5, 2026 filings?

No; Moderna has submitted applications but approvals are pending from the respective regulators.