Moderna Receives European Commission Marketing Authorization for COVID-19 Vaccine mNEXSPIKE

Rhea-AI Summary

Moderna (NASDAQ:MRNA) announced the European Commission granted marketing authorization for mNEXSPIKE (mRNA-1283) for active immunization against COVID-19 in individuals aged 12 and older.

The authorization covers all 27 EU member states plus Iceland, Liechtenstein and Norway. A Phase 3 trial (~11,400 participants) showed mNEXSPIKE had 9.3% higher relative efficacy versus Spikevax and 13.5% higher in adults 65+. Safety was similar with fewer local reactions. Moderna expects to make mNEXSPIKE available in Europe pending regulatory timelines and local access pathways.

Positive

• EU marketing authorization valid across 27 EU states plus Iceland, Liechtenstein, Norway
• Phase 3 trial enrolled ~11,400 participants aged 12+
• 9.3% higher relative vaccine efficacy vs Spikevax (overall)
• 13.5% higher relative vaccine efficacy in adults 65+
• Safety profile similar to Spikevax with fewer local reactions
• Prior approvals in US, Canada, Australia support global rollout

Negative

• None.

Key Figures

Phase 3 enrollment: ≈11,400 participants Age indication: 12 years and older mNEXSPIKE dose: 10 μg +5 more

8 metrics

Phase 3 enrollment ≈11,400 participants Randomized Phase 3 trial for mNEXSPIKE, ages 12+

Age indication 12 years and older Authorized population for mNEXSPIKE in EU/EEA

mNEXSPIKE dose 10 μg Dose used in Phase 3 trial arm

Spikevax dose 50 μg Comparator dose in Phase 3 trial

Relative efficacy (12+) 9.3% higher mNEXSPIKE vs Spikevax, ages 12 and older

Relative efficacy (65+) 13.5% higher Descriptive subgroup, adults 65 years and older

EU Member States 27 states Validity of EU marketing authorization plus EEA countries

Adverse reactions Injection pain, fatigue, headache, myalgia Most common solicited reactions in Phase 3

Market Reality Check

Price: $42.23 Vol: Volume 16,329,744 is 21% ...

normal vol

$42.23 Last Close

Volume Volume 16,329,744 is 21% above the 20-day average of 13,532,705. normal

Technical Trading above 200-day MA at 29.35 with price at 42.23.

Peers on Argus

MRNA gained 5.29% on EU approval while key peers were mixed; HALO rose modestly ...

2 Up

MRNA gained 5.29% on EU approval while key peers were mixed; HALO rose modestly and other biotech peers showed small moves, indicating a stock-specific reaction rather than a broad sector swing.

Previous Covid-19 Reports

5 past events · Latest: Dec 15 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 15	CHMP positive opinion	Positive	+1.6%	CHMP backed EU authorization for mNEXSPIKE in ages 12 and older.
Sep 16	Vaccine data update	Positive	+4.0%	Positive Spikevax LP.8.1 immunogenicity data with strong antibody increases.
Aug 22	Canada approval	Positive	+3.4%	Health Canada approved updated Spikevax targeting LP.8.1, ages 6 months+.
Jul 30	EC LP.8.1 approval	Positive	-8.1%	EC approved updated Spikevax LP.8.1 across EU and associated states.
Jul 25	CHMP LP.8.1 opinion	Positive	+0.4%	CHMP recommended EU authorization for updated Spikevax LP.8.1 vaccine.

Pattern Detected

COVID-19 regulatory and approval updates have usually led to modest positive moves, with one notable negative reaction on an EC approval.

Recent Company History

Recent COVID-19 updates for Moderna show a pattern of incremental regulatory progress and product optimization. The CHMP positive opinion on mNEXSPIKE in Dec 2025 and multiple LP.8.1 variant approvals in Europe and Canada were generally followed by small-to-moderate stock gains, except for an EC approval in Jul 2025 that coincided with an -8.06% move. Today’s full EC marketing authorization for mNEXSPIKE extends this trajectory from recommendation to formal approval in Europe.

Historical Comparison

+0.3% avg move · Past COVID-19 headlines moved MRNA by an average of 0.27%, so today’s 5.29% gain on EC approval is n...

covid-19

+0.3%

Average Historical Move covid-19

Past COVID-19 headlines moved MRNA by an average of 0.27%, so today’s 5.29% gain on EC approval is notably stronger than prior same-tag reactions.

The news reflects progression from a CHMP positive opinion on mNEXSPIKE to full European Commission marketing authorization, extending Moderna’s COVID-19 franchise in Europe.

Market Pulse Summary

This announcement grants European Commission marketing authorization for mNEXSPIKE, Moderna’s third ...

Analysis

This announcement grants European Commission marketing authorization for mNEXSPIKE, Moderna’s third respiratory vaccine in Europe, based on a Phase 3 trial of about 11,400 participants showing higher relative efficacy versus Spikevax and a comparable safety profile. In context of earlier CHMP opinions and multiple global COVID-19 approvals, it extends the company’s respiratory franchise. Investors may watch uptake across 27 EU member states and EEA countries, plus future variant-specific updates and post-marketing safety data.

Key Terms

marketing authorization, phase 3 clinical trial, randomized, observer-blind, +4 more

8 terms

marketing authorization regulatory

"the European Commission (EC) has granted marketing authorization for 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

"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

"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

"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.

non-inferior medical

"primary efficacy objective of the study was to demonstrate non-inferior vaccine efficacy"

Non-inferior describes a result from a clinical or comparative test showing a new product, treatment, or approach is not meaningfully worse than an existing standard by more than an agreed-upon, acceptable difference. Think of it like proving a new car model performs at least close enough to the old one on key measures so consumers won’t lose out. Investors care because non-inferiority outcomes can clear regulatory or market hurdles and preserve commercial potential without needing to beat the incumbent.

relative vaccine efficacy medical

"mNEXSPIKE showed a 9.3% higher relative vaccine efficacy compared to Spikevax"

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.

adverse reactions medical

"The most commonly solicited adverse reactions were injection pain, fatigue, headache"

Adverse reactions are harmful or unintended effects people experience after using a medicine, vaccine, medical device, or treatment; think of them as unexpected problems that show up when a product is used as intended. Investors care because these reactions can trigger regulatory warnings, safety reviews, recalls, reduced sales, or legal costs—similar to how widespread product defects can damage a company’s reputation and future earnings.

myalgia medical

"The most commonly solicited adverse reactions were injection pain, fatigue, headache and myalgia."

Myalgia is the medical term for muscle pain or soreness, ranging from mild achiness to more severe, sharp discomfort, similar to the sensation after an intense workout or a pulled muscle. For investors, reports of myalgia matter because they can appear as side effects in clinical trials or post-market safety reports, affecting a drug’s perceived safety, regulatory review, labeling, and ultimately commercial prospects.

AI-generated analysis. Not financial advice.

mNEXSPIKE is the third Moderna vaccine authorized in the European Union, strengthening the Company's respiratory vaccine portfolio in Europe

CAMBRIDGE, MA / ACCESS Newswire / February 17, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that the European Commission (EC) has granted marketing authorization for 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.

This marketing authorization follows the positive opinion adopted by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) and marks Moderna's third product authorized in the European Union, alongside Spikevax® and mRESVIA®, further strengthening the Company's respiratory vaccine portfolio in Europe. The marketing authorization is valid in all 27 European Union Member States, as well as Iceland, Liechtenstein and Norway. Moderna expects to make mNEXSPIKE available in Europe pending regulatory timelines and local market access pathways.

"We welcome the European Commission's decision, which reflects the strength of the scientific data supporting mNEXSPIKE and our continued commitment to advancing innovative vaccines for populations most at risk," said Stéphane Bancel, Chief Executive Officer of Moderna. "COVID-19 has become an endemic respiratory disease, with older adults continuing to bear a disproportionate burden of severe outcomes. Europe represents a key region for respiratory vaccines, and we are pleased to have a new vaccine available to help protect Europeans when the EU COVID market reopens starting this year in some markets."

The EC decision is supported by results from a randomized, observer-blind, active-controlled Phase 3 clinical trial (EudraCT: 2023-000884-30; ClinicalTrials.gov: NCT05815498), which enrolled approximately 11,400 participants aged 12 years and older. The primary efficacy objective of the study was to demonstrate 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. In the trial, participants received either a 10 μg dose of mNEXSPIKE or a 50 μg dose of Spikevax. mNEXSPIKE showed a 9.3% higher relative vaccine efficacy compared to Spikevax in individuals aged 12 years and older, and in a descriptive subgroup analysis, a 13.5% higher relative vaccine efficacy in adults aged 65 years and older.

In the Phase 3 trial, mNEXSPIKE was found to have a similar safety profile to Spikevax, with fewer local reactions and comparable systemic reactions. The most commonly solicited adverse reactions were injection pain, fatigue, headache and myalgia.

Moderna has already received regulatory approval for mNEXSPIKE in the U.S., Canada and Australia, and continues to pursue approvals in additional markets worldwide.

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.

mNEXSPIKE^®, Spikevax® and mRESVIA® 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; the opportunity in the European respiratory vaccine market and Moderna's geographical expansion; the safety profile of mNEXSPIKE; and potential approvals in additional markets worldwide. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. 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, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, 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

What does the European Commission authorization mean for Moderna (MRNA) and mNEXSPIKE on February 17, 2026?

It permits marketing of mNEXSPIKE for ages 12+ across the EU and EEA countries. According to the company, authorization covers 27 EU member states, Iceland, Liechtenstein and Norway, enabling local market access steps and distribution pending national procedures.

How effective was mNEXSPIKE compared to Spikevax in Moderna's Phase 3 trial (MRNA)?

mNEXSPIKE showed a 9.3% higher relative vaccine efficacy versus Spikevax overall. According to the company, the randomized Phase 3 enrolled ~11,400 participants and a subgroup showed 13.5% higher efficacy in adults aged 65+.

What safety results did Moderna (MRNA) report for mNEXSPIKE in the Phase 3 study?

mNEXSPIKE had a similar safety profile to Spikevax with fewer local reactions. According to the company, common adverse reactions were injection pain, fatigue, headache and myalgia, and systemic reactions were comparable between vaccines.

When will mNEXSPIKE be available to European markets following the February 17, 2026 authorization?

Availability depends on regulatory timelines and local market access pathways in each country. According to the company, Moderna expects to make mNEXSPIKE available in Europe as national processes and procurement reopen this year in some markets.

What age groups are covered by the mNEXSPIKE EU authorization noted by Moderna (MRNA)?

The authorization covers individuals aged 12 years and older for active immunization against COVID-19. According to the company, the Phase 3 trial also included adults 65 and older, where efficacy gains were observed in that subgroup.

Has mNEXSPIKE received approvals in other countries besides the EU for Moderna (MRNA)?

Yes; mNEXSPIKE already has regulatory approval in the US, Canada and Australia. According to the company, Moderna continues to pursue approvals in additional markets worldwide to support broader access.