EMA Committee for Medicinal Products for Human Use Adopts Positive Opinion Recommending Authorization of Moderna's mNEXSPIKE (COVID-19 Vaccine, mRNA)

Moderna (NASDAQ:MRNA) said the EMA's CHMP adopted a positive opinion recommending marketing authorization of mNEXSPIKE (mRNA-1283) for prevention of COVID-19 in individuals aged 12 years and older.

Rhea-AI Summary

Moderna (NASDAQ:MRNA) said the EMA's CHMP adopted a positive opinion recommending marketing authorization of mNEXSPIKE (mRNA-1283) for prevention of COVID-19 in individuals aged 12 years and older. The recommendation follows a Phase 3 trial of ~11,400 participants that reported a 9.3% higher relative vaccine efficacy versus mRNA-1273 and a 13.5% higher rVE in adults aged 65+. Safety was similar to mRNA-1273 with fewer local reactions. The European Commission will decide on authorization; if approved, Moderna expects to make mNEXSPIKE available in EU markets pending regulatory timelines and local access pathways. Moderna noted prior approvals from the U.S. FDA and Health Canada.

Positive

• CHMP positive opinion recommending EU marketing authorization
• Phase 3 trial enrolled ~11,400 participants
• 9.3% higher relative vaccine efficacy vs mRNA-1273 (overall)
• 13.5% higher rVE in adults aged 65+
• Existing approvals from FDA and Health Canada

Negative

• European Commission decision pending, authorization not final
• Label limited to individuals aged 12 years and older, not younger children
• Modest efficacy edge (9.3% rVE) vs comparator, not a large margin

Argus Dec 15 session

+1.56% close to close Open Argus

Details

News Market Reaction – MRNA

In the Dec 15 session, MRNA gained 1.56%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement underscores a major regulatory step for Moderna’s COVID-19 franchise, with a posit...

Analysis

This announcement underscores a major regulatory step for Moderna’s COVID-19 franchise, with a positive CHMP opinion for mNEXSPIKE based on a Phase 3 trial of about 11,400 participants and up to 13.5% higher relative vaccine efficacy in older adults. It adds to prior Spikevax updates and international approvals in 2025. Investors may track the European Commission’s decision, eventual uptake in individuals aged 12+, comparative safety versus mRNA‑1273, and how this product supports Moderna’s goal of expanding its respiratory vaccine portfolio and geographic diversification.

Key Figures

Phase 3 enrollment: ≈11,400 participants Age indication: 12 years and older mRNA-1283 dose: 10 μg +4 more

Phase 3 enrollment

≈11,400 participants

Randomized Phase 3 trial, age 12+

Age indication

12 years and older

Planned mNEXSPIKE use population

mRNA-1283 dose

10 μg

Single mNEXSPIKE dose in Phase 3 trial

Comparator dose

50 μg

mRNA-1273 (Spikevax) dose in Phase 3 trial

Relative efficacy (12+)

9.3% higher rVE

mRNA-1283 vs mRNA-1273 in individuals 12+

Relative efficacy (65+)

13.5% higher rVE

Descriptive subgroup, adults 65+

Onset window

14 days

Primary efficacy assessed from day 14 post-vaccination

Historical Context

5 past events · Latest: Nov 20

5 events

1. Nov 20

   Analyst Day strategy

   24h Move

   -7.5%

   Outlined 3-year growth, margin, cost, and oncology pipeline plans.

2. Nov 20

   Debt financing

   24h Move

   -7.5%

   Closed up to $1.5B non-dilutive term loan with staged draws.

3. Nov 19

   Manufacturing expansion

   24h Move

   -3.0%

   Onshoring drug product manufacturing with >$140M Norwood investment.

4. Nov 18

   Conference appearance

   24h Move

   +0.7%

   Scheduled presentation at major healthcare conference with webcast.

5. Nov 06

   Q3 earnings update

   24h Move

   +3.3%

   Reported $1.0B Q3 revenue, narrowed guidance, improved expense outlook.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

committee for medicinal products for human use, marketing authorization, phase 3 clinical trial, randomized, +4 more

8 terms

committee for medicinal products for human use regulatory

"the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted"

The Committee for Medicinal Products for Human Use is the expert scientific panel within the European medicines regulator that assesses whether medicines for people are safe, effective and of acceptable quality, and issues formal opinions used in the drug-approval process. Its assessments act like a gatekeeper or safety inspector for entering the European market, so the committee’s opinion can materially affect a drug’s commercial prospects, regulatory risk and a company’s stock valuation.

marketing authorization regulatory

"has adopted a positive opinion recommending marketing authorization of mNEXSPIKE"

An official government approval that allows a drug, vaccine, or medical device to be sold and promoted in a specific country or region. Think of it as a safety and effectiveness passport issued after regulators review the product’s tests and manufacturing; for investors, receiving this authorization typically unlocks sales, revenue potential, and lower regulatory risk, while delays or denials can substantially affect a company’s value and timeline.

phase 3 clinical trial medical

"supported by results from a randomized, observer-blind, active-controlled Phase 3 clinical trial"

A phase 3 clinical trial is a large-scale study that tests a new medical treatment or drug to determine if it is safe and effective for widespread use. It often involves hundreds or thousands of participants and compares the new treatment to existing options or a placebo. For investors, the results of this phase are crucial, as successful outcomes can lead to regulatory approval and commercial success, while failures may halt development.

randomized medical

"supported by results from a randomized, observer-blind, active-controlled Phase 3 clinical trial"

Randomized means participants or units in a study are assigned to different groups by chance rather than by choice, like flipping a coin to decide who gets a new treatment and who gets a comparison. For investors, randomized designs matter because they reduce bias and make results more trustworthy, so outcomes from randomized studies carry more weight when assessing regulatory approval, commercial prospects, and the risk that trial results will change a company’s valuation.

observer-blind medical

"supported by results from a randomized, observer-blind, active-controlled Phase 3 clinical trial"

Observer-blind describes a study setup where the people who evaluate results do not know which treatment each participant received, even if others involved might know. For investors, this matters because it reduces the chance that personal expectations or knowledge will skew measurements of effectiveness or safety, making reported outcomes more reliable—similar to a referee judging a game without knowing which team used a new piece of equipment.

active-controlled medical

"supported by results from a randomized, observer-blind, active-controlled Phase 3 clinical trial"

An active-controlled study is a trial in which the new treatment is compared against an existing, approved treatment instead of a placebo. For investors, this matters because results show how the new product stacks up against the current standard—like testing a new phone by comparing it to a popular model rather than to no phone—so positive results can indicate real competitive advantage and clearer market value.

relative vaccine efficacy medical

"mRNA-1283 showed a 9.3% higher relative vaccine efficacy (rVE) compared to mRNA-1273"

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.

systemic reactions medical

"with fewer local reactions and comparable systemic reactions"

Systemic reactions are side effects that affect the whole body rather than a single spot — for example fever, tiredness, dizziness or drops in blood pressure that involve multiple organs or systems. Think of it as a citywide power outage versus a single house light going out. For investors, they matter because frequent or severe systemic reactions can slow regulatory approvals, reduce patient use, raise liability risk and hurt a product’s commercial prospects.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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mNEXSPIKE is Moderna's third product to receive a positive CHMP opinion alongside Spikevax (COVID-19 Vaccine, mRNA) and mRESVIA (Respiratory Syncytial Virus Vaccine)

mNEXSPIKE will be available in the European Union, subject to authorization by the European Commission

CAMBRIDGE, MA / ACCESS Newswire / December 15, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization of mNEXSPIKE® (mRNA-1283), a new COVID vaccine, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 years and older. Following the CHMP's positive opinion, the European Commission will make a marketing authorization decision.

The CHMP's positive opinion for mNEXSPIKE reflects Moderna's continued commitment to advancing innovative vaccines that protect the most vulnerable," said Stéphane Bancel, Chief Executive Officer of Moderna. "Across Europe, adults aged 65 and older remain disproportionately affected by severe COVID outcomes, and if authorized, mNEXSPIKE will be another important tool in addressing this ongoing public health need. Europe represents a significant market for respiratory virus vaccines, and we are excited about the opportunity to drive sales growth in 2026 and 2027 through this potential new product launch and geographic diversification. I want to thank our teams for their exceptional work and the EMA for its thorough assessment."

Across Europe, COVID-19 continues to persist year-round, with periodic case increases driven by waning immunity and the emergence of new Omicron-lineage variants, as demonstrated through the European Centre for Disease Prevention and Control's (ECDC) respiratory virus surveillance system.^[1] These trends confirm that COVID-19 has become an established, endemic respiratory pathogen in the region, requiring targeted protection for vulnerable populations.

The CHMP's positive opinion for mNEXSPIKE is supported by results from a randomized, observer-blind, active-controlled Phase 3 clinical trial (ClinicalTrials.gov Identifier: NCT05815498), which enrolled approximately 11,400 participants aged 12 years and older. The primary efficacy objective in this study was to demonstrate the non-inferior vaccine efficacy against COVID-19 starting 14 days after mNEXSPIKE compared to that after the comparator vaccine, mRNA-1273 (Spikevax®), Moderna's original COVID-19 vaccine. Participants received either a 10 μg dose of mRNA-1283 or a 50 μg dose of mRNA-1273. mRNA-1283 showed a 9.3% higher relative vaccine efficacy (rVE) compared to mRNA-1273 in individuals aged 12 years and older, and in a descriptive sub-group analysis, a 13.5% higher rVE in adults aged 65 and older.

In the Phase 3 trial, mRNA-1283 was found to have a similar safety profile to mRNA-1273, with fewer local reactions and comparable systemic reactions. The most commonly solicited side effects were injection site pain, fatigue, headache and myalgia.

Subject to the European Commission's decision, Moderna expects to make mNEXSPIKE available in Europe pending regulatory timelines and local market access pathways. mNEXSPIKE is Moderna's third product to receive a positive CHMP opinion alongside Spikevax and mRESVIA®, the Company's approved respiratory syncytial virus (RSV) vaccine.

Moderna has filed mRNA-1283 for approval with regulators in multiple markets around the world, and has received approval from the U.S. Food and Drug Administration (FDA) and Health Canada.

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.

Spikevax®, mRESVIA® and mNEXSPIKE® are registered trademarks of Moderna.

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: the availability of mNEXSPIKE in Europe for the 2026-2027 season; the European Commission's pending marketing authorization decision; the opportunity in the European respiratory virus vaccine market; the ability of Moderna's COVID vaccines to generate an immune response and to protect against circulating COVID strains; and the safety profile of mNEXSPIKE. 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

^[1] https://www.ecdc.europa.eu/en/news-events/slow-increases-covid-19-observed-across-eueea-new-variant-emerges

SOURCE: Moderna, Inc.

View the original press release on ACCESS Newswire

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Moderna (MRNA) announce about mNEXSPIKE on December 15, 2025?

Moderna announced the EMA CHMP adopted a positive opinion recommending EU authorization of mNEXSPIKE (mRNA-1283) for ages 12+.

What were the Phase 3 results for mNEXSPIKE reported by Moderna (MRNA)?

The Phase 3 trial of ~11,400 participants showed a 9.3% higher relative vaccine efficacy vs mRNA-1273 and 13.5% higher rVE in adults 65+.

Is mNEXSPIKE (MRNA) fully authorized in the EU after the CHMP opinion?

No; the CHMP issued a positive opinion, and the European Commission must grant final authorization before EU availability.

What age groups would mNEXSPIKE cover if authorized in the EU (MRNA)?

The recommendation is for active immunization to prevent COVID-19 in individuals aged 12 years and older.

How does mNEXSPIKE's safety profile compare to Moderna's Spikevax (MRNA)?

In the Phase 3 trial, mRNA-1283 had a similar safety profile to mRNA-1273 with fewer local reactions and comparable systemic reactions.