CHMP Backs EU Approval of MRNA's New COVID-19 Vaccine mNexspike

Moderna MRNA announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the EU approval of mNexspike (mRNA-1283). This is MRNA’s next-generation refrigerator-stable COVID vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 years and older.

A final decision from the European Commission is expected shortly. Subject to this approval, Moderna plans to make mNexspike available across Europe in line with regulatory timelines and local market access pathways.

mNexspike marks MRNA’s third product to receive a positive CHMP opinion, joining Spikevax (mRNA-1273), Moderna’s original COVID-19 vaccine, and mResvia (mRNA-1345), the company’s approved respiratory syncytial virus vaccine. Spikevax is approved/authorized for use in the EU in individuals aged six months and older.

How Effective is MRNA’s New COVID-19 Jab?

CHMP’s positive opinion for mNexspike is supported by data from a randomized phase III study involving approximately 11,400 patients aged 12 years and older. The study met its primary objective by demonstrating non-inferior vaccine efficacy against COVID-19 starting 14 days post-vaccination compared to Spikevax. Participants received either a 10 μg dose of mNexspike or a 50 μg dose of Spikevax, with the former delivering a 9.3% higher relative vaccine efficacy (rVE) in the overall study population and a 13.5% higher rVE in a descriptive subgroup analysis of adults aged 65 and older.

From a safety standpoint, mNexspike showed a profile comparable to Spikevax, with fewer local reactions and similar rates of systemic adverse events. The most reported side effects included injection-site pain, fatigue, headache, and myalgia, reinforcing a well-characterized tolerability profile supportive of broad use.

In the past year, Moderna shares have lost 26.6% against the industry’s 11.6% growth.

CHMP’s positive opinion for mNexspike underscores Moderna’s strategy to expand its next-generation vaccine portfolio and address unmet needs among high-risk populations, particularly older adults who remain vulnerable to severe COVID-19 outcomes. If approved, the vaccine could support Moderna’s growth outlook by strengthening its respiratory franchise and contributing incremental revenues in the EU beginning in 2026-2027 through a new product launch and broader geographic penetration.

COVID-19 continues to circulate year-round across the EU, with periodic surges linked to waning immunity and the emergence of Omicron-lineage variants, reinforcing its status as an endemic respiratory disease. This persistent backdrop supports ongoing demand for updated vaccines, particularly those designed to protect elderly and other at-risk populations.

MRNA’s New COVID-19 Jab Already Approved in the US

We remind investors that in June 2025, Moderna announced FDA approval for mNexspike, although for a label narrower than initially targeted.

mNexspike is approved in the United States for older adults aged 65 and for individuals aged 12-64 with at least one underlying condition that puts them at high risk for severe COVID-19. Moderna had originally sought broader approval for use in individuals aged 12 and older, regardless of health status.

Per Moderna, mNexspike offers improved shelf life and storage benefits — key advantages for broad U.S. distribution, especially in areas with limited cold-chain infrastructure. MRNA has also submitted regulatory applications for mNexspike seeking its approval across multiple other global markets.

Moderna, Inc. Price and Consensus

Moderna, Inc. price-consensus-chart | Moderna, Inc. Quote

MRNA’s Zacks Rank & Stocks to Consider

Moderna currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are ANI Pharmaceuticals ANIP, CorMedix CRMD and Castle Biosciences CSTL, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share (EPS) have increased from $7.29 to $7.54. Over the same period, EPS estimates for 2026 have surged from $7.79 to $8.15. Shares of ANIP have surged 46% in the past year.

ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 21.24%.

Over the past 60 days, estimates for CorMedix’s 2025 EPS have increased from $1.85 to $2.87, while 2026 EPS estimates have risen from $2.49 to $2.88 over the same period. Shares of CRMD surged 32.7% over the past year.

CorMedix’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 27.04%.

Over the past 60 days, the loss estimate for Castle Biosciences has narrowed from 65 cents to 34 cents in 2025. Over the same period, loss estimates for 2026 have improved from $2.10 to $1.06. CSTL stock has rallied 38.2% over the past year.

Castle Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining quarter, with the average surprise being 66.11%.

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